Pharmaceuticals, Inc. (Nasdaq: IDEV) announced positive results of the
ongoing Phase III extension study of SUPPRELIN(R) LA (histrelin acetate),
the only once-yearly subcutaneous implant for the treatment of central
precocious puberty or early onset puberty, at the Lawson Wilkins Pediatric
Endocrine Society (LWPES) Annual Meeting. This study evaluated the two-year
safety and efficacy of SUPPRELIN LA in children who received a second
implant following an initial year of therapy. The study found that
SUPPRELIN LA demonstrated continued profound hormone suppression with no
escapes (breakthrough of hormones) and led to continued decreases in rates
of growth, skeletal maturation and body mass index at 24 months compared to
12 months.
"This study confirms that SUPPRELIN LA maintains remarkable suppression
of peak hormone and sex steroid levels for two years in children with
central precocious puberty and that the removal of the first implant and
insertion of the second does not influence efficacy," said Gad Kletter, MD,
Head of Pediatric Endocrinology, Swedish Medical Center, Seattle, WA.
"While the frequent dosing of traditional injections may lead to issues
with long-term compliance, SUPPRELIN LA offers patients, families and
physicians a truly sustained treatment option that only requires action
once a year."
"Central precocious puberty can be a devastating condition physically,
psychologically and socially and is extremely difficult to manage," stated
Bobby Sandage, Jr., Ph.D., Executive Vice President, Research and
Development and Chief Scientific Officer, Indevus Pharmaceuticals. "We are
encouraged by these recent findings and hope they provide an added level of
comfort for patients and families using or considering using SUPPRELIN LA
for the treatment of central precocious puberty."
About the Study
The study was a multi-center, prospective extension study following an
initial 12 month Phase III trial. Thirty-one patients (29 girls and 2 boys)
aged 5 to 11 years opted to have a second implant placed. At all sites, a
pediatric surgeon removed the first implant and inserted a second during
the same procedure. Clinic visits occurred every six months, while GnRHa
stimulation tests were performed at one and 12 months following placement
of the second implant and bone ages were obtained annually. Primary outcome
was peak luteinizing hormone (LH), which helps regulate the menstrual cycle
and egg production in females, after GnRHa stimulation test.
Peak LH declined from 0.92 +/- 0.58 mIU/mL at 12 months to 0.51 +/-
0.33 mIU/mL at 24 months (p< 0.0001) in the naive group and from 0.74 +/-
0.50 mIU/mL at 12 months to 0.45 +/- 0.35 mIU/mL at 24 months (p = 0.0005)
in previously treated subjects. Growth velocity SD score decreased from
-0.42 +/- 2.40 during the first year to -1.75 +/- 3.05 during the second (p
= 0.0033). Mean BMI percentile declined from 90.56 +/- 14.98 at 12 months
to 88.00 +/- 19.63 at 24 months (p=0.0389). Continued prospective follow up
studies are needed to investigate long term effects of the SUPPRELIN LA
subcutaneous implant for the treatment of central precocious puberty.
About SUPPRELIN LA
SUPPRELIN(R) LA was approved by the U.S. Food and Drug Administration
(FDA) on May 3, 2007 and is a once-yearly implant which utilizes the
Company's patented HYDRON(R) Polymer Technology. The implant is inserted
subcutaneously in the inner aspect of the upper arm and is specifically
designed to provide a continuous release over 12 months of approximately 65
mcg/day of the gonadotropin releasing hormone agonist (GnRHa) histrelin to
reduce sex hormones and delay early puberty. SUPPRELIN LA is
contraindicated in patients with hypersensitivity to GnRH or GnRH analogs.
About Central Precocious Puberty
Central precocious puberty (CPP) is the premature development of
secondary sex characteristics that normally occur during puberty. In
females, premature development is usually defined as earlier than 8 years
of age, and in males, as earlier than 9 years of age. Children with CPP
have an increased likelihood of psycho-social problems and also show
significantly advanced bone age that can lessen their ability to attain
full adult height.
About the Lawson Wilkins Pediatric Endocrine Society
The Lawson Wilkins Pediatric Endocrine Society promotes the acquisition
and dissemination of knowledge of endocrine and metabolic disorders from
conception through adolescence. The Society has nearly 1000 members
representing the multiple disciplines of pediatric endocrinology. The
members are dedicated to research and treatment of children with endocrine
disorders; reproductive, bone, thyroid, diabetes, obesity, growth,
pituitary and adrenal. The Society works to ensure the continuing education
of its membership.
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the acquisition, development and commercialization of products
to treat conditions in urology and endocrinology. The Company's approved
products include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder,
VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central
precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The
Indevus development pipeline contains multiple compounds within the
Company's core therapeutic areas in addition to several partnered or
partnerable programs. The most advanced compounds in development include,
VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000
for the prevention of infection by HIV and other sexually-transmitted
pathogens, the octreotide implant for acromegaly, and a biodegradable
ureteral stent used in association with the adjunctive treatment of kidney
stones.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, this
press release contains forward-looking statements that involve risks and
uncertainties that could cause the Company's actual results and financial
condition to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties are set forth in
the Company's filings under the Securities Act of 1933 and the Securities
Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but
are not limited to: dependence on the success of SANCTURA, SANCTURA XR,
NEBIDO, VANTAS and SUPPRELIN LA; effectiveness of our sales force;
competition and its effect on pricing, spending, third-party relationships
and revenues; dependence on third parties for supplies, particularly for
histrelin, manufacturing, marketing, and clinical trials; risks associated
with being a manufacturer of some of our products; risks associated with
contractual agreements, particularly for the manufacture and co-promotion
of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS,
SUPPRELIN LA and VALSTAR; reliance on intellectual property and having
limited patents and proprietary rights; dependence on market exclusivity,
changes in reimbursement policies and/or rates for SANCTURA, SANCTURA XR,
VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by
the healthcare community of our approved products and product candidates;
uncertainties relating to clinical trials, regulatory approval and
commercialization of our products, particularly SANCTURA XR, NEBIDO, and
VALSTAR; product liability and insurance uncertainties; risks relating to
the Redux-related litigation; need for additional funds and corporate
partners, including for the development of our products; history of
operating losses and expectation of future losses; uncertainties relating
to controls over financial reporting; difficulties in managing our growth;
valuation of our Common Stock; risks related to repayment of debts; risks
related to increased leverage; general worldwide economic conditions and
related uncertainties; and other risks. Indevus undertakes no obligation to
publicly update any forward- looking statement, whether as a result of new
information, future events or otherwise.
Indevus Pharmaceuticals, Inc.
http://www.indevus.com
View drug information on Sanctura; Supprelin LA; Valstar.
