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OTC SELDANE NDA RESUBMISSION TARGETED FOR FIRST QUARTER 1992, WITH SALES AT PRODUCT MATURITY PROJECTED AT $ 500-750 MIL.; TARGOCID HAS "1A" RATING AT FDA

Executive Summary

Marion Merrell Dow plans to resubmit an NDA for its over-the- counter version of Seldane (terfenadine) during the first quarter of 1992, company Chairman and CEO Joseph Temple told analysts on Dec. 3. Appearing at the Mabon Securities Research Conference in New York City, Temple said the U.S. filing for OTC Seldane "is right on schedule for the first quarter of 1992." Marion Merrell Dow is projecting annual U.S. sales of the OTC nonsedating antihistamine at $ 500 mil. to $ 750 mil. once the product reaches maturity. Sales of prescription Seldane and the recently launched Seldane-D approached $ 600 mil. through nine months of 1991 and may top $ 800 mil. for the year. Temple acknowledged that there have been questions about whether FDA would approve an OTC Seldane. While "we don't predict the FDA's actions," Temple said, "you should expect us to know a lot about their very specific questions and concerns about Seldane and we wouldn't file an application if we weren't serious and didn't believe that we could get approval." The NDA for OTC Seldane was withdrawn from FDA in the autumn of 1990 due to concerns about cardiovascular side effects associated with prescription Seldane. Following an FDA Pulmonary- Allergy Drugs Advisory Committee meeting, Seldane was relabeled and the company sent out a "Dear Doctor" letter reviewing those concerns ("The Pink Sheet" June 16, 1990, p. 6). Marion Merrell Dow may still have time to launch an OTC brand before prescription Seldane goes off patent in April 1994. The company appears to have a success in its first Seldane line extension with Seldane-D (terfenadine/pseudoephedrine), an antihistamine/decongestant combo product approved by FDA on Aug. 19. Temple predicted that 1991 sales will be "in the $ 40-$ 45 mil. range," which puts the product on track with MMD projections made last April that sales in the first 12 months of U.S. marketing could reach $ 140 mil. "In its sixth week on the market, Seldane-D passed [Sandoz'] Tavist-D to become the number one product in the [prescription] combination anti-allergy market," Temple noted. "And, in week number 10, Seldane D passed [Johnson & Johnson's] Hismanal, a single entity antihistamine, for the number two spot in new prescriptions in the total upper respiratory market. Seldane-D is now second only to Seldane." In addition to Seldane-D, Marion Merrell Dow has one new product and a wave of line extensions that will reach the market in coming months. Temple noted that the company has received approvals for its Nicoderm smoking cessation patch (see related story, T&G-1) and injectable Cardizem (diltiazem), and has once- daily Cardizem CD and a 4 mg version of its Nicorette gum at the "approvable stage." Temple reported that the Cardizem CD package insert "has been resolved" with FDA and "the only issue left to be resolved" is a plant inspection. The one-a-day version of the calcium channel blocker will be marketed for hypertension but not angina. "The exclusivity of Cardizem CD is tremendously important to us," Temple told the analysts. "No one can use the ANDA process for approval of their version of Cardizem CD prior to the end of 1994 or three years after approval." The company's ANDA exclusivity for immediate release Cardizem expires in November 1992. Injectable Cardizem was approved in October for atrial fibrillation or atrial flutter and paroxysmal supraventricular tachycardia ("The Pink Sheet" Oct. 28, In Brief). Temple reported that product shipments are "taking place this week" and MMD's hospital sales force will begin promoting the product the week of Dec. 16. Marion Merrell Dow hopes the availability of injectable Cardizem will help steer patients once they are stabilized to one of the oral dosage forms of Cardizem. Use of the injectable product by physicians "should result in increased usage in long- term Cardizem oral," Temple predicted. While he did not quantify the expected extent of this ripple effect from injectable Cardizem, Temple noted that "it was a significant part of our commercial rationale for bringing this product to market." The Cardizem product family continues to be the most important product franchise for Marion Merrell Dow. Sales through the third quarter of 1991 were $ 638 mil., up 15% from the same period in 1990. The sales figure includes product revenues from Canada's Nordic Laboratories, which became a wholly owned MMD subsidiary earlier this year. Temple reported that Targocid (teicoplanin), MMD's antibiotic for gram positive infections, has been given a "1A" priority review rating by FDA. An NDA for the product was filed in March 1991. Targocid, which Temple said can be used in both inpatient and outpatient settings, has generated sales in Europe of $ 42 mil. through the first nine months of 1991. The company expects the product ultimately to generate over $ 200 mil. in sales worldwide. Other MMD products in late-stage development -- and that could reach FDA by the end of 1993 -- include: Deflazacort, a bone-sparing corticosteroid for treating asthma and rheumatoid arthritis that is currently in Phase III. Temple said the product results in half the bone loss of prednisone. MMD predicted that deflazacort sales at maturity could reach $ 200 mil.-$ 300 mil.; Sabril (vigabatrin), an anti-seizure drug currently in Phase III, which Temple said could be the first new anti-epilepsy drug introduced in the U.S. in 20 years. MMD estimated potential annual sales at maturity for the product at $ 150 mil.-$ 250 mil.; and, Anemet, for nausea and vomiting resulting from chemotherapy. The product, billed as MMD's "first major oncology product," is entering Phase III and has potential annual sales at maturity of $ 150 mil.-$ 250 mil., MMD predicted. Temple also commented on Marion Merrell Dow's continuing effort to prioritize its consolidated R&D pipeline. In February, he noted, the firm reviewed its R&D pipeline and identified 68 projects considered most viable. "Prioritization number two" began in October and is targeted for completion in the first half of 1992, Temple said. He noted that the preliminary conclusions from this second review are: "(1) the pipeline is still too full; (2) we're still very excited about what's in it; (3) we need to focus still more to move the best candidates forward even faster; and (4) we'll have more compounds for outlicensing."

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