Spectrum Pharmaceuticals Announces Filing of ANDA for Carboplatin With the FDA
Tuesday October 14, 8:00 am ET
IRVINE, CA--(MARKET WIRE)--Oct 14, 2003 -- Spectrum Pharmaceuticals, Inc. (NasdaqSC:SPPI ) today announced the filing of an Abbreviated New Drug Application (ANDA) for carboplatin injection with the U.S. Food and Drug Administration. Upon approval of the ANDA and expiration of the patent, Spectrum will oversee the manufacturing and marketing of the drug in the United States.
"Filing of the carboplatin injection ANDA marks the next step in our generic strategy," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We plan on making one additional ANDA filing this year, and between three to five filings during 2004 as we broaden our generic drug portfolio and expand our potential sources of revenue."
Carboplatin is a platinum-based, anti-cancer drug marketed by Bristol-Myers Squibb. The exclusivity on carboplatin injection expires in 2004. Carboplatin sales in the United States continue to grow and are estimated to be in excess of $600 million annually, as the drug is heavily used in the treatment of a wide variety of tumor types.
In January 2003, Spectrum filed its first ANDA through its subsidiary NeoJB for ciprofloxacin. NeoJB's ciprofloxacin will be manufactured by JB Chemicals & Pharmaceuticals, Ltd., Spectrum's joint venture partner in NeoJB. The ciprofloxacin ANDA was accepted by the US FDA in March 2003, and is currently being reviewed by the agency. In August 2003, the Company signed a distribution and marketing agreement with Lannett Company, Inc. for ciprofloxacin. Spectrum plans to begin selling ciprofloxacin through Lannett upon approval of the ANDA and expiration of the ciprofloxacin patent. The Company expects to generate revenue from ciprofloxacin during 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 United States Food and Drug Administration. 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 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 about the Company, 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 the prospects for approval of our ANDA's, our expected schedule for generating revenues from ciprofloxacin, the expected market size for carboplatin and 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 the possibility that our products may not receive approval from the FDA in a timely manner or at all, announcements of new products by our competitors, our lack of revenues and need for additional financing, the possibility that our existing drug product candidates may not prove to be safe or effective, our limited experience in establishing strategic alliances, our limited experience with the generic drug industry and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
For further information, please contact:
Spectrum Pharmaceuticals, Inc.
(949) 788-6700, ext. 247