Novartis AG NVS announced new positive two-year results on psoriasis drug Cosentyx from the extension study of the pivotal Phase III FIXTURE and ERASURE trials.
These results were presented at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco.
We remind investors that the FDA has approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis in adult patients, who require systemic therapy or phototherapy (light therapy). The drug also received approval in the EU as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients.
Approximately 995 patients, who achieved Psoriasis Area Severity Index (PASI) 75 response after a year of therapy (Week 52), received Cosentyx 300 mg, Cosentyx 150 mg or placebo for an additional year (Week 104). Results from the trials after two full years of therapy showed that 7 out of 10 (71%) patients treated with Cosentyx 300 mg had clear or almost clear skin (PASI 90); 4 out of 10 (44%) had clear skin (PASI 100) and almost 9 out of 10 (88%) patients maintained their PASI 75 response.
Meanwhile, Novartis is also evaluating Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis. Regulatory applications for these indications are scheduled in 2015.
The results from the extension study further reinforced the efficacy of Cosentyx. The drug’s approval in the U.S. and Europe was a great boost for Novartis as it will further strengthen the company’s dermatology portfolio.
We remind investors that Novartis undertook a series of actions to reorganize its portfolio in 2014 in order to focus on its core businesses of pharmaceuticals, eye care and generics. Sales of Diovan Mono, one of the company's key drugs, are expected to be impacted by generics in 2015. Exforge and Gleevec are also facing generic competition.
We note that Celgene Corp. CELG also gained EU approval for Otezla for psoriatic arthritis and psoriasis earlier in 2015. Otezla was approved in the U.S. in 2014 for the same indication.
Novartis currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Salix Pharmaceuticals SLXP and Lannett Company, Inc. LCI. Both sport a Zacks Rank #1 (Strong Buy).
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