IRVINE, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that the Company's generic drug manufacturing partner in India, J.B. Chemicals & Pharmaceuticals, Limited (Bombay Stock Exchange: JBCPL) has received United States Food and Drug Administration (FDA) approval to manufacture tablet dosage forms of drug products, including ciprofloxacin, at its pharmaceutical manufacturing facility at Panoli, Gujarat, India, for marketing in the United States, subject to approval of an Abbreviated New Drug Application (ANDA) by the FDA.
The FDA granted this status after it completed the inspection of JBCPL's manufacturing facility in the fourth quarter of 2003 and found it to be in compliance with current Good Manufacturing Practices (cGMP) standards and acceptable for the manufacture of drug products for the U.S. market. The inspection was triggered by the filing of an ANDA with the FDA for ciprofloxacin tablets by NeoJB, LLC, a joint venture between Spectrum Pharmaceuticals and J.B. Life Science Overseas Ltd, a subsidiary of J.B. Chemicals & Pharmaceuticals. Spectrum Pharmaceuticals filed a second ANDA through NeoJB in December 2003 for fluconazole tablets, an antifungal drug. Under the terms of the joint venture agreement, JBCPL will manufacture ciprofloxacin and fluconazole tablets and Spectrum will oversee marketing and distribution of the drugs in the United States. If approved by the FDA, Spectrum expects to generate revenue from sales of ciprofloxacin and fluconazole beginning in 2004 and 2005, respectively.
"The FDA's acceptance of the JBCPL manufacturing facility in Panoli marks an important milestone in implementing Spectrum's generic strategy," stated Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We believe that the FDA-approved manufacturing capabilities of our Indian partner confers an important competitive advantage as we seek to capitalize on the continued demand for high-quality generic drugs. We plan to continue to expand our generic drug portfolio and expect to file several additional ANDAs in 2004 through our relationships in India."
About J.B. Chemicals & Pharmaceuticals, Limited (JBCPL)
JBCPL is an internationally known pharmaceutical company headquartered in Mumbai, India. Today, its products are marketed in over 50 countries.
For more information on JBCPL, visit their website at http://www.uniquepharma.com/ .
About Spectrum Pharmaceuticals
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. 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 relationship with JBCPL, our generic business and its future, the generic drug industry, the capabilities of JBCPL, our ability to generate revenues or 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 existing or future drug 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, the possibility of changes to the demand for high quality generic drugs, a change in the effectiveness of our manufacturing partners in India, 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.