Label Expansion for Roche's Actemra - Analyst Blog

Roche Holdings Ltd. (RHHBY) recently announced that the US Food and Drug Administration (FDA) approved Actemra (tocilizumab) to be used for slowing structural joint damage, improving physical function, and achieving major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate.

The label expansion was based on positive results from the phase III LITHE trial, which showed that patients receiving Actemra in combination with methotrexate suffered significantly less damage to their joints at one year compared with patients who received methotrexate alone.

Actemra, which is marketed as RoActemra in the European Union, was approved by the FDA in January 2010, for the treatment of adult patients with moderately to severely active RA. The drug is also available in Mexico, India, Brazil, Switzerland and Australia.

Roche is also studying RoActemra for the treatment of systemic juvenile idiopathic arthritis (sJIA). The company reported positive late-stage trial results on RoActemra for the said indication in June 2010.

The supplemental approval of Actemra comes as a breather for Roche, caught up as it is in a number of pipeline debacles. These include the negative results on Avastin in gastric and prostate cancer patients, discontinuation of development of ocrelizumab for rheumatoid arthritis due to an unfavorable risk-benefit profile and a delay in the development of type II diabetes treatment, taspoglutide, due to a higher incidence of hypersensitivity reactions in late-stage trials.

We currently have a Zacks #4 Rank (short-term Sell rating) on Roche. We note that the company's primary competitors include Eli Lilly & Co. (LLY), Bristol-Myers Squibb Co. (BMY), Genzyme Corp. (GENZ) and GlaxoSmithKline plc (GSK).

 
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