Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY) Zelboraf Combo Gets FDA Priority Review

Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY) combination therapy, with the approval expected in the next 6 months, is anticipated to be a huge success for the company. The company reported that the US FDA has approved a priority review status for its treatments for a fatal type of skin cancer.

Speedy review

The U.S.FDA will conduct a speedy review for Roche’s combination treatment of Zelboraf and cobimetinib drug. The drug is developed by Roche’s Genentech unit and Exelixis, Inc. (NASDAQ:EXEL). The combination of drugs is to treat those patients who are suffering from ‘BRAF V600 mutation-positive melanoma.’ The final decision is anticipated to come by August. Zelboraf is the first BRAF inhibitor and is passed by FDA to treat patients suffering from melanoma. The drug has been selling in the market since 2012.

The impact on revenue

Roche’s Zelboraf has contributed significantly in company revenue in past two years. Now, the combination therapy with better efficacy will further help the company to increase its market share. The final approval is bound to benefit both Exelixis and Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY). The company will get a 50% share from the increased sales in the United States. Also, it will generate royalties on total sales from all nations. Both firms are anticipating a positive response for combo treatment in Europe.

The management view

Michael Morrissey, the CEO of Exelixis, said that the management is optimistic about the probable success of the drug. The FDA’s approval of the cobimetinib NDA is one step ahead in developing an effective treatment for patients suffering from fatal form of melanoma. The FDA has given its nod for an expedited review for combo treatment. The approval comes on the back of positive data from the Phase III study. Roche’s combo treatment will face major competition from GlaxoSmithKline plc (ADR)(NYSE:GSK)’s Mekinist.It was approved for the same purpose in Europe in 2014.

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