Indevus Announces Authorization for Approval of VANTAS(R) in Selected European Countries
- Category: Proteins and Peptides
- Published on Friday, 01 June 2007 04:00
- Hits: 1861
LEXINGTON, MA, USA | May 31, 2007 | 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(R) (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(R) 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(R) 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.
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) for overactive bladder, VANTAS(R) for advanced prostate cancer, and DELATESTRYL(R) to treat male hypogonadism, all of which are currently marketed, as well as SUPPRELIN(R) 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(R) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and pagoclone for stuttering.
SOURCE: Indevus Pharmaceuticals, Inc.