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Executive Summary

Reid-Rowell's Rowasa is the first 5-ASA (5-aminosalicylic acid) product approved by FDA. Approved Dec. 28 for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis, Rowasa carries a 1 B rating, a new chemical entity with a modest therapeutic gain. The company plans to launch the 5-ASA (mesalamine) rectal suspension enema within the next couple of weeks. Rowasa will be available in a unit dose pack of seven bottles at an average wholesale price of $44. Each bottle contains 4 g mesalamine in 60 ml suspension. Reid-Rowell estimates that the U.S. market for Rowasa will be $6-7 mil. during the first year. Rowasa has been marketed in Canada as Salofalk since its introduction there in November 1986. Salofalk is marketed by the Montreal-based firm Interfalk, a subsidiary of Falk, a West German company with whom Reid-Rowell has an information exchange agreement for 5-ASA. Reid-Rowell has ongoing clinicals in Canada for 5-ASA in tablet and suppository dosage forms. The enema is being studied in different doses for long term maintenance and pediatric use, Reid-Rowell said. The company expects to file an NDA for the suppository in the later part of 1988. Rowasa's NDA was filed in June 1986. Rowasa is one of the 1987 crop of year-end new chemical entity approvals. For the year, FDA approved 21 NCEs, with 15 approvals coming in December in FDA's traditional end-of-year desk clearing. The agency noted in Rowasa's approval letter that Reid-Rowell has "agreed to conduct Phase IV studies; the first to perform a dose ranging trial of Rowasa rectal suspension enema in patients with active mild to moderate distal ulcerative colitis; the second to evaluate the pharmaco-kinetics and renal effects of Rowasa rectal suspension enema in comparison to sulfasalazine." Norwich Eaton's NDA for Asacol (mesalamine) for the induction and maintenance of remission of ulcerative colitis is pending. On Sept. 14, 1987, FDA's G-I Drugs Advisory Committee determined that an additional placebo-controlled comparative trial was necessary for Asacol's approval, since the panel concluded that only one study showed efficacy ("The Pink Sheet" Sept. 14, p. 5). Norwich Eaton maintained that Asacol has a better safety profile than sulfasalazine because it does not contain sulfapyridine, the acid believed to cause adverse effects in sulfasalazine. Neither Asacol nor Rowasa contain sulfapyridine. Reid-Rowell is primarily a marketer of branded generics, however, it markets speciality products such as Cortenema, a Rx hydrocortisone retention enema and Chenix (chenodiol), an orphan drug for gallstone-dissolving. Reid-Rowell was acquired in March 1986 by the Belgian firm Solvay & Cie ("The Pink Sheet" March 3, 1986, p. 4). Another NCE approval was Roche's (Medi-Physics) in vivo diagnostic Spectamine (iofetamine HCI) injection on Dec. 24. Spectamine is indicated for use as a lipid-soluble brain-imaging agent and "has been shown useful in the evaluation of nonlacunar stroke," the package insert says. Spectamine was classified as a C drug, little or no therapeutic gain. Another NCE diagnostic agent, Rorer's Parathar (teriparatide acetate) for injection, was approved on Dec. 23 as a C drug. The orphan product was approved "as a diagnostic agent to assist in establishing the diagnosis in patients presenting with . . . evidence of hypocalcemia due to either hypoparathyroidism or pseudohypoparathyroidism," the labeling states. The test will distinguish between the two disorders "but not between these conditions and normal," the labeling points out. Kendall McGaw's orphan product Ucephan (sodium benzoate/sodium phenylacetate solution) was approved Dec. 23. Ucephan is indicated as adjunctive thereapy for the prevention and treatment of hyperammonemia in chronic management of patients with urea cycle enzymopathies. FDA classified Ucephan as a 1, 4, B drug, a new molecular entity and a new combination with a modest therapeutic gain. FDA also asked in the approval letter that pharmacokinetic studies be done with Ucephan. The drug will be launched within the first quarter of 1988, Kendall McGaw said. Sterling's Corotrope (milrinone) I.V. was approved on Dec. 31 for the treatment of congestive heart failure. The intravenous formulation of Corotrope was unanimously recommended for approval for the short-term management of congestive heart failure by FDA's Cardio-Renal Drugs Advisory Committee at its Dec. 7 meeting ("The Pink Sheet" Dec. 14, p. 7). By a five-to-three vote the panel recommended approval of the oral version of milrinone as a last-resort treatment for CHF. Corotrope I.V. may cannibalize Sterling's first generation I.V. inotropic agent Inocor (amrinone), which is indicated for the short-term management of CHF. Other late December approvals included: Beecham's Bactroban (mupirocin) topical antibiotic for impetigo; Ortho's Terazol-7 (terconazole) vaginal antifungal; Alcon Labs' Iopidine (aplonidine); Giapharmex S.p.A.'s Deursil (ursodiol); and Abbott's Cefmax (cefmenoxime HCl).

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