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ROBERTS LAUNCHING SUPPRELIN (HISTRELIN),

Executive Summary

ROBERTS LAUNCHING SUPPRELIN (HISTRELIN), giving the Eatontown, N.J.-based marketer of multi-source and OTC drugs its first proprietary U.S. product. Roberts Pharmaceuticals, which licensed exclusive worldwide rights to Supprelin from Ortho in April ("The Pink Sheet" April 20, T&G-8), announced the product launch on Dec. 23. The first drug for the orphan indication of central precocious puberty (CPP), histrelin was approved with a "1A" rating (new molecular entity designated by FDA as providing an important therapeutic gain) on Dec. 24, 1991 ("The Pink Sheet" Jan. 6, 1992, p. 12). Roberts has hired a 12-person specialty task force that will detail to pediatric endocrinologists the injectable inhibitor of gonadotropin secretion. The addition of this group brings Roberts' field force to about 75 representatives, the company said. Schering-Plough manufactures the product for Roberts. Supprelin is supplied in .6 ml vials in three strengths: 200 mcg/ml, 500 mcg/ml and 1,000 mcg/ml, delivering 120 mcg, 300 mcg and 600 mcg of drug, respectively. Roberts said the AWP for a 30-day supply of the three strengths will be $241.99, $372.30, and $539.83. Recommended dosage is 10 mcg per kg of body weight. On Dec. 28 Roberts announced the completion of an agreement to acquire three multi-source compounds from Searle: the gastrointestinal antispasmodics Pro-banthine (propantheline) and Banthine (methantheline) and the oral contraceptive Norethin (norethindrone 1 mg/mestranol .05 mg). Roberts said the total purchase price was $35 mil. "consisting of a series of cash payments over time." Roberts said the acquisition of the OC is meant to "establish a franchise in the area of women's health" prior to the approval of Somagard for endometriosis; Norethin is Roberts' first women's health product. Propantheline sales could benefit from the HHS Agency for Health Care Policy and Research's urinary incontinence treatment guidelines, which cite the drug as an effective and recommended off-label treatment for the condition ("The Pink Sheet" March 30, 1992, p. 11). Roberts said it has no plans to perform studies of propantheline in urinary incontinence. Roberts is also acquiring U.S. marketing rights to Bristol- Myers Squibb's Quibron line of theophylline and theophylline/guaifenisin combination tablets and capsules for the treatment of asthma, including Quibron, Quibron-300, Quibron-T, and Quibron-T/SR. The Quibron all-cash transaction, announced Dec. 23, will allow Roberts' sales force to "call upon asthma specialists to promote Quibron in anticipation of the expected launch in 1995 of our new anti-asthma drug Maxivent." A non-theophylline based tablet for asthma treatment, Maxivent (doxofylline) was initially developed by ABC Labs and is approved in Italy. The drug is in Phase III clinical trials in the U.S. Rounding out the product expansion spree, Roberts announced Dec. 30 the completion of its acquisition from DuPont Merck of rights to market the oral anti-arrhythmic Ethmozine (moricizine) worldwide, except Japan. The deal was first announced Dec. 18 ("The Pink Sheet" Dec. 21, In Brief). DuPont Merck launched the drug for life-threatening ventricular arrhythmias in the U.S. in 1990.
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