PURDUE FREDERICK MS CONTIN CONTINUED MARKETING

PURDUE FREDERICK MS CONTIN CONTINUED MARKETING will be allowed on a regular basis, Purdue Frederick VP-General Counsel Howard Udell told "The Pink Sheet" in a July 9 letter. "MS Contin will continue to be available to hospitals, physicians and patients through regular channels of commercial distribution and FDA will not interfere with such continued availability," Udell said. The letter corrected an FDA memo of a meeting between the agency and the firm. The memo described conditions for continued marketing of the Purdue Frederick sustained release morphine product. FDA issued the firm a regulatory letter earlier this year, contending MS Contin is a "new drug" requiring NDA approval. The FDA memo asserted that the firm would submit an NDA and a compassionate IND so that patients could receive the drug while the agency reviewed an NDA for the product ("The Pink Sheet" July 8, T&G-5). Udell explained that "FDA is of the opinion that MS Contin should be available to patients under a compassionate IND." Purdue Frederick, he added, "has not agreed that this is legally required or a feasible method of assuring continued availability of the product. Udell stated that "FDA and Purdue Frederick have agreed to discuss this matter," but "during the review process and during the continued discussions between Purdue Frederick and FDA" the product will be available through regular distribution channels. The Purdue Frederick exec noted that the firm has already submitted a regular IND to cover clinical research on MS Contin. Udell also pointed out that Purdue Frederick continues to maintain that MS Contin does not require NDA approval. "In an attempt to resolve our differences amicably Purdue Frederick has agreed to file an NDA notwithstanding its view that there is no legal requirement to do so," Udell said. PURDUE FREDERICK EXPLAINS MS CONTIN AGREEMENT WITH FDA Excerpted from a July 9 letter to "The Pink Sheet" from Purdue Frederick VP-General Counsel Howard Udell. 1. FDA adheres to its position that MS Continis a "new drug" requiring an NDA. 2. Purdue Frederick adheres to its position that MS Contin is an "old drug" not subject to new drug regulations. 3. In an attempt to resolve our differences amicably Purdue Frederick has agreed to file an NDA notwithstanding its view that there is no legal requirement to do so. 4. FDA has agreed to expeditiously review the NDA. 5. Purdue Frederick has agreed to file an IND to cover clinical research with MS Contin. This IND has already been filed. 6. FDA is of the opinion that MS Contin should be available to patients under a compassionate IND. Purdue Frederick has not agreed that this is legally required or a feasible method of assuring continued availability of the product. FDA and Purdue Frederick have agreed to discuss this matter. 7. During the review process and during the continued discussions between Purdue Frederick and FDA, MS Contin will continue to be available to hospitals, physicians and patients through regular channels of commercial distribution and FDA will not interfere withsuch continued availability.