Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
Anacor Pharmaceuticals (NASDAQ:ANAC) prices $75M aggregate principal amount 2.00% Convertible Senior Notes due 2021 in a private placement. Over-allotment is $7.5M aggregate principal amount. An additional $8M aggregate principal amount will be sold to one of the company's affiliates in a concurrent private transaction.
The conversion rate is 32.2061 shares of common stock per $1,000 principal amount (~$31.05 per share) subject to future adjustment. The notes will not be redeemable at Anacor's option prior to October 15, 2018. Afterward, the notes will be redeemable at Anacor's option if the last reported sale price of the company's common stock for at least 20 trading days in any 30-trading-day period exceeds 130% of the conversion price.
Net proceeds to Anacor will be ~$72M. The funds will used to repay its current indebtedness under its loan and security agreement and for general corporate purposes.
Exclusive distributor Sandoz's PharmaDerm division (NVS +0.1%) launches Anacor Pharmaceuticals' (ANAC -0.4%) Kerydin (tavaborole) topical solution 5% in the U.S. The product is the first oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails.
Anacor Pharmaceuticals (NASDAQ:ANAC) enters into an exclusive agreement with Sandoz (NYSE:NVS) to commercialize Anacor's Kerydin (tavaborole) topical solution in the U.S. Sandoz's PharmaDerm division will be responsible for the sales and marketing of the recently-FDA cleared antifungal for the treatment of onychomycosis of the toenails.
Under the terms of the agreement, Sandoz will pay Anacor an upfront fee of $40M and a milestone payment of $25M in January 2015. The companies will share profits equally after Sandoz receives the first $50M in gross profits. Anacor will receive a minimum of $45M in profit-sharing payments in 2016. It will also have the option to repurchase the rights to Kerydin after three years or December 31, 2017 at a yet-to-be-determined price.
The U.S. regulator clears Anacor Pharmaceuticals' (ANAC) Kerydin (tavaborole) topical solution for the treatment of onychomycosis of the toenails. It is a clear, colorless alcohol-based solution that is applied with a dropper to the infected toenail once daily for 48 weeks.