Roche Holdings Ltd. (RHHBY) recently received approval from the US Food and Administration (FDA) for its drug – Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma (skin cancer). The regulatory body also approved the cobas 4800 BRAF V600 mutation test.
We note that the company is seeking approval of Zelboraf for the said indication in the European Union (EU), Switzerland, Australia, New Zealand, Brazil, India, Mexico and Canada.
While Roche has co-developed the drug with Plexxikon, which was recently acquired by Daiichi Sankyo, the diagnostic test has been developed by Roche to identify patients eligible for treatment with Zelboraf.
We remind investors that Roche had submitted the new drug application (NDA) for Zelboraf to the FDA in May 2011, based on results from two clinical studies – BRIM2 and BRIM3.
In June 2011, the company presented encouraging data from BRIM 3 study on Zelboraf. Data revealed that patients treated with Zelboraf experienced a significant improvement in overall survival, with the risk of death reducing by 63% compared to chemotherapy. The study also met the co-primary endpoint of reducing the risk of disease aggravation by 74% versus chemotherapy.
Last week, Roche announced that the European Commission approved RoActemra (tocilizumab) for use as a treatment for active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients aged two years and above. The patients had responded inadequately to treatments by NSAIDs (nonsteroidal anti-inflammatory drugs) and systemic corticosteroids.
Outside Europe, where RoActemra is marketed as Actemra, the drug is already available as a treatment for active sJIA in patients two years and older.
Further, Actemra is currently marketed worldwide for the treatment of rheumatoid arthritis in adults who have either responded to, or who were intolerant of previous therapy with one or more disease-modifying anti-rheumatic drugs or tumor necrosis factor (TNF) inhibitors.
Roche’s Actemra primarily faces competition from UCB’s (UCBJF) Cimzia and Abbott Labs’ (ABT) Humira.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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