Valeant Pharmaceuticals Intl Inc's (NYSE:VRX) Ortho Dermatologics division announced results from the Pivotal Phase 3 long-term extension study (AMAGINE-2), which demonstrated that SILIQ™ (brodalumab) injection provided sustained high levels of skin clearance (PASI 100) over more than two years in patients with moderate-to-severe psoriasis. These findings are being presented for the first time today at the 2017 Fall Clinical Dermatology Conference in Las Vegas.
"Over a two-year trial, a PASI 100 response rate was reached by 59 percent of a sub-analysis group of patients, demonstrating that SILIQ is a long-term option to treat moderate-to-severe psoriasis," stated Alan Menter, M.D. "This is highly important as patients always fear a flare-up of their psoriasis after initial clearing."
SILIQ is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ has a Black Box Warning and a Risk Evaluation and Mitigation Strategy (REMS) due to observed suicidal ideation and behavior in clinical trials. SILIQ is contraindicated in patients with Crohn's disease. Serious infections have occurred; therefore caution should be exercised when considering the use of SILIQ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment and avoid use of live vaccines.
"For patients with and without prior ustekinumab exposure, SILIQ demonstrated improved skin clearance," said Lawrence J. Green, M.D., associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. "More than 65 percent of both ustekinumab-naïve and -experienced patients in AMAGINE-1 receiving SILIQ treatment experienced complete clearance (PASI 100) at week 52, making this an excellent solution with proven results for a wide range of patients with moderate-to-severe psoriasis."
Dr. Lawrence Green will be presenting additional information about SILIQ during a product theatre titled, "A New Mechanism of Action in the Treatment of Moderate-to-Severe Plaque Psoriasis" on Thursday, October 12th at 1pm – 2pm PT.
"I am pleased to see the durable efficacy of SILIQ demonstrated through these additional findings," said Joseph C. Papa, chairman and CEO, Valeant. "This dermatologic innovation has been shown to not only provide relief for many patients who suffer from moderate-to-severe plaque psoriasis, but also had an overall positive impact on the quality of life of these patients."
Long-term Efficacy of Brodalumab for the Treatment of Moderate-to-Severe Psoriasis Study (AMAGINE-2)
Results from the long-term extension study (AMAGINE-2) found that SILIQ provided sustained high levels of skin clearance (PASI 100) over more than two years in those with moderate-to-severe psoriasis. Further, a sub-analysis group of patients who received any dose of brodalumab in the induction phase and SILIQ during the maintenance and long-term extension (LTE) phases demonstrated similar response rates. Patients who received either study dose of brodalumab in the induction phase and SILIQ throughout the maintenance and LTE phases at week 120, had a PASI 100 response rate of 59.0% (N=178), and PASI 90 response rate of 76.4% (N=178). At week 52, the same set of patients had a PASI 100 response rate of 63.4% (N=290) and PASI 90 response rate of 85.9% (N=290). At week 120, SILIQ continued to be generally well-tolerated with a safety profile comparable to that observed in the 52-week period.
Efficacy of Brodalumab in Ustekinumab-Naive and -Experienced Patients With Moderate-to-Severe Plaque Psoriasis (AMAGINE-1) Study
Results of a phase III, multicenter, randomized, double-blind, placebo-controlled study (AMAGINE-1) of the efficacy of brodalumab in a subset of patients with prior exposure to ustekinumab, demonstrated that SILIQ was similarly efficacious with improved skin clearance in patients both with and without prior ustekinumab exposure. Among patients receiving continuous SILIQ, rates of 100% reduction in PASI score (PASI 100) was 65.2% (43 of 66) and 76.5% (n=13 of 17) in ustekinumab-naive and -experienced patients at week 52, respectively. PASI 90 were 75.8% (50 of 66) in ustekinumab-naive and 88.2% (15 of 17), in ustekinumab-experienced patients.
Impact of Brodalumab Treatment on Psoriasis Symptom Severity and Improvements in Health-Related Quality of Life Study
Psoriasis symptoms have a significant negative impact on health-related quality of life, impairing physical functioning and well-being. Previously, data has shown that treatment with SILIQ provided rapid improvement in Psoriasis Area and Severity Index (PASI) and psoriasis symptoms in patients with moderate-to-severe psoriasis. This improvement with SILIQ can also be demonstrated by comparing baseline data with measurements at week 12 in terms of improvement in psoriasis symptom inventory scores (PSI) and Dermatology Quality of Life Index (DLQI) scores, which are highly correlated. Additionally, an improvement in psoriasis symptoms inventory score correlated with decreased PASI scores with SILIQ treatment.
Shares of Valeant are currently trading at $14.01, down $0.28 or -1.96%. VRX has a 1-year high of $24.30 and a 1-year low of $8.31. The stock's 50-day moving average is $14.02 and its 200-day moving average is $13.51.
On the ratings front, VRX stock has been the subject of a number of recent research reports. In a report issued on October 4, H.C. Wainwright analyst Ram Selvaraju reiterated a Hold rating on VRX, with a price target of $17, which implies an upside of 19% from current levels. Similarly, on October 3, Canaccord Genuity's Neil Maruoka reiterated a Hold rating on the stock and has a price target of $16.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Neil Maruoka have a yearly average loss of 5.3% and a return of 0.0% respectively. Selvaraju has a success rate of 38% and is ranked #4586 out of 4694 analysts, while Maruoka has a success rate of 41% and is ranked #3233.
Sentiment on the street is mostly neutral on VRX stock. Out of 13 analysts who cover the stock, 7 suggest a Hold rating , 3 suggest a Sell and 3 recommend to Buy the stock. The 12-month average price target assigned to the stock is $21.50, which represents a potential upside of 50% from where the stock is currently trading.
Valeant Pharmaceuticals engages in the development, manufacture, and market of a broad range of pharmaceutical products in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. It operates through the following segments: The Bausch + Lomb/International, The Branded Rx, and The U.S. Diversified products.
