Valeant's (VRX) Plaque Psoriasis Drug Approved in the U.S.
Valeant Pharmaceuticals International, Inc. VRX recently announced that the the FDA has approved its Biologic License Application (BLA) for Siliq (brodalumab) injection the treatment of moderate-to-severe plaque psoriasis in adult patients. The FDA has approved the subcutaneous use of the drug.
The company is likely to launch the drug in the U.S market in the second half of 2017.
Valeant’s shares have significantly underperformed the Zacks classified Medical-Drugs industry in the last one year. Its shares lost 82.6%, while the industry registered an increase of 0.2%.
We remind investors that Amgen AMGN had submitted the first Investigational New Drug Application (IND) for Siliq in 2008. Thereafter, the sponsorship of the program was granted to AstraZeneca AZN, which subsequently transferred the rights to Valeant. The companies had inked the agreement in Aug 2015, which granted Valeant an exclusive license to develop and commercialize brodalumab globally, excluding Japan and certain other Asian countries.
Valeant’s BLA has passed through 21 studies conducted by Amgen and four studies conducted by Amgen’s partner in Japan. The candidate met all primary endpoints across the three pivotal phase III studies which showed that more than 50% of patients who used Siliq achieved total skin clearance within a year. SILIQ is the only product that has demonstrated 100% improvement in the psoriasis area and severity index (PASI 100) during clinical trials as a primary endpoint.
We note that Siliq has a Black Box Warning for risks in patients with a history of suicidal thoughts or behavior. SILIQ was approved with a Risk Evaluation and Mitigation Strategy (REMS), which involved a one-time enrollment for physicians and one-time informed consent for patients.
However, Valeant's right to develop and commercialize brodalumab in Europe was terminated in Jul 2016. Owing to the termination of rights in the continent, AstraZeneca will now have pay an upfront fee to Valeant along with certain sales-based milestone payments. Additionally, one of the pre-launch milestones to be paid by Valeant to AstraZeneca has been reduced.
We note that the Marketing Authorisation Application (MAA) for brodalumab in moderate-to-severe psoriasis was accepted by the European Medicines Agency (EMA) in the fourth quarter of 2015. Presently, LEO Pharma holds exclusive rights to develop and commercialize brodalumab in Europe. Moreover, the drug was approved in Japan for the same indication in Jul 2016.
Siliq’s approval would boost investor confidence in the company, which is currently divesting non-core assets.
Valeant Pharmaceuticals International, Inc. Price
Valeant Pharmaceuticals International, Inc. Price | Valeant Pharmaceuticals International, Inc. Quote
Zacks Rank & Key Pick
Valeant currently carries a Zacks Rank #5 (Strong Sell). A better-ranked stock in the health care sector is Cellectis S.A. CLLS, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cellectis’s loss estimates narrowed from $2.33 to $1.80 for 2016 and from $2.94 to $1.69 for 2017 over the last 60 days. The company posted positive surprises in three of the four trailing quarters with an average beat of 111.20%.
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