Exelixis Inc.’s EXEL shares dropped 7.2% as the company announced that the FDA is extending the review period for partner Roche’s RHHBY new drug application for skin cancer candidate, cobimetinib by three months. A response from the FDA should now be out by Nov 11, 2015.
Exelixis stated that the delay was to accommodate FDA review of additional data submitted by Roche from the phase III registrational study (coBRIM) on cobimetinib and Zelboraf for BRAF V600 mutation-positive advanced melanoma.
Meanwhile, cobimetinib (in combination with Zelboraf) is under review in the EU for the treatment of treatment-naïve patients suffering from unresectable locally advanced melanoma with a BRAF V600 mutation.
Cobimetinib is one of the most advanced candidates in Exelixis’ pipeline. We note that Exelixis has exercised its option to co-promote cobimetinib (upon approval) with Roche in the U.S. in 2013 and will be entitled to receive an equal share of U.S. profits and loss initially. Exelixis’ share will decrease with increase in sales. Under this agreement, the company will also share the marketing and commercialization costs in the U.S. equally with Roche. Additionally, Exelixis is eligible to receive royalties on product sales outside the U.S.
Some drugs approved for unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor include Merck & Co. Inc.’s MRK Keytruda and Bristol-Myers Squibb Company’s BMY Opdivo.
Exelixis carries a Zacks Rank #3 (Hold). Merck is a better-ranked stock with a Zacks Rank #2 (Buy).
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