Two Year Study Confirms Supprelin LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty
LEXINGTON, Mass., May 05, 2008 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. 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.
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.
Contact: Michael W. Rogers Brooke D. Wagner Executive Vice President and CFO VP, Corp. Communications (781) 861-8444 (781) 402-3410
CONTACT: Michael W. Rogers, Executive Vice President and CFO,+1-781-861-8444, or Brooke D. Wagner, VP, Corp. Communications,+1-781-402-3410, both of Indevus Pharmaceuticals, Inc.
Web site: http://www.indevus.com/
Ticker Symbol: (NASDAQ-NMS:IDEV)
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Posted: May 2008