Spectrum Pharmaceuticals Announces FDA Acceptance of ANDA Filing for Ciprofloxacin
IRVINE, Calif., May 9 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that the US Food and Drug Administration (FDA) has accepted for filing its Abbreviated New Drug Application (ANDA) for ciprofloxacin. The filing was made by the Company's NeoJB subsidiary on behalf of J.B. Chemicals & Pharmaceuticals, Ltd. (Bombay Stock Exchange: JBCPL). Upon approval of the ANDA and expiration of the patent in December 2003, JBCPL will manufacture ciprofloxacin and NeoJB will market the drug in the United States. The Company hopes to generate revenue from the sale of ciprofloxacin in 2004.
"We are pleased with the FDA acceptance of the ANDA filing for our first generic drug, ciprofloxacin," stated Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "This ANDA acceptance is a significant milestone in our ongoing effort to build Spectrum Pharmaceuticals' generic drug business. While we await the FDA's action on our application for ciprofloxacin, we are working on our distribution and marketing arrangements, as well as at least two more additional ANDA filings planned for this year."
Last year, Spectrum and JBCPL formed NeoJB LLC to enable Spectrum to benefit from JBCPL's high quality, lower cost drug manufacturing capabilities through the sale of JBCPL's generic drugs in the United States. JBCPL will benefit from Spectrum's skills in managing the regulatory and marketing functions in the United States. NeoJB LLC is an 80% and 20% joint venture of Spectrum and a subsidiary of J.B. Chemicals & Pharmaceuticals Ltd. respectively.
JBCPL is an internationally known pharmaceutical company headquartered in Mumbai, India. Today, its products are marketed and well accepted in over 50 countries and it has 12 manufacturing facilities producing a diverse range of high quality bulk drugs for domestic use and as a supplier to international markets. They also sell intermediates, pharmaceutical specialties, radio- diagnostics, herbal remedies and generic drugs. JBCPL produces and markets a family of herbal products under the "Doktor Mom" label. Doktor Mom is the brand leader among cough remedies in Russia, and has been awarded the Reader's Digest Most Trusted European Brand Award for the past two years. In addition, JBCPL is actively involved in the research and development of new drug products, such as JB-7/G a cox-II inhibitor, which is expected to enter clinical development in the United States as an anti-inflammatory. For more information on JBCPL visit their website at 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. 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, 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 risks 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