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Spectrum Pharmaceuticals (SPPI) Announces Filing Of ANDA For Fluconazole With The FDA


10/19/2005 5:09:33 PM

IRVINE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for fluconazole tablets. The filing was made by NeoJB, LLC, a joint venture between Spectrum Pharmaceuticals and J.B. Life Science Overseas Ltd a subsidiary of J.B. Chemicals & Pharmaceuticals, Limited (Bombay Stock Exchange: JBCPL). Under the terms of the agreement, JBCPL will manufacture fluconazole tablets and NeoJB will oversee marketing and distribution of the drug in the United States. If approved by the FDA, Spectrum expects to generate revenue from sales of fluconazole in 2005.

Fluconazole is currently marketed by Pfizer under the brand name Diflucan(R) and is used to treat various fungal infections. According to industry sources, annual sales of Diflucan(R) tablets in the U.S. are estimated to be in excess of $500 million.

"We continue to make rapid progress in implementing our generic strategy," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "By filing the ANDA for fluconazole, our third ANDA this year, we met yet another important milestone that we set for 2003. With the recent addition of two industry veterans, with a combined experience of participating in filing over 125 ANDAs and launch of multiple generic drugs at leading drug companies, and our partner's experience as a leader in launch of multiple Generic Drugs in India and other countries, we believe we are well positioned to continue to broaden our generic drug portfolio. To this end, we expect to file in 2004 several additional ANDAs, including at least two for ophthalmic products, through our relationships in India. We plan to use any revenue realized from our generic business to continue to advance our existing late-stage oncology product candidates as well as to expand our pipeline through the acquisition of additional late- stage compounds."

Spectrum Pharmaceuticals, filed two ANDAs earlier this year for ciprofloxacin and carboplatin injection that, if approved, could generate revenue in 2004 and 2005, respectively.

JBCPL is an internationally known pharmaceutical company headquartered in Mumbai, India. Today, its products are marketed and well accepted in over 50 countries. For more information on JBCPL, visit their website at http://www.uniquepharma.com/ .

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, and 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(TM) 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 is also seeking to out-license its pipeline of neurological drug candidates for disorders such as attention-deficit hyperactivity disorder, schizophrenia, mild cognitive impairment and neuropathy. For additional information, including SEC filings, visit the Company's web site at http://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, to the prospects for approval of our ANDAs, our expectations regarding generating revenues from our generics business, the expected market size for fluconazole, capabilities of our strategic partners, our ability to achieve profitability, 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, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our management's limited experience working together 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: Rajesh C. Shrotriya, M.D., CEO and President of Spectrum Pharmaceuticals, Inc., +1-949-743-9295.

Spectrum Pharmaceuticals, Inc.

CONTACT: Rajesh C. Shrotriya, M.D., CEO and President of SpectrumPharmaceuticals, Inc., +1-949-743-9295


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