Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced that the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) has voted by a margin of 18 to 0 for the approval of brodalumab injection, 210 mg, for adult patients with moderate-to-severe plaque psoriasis with conditions related to product labeling and post-marketing/risk management obligations.
The committee’s recommendation will be considered by the FDA in its review of the Biologics License Applications (BLA) for brodalumab, a monoclonal antibody that targets the IL-17 receptor. As previously announced, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
“The positive recommendation by the FDA’s advisory committee represents an important milestone toward our goal of delivering brodalumab to patients who suffer from moderate-to-severe plaque psoriasis,” said Joseph C. Papa, chairman and chief executive officer. “Brodalumab has the potential to improve the lives of many patients suffering from this chronic, debilitating disease, and we greatly appreciated the opportunity to present our body of evidence to the panel. We look forward to working collaboratively with the FDA as it continues its review process.”
“Brodalumab is an extraordinary drug that has meaningfully improved the quality of life of some of my most difficult-to-treat psoriasis patients, many of whom achieved complete skin clearance with this treatment,” said Dr. Mark Lebwohl, Chairman, Department of Dermatology, Mount Sinai School of Medicine. “I am very pleased that the Advisory Committee has recommended that this life-changing treatment should be available to psoriasis patients who require a treatment with brodalumab’s unique mechanism of action, and I look forward to prescribing this therapy to patients who are suffering from the devastating effects of moderate to severe plaque psoriasis.”
As previously announced, the Marketing Authorisation Application (MAA) for brodalumab in psoriasis was accepted by the European Medicines Agency (EMA) in Q42015. In August 2015, Valeant entered into a collaboration agreement with AstraZeneca (AZN.LN, NYSE:AZN ) granting Valeant an exclusive license to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd. In July 2016, AstraZeneca and Valeant amended Valeant’s license for brodalumab to terminate Valeant’s right to develop and commercialize brodalumab in Europe. LEO Pharma currently holds exclusive rights to develop and commercialize brodalumab in Europe, and Valeant holds the license to develop and commercialize brodalumab in the U.S and other territories, other than Japan and certain other Asian countries. In July 2016, brodalumab was granted approval from the Ministry of Health, Labour and Welfare Japan. (Original Source)
Shares of Valeant Pharmaceuticals closed today at $23.54, up $0.04 or 0.17%. VRX has a 1-year high of $263.81 and a 1-year low of $18.55. The stock’s 50-day moving average is $23.37 and its 200-day moving average is $48.31.
On the ratings front, Valeant has been the subject of a number of recent research reports. In a report released yesterday, Canaccord Genuity analyst Neil Maruoka reiterated a Hold rating on VRX, with a price target of $28, which represents a potential upside of 18.9% from where the stock is currently trading. Separately, on the same day, Mizuho’s Irina Rivkind Koffler reiterated a Sell rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Neil Maruoka and Irina Rivkind Koffler have a total average return of -31.8% and 24.9% respectively. Maruoka has a success rate of 16.0% and is ranked #3970 out of 3977 analysts, while Koffler has a success rate of 58.6% and is ranked #18.
The street is mostly Neutral on VRX stock. Out of 17 analysts who cover the stock, 9 suggest a Hold rating , 5 suggest a Buy and 3 recommend to Sell the stock. The 12-month average price target assigned to the stock is $33.90, which represents a potential upside of 44.0% from where the stock is currently trading.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology, and branded generics. The company operates through two operating and reportable segments: (i) Developed Markets and (ii) Emerging Markets. The Developed Markets segment consists of (i) sales in the U.S. of pharmaceutical products, OTC products, and medical device products, as well as alliance and contract service revenues, in the areas of eye health, dermatology and podiatry, aesthetics and dentistry, (ii) sales in the U.S. of pharmaceutical products indicated for the treatment of neurological and other diseases, as well as alliance revenue from the licensing of various products it developed or acquired, and (iii) pharmaceutical products, OTC products, and medical device products sold in Canada, Australia, New Zealand, Western Europe and Japan. The Emerging Markets segment consists of branded generic pharmaceutical products and pharmaceuticals, OTC products, and medical device products. Products are sold primarily in Central and Eastern Europe (primarily Poland and Russia), Asia, Latin America (Mexico, Brazil, and Argentina and exports out of Mexico to other Latin American markets), Africa and the Middle East.