ROBINS LAUNCHING REFORMULATED DIMETAPP OTC ON JUNE 3, COMPANY ANNOUNCES AT ITS ANNUAL MEETING; LATEST IN-LICENSE IS BAYER ANTIHYPERTENSIVE MUZOLAMINE

Robins' reformulated Dimetapp cold/alergy products will be launched OTC on June 3, Robins President and CEO E. Clairborne Robins Jr. announced at the company's annual meeting May 30. Explaining the reasons for the Rx-to-OTC switch, Robins said "Dimetapp sales have been relatively flat in recent years and, due to changes in law, there are increasing numbers of Dimetapp Rxs being filled with substitute products." He stated that "now is the time to build on Dimetapp's reputation and to increase sales as we make the product more accessible and promote it properly." The company's Rx formulation consisted of brompheniramine maleate, phenylephrine HCI and phenylpropanolamine. The OTC version will include only the brompheniramine/phenylpropanolamine combo. FDA approved a supplemental NDA for Dimetapp extentabs on May 14. Dimetapp tablets and elixers will be included in the OTC cough/cold monograph. Robins said it sent letters to the trade and physicians in May and will begin promotion to the trade the week of June 3. Promotion to consumers is scheduled to begin in September. Citing the company's previous experience in switching Robitussin to OTC, Robins said that product went from sales of $18 mil. as an Rx drug to $80 mil. OTC. "We believe we can use our marketing expertise to dramatically enhance sales of the new Dimetapp elixers, tablets and extentabs," Robins stated. "I can tell you today that initial acceptance from retailers has been enthusiastic and that we are very enthusiastic about this change." Robins also announced that the company was discontinuing its Extend 12 12-hour cough medicine because it "simply has not lived up to expectations." The product utilizes Pennwalt's Pennkinetic delivery systems. The Robins exec commented: "Whether it was the concept of a controlled release liquid, or the result of a profusion of new products introduced during the last several years, for some reason this good product never gained the consumer acceptance we envisioned." The company reported that it has expanded its presence in Japan via a joint venture with Showa Shinyaku Company. Robins said the joint venture, A.H. Robins-Showa, Ltd., "will make the sustained release technologies of our Eurand Group available to the Japanese market." The new company is already operational and production is expected to begin later this year or in early 1986. Commenting on its Rx products, Robins noted that it has signed an agreement with Bayer AG for the development of the fast acting diuretic muzolamine for the U.S. market. He said preliminary plans are underway to begin clinical trials. Robins also commented that an NDA for the antihypertensive Tenex (guanfacine HCI) is nearing completion at FDA "with no problems that would potentially interfere with approval." He added that Robins believes the drug "has great promise in its important theraeptic area." Robins also said the company recently initiated large-scale Phase III studies on the antihypertensive bopindolol which is being developed under license from Sandoz. The exec also noted that during the first quarter Robins has filed an IND for an antiemetic compound "which has demonstrated extremely potent antiemetic properties in animals." He added that although clinicals are just beginning "interest in this new drug by oncologists is very high." The firm also anticipates filing an NDA for an orphan indication for Pondimin in the treatment of autistic children in 1986. Robins said studies with autistic children at approximately 25 medical centers are nearly complete. Pondimin (fenfluramine HCI) is currently indicated in the management of exogenous obesity as a short-term adjunct in a regimen of weight reduction.

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