Par’s Megace Extra Strength May Launch With Contract Sales Force
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will likely seek an exclusive sales force of 40 to 80 reps for the reformulated version of Bristol’s megestrol oral suspension product. Par expects to launch in mid-2005; its 505(b)(2) NDA has a user fee date of April 29.
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Par expects to use a contract sales organization in launching its new formulation of Bristol-Myers Squibb's Megace oral suspension. "It's likely that we'll wind up using a CSO at the beginning, as opposed to owning those sales reps," Par CEO Scott Tarriff said on a July 29 earnings call. The company will likely seek a sales force of 40 to 80 reps to support the product, Tarriff said. "Whatever we do, we want it to be a dedicated sales force," the exec said. "We're not interested in a part-time force, or a force where you share someone else's products in one sales force." Par filed an NDA under the 505(b)(2) pathway June 29 for megestrol oral suspension using NanoCrystal Dispersion technology. The NDA has a user fee date of April 29; Par said it hopes to launch the product by mid-2005. Megace oral suspension is indicated for the treatment of anorexia, cachexia or unexplained weight loss in AIDS patients. The NCD formulation improves the product's bioavailability, Par said. Par has marketed a generic version of Megace oral suspension since July 2001. In August 2003, the company licensed the Megace brand name from Bristol for the NCD formulation. Par hopes to market the new formulation as Megace Extra Strength . Under the Megace licensing agreement, Par helped fund promotion of Megace oral suspension to retain brand awareness among physicians. Although sales of Par's generic declined 17% to $18.3 mil. in the second quarter, Par believes its script growth will provide a solid platform for launch of the NCD formulation. "We've increased our sampling program" for generic Megace "and now we are at an all-time high in terms of prescriptions dispensed since we've been tracking weekly Rxs," Tarriff said. "Our share is about 65% or 66% of the market. Rxs are ramping up or growing, and this will help us transition into the new product." Par said it has settled patent litigation with Teva relating to generic megestrol. At issue was whether Teva, which also markets megestrol oral suspension, infringed Par's patents. Trial in the case was scheduled for April 2005. As part of the settlement, "Par will grant a license to Teva for a limited number of units, and Par will, in return, receive a royalty on Teva's sales," Par said. - Elizabeth Walker |