ELAN NICOLAN NICOTINE PATCH NDA IS UNDER "VERY ACTIVE REVIEW

Executive Summary

ELAN NICOLAN NICOTINE PATCH NDA IS UNDER "VERY ACTIVE REVIEW" at FDA and could be approved during the company's fiscal year 1992, Elan Chairman and CEO Donald Panoz told a Jan. 9 Hambrecht & Quist health care conference in San Francisco. An NDA for the transdermal product, which will be marketed by Warner-Lambert, was filed in August 1989. The NDA, Panoz said, "is through a process of very active review and we hope to hear good news on that during this coming financial year [which begins April 1]." Nicolan currently is the leader in the race to reach the U.S. market among several nicotine patches in development. Marion Merrell Dow announced Jan. 7 that it has just filed an NDA for its Alza-developed Nicoderm patch (see related T&G). Cygnus is predicting an early 1991 filing for its nicotine patch developed with Pharmacia Leo. Elan is also expecting approval of its once-daily nifedipine (Nifelan) "sometime in our upcoming financial year," Panoz told the analysts. An NDA for the product, which will be marketed by Miles, was filed in July 1989. Pfizer currently markets nifedipine under the Procardia brand, along with a once-daily formulation, Procardia XL, developed by Alza. Nifelan could be the third calcium channel blocker using Elan's sustained release delivery technology to reach the U.S. market. Marion Merrell Dow's Cardizem SR (diltiazem) was approved in 1988, and Lederle's Verelan (verapamil) was approved last year. A fourth product, once-daily Cardizem QD, is also pending at FDA. Nicolan and Nifelan will join Verelan as products earning royalties for Elan in the 20%-35% range, Panoz indicated. Products licensed earlier in development, such as Cardizem SR and Cardizem QD, were licensed for a royalty in the 5%-10% range, Panoz said. The higher royalties are "a direct result" of Elan's decision in 1987 to change its strategy and take a more active role in bringing its products to the market, Panoz added. In addition, Elan is moving its first wholly proprietary products into clinicals, Panoz told the meeting. "We're ready to file INDs" for EL-1335, an antibody for resistant staph infections, Panoz reported. A second non-licensed Elan product is EL 970, a multiple sclerosis treatment licensed from Rush Presbyterian-St. Luke's Medical Center in Chicago. The drug's orphan status has been transferred to Elan by FDA as well, Panoz said. Elan expects to begin clinical studies in the U.S. "in the next few months," he noted. Separately, Elan announced on Jan. 9 that it had acquired worldwide rights to Panoject, a small infusion pump that can be incorporated into a wristwatch-sized electronic infusion device. Panoject can be used for "virtually any drug administered by injection or I.V. drip," the company said. Initial candidates will be insulin, analgesics, chemotherapy agents, hormones and injectible peptides. The pump originally was developed by Scientific Innovations.