Nearly twice as many Americans as the entire population of Los Angeles have it. Of those 7.5 million individuals, six in 10 say the disease causes problems for them in everyday life. Over $11 billion in direct and indirect costs is spent every year on it.
What is this serious disease? Psoriasis.
Although several treatments are currently available, it remains the most common autoimmune disease in the U.S. Quite a few drugmakers are fervently working to roll out new medications for psoriasis, though. Here are three with potentially revolutionary medications on the way.
1. Novartis (NYSE: NVS)
Novartis hopes to secure regulatory approval in 2014 for its new psoriasis biologic secukinumab. The Swiss pharmaceutical firm completed late-stage testing of secukinumab earlier this year, and expects to submit for approval before the end of 2013.
Secukinumab delivered great results in clinical studies, showing clear superiority over Amgen's (NASDAQ: AMGN) megablockbuster Enbrel, which is a current standard of care treatment for psoriasis. While details from the phase 3 trial won't be revealed until October, Novartis said that all primary and secondary endpoints were successfully met.
2. Celgene(NASDAQ: CELG)
While many of its rivals focus on new injectable drugs, Celgene looks to lead the way with a new oral medication. The biotech submitted a New Drug Application, or NDA, for apremilast as a treatment for psoriatic arthritis earlier this year, and plans to file for regulatory approval of the psoriasis indication in the U.S. and Europe before the end of 2013. If all goes well, apremilast could be commercially available in the second half of next year.
Celgene hopes to create a middle market for patients who can no longer take methotrexate but don't want to use more costly biologics like Enbrel and Humira. Although some observers were disappointed by phase 3 results for apremilast, because they weren't as impressive as earlier study results, Celgene views the expected launch of the drug as a "transformational" step for the company -- and hopefully for psoriasis patients, as well.
3. Lilly (NYSE: LLY)
Lilly isn't quite as far along with its psoriasis biologic ixekizumab, but clinical studies are progressing nicely, so far. The big drugmaker has several phase 3 trials in process that are expected to conclude in the second quarter of 2014.
Ixekizumab showed considerable promise in a mid-stage study that wrapped up last year. Up to 83% of patients taking the drug achieved a 75 percent improvement in Psoriasis Area and Severity Index, or PASI, scores. PASI is the standard measurement of severity of psoriasis. Thirty-nine percent of patients taking the 150 mg dose of ixekizumab experienced 100% improvement in skin conditions.
Nipping at their heels
While these three companies might be the farthest along, several others are nipping at their heels. Amgen's brodalumab inhibits the interleukin-17 receptor, seen as a major factor in psoriasis. Brodalumab advanced to a phase 3 study earlier this year.
Pfizer (NYSE: PFE) hopes to add the psoriasis indication for Xeljanz, which is already approved in the U.S. for treating rheumatoid arthritis. The drug is currently in a phase 3 study for psoriasis. Xeljanz encountered a setback in Europe this year, though. The European Committee for Medicinal Products for Human Use, or CHMP, recommended against approval for the drug in treating rheumatoid arthritis because of concerns over its safety profile.
Some predict that the worldwide market for psoriasis drugs could double by 2022 to more than $7.6 billion. That market size should present a compelling target for these and other companies developing new psoriasis treatments. It also should result in great opportunities for investors. Most importantly, the millions of people who suffer from psoriasis can look forward to more effective treatment options in the days ahead.
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