Ortho Dermatologics, a division of Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced it has submitted a New Drug Application (NDA) to the FDA for IDP-118 (halobetasol propionate and tazarotene) lotion. IDP-118 is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene for the treatment of plaque psoriasis.
“We are greatly encouraged by the efficacy and safety results of the IDP-118 clinical program and proud of the dedication of our medical and R&D teams who were able to expedite the NDA filing ahead of internal expectations for this promising treatment,” said Joseph C. Papa, chairman and CEO, Valeant. “This submission reflects our unwavering commitment to investing in our pipeline tobring forward novel treatment innovations that help improve the lives of our customers and their patients.”
Both approved to treat plaque psoriasis, halobetasol propionate and tazarotene, when used separately, are limited to a four-week or less duration of use. Based on existing data from clinical studies, the combination of these ingredients in IDP-118 with a dual mechanism of action, potentially allows for expanded duration of use, with reduced adverse events.
The NDA submitted for IDP-118 includes data from two successful Phase 3 multi-center, randomized, double-blind clinical trials in 418 subjects 18 years of age and older with 3%-12% clinical involvement of the body surface area for plaque psoriasis. In both studies, IDP-118 met the primary efficacy endpoint achieving a “clear” to “almost clear” score and at least a 2 grade improvement based on an Investigator Global Assessment (IGA) at 8 weeks, and clear to almost clear and at least 2 grade improvement during a 4 week follow up visit at week 12. The NDA also includes a long-term safety study with patients followed for one year. The most common adverse events were contact dermatitis (7.4%) and application site pain (2.6%).
The Phase 3 program was preceded by a successful Phase 2 study where the combination product IDP-118, with a treatment success rate of 52.5%, was superior to each of the actives halobetasol propionate and tazarotene as well as the vehicle, which demonstrates the IDP-118 formulation is superior to using the individual actives separately.
Shares of Valeant are currently trading at $13.14, down $0.19 or -1.43%. VRX has a 1-year high of $30.77 and a 1-year low of $8.31. The stock’s 50-day moving average is $15.33 and its 200-day moving average is $13.29.
On the ratings front, VRX has been the subject of a number of recent research reports. In a report issued on August 29, Cantor analyst Louise Chen reiterated a Buy rating on VRX. Separately, on the same day, Mizuho’s Irina Rivkind Koffler maintained a Sell rating on the stock and has a price target of $7.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Louise Chen and Irina Rivkind Koffler have a yearly average loss of 10.0% and a return of 16.2% respectively. Chen has a success rate of 40% and is ranked #4516 out of 4642 analysts, while Koffler has a success rate of 52% and is ranked #183.
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 $18.80, which represents a potential upside of 41% from where the stock is currently trading.
Valeant 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.