Indevus Pharmaceuticals Reports Positive Results of Phase II Octreotide Implant Trial
Company Plans to Initiate Phase III Program in First Half of 2008
LEXINGTON, Mass., Nov. 28 -- Indevus Pharmaceuticals, Inc. today announced positive results from its Phase II octreotide implant trial in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone (GH) and insulin- like growth factor 1 (IGF-1). The implant utilizes the Company's patented Hydron technology to deliver effective levels of octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to block release of GH. In the recently completed six-month trial, the octreotide implant effectively suppressed levels of GH and IGF-1 at rates similar to those seen with current FDA approved injectable formulations of octreotide. In addition, the drug was well tolerated.
"I am extremely pleased to report the successful completion of our octreotide implant trial and we are looking forward to the initiation of our Phase III program in the first half of 2008," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The market opportunity for a six-month octreotide implant for the treatment of acromegaly is substantial. The results of the trial demonstrate the potential of our octreotide implant, the only once every six month treatment, to improve the treatment options for people who suffer from this life-long debilitating condition. In addition, based on the successful results of this trial, we are exploring opportunities to expand our octreotide development program to address other indications where injectable formulations of octreotide are currently utilized, including carcinoid tumors."
The trial was an open-label study designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre- hydrated and non-hydrated (dry) implants and evaluated the suppression of growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5 ng/mL on entry into the study, indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH at this level in 94% of patients. This response rate is similar to the rate seen with Sandostatin(R) LAR(R) (83 to 97%). Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. Sandostatin LAR produces a similar age-adjusted normalization of IGF-1 concentrations (51 to 67%).
The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achieved suppression to <2.5 ng/mL. This response rate is similar to the rate seen from partial responders when treated with Sandostatin LAR (32% and 4% respectively).
All enrolled patients completed the six-month trial and there were no serious or severe adverse events reported.
The trial also confirmed by pharmacokinetic analysis that there was no difference in the predictable, steady release of octreotide from either the pre-hydrated or non-hydrated octreotide implants. The Company intends to utilize the non-hydrated (dry) octreotide implant in its Phase III program. The octreotide implant employs the same patented Hydron technology utilized in the Company's currently approved and marketed products SUPPRELIN(R) LA and VANTAS(R).
Acromegaly is a chronic hormonal disorder that occurs when a pituitary tumor produces excess growth hormone, or GH. It most commonly affect 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 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 block 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) XR and SANCTURA(R) 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, octreotide for acromegaly, 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(R), SANCTURA(R) XR, NEBIDO(R), VANTAS(R) and SUPPRELIN(R) LA; the early state of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR(TM); 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; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; changes in reimbursement policies and/or rates for SANCTURA, VANTAS, SUPPRELIN LA, DELATESTRYL(R) and any future products; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux- related litigation; the risk that the businesses of Indevus and Valera Pharmaceuticals, Inc. will not be integrated successfully during the period following the related merger; the risk that the cost savings and any other synergies from the merger may not be fully realized or may take longer to realize than expected; market acceptance for the merger and approved products; risks of regulatory review and clinical trials; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; the effect of changes in governmental regulations 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.