July 17, 2012 10:47 pm

Horizon’s Rayos/Lodotra approval anticipated in arthritis but not expected to see wide use - physicians

This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com


Horizon Pharma’s (NASDAQ:HZNP) Rayos, known as Lodotra in Europe, is expected to gain approval in rheumatoid arthritis at its 26 July Prescription Drug User Fee Act (PDUFA) date, experts told Biopharm Insight. But since rheumatologists are comfortable with generic and effective glucocorticoids, the experts interviewed said they believed Rayos would probably not be widely used.

Rayos is a modified-release prednisone formulation. Since the side effects of prednisone are known, rheumatologists see no roadblocks to approval. They said they are not convinced, however, that Rayos offers superiority over generic prednisone.

The drug has estimated peak sales of USD 81m by 2016, according to Biopharm Insight data.

Horizon did not return calls for comment.

Prednisone does have severe side effects, so it can only be used at levels where it is not a disease-modifying treatment, said Dr Shervin Assassi, assistant professor of rheumatology, University of Texas Health Science Center at Houston Medical School. Even with a different preparation, it’s unlikely that Rayos will have much impact on the field, he said. The goal whenever using prednisone is to use as little as possible, regardless of whether it is a modified-release formulation, said Dr Nan-Hsien Kuo, attending rheumatologist, New York Hospital Queens.

Only Niche Use Likely

The patient population targeted by Rayos would be a small minority, because most patients can tolerate and get 24 hours of efficacy with inexpensive prednisone, said Kuo. In a small percentage, though, a modified-release formulation could definitely be worth the added cost, he said.

In patients who don’t get a full day of efficacy from standard once-daily prednisone, rheumatologists might split the dose into two pills taken twice a day. This can have additional side effects, like sleep disturbance, explained Kuo.

A modified-release drug would help these patients, with a more steady effect rather than the “high burst” followed by diminishing effects of standard prednisone dosing, he said. Rayos is formulated to be taken close to bedtime (approximately 10 pm), with the drug kicking in close to 4 am to relieve morning pain and stiffness of arthritis.

Dr Marc Levesque, associate professor of medicine in rheumatology, University of Pittsburgh, said rheumatologists have known about this night-time approach for some time. If there is a significant need, it’s hard to imagine it would have taken the pharmaceutical industry this long to capitalize on it, Levesque noted.

Specialists remain concerned with the drug’s price compared to [generic] prednisone, said Dr Nathan Wei, a rheumatologist and CEO at Arthritis Treatment Center in Maryland.

Competition in modified-release glucocorticoid for rheumatoid arthritis includes Zalicus’ (NASDAQ:ZLCS) Synavive. The drug is a modified-release formulation of synergistic prednisolone and dipyramidamole. Zalicus hopes to have top-line Phase IIb data in 3Q12, according to CFO Justin Renz.

Horizon’s market cap is USD 251m.


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