September 30, 2008
Indevus Announces Initiation of Phase III Clinical Trial of Octreotide Implant for Acromegaly
LEXINGTON, Mass., Sept. 30 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced the initiation of a Phase III clinical trial of the Company's novel octreotide implant for acromegaly. This trial is designed to test the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly. The implant utilizes the Company's patented HYDRON(R) Polymer Technology to deliver effective levels of octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to suppress release of growth hormone (GH).
Approximately 34 clinical sites in six countries are participating in this open-label Phase III trial. Participants in the trial will be randomized in a 3:1 ratio to either the octreotide implant or monthly injections of Sandostatin(R) LAR(R) (S-LAR). The trial is expected to recruit approximately 140 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, to somatostatin analogues and will be randomized to the octreotide implant or S-LAR. The primary efficacy endpoint of the Phase III trial is the suppression of GH and IGF-1."Based on the results seen in our Phase II acromegaly studies, we are pleased to continue the clinical development of the octreotide implant in acromegaly", said Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Providing an improved treatment option to individuals who suffer with this serious disease is an important milestone for both our octreotide program and our HYDRON(R) polymer technology. We expect that this single, large and well-controlled Phase III trial in acromegaly will serve as the basis 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 is used, including acromegaly and carcinoid syndrome. The global somatostatin market was approximately $1.2B in 2007. In the U.S., the product will be perfectly aligned with our urology and endocrinology specialty sales and marketing groups and, assuming a successful trial, could be launched in the U.S. in early 2011. In international markets we intend to seek commercialization partners. We also plan to pursue other significant indications for the octreotide implant, particularly carcinoid syndrome. We intend to begin a Phase II trial in carcinoid early next year."
Acromegaly is a chronic hormonal disorder that occurs when a pituitary tumor produces excess growth hormone, or GH. It most commonly affects middle-aged adults, and if untreated, causes enlargement of certain bones, cartilage, muscles, organs and other tissues, leading to serious illness and potential premature death. There are approximately 1,000 new acromegaly patients diagnosed per year and 18,000 total patients in the United States.
About Octreotide Implant
The Indevus octreotide implant is a proprietary formulation of octreotide in a six-month implant utilizing 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 of octreotide, a long-acting octapeptide that mimics the natural hormone somatostatin to suppress release of growth hormone (GH), over a six month period.
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 carcinoid syndrome, and pagoclone for stuttering.
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; need for additional funds and corporate partners, including for the development of our products; 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; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; 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.
CONTACT: Michael W. Rogers, EVP and Chief Financial Officer,+1-781-861-8444, or Robin L. DeCarlo, Director, Corporate Communications,+1-781-402-3405, both of Indevus Pharmaceuticals, Inc.
Web site: http://www.indevus.com/