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Exelixis, Inc.

Partner : Roche

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Exelixis Provides Update on Genentech’s Pending New Drug Application for Cobimetinib, an Exelixis-Discovered Compound

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jul. 1, 2015-- Yesterday, Exelixis’ (NASDAQ:EXEL) partner Genentech, a member of the Roche Group, informed Exelixis that, in order to accommodate its review of a supplemental data submission, the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech’s New Drug Application (NDA) for cobimetinib by the standard extension period of three months, from August 11, 2015 to November 11, 2015.

FDA extended its review after Genentech submitted, at FDA request, additional data from coBRIM, the phase 3 registrational trial of cobimetinib and vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma.

Exelixis discovered cobimetinib, a selective inhibitor of MEK, internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND. Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.

In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, 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 equally in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.
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Source: press release, 7/01/15. http://www.exelixis.com/investors-media/press-releases

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Exelixis Announces Acceptance of New Drug Application for Cobimetinib in Combination with Vemurafenib for Treatment of Patients with BRAF V600 Mutation-Positive Advanced Melanoma
- FDA Grants Priority Review, Assigns Action Date of August 11, 2015 -

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb. 19, 2015-- Exelixis, Inc. (NASDAQ:EXEL) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib for patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib is a specific MEK inhibitor that was discovered by Exelixis and is now the subject of a worldwide co-development agreement between Exelixis and Genentech, a member of the Roche Group.

FDA has granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 11, 2015. A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

“The FDA’s acceptance of the cobimetinib NDA brings us one step closer to a potential new treatment option for patients with advanced BRAF V600 mutation-positive melanoma, a form of the disease for which new approaches are needed,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We applaud Genentech on this regulatory progress, and we look forward to working with them, as well as with Roche, to commercialize and co-promote the combination in the event that it is approved.”

The NDA is based on data from coBRIM, a phase 3 pivotal trial conducted by Genentech. Roche also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for the combination of cobimetinib and vemurafenib in 2014.
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Source: press release, 2/19/15. http://www.exelixis.com/investors-media/press-releases

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Exelixis’ Collaborator Genentech Files New Drug Application for the Combination of Cobimetinib and Vemurafenib for the Treatment of Patients With BRAF V600 Mutation-Positive Advanced Melanoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 15, 2014-- Exelixis, Inc. (NASDAQ:EXEL) today announced its collaborator Genentech, a member of the Roche Group, has completed the filing of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year.

The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma. As presented during the Presidential Symposium at the European Society for Medical Oncology 2014 Congress, coBRIM met its primary endpoint, demonstrating a statistically significant increase in investigator-determined progression-free survival (PFS). The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone (hazard ratio [HR] = 0.51, 95 percent CI 0.39-0.68; p < 0.0001). The safety profile of the combination was consistent with that observed in a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab abnormalities, elevated creatine phosphokinase and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab abnormalities.
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Source: press release, 12/15/14. 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 FDA: PDUFA DATE

Dates: 2015-11-11

Results:

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FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma
-- Exelixis and Genentech to Co-Promote COTELLIC in the United States;

COTELLIC is expected to be available in the U.S. within two weeks –

--U.S. Profit Share Arrangement Will Provide Exelixis a Second Source of Product Revenue --

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 10, 2015-- Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved COTELLIC™ (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. COTELLIC and vemurafenib are not used to treat melanoma with a normal BRAF gene. COTELLIC is a selective inhibitor of MEK that was discovered by Exelixis and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group. This is the second regulatory approval for COTELLIC, which was first approved in Switzerland in late August 2015.

Genentech sponsored the COTELLIC U.S. New Drug Application (NDA), having led the compound’s development since midway through the initial phase 1 clinical trial. Genentech filed its NDA in December 2014; the FDA accepted the filing and granted it Priority Review in February 2015. Separately, Roche filed a Marketing Authorization Application (MAA) with the European Medicines Agency in late 2014, and the Committee for Medicinal Products for Human Use issued a positive opinion for the MAA in September 2015. Roche anticipates a decision from the European Commission by year-end.

“The approval of COTELLIC for use in combination with vemurafenib is an important milestone for the melanoma community, and also for Exelixis, as it is the second medicine discovered in our laboratories to receive regulatory approval in the United States,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to working with Genentech and Roche to bring this important new treatment option for BRAF V600E and V600K mutation-positive advanced melanoma to patients, physicians, and caregivers.”

The COTELLIC approval is based on data from the phase 3 coBRIM study, which showed COTELLIC plus vemurafenib reduced the risk of disease worsening or death (progression-free survival; PFS) by about half in people who received the combination (HR=0.56, 95 percent CI 0.45-0.70; p<0.001), with a median PFS of 12.3 months for COTELLIC plus vemurafenib compared to 7.2 months with vemurafenib alone. An interim analysis also showed the combination of COTELLIC and vemurafenib helped people live significantly longer (overall survival) than vemurafenib alone (HR=0.63, 95 percent CI 0.47-0.85; p=0.0019). The objective response rate (tumor shrinkage) was higher with COTELLIC plus vemurafenib compared to vemurafenib alone (70 vs. 50 percent; p<0.001), as was the complete response rate (complete tumor shrinkage, 16 vs. 10 percent).

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.

The final overall survival analysis from the coBRIM trial will be presented at the Society for Melanoma Research 2015 International Congress, which will be held in San Francisco from November 18-21.

In November 2013, Exelixis exercised its option under the 2006 collaboration agreement to co-promote COTELLIC in the United States; accordingly, Exelixis will field 25% of the sales force, closely coordinating its efforts with Genentech. 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. The company is also eligible to receive royalties on any sales of the product outside the country, including in Switzerland, where COTELLIC was first approved, and in the European Union, where Roche anticipates a regulatory decision by year-end.

Dr. Morrissey continued: “The approval of COTELLIC represents a major achievement for Exelixis and for all of the employees, past and present, who contributed to the program since its inception. As we enter the commercialization phase of our partnership with Genentech and Roche, our agreement enables Exelixis to participate meaningfully in the product’s introduction and ongoing sales. In the United States, our team is fully prepared to co-promote COTELLIC. Outside of the country, we are eligible to receive royalties on sales. Exelixis is excited to be working with Genentech and Roche to ensure that the commercialization phase of our cobimetinib partnership mirrors the productivity and success seen during COTELLIC discovery and clinical development.”
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Source: press release, 11/11/15. http://www.exelixis.com/investors-media/press-releases

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