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MARION MERRELL DOW's TARGOCID NDA IN PROCESS OF BEING FILED

Executive Summary

MARION MERRELL DOW's TARGOCID NDA IN PROCESS OF BEING FILED, company Exec VP and Chief Operating Officer David Sharrock indicated at the annual Hambrecht & Quist Life Sciences conference Jan. 7 in San Francisco. The NDA for Targocid (teicoplanin), an antibiotic for gram positive infections, is being filed "even as we speak," Sharrock said. The company expects the submission to be completed during the current January-March quarter. A glycopeptide, Targocid is administered as an I.V. in the hospital setting. It is already approved in 13 countries, including Germany, France, the U.K. and Italy, the company said. Sharrock projected 1990 worldwide sales at more than $ 35 mil. The NDA for MMD's Nicoderm nicotine transdermal patch is another recent submission, Sharrock said: "That review is just beginning." The product was developed for Marion Merrell Dow by Alza using the latter's transdermal therapeutic system (TTS) ("The Pink Sheet" Oct. 29. p. 16). Nicoderm is apparently behind Elan/Warner-Lambert's Nicolan nicotine patch, which is expected to be approved this year (see related T&G). NDAs for three MMD line extensions are also pending at FDA. Cardizem QD, a once-a-day formulation of the calcium channel blocker Cardizem (diltiazem) submitted last February, is "progressing smoothly," Sharrock noted. Two new formulations of the ulcer treatment Carafate (sucralfate), a suspension and a twice-daily dose, also await approval. The NDA for the nonsedating antihistamine/decongestant combo Seldane D "is in the final stages at FDA," Sharrock said. He emphasized that the company has not given up on taking Seldane (terfenadine) OTC despite concerns raised by FDA's Pulmonary- Allergy Drugs Advisory Committee about the cardiovascular side effects of the drug ("The Pink Sheet" June 18, p. 6). "We must resubmit out OTC NDA for Seldane following the collection of some additional data," Sharrock explained. Marion Merrell Dow's pending NDAs "will produce sales of at least $ 1.2 bil. by 1995," Sharrock predicted. For Seldane D alone, the company is projecting potential sales of $ 200 mil. Sharrock also predicted that MMD's 1990 financial results would be "in line with Wall Street expectations." The company expects to report sales for the year "in the $ 2.45 bil. range," up 11%, and earnings per share between $ 1.70 and $ 1.75, a 20% increase. Worldwide sales for Seldane were up an estimated 39% in 1990 to $ 550 mil., Sharrock reported. A 25% increase in U.S. sales to $ 380 mil. for the nonsedating antihistamine was largely attributable to Marion Merrell Dow's newly integrated sales force, and a "strong direct-to-consumer advertising campaign which had the full blessing of FDA," he said. As a result, "physician calls are up 25% over 1989." Sales for the Cardizem products family also topped one-half of a billion dollars -- reaching $ 745 mil. in 1990, Sharrock noted. Sales of MMD's family of calcium channel blockers for angina and hypertension were up 15% over last year, according to the company's preliminary 1990 results. Cardizem SR, approved in January 1989 for sustained-release treatment of hypertension, accounted for 33% of total Cardizem prescriptions, the exec said. Sharrock predicted continued growth for the Cardizem line, pointing out that the integration of Marion's and Merrell Dow's respective sales forces behind the product only occurred in the second quarter of 1990. "We have just recently, within the last month, completed the full rotation of our sales training programs," Sharrock said, adding that "we now have 1,100 sellers promoting the Cardizem family." In addition, the company boosted advertising and promotional spending for Cardizem by 40% in 1990, "and we will continue at these higher levels in 1991," Sharrock added. The company also anticipates that results from several clinical studies in 1991 will favorably distinguish Cardizem from its competitors. Carafate generated an estimated $ 200 mil., down 5% in the face of heavy competition and decreased promotional activities, Sharrock said. The smoking cessation nicotine gum product Nicorette registered sales of $ 103 mil., up 29% from 1989. Nicorette got a boost from its first direct-to-consumer ad campaign that used the prescription product's brandname. According to preliminary results, all other MMD products together accounted for $ 60 mil. in sales last year, Sharrock said. MMD President Fred Lyons told the conference that the company has formed an R&D council to complete the integration of Marion and Merrell Dow product development programs. This "multidisciplinary team" will work, on a "product focused" basis, to bring products from discovery to marketing, Lyons said. Another facet of the merged companies' R&D reorganization has been an ongoing effort to "prioritize" developmental products. The pipeline began with "61 new products plus 30 line extensions," Lyon said. MMD plans to unveil its streamlined new pipeline at a Feb. 26-27 analysts meeting in Kansas City, Mo.
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