Spectrum Pharmaceuticals and FDC Ltd. Enter Into Generic Drug Marketing and Supply Agreement
"We are very excited about entering into a partnership with Spectrum to bring high quality, affordable eye-care alternatives to patients in the United States," stated Nandan Chandavarkar, Executive Director of FDC Ltd. "Our Company finds the United States generic ophthalmic and otic market attractive and underserved. We have been impressed with the rapid progress that Spectrum has made in filing ANDAs with the FDA and building its base in the generic business. With our manufacturing capabilities and Spectrum's knowledge of the U.S. pharmaceutical market, we believe we have a formula for success."
Prescription sales for eye care pharmaceuticals in the U.S. exceed $2 billion and continue to grow with the aging population. "FDC has six decades of experience of manufacturing high quality ophthalmic and other products, and we are pleased to have the opportunity to help bring their products to patients in the United States," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We have already identified products that we plan to begin work on immediately, and expect to expand the list of partnered products as we move forward with the development and approval of our initially selected drugs. This diversification into the eye care segment is consistent with our overall Company strategy of focusing on specialty markets where there is relatively limited competition."
Under the terms of the agreement, Spectrum has exclusive rights to market and distribute products, mutually agreed upon by both parties, in the United States. Initially, the agreement calls for ophthalmic products with plans for expanding the list. FDC will manufacture and conduct the necessary tests for approval of the products, and Spectrum will be responsible for all regulatory, marketing and distribution matters in the United States. Spectrum and FDC expect that at least two ANDA filings with the U.S. Food and Drug Administration on behalf of FDC will occur during 2004.
FDC (Bombay Stock Exchange: FDC) manufactures ophthalmic and otic drugs in unit and multi-dose packages as well as select active bulk ingredients (API's) at a U.S. FDA approved plant in Roha, India. The bulk drugs manufactured at this plant are either exported (more than 80% of the production) or formulated into finished drug products at the Company's plants in Mumbai, Goa, Nasik and Aurangabad. The Company's modern plant in Goa commenced commercial production in September 2000, and was designed to meet MHRA/EU GMP/FDA standards. The Company is also setting up a second manufacturing plant at a separate site in Goa, which will provide additional capabilities with quality systems meeting the highest International (ISO) GMP Standards. Scale-up runs and commercial production are expected to commence in March 2004.
Spectrum Pharmaceuticals' primary focus is to develop in-licensed drugs for the treatment and supportive care of cancer patients. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG, which has been granted fast-track status by the U.S. FDA. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. Eoquin is being studied in the treatment of superficial bladder cancer, and may have applications as a radiation sensitizer. The Company is actively working to develop, seek approval for and oversee the marketing of generic drugs in the U.S. Spectrum filed two ANDAs with the FDA earlier this year. If approved by the FDA, the Company may have revenues as early as 2004. The Company also has a pipeline of pre-clinical neurological drug candidates for disorders such as attention-deficit hyperactivity disorder, schizophrenia, mild cognitive impairment and pain, which it is actively seeking to out- license or co-develop. For additional information, visit the Company's web site 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 relationship with FDC Limited and the expected products or market size and market share for products intended for development by Spectrum and FDC, as well as any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include our limited experience with the generic drug industry, our lack of revenues and need for additional financing, the possibility that our existing drug product candidates and those of FDC may not be approved by the FDA, our limited experience in establishing strategic alliances, and other risks that are described in further detail in our reports filed with the Securities and Exchange Commission.
For further information please contact: Rajesh C. Shrotriya, M.D., CEO and President of Spectrum Pharmaceuticals, Inc., +1-949-788-6700, ext. 295.