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SANDOZ DYNACIRC CALCIUM CHANNEL BLOCKER CLEARED FOR U.S.

Executive Summary

SANDOZ DYNACIRC CALCIUM CHANNEL BLOCKER CLEARED FOR U.S. marketing on Dec. 20 for the treatment of mild to moderate hypertension. Approval comes five years after the NDA was originally submitted in December 1985. The twice-daily antihypertensive was given a "1-C" rating (new chemical entity with little or no therapeutic gain); the drug will try to find a position in a market with five major brands and two standard-release products available as generics. Sandoz says a launch is expected "in the near future." DynaCirc is the subject of a co-promotion agreement between Sandoz and Glaxo's Allen & Hanburys division under a cross-licensing deal announced in December 1987. Sandoz traded co-promotion rights to DynaCirc for the rights to develop an OTC version of Glaxo's Zantac (ranitidine) anti-ulcer product for the U.S. ("The Pink Sheet" Jan. 4, 1988, p. 16). If an OTC ranitidine is approved in the U.S., Glaxo is supposed to have the primary marketing and distribution rights to DynaCirc, and Sandoz becomes the co-promoter. Glaxo did not talk about OTC ranitidine at a recent review of its major commercial markets and prospects. "The combined professional sales force committed to DynaCirc is approximately 1,300 sales representatives," Sandoz said. At the time of the deal, Glaxo predicted a 1988 approval. Sandoz began running "coming soon" ads in December of 1988 in preparation for a launch two years ago. The delay has made the market much tougher for Sandoz: generic nifedipine has recently entered the market and Pfizer has been successfully switching the market to its once-a-day Procardia XL. Pfizer says that that product, in combination with its standard release brand of Procardia, is now the leader in the cardiovascular field in terms of new prescriptions, surpassing Merck's Vasotec ("The Pink Sheet," Nov. 5, p. 7). Sandoz has an NDA pending for a once-a-day version of DynaCirc licensed from Alza, which developed the system for Procardia XL. DynaCirc will be the third of the second generation calcium channel blockers, joining Syntex' Cardene (nicardipine) and Miles' Nimotop (nimodipine) as the only approved second-generation calcium channel blockers. Miles' Baypress (nitrendipine), Merck's Plendil (felodipine), and Pfizer's Norvasc (amlodipine) have had NDAs pending at FDA. Isradipine has also been studied for atherosclerosis. A study at six U.S. centers was begun in mid-1989. The product is further being evaluated for treatment of stroke patients in Europe ("The Pink Sheet" June 26, 1989, T&G-3).

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