FDA green-lights Horizon Pharma's Rayos

The FDA stamped an approval on Horizon Pharma's delayed-release version of prednisone, giving the Deerfield, IL-based outfit two drug approvals in as many years. And Horizon CEO Timothy Walbert, a former Abbott Labs ($ABT) exec, plans to waste little time with a U.S. launch of the corticosteroid for treating rheumatologic conditions such as rheumatoid arthritis planned for the fourth quarter of 2012.

Horizon ($HZNP) only sought approval of the drug, which will be marketed in the U.S. under the name Rayos, for the big indication of rheumatoid arthritis. Yet the FDA nod gives the company's drug approval for treating a range of illnesses that includes RA, polymyalgia rheumatic, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease (COPD).

But has the latest FDA approval made things brighter over at Horizon? TheStreet's Adam Feuerstein noted a "hitch" in the FDA's label for the delayed-release drug--there was no section on the efficacy of Rayos versus immediate-release prednisone.

Horizon's shares were down by more than 12% in after-hours trading on Thursday afternoon.  

Even with the FDA nod, Horizon faces the challenge of convincing prescribers of the merits of its new drug. The drug was designed so that patients with RA could take it before bed, with the outer layer of the drug keeping it from releasing pain-killing prednisone until four hours later, helping to combat the aches and pains patients feel after bedtime, the Chicago Tribune reported.

As the newspaper points out, Horizon's Walbert raised more than a quarter of a billion dollars to pick up Rayos--which the company's partner Mundipharma markets in Europe--and its drug approved last year, Duexis. The latter med, another pain treatment for patients with RA, had a slow start on the market since its U.S. debut in December. Horizon lost $23.7 million in the most recent quarter with sales of just $2.5 million.

- here's the release
- see the Tribune's article

Special Report: Horizon Pharma - Biotech IPO of 2011

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