LEXINGTON, Mass., Sept. 30 IndevusPharmaceuticals, Inc. (Nasdaq: IDEV) today announced the initiation of a PhaseIII clinical trial of the Company's novel octreotide implant for acromegaly.This trial is designed to test the efficacy, safety and tolerability of theoctreotide implant in patients with acromegaly. The implant utilizes theCompany's patented HYDRON(R) Polymer Technology to deliver effective levels ofoctreotide for six months. Octreotide is a synthetic peptide that mimics thenatural hormone somatostatin to suppress release of growth hormone (GH).
Approximately 34 clinical sites in six countries are participating in thisopen-label Phase III trial. Participants in the trial will be randomized in a3:1 ratio to either the octreotide implant or monthly injections ofSandostatin(R) LAR(R) (S-LAR). The trial is expected to recruit approximately140 patients in the U.S. and Europe. Patients must be known responders,having well-maintained GH and insulin-like growth factor 1 (IGF-1) levels, tosomatostatin analogues and will be randomized to the octreotide implant orS-LAR. The primary efficacy endpoint of the Phase III trial is thesuppression of GH and IGF-1.
"Based on the results seen in our Phase II acromegaly studies, we arepleased to continue the clinical development of the octreotide implant inacromegaly", said Glenn L. Cooper, M.D., chairman and chief executive officerof Indevus. "Providing an improved treatment option to individuals who sufferwith this serious disease is an important milestone for both our octreotideprogram and our HYDRON(R) polymer technology. We expect that this single,large and well-controlled Phase III trial in acromegaly will serve as thebasis for U.S. and international marketing applications.
"This product represents a large commercial opportunity for the Company,"continued Dr. Cooper. "There are multiple indications in which octreotide isused, including acromegaly and carcinoid syndrome. The global somatostatinmarket was approximately $1.2B in 2007. In the U.S., the product will beperfectly aligned with our urology and endocrinology specialty sales andmarketing groups and, assuming a successful trial, could be launched in theU.S. in early 2011. In international markets we intend to seekcommercialization partners. We also plan to pursue other significantindications for the octreotide implant, particularly carcinoid syndrome. Weintend to begin a Phase II trial in carcinoid early next year."
Acromegaly is a chronic hormonal disorder that occurs when a pituitarytumor produces excess growth hormone, or GH. It most commonly affectsmiddle-aged adults, and if untreated, causes enlargement of certain bones,cartilage, muscles, organs and other tissues, leading to serious illness andpotential premature death. There are approximately 1,000 new acromegalypatients diagnosed per year and 18,000 total patients in the United States.
About Octreotide Implant
The Indevus octreotide implant is a proprietary formulation of octreotidein a six-month implant utilizing the Company's patented HYDRON(R) PolymerTechnology. The implant is inserted subcutaneously in the inner aspect of theupper arm and is specifically designed to provide a continuous release ofoctreotide, a long-acting octapeptide that mimics the natural hormonesomatostatin to suppress release of growth hormone (GH), over a six monthperiod.
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical companyengaged in the acquisition, development, and commercialization of products totreat conditions in urology and endocrinology. The Company's approved productsinclude SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) foradvanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, andDELATESTRYL(R) to treat male hypogonadism. The Indevus development pipelinecontains multiple compounds within the Company's core therapeutic areas inaddition to several partnered or partnerable programs. The most advancedcompounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R)for male hypogonadism, PRO 2000 for the prevention of infection by HIV andother sexually-transmitted pathogens, the octreotide implant for acromegalyand carcinoid syndrome, and pagoclone for stuttering.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, thispress release contains forward-looking statements that involve risks anduncertainties that could cause the Company's actual results and financialcondition to differ materially from those anticipated by the forward-lookingstatements. These risks and uncertainties are set forth in the Company'sfilings under the Securities Act of 1933 and the Securities Exchange Act of1934 under "Risk Factors" and elsewhere, and include, but are not limited to:dependence on the success of SANCTURA, SANCTURA XR, NEBIDO, VANTAS andSUPPRELIN LA; need for additional funds and corporate partners, including forthe development of our products; effectiveness of our sales force; competitionand 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 amanufacturer of some of our products; risks associated with contractualagreements, particularly for the manufacture and co-promotion of SANCTURA andSANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR;reliance on intellectual property and having limited patents and proprietaryrights; dependence on market exclusivity, changes in reimbursement policiesand/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL andany future products; acceptance by the healthcare community of our approvedproducts and product candidates; uncertainties relating to clinical trials,regulatory approval and commercialization of our products, particularlySANCTURA XR, NEBIDO, and VALSTAR; product liability and insuranceuncertainties; risks relating to the Redux-related litigation; history ofoperating losses and expectation of future losses; uncertainties relating tocontrols over financial reporting; valuation of our Common Stock; risksrelated to repayment of debts; risks related to increased leverage; generalworldwide economic conditions and related uncertainties; and other risks.Indevus undertakes no obligation to publicly update any forward-lookingstatement, whether as a result of new information, future events or otherwise.
SOURCE Indevus Pharmaceuticals, Inc.