LEMMON's NEW BRANDNAME DRUG DIVISION, GATE PHARMACEUTICALS, will market several products under the Gate label. Gate brand drugs will include Orap (pimozide), an orphan drug for Tourette's Syndrome, and the prescription appetite suppressant Adipex-P (phentermine HCl). The generic drug firm Lemmon announced March 1 that its existing brand drug division has been designated as Gate Pharmaceuticals and will be headed by current director Phil Millman. Orap was acquired by Lemmon from J&J's McNeil Labs on June 1, 1988. The drug was approved in July 1984 for "the suppression of motor and phonic ticks in patients with Tourette's Disorder who have failed to respond satisfactorily to standard treatment [haloperidol]" ("The Pink Sheet" Aug. 13, 1984, p. 5). There are an estimated 100,000 Americans with Tourette's. * Gate will share Lemmon's physical plant, manufacturing and marketing capabilities. Gate will have its own field sales force of about 25 people split off from Lemmon's existing key account force of approximately 50. The Gate detail force will also market to professionals other drugs previously sold by Lemmon, including the hydrocortisone cream Alphaderm, which will continue to be sold under the Lemmon label. Commenting on the creation of the Gate brand, Lemmon CEO William Fletcher said: "The focus will be on development and delivery to the U.S. marketplace of specialized therapeutic class products that enjoy market exclusivity." Another apparent impetus for the creation of Gate is to distance the company's namebrand pharmaceutical products from the somewhat tarnished reputation of generic drugs in general. Lemmon has three drugs with orphan designations currently in its pipeline that could be developed as Gate products. Normosang (copolymer 1 or COP-1) for multiple sclerosis is in Phase II/III; zinc acetate for Wilson's Disease, or hepatolenticular degeneration, in Phase III; and 24, 25 dihydroxy-cholcalciferol for the treatment of renal osteodystrophy, also in Phase III. The vitamin D derivative is sold by the Israeli parent of Lemmon, Teva Pharmaceutical, outside the U.S., as Osteo-D.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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