Novartis' Cosentyx Positive in Psoriatic Arthritis Study - Analyst Blog
Novartis AG NVS announced positive one-year results from a pivotal multi-center, randomized, placebo-controlled phase III study (FUTURE 2) on Cosentyx. FUTURE 2 evaluated the efficacy and safety of Cosentyx for the treatment of patients suffering from psoriatic arthritis.
Novartis reported that FUTURE 2 met its primary endpoint at week 24 as subcutaneous doses of Cosentyx (300 mg and 150 mg) led to improvements that sustained over one year of treatment in the majority of patients. Response rates were significantly higher in both Cosentyx arms (54% in the 300 mg cohort and 51% in the 150 mg cohort) compared to placebo (15%). Moreover, response rates measured by the American College of Rheumatology response criteria 50 (a standard tool for assessing 50% improvement from baseline in signs and symptoms of PsA) were sustained for one year in both Cosentyx 300 mg and 150 mg groups (44% and 39% respectively). Cosentyx was well tolerated among the patients.
These data were published in The Lancet following fast track review.
According to company sources, nearly 40% of psoriatic arthritis patients remain dissatisfied with the treatments commercially available. Hence, the company believes that there is a high unmet need for new therapies for patients suffering from the disease.
We note that Cosentyx 300 mg is already approved as a first-line systemic treatment of moderate-to-severe plaque psoriasis in patients in Europe and as a treatment for moderate-to-severe plaque psoriasis in systemic therapy or phototherapy candidates in the U.S.
Novartis has submitted global regulatory application for Cosentyx for the treatment of psoriatic arthritis. The company is also looking to get the candidate approved for ankylosing spondylitis and has filed a global regulatory application for this indication.
Meanwhile, Novartis has entered into an agreement to acquire privately held Spinifex Pharmaceuticals, Inc. The latter is currently developing a candidate – EMA401 – for post-herpetic neuralgia. Financial terms of the deal have not been disclosed.
Update on Farydak
Late last week, Novartis’ Farydak (in combination with Velcade and Decadron) received a positive opinion from the Committee for Medicinal Products for Human Use for the treatment of patients suffering from relapsed and/or refractory multiple myeloma, who have received at least two prior regimens including Velcade and an immunomodulatory agent. A response from the European Commission is expected by Sep 2015.
Novartis carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Novo Nordisk A/S NVO, Bayer AG BAYRY and Abbott Laboratories ABT. All these stocks carry a Zacks Rank #2 (Buy).
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