KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that the company has completed dosing subjects in a U.S. Phase 1 clinical trial of its third drug candidate, KB003. The study is a placebo-controlled, single-dose, dose-escalation Phase 1 trial in healthy volunteers, with safety and immunogenicity as primary endpoints.


KB003 is a Humaneered™ monoclonal antibody targeted to GM-CSF, and it shares the same epitope (target) and pharmacokinetic properties with KB002, its chimeric (mouse) precursor. They are part of a major development program that collectively includes five Phase 1 and Phase 2 proof-of-principle clinical trials for inflammation-related diseases, including persistent asthma and rheumatoid arthritis. Animal studies have suggested the drug candidate also has potential in multiple sclerosis, chronic obstructive pulmonary disease ("COPD"), psoriasis, and other indications.


"This antibody is another example of the power of Humaneering™ technology," said Geoffrey Yarranton, KaloBios' Chief Scientific Officer. "We believe that high affinity antibodies that are close to human germline will be preferred when choosing antibody treatments for chronic diseases in large patient populations. We are especially excited about the use of this antibody in future repeat-dose chronic clinical trials in humans."


"We now have the most comprehensive clinical research program in the world for targeting GM-CSF," said Tillman Pearce, KaloBios' Chief Medical Officer. "We have treated our last patient in our Phase 1/2 rheumatoid arthritis trial, are making great progress with our Phase 2 persistent asthma trials, and have other confidential clinical trials underway. We can now leverage the data that we obtain from these KB002 studies to guide our KB003 multiple-dose trials."


About KaloBios


KaloBios Pharmaceuticals, Inc., a U.S. based, private monoclonal company, uses its proprietary platform technology to develop first or best-in-class human antibody therapeutics. The company has multiple programs that are in five Phase 1/2 clinical trials: KB001 is an anti-infective for Pseudomonas aeruginosa infections being tested in cystic fibrosis and soon to be tested in intensive care patients on a ventilator, and KB002 and KB003 are being evaluated in inflammatory conditions such as rheumatoid arthritis and asthma. The company's Humaneering™ technology offers advantages over other methods of human antibody creation in terms of immunogenicity, potency, and manufacturing yields.

KaloBios

Preliminary results
were released from a late-stage clinical trial of Rituxan (rituximab)
for the treatment of lupus. The study did not meet its primary or secondary
endpoints of clinically reducing the severity of SLE (systemic lupus
erythematosus) in people with moderate disease.


The findings are initial results from a Phase II/III study conducted by
Genentech, Inc., known as the EXPLORER study. Rituxan is approved by the
U.S. Food and Drug Administration for the treatment of non-Hodgkin's
lymphoma, and was more recently approved, in combination with methotrexate,
to treat rheumatoid arthritis. More detailed findings from the trial are
expected to be presented at a medical conference this fall.



Following is a statement about the study results from Sandra C.
Raymond, President & CEO of the Lupus Foundation of America:



"Demonstrating the impact of a treatment in a lupus clinical trial can
be difficult, as lupus manifests itself differently in different people,
and can increase and decrease in severity from one day to another. So while
these new results are disappointing, they are not necessarily surprising.



"People with lupus have been waiting for a new treatment for nearly 45
years while suffering from this disabling and sometimes life-threatening
disease. But it's important to remember that there are a variety of
promising therapies in the near-term pipeline - including an ongoing study
of Rituxan for the treatment of lupus nephritis (kidney disease). That
study assesses Rituxan's potential in a focused subset of lupus patients
with a highly objective outcome. Thus, we remain optimistic that we are
coming ever closer to new and better treatments for lupus.



"Lupus patients have suffered without a new treatment for more than
four decades. For this reason, we are grateful to the companies that are
searching for new lupus treatments. The millions of people who battle lupus
with their families every day have waited long enough."



About Lupus



Lupus is the result of an unbalanced immune system that can become
destructive to any major organ or tissue in the body. Lupus is
unpredictable and potentially fatal, yet no satisfactory treatment or cure
exists. Its health consequences may include heart attacks, strokes,
seizures, or sudden organ failure. Current treatments are
immune-suppressing agents, which have toxic side effects, increasing risks
for infections and other bodily damage. The LFA estimates that more than
1.5 million Americans have some form of lupus.



Although lupus can strike any person at any age, nine of 10 people with
lupus are women of childbearing age (ages 15-45). Lupus is two to three
times more common among women of color, including African Americans,
Hispanics, Native Americans and Asians.



About the Lupus Foundation of America



The LFA is the nation's foremost nonprofit voluntary health
organization dedicated to finding the causes of and cure for lupus, and
providing support, services, and hope to all people affected by lupus. The
LFA and its network of nearly 300 chapters, branches, and support groups
conduct programs of research, education, and advocacy.


Lupus Foundation of America

http://www.lupus.org

Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing monoclonal antibodies for the treatment of cancer and
hepatitis C virus infection (HCV), announced that it has completed
enrollment in the first stage of its Phase II trial of bavituximab in
combination with chemotherapy in patients with advanced breast cancer. The
main objective of the safety and efficacy study is to assess the overall
response rate to the combination of bavituximab with docetaxel, a
chemotherapy drug commonly used to treat breast cancer.


"We are very pleased that patient enrollment in this trial has
proceeded quickly, reflecting the enthusiasm and efficiency of our clinical
colleagues in Europe and the level of patient interest in a potential new
therapy for this difficult disease," said Steven W. King, president and CEO
of Peregrine. "We look forward to providing an update on the trial as
patients continue to be dosed in the study and tumor response data is
generated."



As part of this trial's two-stage design, 15 patients with locally
advanced or metastatic breast cancer have been enrolled initially. The
primary objective of the multi-center, open-label study is to assess
overall tumor response rate to the combination of bavituximab with
docetaxel. The study may be expanded to include up to an additional 31
subjects if promising results are seen in the first 15 patients. Patients
enrolled in the trial will remain in the study until disease progression.



Secondary objectives of the Phase II study include measuring time to
tumor progression, duration of response, overall patient survival and
safety parameters. Patients may continue to receive bavituximab alone after
completion of chemotherapy as long as the cancer does not progress and side
effects are acceptable.



Tumor response in this study will be evaluated using Response
Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being
conducted in the Republic of Georgia according to International Conference
on Harmonization (ICH) and Good Clinical Practices (GCP) standards.



The National Cancer Institute estimates that approximately 178,480 U.S.
women were diagnosed with cancer of the breast in 2007 and about 40,460
women died of the disease. According to the World Health Organization,
breast cancer is the most commonly diagnosed cancer in women, and is second
only to lung cancer as a leading cause of female cancer deaths.



Bavituximab is a monoclonal antibody that binds to a phospholipid
called phosphatidylserine that is usually located inside normal cells, but
which becomes exposed on the outside of the cells that line the blood
vessels of tumors, creating a specific target for anti-cancer treatments.
Bavituximab is believed to help mobilize the body's immune system to
destroy the blood vessels needed for tumor growth and spread. In a Phase Ib
pilot trial in advanced cancer patients, bavituximab plus chemotherapy
appeared to have a safety profile consistent with chemotherapy alone and
showed positive signs of clinical activity, achieving objective response or
disease stabilization in 50% of the evaluable patients. Peregrine has
received regulatory approval to conduct three Phase II trials to study the
anti-tumor effects of bavituximab in combination with chemotherapy. These
include two breast cancer protocols and a non-small cell lung cancer
protocol. Bavituximab is in clinical trials in the U.S. in patients with
advanced solid tumors and in patients co-infected with HCV and HIV.



About Peregrine Pharmaceuticals



Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative product candidates in clinical trials for the
treatment of cancer and hepatitis C virus (HCV) infection. The company is
pursuing three separate clinical programs in cancer and HCV infection with
its lead product candidates bavituximab and Cotara(R). Peregrine also has
in-house manufacturing capabilities through its wholly owned subsidiary
Avid Bioservices, Inc. (http://www.avidbio.com), which provides development
and bio-manufacturing services for both Peregrine and outside customers.
Additional information about Peregrine can be found at
http://www.peregrineinc.com.



Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. The forward-looking statements involve risks and uncertainties
including, but not limited to, the risk that the standard docetaxel
response rate will not be improved as a result of the combination therapy,
and the risk that the results from this trial will not be consistent with
the results of prior trials or preclinical studies. It is important to note
that the company's actual results could differ materially from those in any
such forward-looking statements. Factors that could cause actual results to
differ materially include, but are not limited to, uncertainties associated
with completing preclinical and clinical trials for our technologies; the
early stage of product development; the significant costs to develop our
products as all of our products are currently in development, preclinical
studies or clinical trials; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory
approval for our technologies; anticipated timing of regulatory filings and
the potential success in gaining regulatory approval and complying with
governmental regulations applicable to our business. Our business could be
affected by a number of other factors, including the risk factors listed
from time to time in the company's SEC reports including, but not limited
to, the annual report on Form 10-K for the year ended April 30, 2007 and
the quarterly report on Form 10-Q for the quarter ended January 31, 2008.
The company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to
update or revise any forward-looking statements in this press release.



Peregrine Pharmaceuticals, Inc.

http://www.peregrineinc.com

Nuvelo, Inc.
(Nasdaq: NUVO) announced positive results from the Phase 1
proof-of-concept trial (n=30) of NU172, demonstrating that the
thrombin-inhibitor achieved rapid onset and offset of anticoagulation after
a single bolus dose with a favorable safety profile.


"There is a significant need for anticoagulants with fewer side effects
and more predictable dosing than treatments currently available today,"
said David J. Schneider, M.D., professor of medicine and director of
cardiology and vascular biology at the University of Vermont. "NU172
represents a new approach to anticoagulation for medical and surgical
procedures through its potential to produce rapid and predictable onset of
anticoagulation followed by rapid reversal once the infusion is
discontinued."



The single-center, Phase 1 trial examined the safety, tolerability and
pharmacokinetics of escalating bolus doses of NU172 in normal, healthy
volunteers. In the trial, NU172 produced dose-dependent increases in
anticoagulation, measured by activated clotting time (ACT). The 2.00 mg/kg
bolus dose of NU172 achieved target ACTs of approximately 400 seconds. Upon
withdrawal of NU172 the ACT showed a rapid return toward baseline with a
plasma half-life of NU172 of approximately 10 minutes. No serious adverse
events occurred in the trial.



"We are very encouraged by these findings and NU172's potential to
address the need for rapid onset and offset of anticoagulation in medical
procedures such as coronary artery bypass graft surgery and percutaneous
coronary intervention," said Dr. Ted W. Love, chairman and chief executive
officer of Nuvelo. "We plan to launch a Phase 1b trial of bolus dosing
followed by escalating infusion doses of NU172 later this quarter, which
should enable us to quickly begin a Phase 2 study evaluating NU172 in
medical or surgical procedures in the fourth quarter of 2008 or the first
quarter of 2009."



According to the American Heart Association, more than 450,000 coronary
artery bypass graft (CABG) procedures and more than 1.2 million
percutaneous coronary interventions (PCIs) are performed annually in the
United States. Heparin, which must be paired with its antitode protamine
for reversal, is the current standard of care for anticoagulation in CABG
surgeries and PCI.



About Aptamers and NU172



Aptamers are chemically synthesized single-stranded nucleic acids that
form well-defined three-dimensional shapes, allowing them to bind target
molecules in a manner that is conceptually similar to antibodies.
Characteristics of aptamers include high specificity and affinity, and the
ability to target protein-protein interactions.



NU172 is an aptamer designed to directly inhibit thrombin's ability to
stimulate blood clot formation in the setting of medical procedures where
human blood is exposed to foreign materials. Specifically, NU172 is being
studied for use as a potential short-acting anticoagulant during procedures
such as coronary artery bypass graft surgery and percutaneous
interventions. Data from the Phase 1 trial and preclinical studies suggest
that NU172 has the potential for predictable anticoagulant effects, rapid
onset and offset of action, and avoidance of thrombocytopenia.



About Nuvelo and Archemix's Joint Collaborative Effort



In August 2006, Nuvelo expanded its collaboration with Archemix to
develop and commercialize aptamers that have a short-acting anticoagulant
effect. Under the agreement, Archemix is responsible for discovery of
short-acting aptamers for use in medical procedures, and Nuvelo leads
development and worldwide commercialization of these aptamers.



About Nuvelo



Nuvelo, Inc. is dedicated to improving the lives of patients through
the discovery, development and commercialization of novel drugs for acute
cardiovascular disease, cancer and other debilitating medical conditions.
Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor
in Phase 1 development for use as a potential short-acting anticoagulant
during medical or surgical procedures; and preclinical candidate NU206, a
Wnt pathway modulator for the potential treatment of chemotherapy/radiation
therapy-induced mucositis and inflammatory bowel disease. In addition,
Nuvelo is pursuing research programs in leukemia and lymphoma therapeutic
antibodies and Wnt signaling pathway therapeutics to further expand its
pipeline and create additional partnering and licensing opportunities.



This press release contains "forward-looking statements," which include
statements regarding the timing, progress and anticipated completion of
Nuvelo's clinical stage and research programs, the anticipated availability
of top-line data, projected operating expenses and cash usage and the
potential benefits that patients may experience from the use of our
clinical stage compounds, which statements are hereby identified as
"forward-looking statements" for purposes of the safe harbor provided by
the Private Securities Litigation Reform Act of 1995. Such statements are
based on our management's current expectations and involve risks and
uncertainties. Actual results and performance could differ materially from
those projected in the forward- looking statements as a result of many
factors, including, without limitation, uncertainties relating to drug
discovery and the regulatory approval process; clinical development
processes; enrollment rates for patients in our clinical trials; changes in
relationships with strategic partners and dependence upon strategic
partners for the performance of critical activities under collaborative
agreements; and the impact of competitive products and technological
changes. These and other factors are identified and described in more
detail in Nuvelo's filings with the SEC, including without limitation
Nuvelo's annual report on Form 10-K for the year ended December 31, 2007
and subsequent filings. We disclaim any intent or obligation to update
these forward-looking statements.


Nuvelo, Inc.

http://www.nuvelo.com

Medarex, Inc.
(Nasdaq: MEDX) announced that the following clinical and preclinical
abstracts for ipilimumab in melanoma, prostate cancer and other cancers, as
well as for anti-PD-1 and anti-CD70 antibody candidates for cancer
treatment, are expected to be the subject of presentations at the Annual
Meeting of the American Society of Clinical Oncology, being held May
30-June 3, 2008 in Chicago:


Survival, Response, Safety and Biomarker Data of Ipilimumab in Melanoma



-- "Antitumor response and new lesions in advanced melanoma patients on
ipilimumab treatment" (Abstract #3020, Developmental Therapeutics:
Immunotherapy Session) -- Poster presentation and discussion from 2:00
p.m. to 6:00 p.m. local time on Friday, May 30, 2008.



-- "Long-term survival of patients with advanced melanoma who received
ipilimumab administered at 10mg/kg every 3 weeks for 4 doses (induction
dosing)" (Abstract #3018, Developmental Therapeutics: Immunotherapy
Session) - Poster presentation and discussion from 2:00 p.m. to 6:00
p.m. local time on Friday, May 30, 2008.



-- "Potential immune biomarkers of gastrointestinal toxicities and
efficacy in patients with advanced melanoma treated with ipilimumab
with or without prophylactic budesonide" (Abstract #3022, Developmental
Therapeutics: Immunotherapy Session) -- Poster presentation and
discussion from 2:00 p.m. to 6:00 p.m. local time on Friday, May 30,
2008.



-- "Novel efficacy criteria for antitumor activity to immunotherapy using
the example of ipilimumab, an anti-CTLA-4 monoclonal antibody"
(Abstract #3008, Developmental Therapeutics: Immunotherapy
Session) -- Oral presentation beginning at 4:30 p.m. local time one
Saturday, May 31, 2008.



-- "Effect of prior treatment status on the efficacy and safety of
ipilimumab monotherapy in treatment-naive and previously treated
patients with advanced melanoma" (Abstract #9055, Melanoma
Session) -- Poster presentation from 2:00 p.m. to 6:00 p.m. local time
on Saturday, May 31, 2008.



-- "An analysis of the effectiveness of specific guidelines for the
management of ipilimumab-mediated diarrhea/colitis: prevention of
gastrointestinal perforation and/or colectomy" (Abstract #9063,
Melanoma Session) - Poster presentation from 2:00 p.m. to 6:00 p.m.
local time on Saturday, May 31, 2008.



-- "Model-based evaluation of ipilimumab dosage regimen in patients with
advanced melanoma" (Abstract #9073, Melanoma Session) -- Poster
presentation from 2:00 p.m. to 6:00 p.m. local time on Saturday, May
31, 2008.



-- "Safety and efficacy of ipilimumab with or without prophylactic
budesonide in treatment-naive and previously treated patients with
advanced melanoma" (Abstract #9010, Melanoma Session) -- Oral
presentation beginning at 10:15 a.m. local time on Sunday, June 1,
2008.



-- "Efficacy and safety of ipilimumab induction and maintenance dosing in
patients with advanced melanoma who progressed on one or more prior
therapies" (Abstract #9021, Melanoma Session) -- Poster presentation
and discussion from 2:00 p.m. to 6:00 p.m. local time on Sunday, June
1, 2008.



-- "Disease control and long-term survival in chemotherapy-naive patients
with advanced melanoma treated with ipilimumab (MDX-010) with or
without dacarbazine" (Abstract #9022, Melanoma Session) -- Poster
presentation and discussion from 2:00 p.m. to 6:00 p.m. local time on
Sunday, June 1, 2008.



-- "Dose effect of ipilimumab in patients with advanced melanoma: results
from a phase 2, randomized, dose-ranging study" (Abstract #9025,
Melanoma Session) -- Poster presentation and discussion from 2:00 p.m.
to 6:00 p.m. local time on Sunday, June 1, 2008.



-- "Prolonged survival in objective responders to ipilimumab therapy"
(Abstract #20004) -- Publication only.



Response and Safety Data of Ipilimumab in Prostate



-- "Phase 1 trial of ipilimumab (IPI) alone and in combination with
radiotherapy (XRT) in patients with metastatic castration resistant
prostate cancer (mCRPC)" (Abstract #5004, New Targeted Strategies for
Patients with Prostate Cancer Session) -- Oral presentation beginning
at 11:30 a.m. local time on Monday, June 2, 2008.



-- "Expanded phase 1 combination trial of GVAX immunotherapy for prostate
cancer and ipilimumab in patients with metastatic hormone-refractory
prostate cancer (mHRPC)" (Abstract #5146, Genitourinary Cancer Session)
-- Poster presentation from 8:00 a.m. to 12:00 p.m. local time on
Saturday, May 31, 2008.



Clinical and Preclinical Data of Additional Immunotherapy and
Antibody-Drug Conjugate Programs



-- "Safety and activity of MDX-1106 (ONO-4538), an anti-PD-1 monoclonal
antibody, in patients with selected refractory or relapse malignancies"
(Abstract #3006, Developmental Therapeutics: Immunotherapy
Session) -- Oral presentation beginning at 4:00 p.m. local time on
Saturday, May 31, 2008.



-- "Antitumor activity of anti-CTLA-4 monoclonal antibody (mAb) in
combination with ixabepilone in preclinical tumor models" (Abstract
#3048, Developmental Therapeutics: Immunotherapy Session) -- Poster
presentation from 2:00 p.m. to 6:00 p.m. local time on Sunday, June 1,
2008.



-- "Effect of a fully human anti-CD70 antibody on apoptosis and
dephosphorylation of MAPK proteins in chronic lymphocytic leukemia"
(Abstract #3073, Developmental Therapeutics: Immunotherapy
Session) -- Poster presentation from 2:00 p.m. to 6:00 p.m. local time
on Sunday, June 1, 2008.



More information about the ASCO Annual Meeting may be found at
http://www.asco.org.



About Medarex



Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 40 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase 3 clinical trials or the subject of regulatory
applications for marketing authorization. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its website at http://www.medarex.com.



Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.


Medarex, Inc.

http://www.medarex.com

Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) announced today that its lead product
candidate, R788, has successfully treated lupus prone mice and
significantly improved their survival as reported in a recently published
study of the drug candidate. R788 (fostamatinib disodium) is an orally
bioavailable syk kinase inhibitor, which has shown clinically significant
results in treating patients with rheumatoid arthritis and immune
thrombocytopenic purpura in clinical trials. A third clinical trial of R788
in patients with B-cell lymphoma will be completed later this year. Rigel
also expects to initiate a Phase 2 clinical trial in lupus in the second
half of 2008.


The study, which evaluated the potential of R788's effect on the immune
cascade in an in vivo lupus model, has been published in Arthritis and
Rheumatism and is titled - "An Orally Bioavailable Spleen Tyrosine Kinase
Inhibitor Delays Disease Progression and Prolongs Survival in Murine
Lupus," (May 2008, Volume 58, No. 5, p.1433).



"These results are impressive and consistent with R788's mechanism of
action," said Donald G. Payan, M.D., executive vice president and president
of discovery and research at Rigel. "Given this mechanism, R788 has the
potential to treat a broad range of immune-related disorders, a number of
which we are advancing in the clinic."



Summary of results



The study evaluated the effects of three doses of R788 versus a control
group and an untreated group of lupus-prone mice. The mice in the R788
groups orally received 10 mg/kg, 20 mg/kg or 40 mg/kg twice a day, for 240
days. Baseline, periodic and terminal measurements of renal enzymes and
proteinuria (presence of proteins in the urine associated with kidney
malfunctions), blood urea nitrogen, and other tests were done on all
subjects in the treatment and control groups.



At the completion of the study, only 2 of the 29 mice in the 40 mg/kg
group had elevated proteinuria compared to 21 of the 30 mice in the control
group. All 29 (100%) of the mice treated with 40 mg/kg of R788 survived the
duration of the study, compared to 14 of the 30 (47%) mice in the control
group. The mice treated with 10 mg/kg and 20 mg/kg of R788 demonstrated
results that were between those of the control group and the 40 mg/kg
group. In a separate study, where treatment was initiated after the onset
of disease, the researchers noted that the majority of the animals (~95%)
given the 40 mg/kg dose had elevated proteinuria levels that decreased
following the onset drug treatment.



Systemic Lupus Erythematosus (SLE)



Lupus is an autoimmune disease, which affects nearly 2 million
Americans, the majority of whom are women (90%). The disease affects
various parts of the body including the kidneys, skin, joints, heart,
lungs, and brain. Its effects can be mild, limited to a couple of organs in
the body and occasional flare-ups, or can cause serious and
life-threatening complications. Like other autoimmune diseases the primary
characteristic of lupus is inflammation, which causes swelling, pain, loss
of function and may ultimately destroy the involved organ if left
untreated. Current therapies for lupus treat the symptoms of the disease
and include non-steroidal anti-inflammatory drugs (NSAIDS),
corticosteroids, and, in severe cases where organ damage is at risk,
immunosuppressant drugs.



About Rigel



Rigel is a clinical-stage drug development company that discovers and
develops novel, small-molecule drugs for the treatment of
inflammatory/autoimmune diseases and cancer, as well as viral and metabolic
diseases. Our goal is to file one new investigational new drug (IND)
application in a significant indication each year. Rigel has achieved this
goal every year since 2002. Our pioneering research focuses on
intracellular signaling pathways and related targets that are critical to
disease mechanisms. Rigel's productivity has resulted in strategic
collaborations with large pharmaceutical partners to develop and market our
product candidates. Rigel has product development programs in
inflammatory/autoimmune diseases such as rheumatoid arthritis,
thrombocytopenia and asthma, as well as in cancer.



This press release contains "forward-looking" statements, including
statements related to the preclinical data and plans and potential efficacy
of R788. Any statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking
statements. Words such as "believe," "may," "can," "support," "indicate,"
"potential," "expects" and similar expressions are intended to identify
these forward-looking statements. There are a number of important factors
that could cause Rigel's results to differ materially from those indicated
by these forward-looking statements, including risks associated with the
timing and success of clinical trials and the commercialization of product
candidates, potential problems that may arise in the clinical testing and
approval process and Rigel's need for additional capital, as well as other
risks detailed from time to time in Rigel's SEC reports, including its Form
10-K for the year ended December 31, 2007. Rigel does not undertake any
obligation to update forward-looking statements.


Rigel Pharmaceuticals, Inc.

http://www.Rigel.com

Traditionally thoracic aortic aneurysm disease has been treated with surgery requiring a large chest incision and placement of a synthetic graft to repair the artery. However, a new study indicates that use of the minimally invasive W.L. GORE TAG® Thoracic Endoprosthesis to treat descending thoracic aneurysms appears to be superior to open surgical repair in anatomically suitable patients.


Investigator Ellen D. Dillavou, MD, from the division of vascular surgery at the University of Pittsburgh Medical Center, said this is the first study to look at the long-term (five-year) outcomes of the two procedures. "Our researchers studied outcomes of the TAG endograft after its implantation in 140 patients compared to 94 patients who had similar aneurysms repaired by open surgery, between September 1999 and May 2001, as well as 51 more patients who were added in 2003 after revision of the endograft." The long-term follow-up of the multi-center device trial which took place at centers throughout the United States, is detailed in the May 2008 issue of the Journal of Vascular Surgery.


Follow-up consisted of patient visits, computed tomography scans and X-rays at one and six months, then annually for five years. "Initially and at five years, TAG patients had better results," said Dr. Dillavou. "At five years aneurysm-related mortality was 2.8 percent compared to 11.7 percent in open surgery patients, and major adverse events were 57.9 percent vs. 78.7 percent. Endoleaks in TAG patients decreased from 8.1 percent at one month to 4.3 percent at five years."


There were no aneurysm ruptures reported in either group over the study period and no deaths due to aneurysm-related causes after one year in either group. At five years, secondary procedures in the TAG group were lower (15.0 percent vs. 31.9 percent) and many were managed with a minimally invasive approach. Only five TAG patients underwent major aneurysm-related re-interventions (3.6 percent), including one arch aneurysm repair, one open aneurysm repair and three patients with minimally invasive procedures for endoleaks.


Dr. Dillavou added that at five years, aneurysm sac size decreased in 50 percent of the patients and increased in 19 percent of them, compared to the one-month baseline. Comparison with the modified low-porosity device at two years showed sac increase in 12.9 percent of original vs. 2.9 percent in modified grafts. "Although sac enlargement is concerning, early modified device results indicate this issue may be resolved," said Dr. Dillavou.


"Prior to this report it was not known if minimally invasive repairs would be as durable as traditional open repairs," said Dr. Dillavou. "This study demonstrates that in suitable patients, endovascular repair of thoracic aneurysms has clear and lasting advantages over open aneurysm repair and that the TAG endograft is durable to five years of follow-up. This work confirms that the early advantages of minimally invasive endovascular thoracic aneurysm repair extend to five years of follow-up. TAG patients had fewer deaths and complications from their aneurysms, making this the safest approach for suitable patients."


About Journal of Vascular Surgery


Journal of Vascular Surgery provides vascular, cardiothoracic and general surgeons with the most recent information in vascular surgery. Original, peer-reviewed articles cover clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography and endovascular management. Special issues publish papers presented at the annual meeting of the Journal's sponsoring society, the Society for Vascular Surgery. Visit the Journal web site at http://www.jvascsurg.org.


About the Society for Vascular Surgery


The Society for Vascular Surgery (SVS) is a not-for-profit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,400 vascular surgeons dedicated to the prevention and cure of vascular disease. Visit the website at http://www.VascularWeb.org.


Society for Vascular Surgery

633 N. St. Clair, 24th Fl.

Chicago, IL 60611

United States

http://www.jvascsurg.org

Alexza
Pharmaceuticals, Inc. (Nasdaq: ALXA) announced positive results from
a Phase 1 clinical trial of AZ-007 (Staccato(R) zaleplon). AZ-007 is an
inhalation product candidate being developed for the treatment of insomnia
patients who have difficulty falling asleep, including patients who awake
in the middle of the night and have difficulty falling back asleep.


"This is the fifth product candidate using our single-dose Staccato
technology platform that has completed a Phase 1 clinical trial," said
James V. Cassella, PhD, Senior Vice President of R&D at Alexza. "We have
again shown that the Staccato system can deliver IV-like pharmacokinetics,
even with water insoluble compounds, in a simple, easy-to-use, one-breath
device. We were pleased with the initial results. As we continue our
analysis of the data collected in this study, we plan to present these data
in scientific and medical forums at future dates, and determine the next
steps for this product candidate."



Phase 1 Clinical Trial Results



The AZ-007 Phase 1 clinical trial enrolled 40 healthy volunteers at a
single U.S. clinical center. The purpose of this trial was to assess the
safety, tolerability and pharmacokinetic parameters of a single dose of
AZ-007. Using a double blind, randomized, dose-escalation trial design, 4
doses of AZ-007 (ranging from 0.5 to 4.0 mg) were compared to placebo.



AZ-007 delivered an IV-like pharmacokinetic profile with a median time
to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was
dose proportional across the 4 doses studied, as calculated by power
analysis. Pharmacodynamics, measured as sedation assessed on a 100 mm
visual-analog scale, showed onset of effect as early as 2 minutes after
dosing with AZ-007.



There were no serious adverse events. The most frequently reported
adverse events in subjects receiving AZ-007 were dizziness and somnolence.
These data indicate a rapid onset of effect, apparently directly related to
the IV-like pharmacokinetics, and showed that AZ-007 was generally safe and
well tolerated in this population of healthy volunteers.



About Insomnia



Insomnia is a prevalent disorder that drives a multi-billion dollar
market of prescription medications each year. An estimated 10 to 30% of the
U.S. population experiences either chronic or occasional insomnia. In 2005,
one survey conducted by the National Sleep Foundation showed that 54% of
the respondents experienced a minimum of one symptom of insomnia at least a
few nights a week. Of those, respondents complained primarily of waking up
feeling unrefreshed (38%), waking up frequently during the night (32%),
having difficulty falling asleep (21%), and waking up too early and not
being able to get back to sleep (21%). There is a potentially significant
clinical need for rapid and predictable onset of sleep in patients with
insomnia, as well as a predictable duration of sleep and rapid, clear
awakening.



About AZ-007 (Staccato zaleplon)



AZ-007 is the combination of Alexza's proprietary Staccato system with
zaleplon, a drug belonging to the class of compounds known generally as
hypnotics. The Staccato system technology is a hand-held,
chemically-heated, single dose inhaler designed to generate and deliver
excipient-free drug aerosol for deep lung delivery that results in IV-like
pharmacokinetics.



The Company believes that AZ-007 may provide rapid sleep onset.
Moreover, by coupling the shorter half-life of zaleplon with the lower dose
enabled by the Staccato system technology, the overall product profile may
match well with an unmet clinical need for patients with insomnia.



About Alexza Pharmaceuticals



Alexza Pharmaceuticals is an emerging specialty pharmaceutical company
focused on the development and commercialization of novel, proprietary
products for the treatment of acute and intermittent conditions. The
Company's technology, the Staccato system, vaporizes unformulated drug to
form a condensation aerosol that allows rapid systemic drug delivery
through deep lung inhalation. The drug is quickly absorbed through the
lungs into the bloodstream, providing speed of therapeutic onset that is
comparable to intravenous administration, but with greater ease, patient
comfort and convenience.



Alexza has six product candidates in clinical development. Alexza's
lead program, AZ-004 (Staccato loxapine) for the treatment of acute
agitation in schizophrenic or bipolar disorder patients, is in Phase 3
testing. AZ-001 (Staccato prochlorperazine) for the acute treatment of
migraine headaches has completed Phase 2 testing. AZ-104 (Staccato
loxapine) for the acute treatment of migraine headaches and AZ-002
(Staccato alprazolam) for the acute treatment of panic attacks associated
with panic disorder are in Phase 2 testing. Product candidates in Phase 1
testing include AZ-003 (Staccato fentanyl) for the treatment of
breakthrough pain, which is partnered with Endo Pharmaceuticals in North
America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. More
information, including this and past press releases from Alexza is
available online at http://www.alexza.com.



Safe Harbor Statement



This press release includes forward-looking statements regarding the
development, therapeutic potential and safety of AZ-007. Any statement
describing a product candidate or Alexza's goals, expectations or beliefs
is a forward-looking statement, as defined in the Private Securities
Litigation Reform Act of 1995, and should be considered an at-risk
statement. Such statements are subject to certain risks and uncertainties,
particularly those inherent in the process of developing and
commercializing drugs. The Company's forward-looking statements also
involve assumptions that, if they prove incorrect, would cause its results
to differ materially from those expressed or implied by such
forward-looking statements. These and other risks concerning Alexza's
business are described in additional detail in the Company's Annual Report
on Form 10-K for the year ended December 31, 2007, and the Company's other
Periodic and Current Reports filed with the Securities and Exchange
Commission including the risks under the headings "Failure or delay in
commencing or completing clinical trials for our product candidates could
harm our business" and "If our product candidates do not meet safety and
efficacy endpoints in clinical trials, they will not receive regulatory
approval, and we will be unable to market them". Forward-looking statements
contained in this announcement are made as of this date, and the Company
undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.


Alexza Pharmaceuticals, Inc.

http://www.alexza.com

A novel cell therapy using retinal pigment epithelial (RPE) cells attached to tiny gelatin bead microcarriers implanted in the brain can improve the symptoms of patients with moderate to advanced Parkinson's disease (PD).


Rush University Medical Center neurosurgeon Dr. Roy A. E. Bakay and colleagues from Emory University, Atlanta found the therapy Spheramine was well-tolerated and patients experienced improvement in Parkinsonian symptoms (tremor, rigidity, slowness of movements, and impaired balance and coordination.) These findings were presented at the Annual Meeting of the American Association of Neurological Surgeons in Chicago on April 28, 2008.


The pilot study was initiated at Emory University Hospital and followed six patients with moderate to advanced PD to investigate the safety, tolerability, and efficacy of the Spheramine implantation. The full patient group has been evaluated for four years, and several have been monitored for six years. Bakay and colleagues report long-term improvement or stabilization of symptoms, maintained for a minimum of two years after Spheramine implantation. They note no Spheramine-related serious adverse events were reported and that the most frequent adverse event was postsurgical headache, which spontaneously resolved within one to two weeks.


"The results of this study are very encouraging - Spheramine is well tolerated through several years of follow-up and improvement in parkinsonian symptoms is sustained," stated Bakay.


The cellular product Spheramine consists of RPE cells attached to microcarriers. RPE cells produce levodopa, the precursor of dopamine. Dopamine is a neurotransmitter produced by nerve cells in the brain that progressively declines as the disease progresses.


The RPE cells, which are normally found in the back of the eye, are cultured under standardized conditions and attached to the microscopic beads prior to implantation. The microcarriers are necessary for the cells to survive in the brain. The implanted cells serve as a new potential source of levodopa to enhance dopamine production where it is most needed.


The patients were selected based on disease stage, levodopa responsiveness, and severity of PD symptoms while off medication. An even distribution of Spheramine was surgically implanted into the more affected side of the brain, and patients left the hospital a few days later.


The primary efficacy measure in this trial is the motor score of the Unified Parkinson's Disease Rating Scale (UPDRS) when the patient has been OFF antiparkinsonian medication for at least 12 hours. The researchers report clinical improvements were noted in both UPDRS motor scores off medication (44 percent improvement from baseline at 48 months) and patient-reported quality of life scores (23 percent improvement from baseline of total PDQ-39 score at 48 months). Several of these patients have been monitored for 6 years and the trial has been extended to 10 years of follow-up."


Bakay said positive results in the pilot study prompted the initiation of a Phase IIb, multicenter, double-blind, randomized, sham surgery-controlled study (STEPS) to further evaluate the safety, tolerability and efficacy of Spheramine. Changes from the pilot study included implantation in both sides of the brain and the addition of a sham surgery group. To date, 71 patients have been randomized for either Spheramine or sham surgery and results from the will become available later this year.


Parkinson's Disease


Parkinson's disease is a progressive brain disorder that affects a person's motor skills which worsen as the disease advances. Early in the disease, there is a loss of brain cells that produce the chemical dopamine. Normally, dopamine operates in a delicate balance with other neurotransmitters to help coordinate the millions of nerve and muscle cells involved in movement. Without enough dopamine, this balance is disrupted, resulting in tremor (trembling in the hands, arms, legs and jaw); rigidity (stiffness of the limbs); slowness of movement; and impaired balance and coordination - the hallmark symptoms of PD.


PD affects one in every 100 people over the age of 65. The latest epidemiology studies indicate that worldwide numbers will increase from an estimated 4.1 million in 2005 to 8.7 million people with PD by 2030. There were an estimated 19,500 PD-related deaths in the United States in 2005, an increase of 1,500 deaths from 2004.


It is estimated to cost $23 billion a year in direct and indirect costs and lost productivity. Despite therapeutic advancements, oral medications provide insufficient symptom control after the disease has progressed and new approaches are needed.




Rush University Medical Center

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced the completion of a first dosing regimen in a phase 1 clinical study on healthy volunteers of the HuCAL-derived antibody MOR103 with no adverse events reported. Six healthy volunteers in the first dosing group have been enrolled and received MOR103 injections, three volunteers received placebo. The safety review of the medical data from the lowest dosing group concluded that it was safe to proceed to the second dosing group. The randomized, double-blind, placebo-controlled, single-ascending dose trial will be conducted in approx. 50 healthy volunteers and is being conducted in a Clinical Pharmacology Unit (CPU) in Utrecht, the Netherlands. The trial is scheduled to be finalized in 2008 and final reporting is expected in Q1 2009.


The company's lead development program MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. MorphoSys had submitted the clinical trial application in December 2007 and received the approval by the Dutch authorities six weeks later. The study will evaluate the safety and tolerability as well as pharmacokinetics of escalating doses of MOR103.


"We are very pleased to see our first proprietary drug candidate progress according to plan," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Antibodies that neutralize GM-CSF could represent a new generation of medicines that reduce inflammation with greater beneficial effects."


About MorphoSys


MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys's goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The company currently has therapeutic and research alliances with the majority of the world's largest pharmaceutical companies including Boehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 50 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products. Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford).



For further information please visit http://www.morphosys.com/




About MOR103 to treat RA


Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints and affects in particular a membrane, called synovium, which lines each movable joint. It is a disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. As a systemic disease, RA often affects extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and muscles. The disease affects approximately 4-6 million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium. Here, these blood cells appear to play an important role in causing the synovial membrane to become inflamed.


The HuCAL-based antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases such as psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), asthma, and especially RA. The granulocyte macrophage colony-stimulating factor (GM-CSF) stimulates stem cells to produce granulocytes and macrophages, and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like RA leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103 reduces undesired proliferation and activation of inflammatory granulocytes and macrophages and intervenes in several pathophysiological pathways.

More information and picture material is available here.


HuCAL(R) and HuCAL GOLD(R) are registered trademarks of MorphoSys AG


This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

MorphoSys

The results of a year long clinical trial examining the effects of mushroom supplementation in patients with Human Papillomavirus (HPV) have recently been presented at congress. Dr. Jose Silva Couto and Dr. Daniel Pereira da Silva of the Cervical Pathology Unit of the Portuguese Institute of Oncology in Coimbra, Portugal presented their findings at the 20th European Congress of Obstetrics and Gynaecology, in Lisbon Portugal. This study provides a promising set of results and demonstrates proof-of concept for the question as to whether immunonutrition supplements can be successfully used to improve HPV status in patients.


The poster presentation detailed the results of the evaluation of the Efficacy of Coriolus versicolor Supplementation in patients infected with HPV with low-grade squamous intraepthithelial lesions (LSIL). The Coriolus versicolor mushroom supplied for the study was produced by Mycology Research Laboratories Ltd in tablet form (500 mg/tablet).



Dr. Silva Couto et al. found that Coriolus versicolor supplementation over a period of one year substantially increased regression of the dysplasia (LSIL) and induced clearance of the high risk sub-types of the HPV virus responsible for cervical cancer.


a) Coriolus versicolor supplementation demonstrated a 72% regression rate in LSIL lesions compared to 47.5% without supplementation.


b) Coriolus versicolor supplementation demonstrated a 90% regression rate in the high risk HPV virus sub-types compared to 8.5% without supplementation.



Study Design


The year long study was funded by Mycology Research Laboratories Ltd. The Portuguese pharmaceutical firm Aneid-Produtos Farmacêuticos Lda acted as collaborative partners.


Forty-three (43) patients with HPV Lesions (LSIL) were divided into two groups:


- A Control group (21 patients) who did not receive any treatment


- A treatment group (22 patients) who each received Coriolus versicolor supplementation for a period of one year (6 tablets/day i.e. 3g/day)



Protocol Design


At first observation, patients were examined with colposcopy, biopsy and HPV tipification (hybrid capture). Cervical cytology exams (Pap smear tests) determined the patients' LSIL status and this was confirmed through colposcopy and biopsy.



Four months after the first observations, colposcopy and cervical cytology was again carried out on all patients. At the same time, there was an evaluation of the possible side effects from Coriolus supplementation.


After one year, (at the end of the supplementation period), colposcopy, cervical cytology and HPV typing were carried out on all patients.


Success Parameters


The authors measured the efficacy of Coriolus supplementation in LSIL patients in terms of the evolution of HPV status from High Risk HPV+ status to High Risk HPV- status. High Risk HPV, refers to certain strains of HPV that are known to be associated with causing cervical cancer, such strains include HPV 16, 18, 31 and 45. The persistence of cervical lesions as measured by colposcopy and cytology was also determined.


Study Population


Out of the 43 patients enrolled, 39 completed the trial. Of the four (4) who did not complete the trial, 1 patient left the country and 3 discontinued supplementation due to mild side-effects. The side-effects were not serious and did not warrant further medical intervention.


The age distribution of the two groups was very similar. Patients receiving Coriolus versicolor supplementation had an average age of 31.7 years (minimum age of 19, maximum age of 49 years). The control group had an average age of 33.4 years (minimum age of 19 and a maximum of 51 years).


Results


Of the 39 patients who completed one year of follow-up, 18 took Coriolus supplementation, while the other 21 patients received no therapy (Control group). After 1 year 13 of the 18 patients in the Coriolus group showed normal cervical cytology (72.5%) while only 10 of the patients in the control group did (47.5%).


Of the 39 patients, 22 were positive for high risk HPV subtypes.10 of these patients were in the Coriolus group and 12 in the control group. After 1 year 9 of the 10 in the Coriolus group had reverted to HPV- status (90%) while only 1 of the 12 in the control group had (8.5%).


What do these results mean for HPV patients?


The results from this study are encouraging and provide insight into the effectiveness of Coriolus versicolor as a useful immunonutrition agent. Using Coriolus supplementation for one year resulted in 72.5% of recipients reverting to normal cytology compares with only 47.5% of the control group. Encouragingly, 90% of the Coriolus recipients reverted to a HPV- status compared with only 8.5% in the control group.


While the study sample size is limited in number, the results strongly suggest that using Coriolus versicolor as a food supplementation agent offers doctors a useful nutritional tool when treating HPV (LSIL) patients over the age of 35 or those HPV (LSIL) patients with compromised immune systems.



It is also likely that Coriolus versicolor could be beneficial in HSIL patients who have undergone surgery but who experience recurrent lesions caused by persistent HPV viral infection; the eradication or "control" of the viral infection is key to both LSIL and HSIL patient care.


According to Dr Silva Couto, one of the study authors "At present, we believe that the optimal supplementation period may actually be as short as six months. Further testing is required to determine the best way to reduce the time period from the one year period used in this study.". A shorter period of treatment would aid compliance as well as reducing the already minimal overall cost of therapy.


Why Coriolus versicolor?

As already stated, the mushroom Coriolus versicolor has been used in traditional Asian medicine for a long time. It is now known that Coriolus contains high quantities of Beta-glucans that act to stimulate the immune system. Studies have shown that Coriolus can double the number of natural killer cells after only 8-weeks of treatment.1,2 The benefits of treatment with the fungus has also been tested in patients with chronic fatigue syndrome. Coriolus versicolor (strain CV-OH1) is grown aseptically on sterile, edible grain, harvested and then produced as a tablet following good manufacturing practice according to pharmaceutical guidelines. It is free from pesticide, heavy metals and contaminants.


1. Jean A. Monro, Chronic Fatigue Immune Dysfunction Syndrome. J Integrative Medicine 2004;8:101-108


2. Jean A. Monro Treatment of Cancer with Mushroom Products. Arch Env Health 2003;58:533-537


Will Mycology Research Laboratories be furthering this work?


The Mycology Research Lab´s Managing Director, William Ahern stated: "We realise that the study sample size is small and that taking six tablets per day may be challenging for some individuals, from a compliance viewpoint. However, both Dr Silva Couto et al. have significantly contributed to the development of a nutritional approach to HPV care that is complementary with existing HPV treatment protocols."



Further research is ongoing to determine the optimal treatment period for HPV patients. This study has proven that Coriolus versicolor supplementation has a place in the management of HPV infection. The estimated cost per day for Coriolus versicolor supplementation under this protocol would be € 52.00 per month (€ 1,75 per day) or £ 41,60 per month (£1,40 per day), making Coriolus treatment a viable treatment without undue increases in the cost of therapy.


Mycology Research Laboratories

BR Pharma, a leader in the procurement of pharmaceutical products for comparator clinical trials and named patient programs, announced the appointment of Adele Davis to the new position of Head of Clinical Trials. Davis will be responsible for managing operations of the company's Clinical Trials Procurement Team, heading project management of comparator drug procurement programs and cultivating new business opportunities.


"Adele's worldwide clinical trial drug procurement expertise will be invaluable to BR Pharma and our U.S. business development arm, Pharmarama, as we continue to grow our business internationally," said Rosemary Bensley, managing director of BR Pharma. "She brings a track record of success in planning and implementing comparator procurement projects and building strong relationships with customers and suppliers worldwide. We are delighted to welcome Adele to the executive team."


Prior to joining BR Pharma, Davis was Head of Clinical Trial Supplies at ADAllen Pharma, Ltd., where she spent over five years helping to set up and run the firm's clinical supplies division. In that role she managed complex clinical trials procurement projects, sourced drug supply along with related documentation, conducted customer and supplier audits and established processes that ensured project accuracy.


"BR Pharma is building a truly global business, and I am thrilled to join the organization at this exciting time in its history," Davis said. "Pharmaceutical companies recognize the benefits of conducting clinical trials in emerging markets such as China, India and Eastern Europe. But the complexity of sourcing and procuring comparators for these studies requires specialized knowledge in areas such as blinding, packaging and regulatory documentation. BR Pharma has that knowledge. I look forward to working with Rosemary and the other members of the executive team as we execute our international business development strategy and continue to increase our market share."



About BR Pharma



BR Pharma Ltd. is a leading global clinical trial supply company that specializes in sourcing comparator drugs. The company has more than a decade of experience providing comprehensive procurement, supply chain and distribution services to the world's leading pharmaceutical companies and clinical research organizations. As a fully integrated organization, BR Pharma serves as a single point of contact for sourcing, repacking, blinding and distribution worldwide, thereby enabling its customers to save time and money. Founded by Ben Rabin, a pharmacist with 40 years of experience in retail and wholesale pharmacy in the U.K., BR Pharma is based in London, England with offices in the United States and Germany.

BR Pharma

Cara Therapeutics, Inc
announced that it has initiated a Phase 1 clinical trial of its long-acting
peripheral kappa opioid receptor agonist, CR845. The Phase 1a single-center
clinical trial will evaluate the safety, tolerability, pharmacokinetic
profile, and pharmacological activity of CR845 in a double-blind,
randomized, placebo-controlled, single escalating intravenous dose study in
58 healthy male and female volunteers.



The company is also developing oral and subcutaneous formulations of
CR845.



About CR845



In preclinical studies, CR845 was highly selective for the peripheral
kappa opioid receptor. Animal studies indicate that CR845 is effective in
treating pain of inflammatory, neuropathic and visceral origin and exhibits
analgesic efficacy for up to 18 hours after a single dose. Analgesic
activity was seen after intravenous, subcutaneous, or oral administration.
Unlike currently marketed opioids, CR845 did not inhibit intestinal transit
(ileus) or elicit signs of addiction in animal models. Preclinical studies
also indicate that CR845 possesses anti-itch activity.



About Cara Therapeutics



Cara Therapeutics is a privately held biotechnology company focused on
developing novel, superior therapeutics to treat pain and inflammation
associated with diverse medical conditions. Cara's current pipeline
includes near-term clinical drug candidates identified as mechanistically
distinct, peripherally-acting analgesics.



Forward Looking Statements



Certain statements in this press release are forward-looking statements
that involve a number of risks and uncertainties. Such forward-looking
statements include statements relating to the therapeutic applications of
CR845 and about Cara's strategy, technologies, pre-clinical and clinical
programs, and ability to identify and develop drugs, as well as other
statements that are not historical facts. Actual events or results may
differ materially from Cara's expectations. Factors that could cause actual
results to differ materially from the forward-looking statements include,
but are not limited to, the timing, success and cost of Cara's research and
clinical studies and Cara's ability to obtain additional financing. These
forward- looking statements represent Cara's judgment as of the date of
this release. Cara disclaims any intent or obligation to update these
forward-looking statements.


Cara Therapeutics, Inc.

http://www.caratherapeutics.com

Debiopharm Group
(Debiopharm), a global independent biopharmaceutical development specialist
focusing on serious medical conditions, particularly oncology, presented
positive efficacy results of a phase IIa study with Debio 025, a selective
cyclophilin (Cyp) inhibitor with a potent in-vitro and in-vivo
anti-hepatitis C (HCV) effect. Data indicates that Debio 025 shows an
important additive anti-HCV effect when co-administered with pegylated
Interferon (Peg-IFN) alpha-2a to treatment- naive HCV patients. Debiopharm
presented these findings at the 43rd Annual Meeting of the European
Association for the Study of the Liver, in Milan, Italy.


The double-blind, placebo-controlled study investigated different dose
regimens of Debio 025 in combination with alpha-2a Peg-IFN 180 Mug/week in
treatment naive chronic HCV mono-infected patients. Ninety patients were
randomised to receive either of the following treatment regimens during 29
days: Peg-IFN with placebo; Peg-IFN with Debio 025 200 mg/day; Peg-IFN with
Debio 025 600 mg/day; Peg-IFN with Debio 025 1000 mg/day; and Debio 025
1000 mg/day.



In patients with genotypes 1 and 4, at day 29, the HCV-RNA reduction
was -4.6 log10 IU/mL in the Peg-IFN with Debio 025 600 mg/day arm, and -4.8
log10 IU/mL in the Debio 025 1000 mg/day arm. This was significantly
different (p< 0.05) from the Peg-IFN with placebo, as well as the Debio 025
1000 mg/day monotherapy arms, in which the reduction in viral load was
respectively -2.49 and -2.20. In these two arms, at day 29, the proportion
of subjects with undetectable viral load was 25%. This number increased to
66% in the Peg-IFN with Debio 025 1000 mg/day group.



"To obtain these exciting results after an administration period of
only one month is promising and demonstrates that Debio 025 will be a
breakthrough in the treatment of HCV infections," said Kamel Besseghir, CEO
of Debiopharm S.A. "This unique mechanism of action is the first
alternative treatment to classic HCV therapies."



Debio 025



Debio 025 is a synthetic first-in-class Cyp inhibitor, being tested in
humans as a potential anti-HCV drug. Debio 025 binds strongly to Cyp, host
cell proteins thought to confer a replication advantage to HCV. Its potent
inhibitory activity on the HCV replication was shown in preclinical
studies.



Previous results of a phase Ib study demonstrate that Debio 025
monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10
reduction) in HIV-1/HCV co-infected patients. (Hepatology, Vol. 47, No 3,
2008, Flisiak et al. "The Cyclophilin Inhibitor Debio-025 Shows Potent
Anti-Hepatitis C Effect in Patients Coinfected with Hepatitis C and Human
Immunodeficiency Virus)."



About HCV



HCV is the most prevalent liver disease in the world and is considered
by the World Health Organization as an epidemic. Because HCV can infect a
patient for decades before being discovered, it is often called the
"silent" epidemic. Studies suggest that over 200 million people worldwide
are infected with HCV, an overall incidence of around 3.3% of the world's
population. In the US alone, nearly 4 million people are or have been
infected with HCV and of these, 2.7 million have an ongoing chronic
infection, the majority being between 40 to 60 years old. A fourfold
increase in the number of adults diagnosed with chronic HCV infection is
projected from 1990 to 2015, since most persons with chronic HCV infection
have yet to be diagnosed but are likely to come to medical attention in the
next decade.



About Debiopharm Group



Debiopharm Group is a global biopharmaceutical development specialist
that in-licenses promising biologics and small molecule drug candidates.
Debiopharm develops its products for global registration and maximum
commercial potential for out-licensing to pharmaceutical partners for sales
and marketing. Debiopharm independently funds the worldwide development of
all of its products while providing expertise in pre-clinical and clinical
trials, manufacturing, drug delivery and formulation, and regulatory
affairs.



Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm
has developed three products with global combined sales in excess of
US$2.65 billion in 2007.



For more information on Debiopharm Group, please visit:
http://www.debiopharm.com.


The Debiopharm Group

http://www.debiopharm.com

Every year, nearly 12,000 individuals in the United States and Canada, mostly young adults, sustain a spinal cord injury (SCI). According to the Centers for Diseases Control and Prevention (CDC), SCI costs an estimated $9.7 billion each year in the United States alone. Although there are some surgical interventions, such as decompression, which neurosurgeons administer to SCI patients after injury, these procedures have not dramatically improved overall recovery and outcome. "This is an area of medicine that has not seen tremendous scientific advances, so there remains an urgent need to improve upon current interventions to help restore neurological function in patients with acute SCI," said Michael Fehlings, MD, PhD, FRCSC, FACS, head of the Krembil Neuroscience Center at the University Health Network in Toronto and professor of Neurosurgery at the University of Toronto.


Surgical decompression of the spinal cord is often done after an injury occurs, although the timing of this intervention varies widely. Surgery involves the removal of various tissue or bone fragments that are compressing and comprising the spinal cord. Depending on the unique circumstances of the injury, decompression is accomplished through a variety of surgical approaches, including, for example, approaching the compressed cord from either the front (anterior) or back (posterior).


The role and timing of decompression in patients with SCI is controversial. Despite a strong biological rationale, the clinical data to support early decompression are unconvincing. Accordingly, researchers conducted a prospective multicenter study to evaluate the role and timing of decompressive surgery in a consecutive series of patients with cervical SCI. The Surgical Treatment of Acute Spinal Cord Injury Study (STASCIS) has enrolled 170 patients to date.


The findings of this study, A Prospective Multicenter Trial to Evaluate the Role and Timing of Decompression in Patients with Cervical Spinal Cord Injury: Initial One-Year Results of the STASCIS Study, will be presented by Dr. Fehlings, 10:25 to 10:39 a.m. on Monday, April 28, 2008, during the 76th Annual Meeting of the American Association of Neurological Surgeons in Chicago. Co-authors are Bizhan Aarabi, MD, Marcel Dvorak, MD, FRCSC, Charles G. Fisher, MD, FRCSC, James Harrop, MD, Stephen Lewis, MD, Eric M. Massicotte, MD, FRCSC, Y. Raja Rampersaud, MD, Christopher Shaffrey, MD, and Alexander Vaccaro, MD; FRCSC.


Patients with cervical SCI (American Spinal Injury Association (ASIA) grades A-D) and evidence on computed tomography (CT)/magnetic resonance imaging (MRI) of canal/cord compression were entered into the prospective multicenter nonrandomized case-control study. ASIA grade 'A' designates complete SCI, and Grades 'B' through 'D' designate decreasing levels of neurological involvement. Decompression was achieved by traction and/or surgery. Additional patient demographics were as follows:


-- Males: 78.1 percent, Females: 21.9 percent


-- Mean age 42.2 (±17.3)


-- SCI severity: ASIA A (43.6 percent), B (22.3 percent), C (16.0 percent), D (18.1 percent)


Patients were stratified into "early" (less than 24 hours) or "delayed" (greater than 24 hours) groups based on time to decompression. There were no significant differences in age, gender, or ASIA level or medical comorbidities between the early and delayed groups Outcomes were assessed using the ASIA system. Traction was used in 28.6 percent of patients in the early group and 21.1 percent of patients in the delayed group. To date, six-month and one-year follow-up has been obtained in 108 and 64 cases, respectively.


At six-month follow-up, 24 percent of the patients in the early decompression group had a two-grade or greater improvement in ASIA score compared to 4 percent in the delayed group (p=0.014). "The initial results from our STASCIS research suggest that decompression within 24 hours of injury may be associated with improved neurological recovery at one-year follow-up. However, further recruitment of patients with long-term follow-up is necessary to validate these promising results," stated Dr. Fehlings.


Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 7,200 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.


American Association of Neurological Surgeons (AANS)

5550 Meadowbrook Dr.

Rolling Meadows, IL 60008

United States

http://www.neurosurgerytoday.org

ROXRO PHARMA, Inc.
announced positive top-line data from a clinical study of the company's
novel investigational intranasal pain reliever in the treatment of migraine
and related symptoms.



The placebo-controlled proof of concept study evaluated the efficacy
and safety of ROX-828, an intranasal formulation of the non-steroidal
anti-inflammatory (NSAID) pain reliever ketorolac. Conducted at 17 sites in
Germany and Finland, the trial involved 68 patients who received ROX-828
and 72 patients who received placebo. The study was conducted on an
out-patient basis, with participants instructed to self-administer one dose
of study drug when they experienced a migraine attack.



"While in-depth analysis of the data is currently under way, we are
very excited about the positive response to ROX-828 among patients
suffering from migraine," said ROXRO's Chief Scientific Officer Roger
Whiting. "This is a condition for which rapid onset of action is very
important, and we believe this novel nasal formulation of ROX-828 may offer
a meaningful advantage for patients."



Migraine is a common recurring condition marked by severe, disabling
headaches that are often accompanied by nausea and vomiting. Up to 17
percent of women and 6 percent of men suffer from migraines, which can last
as long as 72 hours if untreated and have a significant impact on quality
of life and productivity. Current treatment options include oral NSAIDs and
triptan pain relievers, yet neither is either suitable or effective for all
migraine sufferers.



"Treating migraine with a potent NSAID in a nasal spray is a sound
scientific approach," said Dr. Volker Pfaffenrath, neurology specialist and
principal study investigator in Germany. "With this novel mode of NSAID
administration and ability to provide pain relief to migraine patients,
ROX-828 clearly merits further clinical investigation."



In the study, patients reported their pain levels at baseline and at
regular intervals (0.5, 1, 1.5, 2, 3, 4, 24, and 48 hours) and those
treated with ROX-828 showed a statistically significant improvement in pain
relief at all time points except 0.5 and 24 hours compared with those who
received placebo.



Statistically significantly more patients achieved pain-free status
with ROX-828 than placebo at 1.5, 3, 4, 24 and 48 hours. At two hours
following dosing, a self-reported measurement tool (the Patients' Global
Impression of Study Efficacy) showed statistically significantly better
results for patients receiving ROX-828 than placebo. Associated migraine
symptoms, including nausea and vomiting, also showed statistically
significant improvement when ROX-828 was compared to placebo at several
time points throughout the observation period.



ROX-828 was generally well-tolerated, with no difference in overall
adverse events between the ROX-828 and the placebo groups. The most common
side effects with ROX-828 were related to nasal irritation.



The analgesic ketorolac has been widely used in the hospital setting
either intravenously or as an intramuscular injection to treat
moderate-to-severe acute pain. ROXRO's clinical data show ROX-828 achieves
peak blood levels at least as fast as an intramuscular injection of
ketorolac without the inconvenience and discomfort of a needle.



"These early results represent an important milestone for our young
company and provide further validation of our strategy to focus on the
unmet needs of patients who suffer from various forms of pain," Dr. Whiting
said.



ROXRO also is developing ROX-888, a different investigational
intranasal formulation of ketorolac, for the treatment of
moderate-to-severe acute pain, such as post-operative pain. The Phase 3
clinical program for ROX-888 is completed, and ROXRO anticipates submitting
a New Drug Application with the U.S. Food and Drug Administration later
this year. If approved, ROX-888 would be the first non-opioid intranasal
analgesic indicated for the treatment of moderate-to-severe acute pain.



ABOUT ROXRO



ROXRO PHARMA, Inc., of Menlo Park, Calif., is a privately owned
specialty pharmaceutical company focused on the treatment of pain. Founded
in 1999, ROXRO in-licenses promising drug candidates for rapid development
in acute pain conditions. The company's highly experienced staff engages a
global network of external experts to conduct pre-clinical and clinical
studies and to manufacture drug products. ROXRO plans to submit an NDA with
the FDA for approval of its lead investigational compound, ROX-888 in 2008.



"Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995



Statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. The
inclusion of forward-looking statements, including those related to
expectations regarding clinical programs, potential business transactions,
product development, and potential benefits of our products and product
candidates, should not be regarded as a representation that any of our
plans will be achieved. Actual results may differ materially from those set
forth in this release due to the risks and uncertainties inherent in our
business, including, without limitation, risks and uncertainties related
to: our research and development efforts, including pre-clinical and
clinical testing; the timing of regulatory submissions and approvals; and
our need for and ability to raise additional capital. You are cautioned not
to place undue reliance on these forward-looking statements which speak
only as of the date hereof. We undertake no obligation to revise or update
this release to reflect events or circumstances that occur after the date
of this release.


ROXRO PHARMA, Inc.

http://www.roxropharma.com

Currently, the most common form of surgery for treating cervical degenerative disc disease is an anterior cervical discectomy and fusion (ACDF). More than 200,000 cervical procedures are performed each year in the United States to relieve compression on the spinal cord or nerve roots. Spinal fusion surgery creates a solid union between two or more vertebrae to help strengthen the spine and alleviate chronic neck pain. There are several types of spinal fusion surgery, as well as varied instrumentation used to secure the fusion.


The solid union created between the vertebrae stops the movement between the bones. While this treatment is effective in helping to reduce pain from motion and nerve root inflammation, the limited mobility of the neck may lead to the herniation of other discs over time.


In July 2007, the PRESTIGE ® cervical disc, a product of Medtronic, became the first and only artificial disc to date approved by the Food and Drug Administration (FDA) for use in the cervical spine. The PRESTIGE cervical disc underwent an FDA-approved multicenter clinical trial in the United States, concluding in 2005.


The PRESTIGE cervical disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from C3 to C7, for intractable radiculopathy and/or myelopathy. This is a stainless-steel device with a ball-in-trough design, held in place with bone screws.


While cervical artificial discs have been shown to preserve motion at the operated segment in most patients, their effectiveness in reducing the rate symptomatic adjacent disc problems has not been established; and although this technology is promising, the long-term safety and effectiveness of implanted metal alloys is unknown. Not all patients with symptomatic degenerative cervical disc disease are candidates, and as with all surgeries, there are related risks.


Researchers recently analyzed data on 541 patients who received either the PRESTIGE cervical disc or fusion. The results of this study, The Economic Impact of the Prestige® Cervical Disc System: Results from a Randomized Clinical Trial, will be presented by Vincent C. Traynelis, MD, (the University of Iowa), 9:45 to 9:59 a.m. on Tuesday, April 29, 2008, during the 76th Annual Meeting of the American Association of Neurological Surgeons in Chicago. Co-authors are Joseph Menzin, PhD (primary author), Bin Zhang, MD, Lisa M. Lines, BS (Boston Health Economics, Inc), Peter J. Neumann, ScD (Tufts Medical Center), and David W. Polly Jr., MD (the University of Minnesota).


Direct costs in 2006 US dollars, were defined as the sum of the costs of the initial surgery, secondary procedures, and medical devices. Based on the human capital approach, work productivity was estimated by multiplying the average daily wage by days of work after surgery. Net benefit was calculated as the gains in work productivity minus incremental medical costs. The following results were noted:


Overall, from a societal perspective, the net benefit of arthroplasty versus fusion was $5,988 at 2 years postsurgery.


-- The total direct cost per patient was $380 higher for arthroplasty patients than for fusion patients.


-- The mean initial procedure cost for the arthroplasty group was $947 higher than for the fusion group.


-- Because of fewer secondary procedures, the mean secondary procedure cost for arthroplasty patients was $567 lower than for fusion patients.


-- Arthroplasty patients returned to work following surgery an average of 38 days sooner than fusion patients, yielding a gain in work productivity of $6,368.


Arthroplasty patients had fewer secondary procedures and returned to work earlier than fusion patients. "From a societal perspective, the economic benefits associated with these outcomes may offset the increased device costs associated with arthroplasty therapy," stated Dr. Tryanelis.


Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 7,200 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.


Boston Health Economics, Inc. (BHE) is an independent research firm located in Waltham, Massachusetts. BHE was responsible for leading the economic evaluation for this clinical trial.


American Association of Neurological Surgeons (AANS)

5550 Meadowbrook Dr.

Rolling Meadows, IL 60008

United States

http://www.neurosurgerytoday.org

Synexus® has achieved a new record for an organisation, which recruits and runs clinical trials, with more than 10,000 patients currently enrolled in late stage clinical trials at 14 hub sites in six countries.


Synexus® has found that its hub site model is increasingly being taken up by the pharma industry as it dramatically reduces costs - often by a factor of 10 - increases the quality of the data and speeds up recruitment.


More than 25 clinical trials are presently being carried out at hub sites in the UK, Poland, Hungary, Bulgaria, India and South Africa, into a wide variety of therapeutic areas including osteoporosis, hypertension, cancer prevention, diabetes, sexual dysfunction, cardiac disease, urinary incontinence, migraine and osteoarthritis.


Michael Fort CEO of Synexus® commented, "We are really pleased to have achieved this milestone of 10,000 patients. We are hoping by next year we will have doubled this number as we increase the capacity of our existing hub sites and open new sites in the US and Eastern Europe. This expansion is being driven from industry which wants to reduce costs and professionalise the recruitment and running of late stage clinical trials."


Synexus® background


Synexus® which is headquartered in Chorley, Manchester, England, is the world's largest multi-national company dedicated to the recruitment and running of late stage clinical trials.


Synexus® recruits participants for clinical trials on behalf of pharmaceutical, biotech and CROs. The clinical trials are then run and managed by Synexus® at 14 hub sites across the UK, Poland, Hungary, Bulgaria, India and South Africa.


Synexus® is presently working with more than thirty different pharma companies on new studies including Pfizer, Merck, Novartis, AZ, GSK, Amgen, BI, Solvay, Daiichi-Sankyo, Astellas, Shire, Reckitt Benckiser, Servier and Abbott as well as with the major CROs Quintiles, PPD, Covance, Kendle and ICON.


Synexus® pioneered the running of clinical trials at hub sites as against the traditional method of contracting with primary care physicians, who on average only recruit and manage five patients each.

Synexus

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has initiated a Phase II study of its small-molecule thrombopoietin (TPO) mimetic, LGD-4665. The 24 patient, double-blind placebo-controlled trial is designed to evaluate the safety and efficacy of LGD-4665 in adult patients with idiopathic thrombocytopenic purpura (ITP) over six weeks of treatment.


LGD-4665 was found to be safe and well tolerated in a Phase I study in healthy human volunteers that was completed in the fourth quarter of 2007. Statistically significant platelet increases were observed with both single and multiple daily dose regimens.


"Initiation of this Phase II trial represents an important milestone in the continued development of LGD-4665. We are pleased to advance another Ligand molecule into studies for the treatment of an important medical disease. We plan to initiate additional clinical studies with LGD-4665 this year," said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "Our TPO drug program is focused on developing LGD-4665 for multiple indications as well as advancing clinically distinctive next generation molecules. We were also pleased to see that the March 2008 edition of R&D Directions magazine listed LGD-4665 among its '100 Great Investigational Drugs.'"


About Idiopathic Thrombocytopenic Purpura


ITP is a bleeding disorder characterized by increased autoimmune platelet destruction and/or inadequate platelet production. The cause of the disease is currently unknown. Some patients with ITP are asymptomatic or have mild bruising in skin or mucosa, while others develop mucosal or central organ bleeding that can become severe. There are approximately 50,000 to 100,000 chronic ITP patients in the U.S. A similar patient population exists in the European Union.


About Ligand Pharmaceuticals


Ligand discovers and develops new drugs that address critical unmet medical needs of patients in the areas of thrombocytopenia, cancer, hepatitis C, hormone-related diseases, osteoporosis and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology.


Forward-Looking Statements


This press release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties and reflect Ligand's judgment as of the date of this press release. These statements include those regarding data analysis and evaluation of LGD-4665, utility or potential benefits to patients, plans for continued development and further studies of LGD-4665 for the treatment of diseases associated with thrombocytopenia. Actual events or results may differ from our expectations. For example, there can be no assurance that other trials or evaluations of LGD-4665 or other TPO-related product candidates will be favorable or that they will confirm results of previous studies, that data evaluation will be completed or demonstrate any hypothesis or endpoint, that LGD-4665 or other TPO-related product candidates will provide utility or benefits to certain patients, that any presentations will be favorably received, that LGD-4665 or other TPO-related product candidates will be useful as a single agent or in combination with other drugs, that marketing applications will be filed or, if filed, approved, or that clinical or commercial development of these product candidates will be initiated, completed or successful or that our rights to LGD-4665 and other TPO-related product candidates will not be successfully challenged. Our stock price may suffer as a result of the failure of any trials to be completed or meet their endpoints or if any actual events differ from our expectations. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases as well as in public periodic filings with the Securities and Exchange Commission, available via http://www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Ligand Pharmaceuticals

Final results of the
IDEAL study, the first large, randomized, clinical study comparing the
leading therapies for chronic hepatitis C, were presented at the 43rd
Annual Meeting of the European Association for the Study of the Liver
(EASL), providing important insights that may help guide clinical practice
for physicians worldwide treating this serious and potentially
life-threatening disease.


The IDEAL study compared combination therapy with PEGINTRON. External link" target="_blank">INTRON. External link" target="_blank">INTRON(TM)
(peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) vs. Pegasys
(peginterferon alfa-2a) and Copegus (ribavirin, USP),(1) as well as a lower
dose of PEGINTRON in an investigational combination with REBETOL. The
results showed that sustained virologic response (SVR),(2) the primary
endpoint of the study, was similar for all three treatment regimens. The
study also showed in secondary analyses that PEGINTRON combination therapy
provided greater predictability of response at important treatment
milestones and significantly lower relapse rates after the end of treatment
than Pegasys and Copegus combination therapy, despite patients in the
Pegasys arm overall receiving a significantly higher median ribavirin dose
over the duration of the study. Safety and tolerability were similar among
the treatment arms.



"IDEAL provides important insights about the similarities and
differences of the two leading combination therapies for hepatitis C, and
how physicians can use these findings to help manage their patients," said
Robert J. Spiegel, M.D., chief medical officer and senior vice president,
Schering-Plough Research Institute.



In IDEAL (Individualized Dosing Efficacy vs. flat dosing to assess
optimaL pegylated interferon therapy), 3,070 previously untreated U.S.
patients with HCV genotype 1, the most common form of the virus worldwide
and most difficult to treat, were randomized and treated with one of three
treatment regimens:



(1) PEGINTRON 1.5 mcg/kg/week and REBETOL 800-1,400 mg/day;



(2) PEGINTRON 1.0 mcg/kg/week and REBETOL 800-1,400 mg/day; and



(3) Pegasys 180 mcg/week and Copegus 1,000-1,200 mg/day



Patients received up to 48 weeks of combination therapy with 24 weeks
of follow-up.



In IDEAL, the combination regimen of Pegasys and Copegus used the
recommended doses in accordance with their approved U.S. labeling, which
includes a flat dose of Pegasys (180 mcg/week) for all patients regardless
of body weight, and 1,000 or 1,200 mg/day of Copegus, adjusted for two
weight categories. PEGINTRON was dosed either at 1.5 mcg/kg/week or an
investigational combination dose of 1.0 mcg/kg/week with REBETOL at a dose
of 800-1,400 mg/day, adjusted by four weight categories.



As a result, 51 percent of patients in the study were assigned the same
dose of ribavirin (either REBETOL or Copegus) based on their weight groups,
39 percent of patients in the Pegasys arm were assigned a higher dose of
ribavirin and 10 percent of patients in the PEGINTRON arms were assigned a
higher dose of ribavirin.



Key Findings from IDEAL



(For the PEGINTRON 1.5 mcg, PEGINTRON 1.0 mcg, and Pegasys combination
arms, respectively.)



-- SVR, the primary endpoint of the study, was similar for the three
treatment regimens (40 vs. 38 vs. 41 percent, respectively) overall, and
among those patients who were assigned equivalent doses of ribavirin based
on their weight group (40 vs. 38 vs. 38 percent, respectively) (ITT).(3,4)



-- Predictability of response at early treatment milestones was
confirmed in a secondary analysis as an important assessment tool for
physicians. More patients in the PEGINTRON combination arms who had
undetectable virus (HCV-RNA) in plasma at treatment week 4 or treatment
week 12 went on to achieve SVR (positive predictive value, PPV) than
patients in the Pegasys combination arm (92 vs. 87 vs. 80 percent, and 81
vs. 83 vs. 74 percent, respectively).(5)



-- Relapse after the end of treatment was lower for patients in the
PEGINTRON combination therapy arms compared to patients receiving Pegasys
and Copegus (24 vs. 20 vs. 32 percent, respectively). In a multivariate
logistic regression analysis, among the factors significantly affecting
relapse were: baseline viral load greater than 600,000 IU/mL vs. less than
or equal to 600,000 IU/mL (p-value less than 0.001); age greater than 40
vs. less than or equal to 40 (p-value less than 0.001); fibrosis F3/4 vs.
F0/1/2 (p-value equal to 0.001); Pegasys regimen vs. PEGINTRON 1.0 mcg
regimen (p-value less than 0.001); glucose fasting greater than or equal to
5.6 vs. less than 5.6 (p-value equal to 0.002); steatosis 0 percent vs.
greater than 0 percent (p-value equal to 0.002); ALT normal vs. elevated
(p-value equal to 0.008); and Pegasys regimen vs. PEGINTRON 1.5 mcg regimen
(p-value equal to 0.012).



-- End of treatment response was higher in the Pegasys combination arm
(53 vs. 49 vs. 64 percent, respectively).



-- Ribavirin dose: One of the key questions of the study has been
whether the protocol-assigned ribavirin dose regimen or the
protocol-specified dose reduction schedule disadvantaged patients in any of
the treatment arms, particularly in the Pegasys combination arm. However,
the final results of IDEAL showed that the majority of patients in the
Pegasys therapy arm received a higher ribavirin dose over the duration of
the study, including patients with ribavirin dose reductions or
discontinuations, based on the actual median ribavirin dose received
(mg/kg/day), regardless of treatment outcome (SVR, relapsers and
nonresponders) [p-value less than 0.001 for ribavirin dose received in the
PEGINTRON 1.5 mcg arm vs. Pegasys arm and p-value less than or equal to
0.001 for ribavirin dose received in the PEGINTRON 1.0 arm vs. Pegasys
arm].



-- Safety and tolerability were similar among the three treatment
groups, with no new peginterferon or ribavirin related adverse events
identified in this large study. Overall adverse events reported for the
three treatment regimens were similar. As seen in other studies with these
treatments, a range of "flu-like symptoms" were the most commonly reported
adverse events for all three treatment regimens. Overall, the proportion of
patients reporting serious adverse events was similar (9 vs. 9 vs. 12
percent, respectively). Discontinuation rates due to adverse events were
similar across the three treatment arms (13 vs. 10 vs. 13 percent,
respectively) as were discontinuations due to psychiatric adverse events (3
vs. 2 vs. 2 percent, respectively).



The complete results of the IDEAL study will be submitted for
peer-reviewed publication, as well as to health authorities worldwide.



About IDEAL



The IDEAL study was undertaken by Schering-Plough as an important step
in meeting the needs of the hepatitis C medical and patient communities to
identify improved treatment strategies to optimize outcomes for patients.
IDEAL, a Phase IIIb, randomized, parallel-group study, was conducted at 118
academic and community centers across the United States. The study treated
3,070 adult patients with chronic HCV genotype 1. Of these, 82 percent of
patients had high viral load (greater than 600,000 IU/mL),(3) 11 percent
had grade F3/4 fibrosis/cirrhosis, and 19 percent were African Americans.
There were no significant differences in patient demographics or disease
characteristics across the three treatment arms.



The comparison of the two PEGINTRON combination therapy doses (1.5 vs.
1.0 mcg/kg/week) was conducted as a post-approval commitment to the U.S.
Food and Drug Administration (FDA). The comparison of the PEGINTRON and
Pegasys combination therapy regimens was added to the study because no
randomized, controlled head-to-head study of the two available
peginterferon regimens had been conducted to date. Cross-study comparisons
and retrospective analyses of previous data are difficult to interpret
because of differences in study designs, patient populations and assay
limits.



Mark Sulkowski, M.D., and John McHutchison, M.D., are the co-principal
investigators of the IDEAL study. They also are co-chairmen of the IDEAL
Publication Committee, which also includes three independent expert members
not associated with the study to provide an unbiased evaluation of the
data. The Publication Committee was responsible for the preparation of the
prespecified data analysis plan for the statistical analysis conducted for
the primary publication of the study results.



About PEGINTRON



In the United States, PEGINTRON is indicated for use alone or with
ribavirin for the treatment of chronic hepatitis C in patients with
compensated liver disease who have not been previously treated with
interferon alpha and who are at least 18 years of age.



Important Safety Information Regarding U.S. Labeling for PEGINTRON and
REBETOL



Alpha interferons, including PEGINTRON and INTRON(R) A, may cause or
aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic,
and infectious disorders. Patients should be monitored closely with
periodic clinical and laboratory evaluations. Patients with persistently
severe or worsening signs or symptoms of these conditions should be
withdrawn from therapy. In many, but not all cases, these disorders resolve
after stopping PEGINTRON and/or INTRON A therapy.



Use with Ribavirin: Ribavirin may cause birth defects and/or death of
the unborn child. Extreme care must be taken to avoid pregnancy in female
patients and in female partners of male patients. Ribavirin causes
hemolytic anemia. The anemia associated with REBETOL therapy may result in
a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and
should be considered a potential carcinogen.



Contraindications



PEGINTRON is contraindicated in patients with hypersensitivity to
PEGINTRON or any other component of the product, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in
cirrhotic CHC patients before or during treatment. INTRON A (Interferon
alfa-2b, recombinant) for Injection is contraindicated in patients with
hypersensitivity to INTRON A or any component of the product, autoimmune
hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in
combination with REBETOL therapy is additionally contraindicated in
patients with hypersensitivity to ribavirin or any other component of the
product, women who are pregnant, men whose female partners are pregnant,
patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell
anemia), and patients with creatinine clearance less than 50 mL/min.



Avoid Pregnancy



REBETOL therapy should not be started until a report of a negative
pregnancy test has been obtained immediately prior to planned initiation of
therapy. Extreme care must be taken to avoid pregnancy in female patients
and in female partners of male patients during therapy and 6 months
post-treatment. Patients should use at least two effective forms of
contraception and have monthly pregnancy tests during therapy and for 6
months after completion of therapy. A Ribavirin Pregnancy Registry has been
established to monitor maternal-fetal outcomes of pregnancies in female
patients and female partners of male patients exposed to ribavirin during
treatment, and for 6 months following cessation of treatment.



Incidence of Adverse Events



There are no new adverse events specific to PEGINTRON as compared to
INTRON A; however, the incidence of some (e.g., injection site reactions,
fever, rigors, nausea) were higher. The most common adverse events
associated with PEGINTRON were "flu-like" symptoms, occurring in
approximately 50% of patients, which may decrease in severity as treatment
continues. Application site disorders were common (47%), but all were mild
(44%) or moderate (4%) and no patient discontinued, and included injection
site inflammation and reaction (i.e., bruise, itchiness, irritation).
Injection site pain was reported in 2% of patients receiving PEGINTRON.
Alopecia (thinning of the hair) is also often associated with alpha
interferons including PEGINTRON.



Psychiatric adverse events, which include insomnia, were common (57%)
with PEGINTRON but similar to INTRON A (58%). Depression was most common at
29%. Suicidal behavior including ideation, suicidal attempts, and completed
suicides occurred in 1% of patients during or shortly after completing
treatment with PEGINTRON.



The following serious or clinically significant adverse events have
been reported at a frequency less than 1% with PEGINTRON or interferon
alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism,
hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis,
development or exacerbation of autoimmune disorders including thyroiditis,
RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea,
pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient
deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal
hemorrhages, and cotton wool spots.



In the PEGINTRON/REBETOL combination trial, the incidence of serious
adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in
the INTRON A/ REBETOL group. The incidence of severe adverse events in the
PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL
group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to
adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5
mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.



In a study with weight-based ribavirin, there was a higher rate of
anemia among patients in the weight-based dosing group (29%) compared to
the flat-dosing group (19%). The majority of these cases were mild and
responded to dose reductions. Serious adverse events were similar between
the two groups (12%), and discontinuations for adverse events (15% in
weight-based dosing and 14% in flat dosing) were also similar. Dose
modifications due to adverse events occurred more frequently in the
weight-based dosing group (29%) compared to the flat-dosing (23%) group.



Additional Safety Information



Relapse of drug addiction/overdose has occurred in patients on
PEGINTRON therapy. Aggressive behavior sometimes directed towards others
has occurred in patients with and without a previous psychiatric disorder
during PEGINTRON and/or INTRON A treatment and follow-up. If patients
develop psychiatric problems, including clinical depression, it is
recommended that patients be carefully monitored during treatment and in
the 6-month follow-up period. If psychiatric symptoms persist or worsen, or
suicidal ideation or aggressive behavior towards others is identified, it
is recommended that treatment with PEGINTRON and/or INTRON A be
discontinued, and the patient be carefully followed with psychiatric
intervention, as appropriate. Cases of encephalopathy have been observed in
some patients, usually elderly, treated with higher doses of PEGINTRON
and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events have been
observed in patients treated with interferon alpha therapies, including
PEGINTRON and INTRON A. Dental and periodontal disorders have been reported
in patients receiving PEGINTRON or INTRON A in combination with REBETOL
therapy.



Please see important full U.S. prescribing information and the
Medication Guide for PEGINTRON at http://www.schering-plough.com.



About Schering Plough



Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to "Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., and
its Web site is http://www.schering-plough.com.



SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the IDEAL study and the potential market for PEGINTRON and
REBETOL. Forward-looking statements relate to expectations or forecasts of
future events. Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results to
differ materially from Schering-Plough's forward-looking statements,
including market forces, economic factors, product availability, patent and
other intellectual property protection, current and future branded, generic
or over-the-counter competition, the regulatory process, and any
developments following regulatory approval, among other uncertainties. For
further details about these and other factors that may impact the
forward-looking statements, see Schering-Plough's Securities and Exchange
Commission filings, including Part I, Item 1A. "Risk Factors" in
Schering-Plough's 2007 10-K/A.


References


1. Pegasys and Copegus are registered trademarks of Hoffmann-La Roche Inc.
Please see the Pegasys and Copegus product inserts for information on
these products.


2. SVR, the protocol specified primary efficacy endpoint, is defined as
achievement of undetectable HCV-RNA in plasma at 24 weeks after the end
of treatment. Per protocol, if a patient did not have a 24-week post-
treatment assessment, the patient's 12-week post-treatment assessment
was utilized.


3. Roche Cobas Taqman 1.0 assay; lower limit of quantitation (LLQ) is 27
IU/mL.


4. Intention-To-Treat (ITT) analysis includes any patient who has taken at
least one dose of any study drug.


5. Sensitivity Analysis: Patients with missing data at follow-up week 24
are included in the analysis if treatment week 4 and treatment week 24
undetectable (HCV-RNA): PPVs at treatment week 4 were 94 vs. 91 vs. 89
percent for the PEGINTRON 1.5 mcg arm, PEGINTRON 1.0 mcg arm and Pegasys
arm, respectively.


Schering Plough Corporation

http://www.schering-plough.com


View drug information on INTRON, INTRON, INTRON