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BIOPHARMACEUTICS CLEARED TO SHIP DRUGS NOV. 19

Executive Summary

BIOPHARMACEUTICS CLEARED TO SHIP DRUGS NOV. 19 after an FDA inspection completed that day found the company's Bellport, N.Y. facility to be in compliance with current Good Manufacturing Practices (cGMPs). On Nov. 22, the generic drug company began shipping five OTC products; 80 mg chewable acetaminophen tablets in fruit and grape flavor, 500 mg acetaminophen tablets and caplets and 50 mg dimenhydrinate tablets. Biopharm expects to submit 15 additional OTC and prescription products to FDA for clearance in 1994. The 20 products constituted 90% of Biopharmaceutics' sales volume of manufactured goods before FDA obtained a temporary restraining order in November 1991 prohibiting the firm from manufacturing any generics because of GMP violations at the facility ("The Pink Sheet" Nov. 11, 1991, T&G-6). The temporary restraining order was followed by a consent decree in late November 1991 under which the firm was required to have an independent consultant verify GMP compliance at the Bellport facility ("The Pink Sheet" Nov. 25, 1991, p. 7). In July, Biopharmaceutics agreed to pay $350,000 to settle a Justice Department investigation into submission of false R&D information on ANDAs for clindamycin 150 mg capsules, carisoprodol with aspirin and chlorzoxazone 500 mg tablets ("The Pink Sheet" July 12, T&G-13). Former company VP Abu Quamruzzaman, was sentenced Oct. 14 to nine months in prison after pleading guilty in July to submitting the false ANDA information for clindamycin 150 mg capsules ("The Pink Sheet" Nov. 8, T&G-21). Biopharmaceutics announced Nov. 19 that the firm has completed the acquisition of Mitolactol (dibromodulcitol, DBD) from Amswiss. The deal was announced initially on Jan. 30. DBD is a peptide displaying anti-tumor activity. Biopharmaceutics also acquired two anti-sense oligonucleotides from AmSwiss. DBD, which has an orphan designation, is in Phase III clinical trials in Europe and the U.S. for cervical cancer. As part of the deal, AmSwiss received 4 mil. restricted common shares and warrants to purchase an additional 2 mil. restricted shares of Biopharm at $2 per share. On Nov. 3, Biopharmaceutics announced that its wholly-owned subsidiary, Anti-Sense Technologies purchased a 50% ownership of KKKI-538, an anti-sense oligonucleotide compound, from the Central Research Institute of the Hungarian Academy of Sciences (CRIC). The company said that during a 30-day test period KKKI-538 induced complete irreversible inhibition of HIV virus production in human cell cultures. Safety tests for acute infection, inhibition assays in chronically infected cells and cell toxicity studies in chronically infected human embryo fibroblasts are currently under way at the Medical University of Debrecen in Hungary. The studies are expected to be completed by Feb. 10. Under the terms of the deal, Biopharmaceutics has agreed to pay CRIC $100,000 in November, $1.7 mil. on Feb. 15, and $3.2 mil. in four $800,000 installments over the next year.
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