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Exelixis, Inc.

Partner : Roche / Genentech

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Cobimetinib U.S. and EU Regulatory Progress. As announced earlier this month, the U.S. Food & Drug Administration (FDA) has accepted for review Genentech’s New Drug Application (NDA) for cobimetinib, an Exelixis-discovered compound, to be used in combination with vemurafenib as a treatment for patients with BRAF V600 mutation-positive advanced melanoma. The FDA granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act Action Date of August 11, 2015. Cobimetinib is the subject of a worldwide co-development agreement between Exelixis and Genentech. Pursuant to this agreement, Exelixis is entitled to an initial equal share of U.S. profits and losses, which share will decrease as sales increase. The parties will share equally in the U.S. marketing and commercialization costs, and, if approved, Exelixis will co-promote the compound in the U.S. Outside the U.S., Exelixis is entitled to receive royalties on sales of cobimetinib. In the European Union, Roche filed a Marketing Authorization Application for cobimetinib used in combination with vemurafenib in September of 2014.
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Source: press release, 2/24/15. http://www.exelixis.com/investors-media/press-releases

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Cobimetinib (GDC-0973) MelanomaOncologyMelanoma (metastatic)MEK inhibitormitogen-activated protein kinase 1

Mechanism of action: Cobimetinib (GDC-0973) is an orally bioavailable small-molecule inhibitor of mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), with potential antineoplastic activity. MEK inhibitor GDC-0973 specifically binds to and inhibits the catalytic activity of MEK1, resulting in inhibition of extracellular signal-related kinase 2 (ERK2) phosphorylation and activation and decreased tumor cell proliferation. Preclinical studies have demonstrated that this agent is effective in inhibiting the growth of tumor cells bearing a B-RAF mutation, which has been found to be associated with many tumor types. A threonine-tyrosine kinase and a key component of the RAS/RAF/MEK/ERK signaling pathway that is frequently activated in human tumors, MEK1 is required for the transmission of growth-promoting signals from numerous receptor tyrosine kinases.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2015-09-25

Results:

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Exelixis Announces European Commission Approval of COTELLIC™ (Cobimetinib) for Use in Combination with Vemurafenib in Advanced BRAF V600 Mutation-Positive Melanoma
-- COTELLIC’s third regulatory approval, following Switzerland (August 2015) and the United States (November 2015) --

-- Exelixis eligible to receive royalties on ex-U.S. sales, including EU, per worldwide collaboration agreement with Roche and Genentech --

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 25, 2015-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission (EC) has approved COTELLIC™ (cobimetinib) for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. COTELLIC was discovered by Exelixis and is now the subject of a collaboration between Exelixis and Genentech, a member of the Roche Group. Roche sponsored COTELLIC’s EU Marketing Authorization Application, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2015.

“The approval of COTELLIC by the European Commission for use in combination with vemurafenib is an important milestone in the development of new treatments that can help patients with advanced melanoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to continuing to execute on our collaboration agreement for COTELLIC.”

The approval in the EU is based primarily on results of the phase 3 coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor COTELLIC in combination with vemurafenib lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with vemurafenib alone (hazard ratio [HR]=0.58, 95 percent confidence interval [CI] 0.46-0.72).1

The objective response rate with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the vemurafenib arm.1 Possible serious side effects with COTELLIC include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of COTELLIC include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. COTELLIC can also cause changes in blood test results.

Additional data were presented in November 2015 at the Society for Melanoma Research congress demonstrating that the combination of COTELLIC plus vemurafenib met its secondary endpoint of improving OS compared to vemurafenib alone. Roche and Genentech have guided that these data will be submitted to the European Medicines Agency for consideration and inclusion in the label.

After discovering COTELLIC internally, Exelixis advanced the product to investigational new drug (IND) status. In late 2006, the company entered into its worldwide collaboration with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop COTELLIC. Under the collaboration agreement, Exelixis is eligible to receive low double-digit royalties on sales of COTELLIC outside the United States. In the United States, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote COTELLIC in the United States and will field 25 percent of the U.S. sales force.

COTELLIC in combination with vemurafenib is now approved in the EU and Switzerland for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The combination is approved in the United States for the treatment of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Further country approvals are anticipated in 2016.
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Source: press release, 11/25/15. http://www.exelixis.com/investors-media/press-releases

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European CHMP Adopts Positive Opinion for Cobimetinib in Combination with Vemurafenib for the Treatment of Advanced Melanoma
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 25, 2015-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) has adopted a positive opinion of the Marketing Authorization Application for cobimetinib, a selective MEK inhibitor discovered by Exelixis, in combination with vemurafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The European Commission is expected to release its final decision regarding the approval of the combination of cobimetinib and vemurafenib by the end of 2015.

“The CHMP’s positive opinion on cobimetinib for use in combination with vemurafenib is an important milestone in bringing this new therapeutic option to patients in Europe,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We congratulate Genentech and Roche on this latest milestone in the European regulatory process. We also look forward to the regulatory decision anticipated this year in the United States, where we are fully prepared to co-promote cobimetinib with our partners.”

The CHMP’s recommendation is based on data from coBRIM, the international, randomized double-blind controlled phase 3 pivotal trial evaluating cobimetinib in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation.

The combination of cobimetinib and vemurafenib recently received its first approval in Switzerland, where cobimetinib is marketed as Cotellic™.

The coBRIM trial was conducted by Roche and Genentech, a member of the Roche Group. Genentech filed a New Drug Application (NDA) for cobimetinib in the United States, for which the Prescription Drug User Fee Act action date is November 11, 2015.
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Source: press release, 9/25/15. http://www.exelixis.com/investors-media/press-releases

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