Novartis Consumer Health Sales Force To Detail Barrier’s Vusion Ointment
This article was originally published in The Pink Sheet Daily
Executive Summary
Barrier also moving forward with Phase IV commitments, exec tells “The Pink Sheet” DAILY.
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Barrier Therapeutics will supplement its 60-person sales force detailing Vusion ointment for diaper rash with candidiasis through a copromote agreement with Novartis Consumer Health, Barrier announced March 6. The deal will more than double Barrier's promotional reach to pediatricians for Vusion (0.25 percent miconazole nitrate, 15 percent zinc oxide, 81.3 percent white petrolatum), the company added. "The key thing is that [Novartis' sales reps] are calling on pediatricians," Barrier Chief Financial Officer Anne VanLent said in an interview with "The Pink Sheet" DAILY. "Their pediatric sales force, which is very complementary to ours as far as the doctors that they are calling on and the territories that they're covering, is a pharmaceutically trained sales force in pediatrics." Under the agreement, Princeton, N.J.-based Barrier will pay Novartis a flat fee for each sales call made to a pediatrician. Novartis' sales reps will begin promoting the product in May, with the partnership extending through 2008. Responsibilities for marketing and product strategy, as well as for the development, manufacture, distribution and sale of the product will remain with Barrier. The antifungal was approved by FDA in February 2006 for "the treatment of diaper dermatitis complicated by candidiasis in infants 4 weeks and older" (1 (Also see "Vusion Breaks “Not Approvable” Barrier With Dermatitis NDA" - Pink Sheet, 16 Feb, 2006.)). It remains the only approved product for that indication. Barrier is moving forward with a postmarketing commitment to conduct both absorption and long-term resistance studies on Vusion, VanLent said. The ointment initially received a "not approvable" letter from FDA in 2005. At the time, the company anticipated having to conduct a second absorption study prior to approval, but FDA later agreed to revisit the study as a Phase IV commitment (2 (Also see "Barrier Submits “Complete Response” For The Drug Formerly Known As Zimycan" - Pink Sheet, 12 Oct, 2005.)). "We were very happy to get this drug approve for infants as young as 4 weeks. I see [the approval] as an indication of how safe [Vusion] is and [of] the amount of work that we've done," VanLent said. "The product has one-eighth of the concentration of the anti-fungal miconazole as the over-the-counter anti-fungals that are sometimes used. I think the issue ... is one of our company having made the investment in the target population to prove that there's something safe, effective and formulated specifically for use in the diaper area," VanLent said. - Shirley Haley ([email protected]) |