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news.Anacor Pharmaceuticals has entered into an exclusive agreement with Sandoz, a Novartis company, pursuant to which Sandoz will distribute and commercialize Anacor’s drug KERYDIN (tavaborole) topical solution, 5% in the United States.
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PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, 2014, Anacor announced that the U.S. Food and Drug Administration (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 $40 million and an additional milestone payment of $25 million 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 (defined as net sales less cost of goods sold) accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50 million 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 $45 million. 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 Anacor’s 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.
"We are pleased to enter into this agreement with Sandoz to commercialize KERYDIN in the U.S. through PharmaDerm," said Paul Berns, Chief Executive Officer of Anacor Pharmaceuticals.
"PharmaDerm’s dedication to branded prescription products to treat dermatological and podiatric diseases makes it an ideal collaborator to launch KERYDIN. In addition, PharmaDerm has an experienced sales force which will be able to reach the specialty physicians who treat large numbers of patients with onychomycosis."