Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced that its affiliate and AstraZeneca plc (ADR) (NYSE:AZN) have amended Valeant’s license for brodalumab, an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis, to terminate Valeant’s right to develop and commercialize brodalumab in Europe.
In August 2015, AstraZeneca and Valeant entered into an agreement granting Valeant an exclusive license to develop and commercialize brodalumab globally, other than in Japan and certain other Asian countries. Under the terms of the amended agreement, Valeant will continue to hold the license to develop and commercialize brodalumab in the U.S, as well as the remainder of the territory outside of Europe. As consideration for the termination of the European rights, AstraZeneca will pay to Valeant an upfront payment and certain sales-based milestone payments and, in addition, one of the pre-launch milestones payable by Valeant to AstraZeneca under the original license has been reduced.
With the termination of Valeant’s licensing rights to brodalumab in Europe, AstraZeneca has entered into an agreement granting LEO Pharma the exclusive rights to develop and commercialize brodalumab in Europe.
On January 25, 2016, Valeant announced that the U.S. Food and Drug Administration (FDA) had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant for brodalumab injection for the treatment of moderate-to-severe plaque psoriasis and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016. In addition, the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant’s BLA on July 19, 2016.
“We are pleased with this new licensing arrangement for brodalumab, which enables us to more sharply focus our efforts on delivering this important treatment to patients in the U.S. and other key markets, while providing us with immediate value and significant ongoing exposure to the treatment’s commercialization in Europe,” said Joseph C. Papa, chairman and chief executive officer of Valeant. “Our current focus is on the upcoming advisory panel, where we will have the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about this novel antibody we are developing.” (Original Source)
Shares of Valeant closed yesterday at $20.14, down $0.13 or -0.64%. 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 $24.87 and its 200-day moving average is $55.97.
On the ratings front, Valeant has been the subject of a number of recent research reports. In a report issued on June 29, BMO analyst Alex Arfaei initiated coverage with a Hold rating on VRX. Separately, on the same day, Wells Fargo’s David Maris maintained 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, Alex Arfaei and David Maris have a total average return of 5.9% and 7.8% respectively. Arfaei has a success rate of 67.5% and is ranked #541 out of 3917 analysts, while Maris has a success rate of 52.5% and is ranked #588.
Overall, 3 research analysts have rated the stock with a Sell rating, 8 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $33.75 which is 67.6% above where the stock closed yesterday.
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.