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February 27, 2014
07:40 EDTANACAnacor completes AN2728 ointment End-of-Phase 2 meeting with FDA
Anacor Pharmaceuticals announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for the topical treatment of mild-to-moderate atopic dermatitis with AN2728 ointment. Anacor will also initiate a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. Subjects who complete either Phase 3 trial will have the option to roll into the long-term safety trial until approximately 500 subjects are enrolled. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for 6 months, during which time subjects will be treated as needed under the direction of the investigator. AN2728 has demonstrated safety and efficacy in 14 other Phase 1 and Phase 2 studies. In all studies, AN2728 was generally considered safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.
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July 29, 2014
07:22 EDTANACFDA PDUFA Date for Anacor Pharmaceuticals Tavaborole is July 29, 2014
July 21, 2014
12:32 EDTANACAnacor price target raised to $35 from $29 at Wedbush
07:03 EDTANACAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.

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