US FDA acceptance of Spectrum's ciprofloxacin ANDA triggers milestone payment
Spectrum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) acceptance of the Abbreviated New Drug Application (ANDA) for ciprofloxacin by the Company's NeoJB subsidiary has triggered a $250,000 investment by a strategic investor. Upon approval of the ANDA, an additional $750,000 investment will be triggered. The Company hopes to generate revenue from the sale of ciprofloxacin in 2004.
On February 7, 2003, Spectrum entered into an agreement with a strategic investor who agreed to invest $1 million in Spectrum Pharmaceuticals to support the Company's emerging generic drug business. The investment is subject to the achievement of two milestones, both of which relate to the first Abbreviated New Drug Application (ANDA) filed by Spectrum with the U.S. Food and Drug Administration (FDA) in January 2003. The investor has agreed to purchase $250,000 of unregistered Spectrum common stock upon approval of the currency transfer by the Reserve Bank of India. The investor has agreed to purchase an additional $750,000 of unregistered Spectrum common stock upon approval of this ANDA by the FDA. The purchase prices in the transactions will be at the closing price of Spectrum stock on the day prior to acceptance and approval, respectively. The investor will not receive warrants.
"We are pleased to have achieved the first milestone in this agreement, and we expect to achieve the second, so that we can move to realize some of the significant revenue opportunities that we see from being a high quality, low-cost supplier in the growing U.S. generic drug market," stated Rajesh C. Shrotriya, chairman, chief executive officer and president of Spectrum Pharmaceuticals, Inc. "This investment should help accelerate and expand our generic drug business, and we appreciate the investor's confidence in our potential."