LEXINGTON, Mass., April 3, 2008 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced the signing of a License, Supply and Distribution Agreement with Orion Corporation granting Orion the rights to market VANTAS(R) (histrelin acetate subcutaneous implant) throughout Europe as well as certain other countries. VANTAS is a 12-month implant for the treatment of advanced prostate cancer which was launched in the U.S. in November 2004 and was approved for use in Denmark in 2005 and in the UK in 2007. VANTAS is currently undergoing the mutual recognition procedure for further European approvals. The VANTAS implant utilizes the Indevus patented HYDRON(R) polymer technology.
Under the terms of the agreement, Orion will pay Indevus a $7 million up-front payment and various contingent payments related to approvals and sales thresholds which total up to $14 million. Additionally, Indevus has agreed to supply VANTAS to Orion at a pre-determined transfer price subject to annual minimum purchase requirements beginning in 2009.
“We are extremely pleased to be partnering with Orion for the sales and distribution of VANTAS in Europe,” stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. “The European market opportunity for VANTAS is potentially greater than the current U.S. opportunity and having a partner with the capabilities of Orion will enable us to effectively address this market.”
Dr. Liisa Hurme, Senior VP heading Orion’s Proprietary Products business said, “We are very excited to bring VANTAS to the European market. As the only approved implant for the treatment of advanced prostate cancer, VANTAS is a highly differentiated product and should be a compelling option for patients and physicians.”
About VANTAS(R)
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.
Prescribing Information
Complete prescribing information for VANTAS(R) is available from the Company upon request.
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 Europe, prostate cancer is the fourth most commonly diagnosed cancer with an estimated 242,960 men diagnosed in 2006. According to IMS data, the LHRH market in Europe is over $1 Billion.
About Indevus Pharmaceuticals, Inc.
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 XR(TM) 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.
About Orion Corporation (http://www.orion.fi)
Orion is a European pharmaceutical and diagnostics company which emphasises the development of innovative medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets pharmaceuticals for humans and animals, active pharmaceutical ingredients as well as diagnostic tests. Orion’s clientele consists mainly of healthcare service providers and professionals. The Group’s net sales in 2007 were EUR 683.6 million and in the end of 2007 there were about 3,170 employees working for the Group. Orion’s shares are listed on the OMX Nordic Exchange Helsinki (ORNAV, ORNBV).
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; 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; need for additional funds and corporate partners, including for the development of our products; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; difficulties in managing our growth; 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.
CONTACT: Michael W. Rogers, Executive Vice President and CFO,
+1-781-861-8444, or Brooke D. Wagner, VP, Corp. Communications,
+1-781-402-3410, both of Indevus Pharmaceuticals, Inc.
Web site: http://www.indevus.com/
http://www.orion.fi/
