IRVINE, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that its licensor for ozarelix, AEterna Zentaris, has entered into a licensing and collaboration agreement with Nippon Kayaku for the fourth generation luteinizing hormone-releasing hormone (LHRH) antagonist, ozarelix. Under the terms of the agreement, Nippon Kayaku has an exclusive license to develop and market ozarelix for all potential oncological indications in Japan. In return, the licensor is to receive an upfront payment upon signature, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to low double- digit royalties on potential net sales. Under its license agreement with AEterna Zentaris, Spectrum is entitled to receive fifty percent of the upfront and milestone payments and royalties AEterna Zentaris' receives under this agreement with Nippon Kayaku.
"This strategic alliance is another step towards recognizing our risk- reduced business model," stated Dr. Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum. "In addition to the financial benefit we shall receive, an agreement with Nippon Kayaku, a key player in the Japanese oncology market, is important validation of the potential of ozarelix."
About Ozarelix and the Development Alliance with AEterna Zentaris
Ozarelix is a fourth generation Luteinizing Hormone Releasing Hormone LHRH antagonist administered as a long-acting formulation that is being studied as a treatment for hormone-dependent prostate cancer and benign prostatic hypertrophy. In August 2004, Spectrum received an exclusive license from AEterna Zentaris to develop and market ozarelix for all potential indications in North America (including Canada and Mexico) and India. In addition, Spectrum will share with AEterna Zentaris upfront and milestone payments, royalties or profits from sales of the product in Japan.
About Nippon Kayaku
Founded in 1916, Nippon Kayaku is a leading Japanese pharmaceutical, agriculture, and chemical company with over US $1.4 billion in revenues. In their Pharmaceutical Division, they manufacture and sell anti-cancer drugs, cardiovascular drugs, immunosuppressants, and other pharmaceuticals and diagnostics for prescription. In the anti-cancer drug field more specifically, they offer a line-up of 17 branded anti-cancer drug products, and are at the top level worldwide both in terms of technology and business performance. They are working with cutting-edge technologies, and have recently entered the clinical phase in development of DDS (Drug Delivery System) pharmaceuticals utilizing nanotechnology.
Spectrum Pharmaceuticals is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at www.spectrumpharm.com.
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire and develop its portfolio of drug candidates, the Company's promising pipeline, that Spectrum will receive a financial benefit from the license, ozarelix' ability to treat hormone-dependent prostate cancer and benign prostatic hypertrophy, that the strategic alliance is another step towards recognizing our risk- reduced business model and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. The information included under About Nippon Kayaku was provided to us by AEterna Zentaris and has not been independently verified.
Rajesh C. Shrotriya, M.D.
Chairman, CEO & President
Sr. VP, Chief Business Officer
Spectrum Pharmaceuticals, Inc.