Healthcare Industry News: NEBIDO
News Release - May 31, 2007
Indevus Announces Authorization for Approval of VANTAS(R) in Selected European CountriesLEXINGTON, Mass., May 31 (HSMN NewsFeed) -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) today announced that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has finalized the referral procedure for VANTAS® (histrelin acetate subcutaneous implant).
Following approval in Denmark in 2005, Indevus filed for Mutual Recognition Procedure (MRP) in the UK, Ireland, Germany, Spain and Italy. The action by the CHMP allows for marketing authorization to occur in these countries.
"We are very excited to have received marketing authorization for VANTAS in these five European countries," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "We plan to complete the process of obtaining final marketing authorization over the next few months and to begin MRP for the remaining countries in the European Union."
Additionally, Indevus announced that following the acquisition of Valera, the Company met with Spepharm Holding B.V., Valera's European marketing partner for both VANTAS and SUPPRELIN® LA, and the companies have mutually agreed to terminate their current Investment and Shareholder Agreement, as well as, their current European License and Distribution Agreement. The finalization of this termination is subject to certain third-party consents.
"Both companies have determined that it is in their best interest to terminate these agreements," stated Noah D. Beerman, executive vice president, chief business officer of Indevus. "Regaining the European rights facilitates the achievement of our overall partnering strategy while Spepharm has refocused its commercialization efforts in other therapeutic areas. Consistent with our strategy of utilizing partners for marketing and distribution outside the U.S., we are actively engaged in discussions with potential European partners, regarding the marketing and distribution rights for VANTAS. This represents one of a number of opportunities for the Company to expand its marketing reach outside of the United States."
Separately, the Company announced that it has also begun shipment of initial commercial supplies of VANTAS to South America and Asia following recent approvals in Argentina and Thailand.
About Prostate Cancer
Prostate cancer is the most common cancer for men and the second leading cause of cancer deaths in men. According to the American Cancer Society, every year approximately 200,000 men in the U.S. are diagnosed with prostate cancer and 30,000 die from this disease. The National Cancer Institute's SEER Program and the National Oncology Database each project that this patient group will grow at an annual rate of 2% to 3% per year through 2008 and beyond. In the EU, prostate cancer is the fourth most commonly diagnosed cancer with an estimated 157,400 men diagnosed in 2000. According to IMS data, the LHRH market in Europe is over $1 Billion.
VANTAS® is a soft and flexible 12-month hydrogel implant that provides histrelin, a luteinizing hormone-releasing hormone (LHRH) agonist, for the palliative treatment of advanced prostate cancer. VANTAS is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any components in VANTAS.
Complete prescribing information for VANTAS is available from the Company upon request.
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® for overactive bladder, VANTAS® for advanced prostate cancer, and DELATESTRYL® to treat male hypogonadism, all of which are currently marketed, as well as SUPPRELIN® LA, which was recently approved for central precocious puberty. 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 SANCTURA XR(TM), the once-daily formulation of SANCTURA, VALSTAR® for bladder cancer, NEBIDO® for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, 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(TM), NEBIDO®, VANTAS® and SUPPRELIN®-LA; the early state of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, VANTAS®, SUPPRELIN®-LA and VALSTAR®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS 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, DELATESTRYL 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.
Source: Indevus Pharmaceuticals
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