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Exelixis Announces Settlement of Dispute with Genentech Regarding Companies' Collaboration Agreement for CobimetinibExelixis, Inc. (NASDAQ:EXEL) announced today a settlement of the company's dispute with Genentech, a member of the Roche Group, concerning the parties' collaboration for the development and commercialization of cobimetinib, which is marketed as COTELLIC®. Effective July 1, 2017, as part of the settlement the companies entered into an amendment (the "Amendment") to the existing Collaboration Agreement, dated December 22, 2006, to revise the revenue and cost-sharing arrangements for the collaboration. The Amendment resolves the companies' dispute pursuant to the arbitration demand filed on June 3, 2016, and aligns both companies' interests in advancing cobimetinib as a promising therapy for patients with multiple forms of cancer. The Amendment applies to COTELLIC®'s initial commercial application in combination with ZELBORAF® (vemurafenib), as well as future commercial uses of COTELLIC®, alone or in combination. Under its terms, Exelixis continues to be entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase as specified in the original 2006 agreement. However, effective as of July 1, 2017, the revenue applied to the profit and loss statement for the COTELLIC® collaboration ("the Collaboration P&L") will be calculated using the average of the quarterly net selling prices of COTELLIC® and any additional branded Genentech product(s) prescribed with COTELLIC®. Exelixis will continue to share U.S. commercialization costs, while Genentech's portion of these costs will now be allocated to the Collaboration P&L based on the number of products in the combination. Exelixis will continue to co-promote COTELLIC® in the U.S., providing up to 25 percent of the U.S. sales force. Outside of the U.S., Exelixis remains eligible for royalties on COTELLIC® sales according to the terms of the original 2006 agreement. "The settlement and revised revenue and commercial cost-sharing arrangements lay the groundwork for our continued work together to maximize cobimetinib's potential to help patients," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "Since signing our collaboration agreement with Genentech more than ten years ago, cobimetinib has advanced from our discovery and early clinical efforts into Genentech's global clinical development organization - where it is now the subject of three ongoing or planned pivotal trials - and into commercial use around the world. With this new framework in place, we look forward to continuing our collaborative efforts with Genentech to maximize this promising medicine's impact on the treatment of cancer." Genentech has been responsible for cobimetinib's clinical development since it opted to further develop the compound following Exelixis' determination of a maximum tolerated dose in phase 1 clinical trials. Since then, Genentech has undertaken a clinical development program focused on evaluating cobimetinib's potential in combination with investigational and approved therapies. This program includes three phase 3 pivotal trials: IMblaze370, an ongoing and fully enrolled study evaluating cobimetinib and atezolizumab in third-line advanced or metastatic colorectal cancer; IMspire150 TRILOGY, an ongoing trial evaluating the combination of cobimetinib, atezolizumab and vemurafenib in patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma; and IMspire170, a planned study evaluating cobimetinib plus atezolizumab in patients with previously untreated BRAF wild-type metastatic or unresectable locally advanced melanoma expected to start in the third quarter of this year. About the Cobimetinib Development Collaboration Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide collaboration agreement 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 cobimetinib. Under the terms of the collaboration, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and shares U.S. commercialization costs. In November 2013, Exelixis exercised its option to co-promote cobimetinib in the United States and fields 25 percent of the U.S. sales force, closely coordinating its efforts with Genentech. Outside of the United States, Exelixis is eligible to receive royalties on any sales. Cobimetinib is now approved in multiple countries, including the U.S., European Union, Switzerland, Canada, Australia and Brazil, to treat specific forms of BRAF mutation-positive unresectable or metastatic melanoma, in combination with vemurafenib. The trade name for cobimetinib is COTELLIC®. Cobimetinib is also the subject of a clinical development program aimed at evaluating its potential in combination with a variety of investigational and approved therapies in disease settings including metastatic melanoma, triple-negative breast cancer and colorectal carcinoma. Important: If a patient's healthcare provider prescribes ZELBORAF® (vemurafenib), the patient should also read the Medication Guide that comes with ZELBORAF®. COTELLIC® Indication COTELLIC® is a prescription medicine that is used with the medicine ZELBORAF® to treat a type of skin cancer called melanoma:
A patient's healthcare provider will perform a test to make sure that COTELLIC® is right for the patient. It is not known if COTELLIC® is safe and effective in children under 18 years of age. Important Safety Information Before taking COTELLIC®, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of COTELLIC®. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine. How should patients take COTELLIC®?
What should patients avoid during treatment with COTELLIC®? Patients should avoid sunlight during treatment with COTELLIC®. COTELLIC® can make a patient's skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:
What are the possible side effects of COTELLIC®? COTELLIC® may cause serious side effects, including:
Patients should check their skin regularly and tell their healthcare provider right away if they have any skin changes including:
A patient's healthcare provider should check the patient's skin before they start taking COTELLIC®, and every two months during treatment with COTELLIC®. A patient's healthcare provider may continue to check the patient's skin for six months after the patient stops taking COTELLIC®. A patient's healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with COTELLIC®.
Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:
See "What should patients avoid during treatment with COTELLIC®?" for information on protecting the skin during treatment with COTELLIC®. The most common side effects of COTELLIC® include:
A patient's healthcare provider will take blood tests during treatment with COTELLIC®. The most common changes to blood tests include:
Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of COTELLIC®. Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555. Please see Full COTELLIC® Prescribing Information and Patient Information for additional Important Safety Information at www.cotellic.com. About Exelixis Exelixis, Inc. (Nasdaq: EXEL) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines to improve care and outcomes for people with cancer. Since its founding in 1994, three products discovered at Exelixis have progressed through clinical development, received regulatory approval, and entered the marketplace. Two are derived from cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors: CABOMETYX™ tablets approved for previously treated advanced kidney cancer and COMETRIQ® capsules approved for progressive, metastatic medullary thyroid cancer. The third product, COTELLIC®, is a formulation of cobimetinib, a reversible inhibitor of MEK, is marketed under a collaboration with Genentech (a member of the Roche Group), and is approved as part of a combination regimen to treat advanced melanoma. Both cabozantinib and cobimetinib have shown potential in a variety of forms of cancer and are the subjects of broad clinical development programs. For more information on Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter (News - Alert). Forward-Looking Statement Disclaimer This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential and continued development of cobimetinib; ongoing activities under the Collaboration Agreement; Exelixis continuing to be entitled to a share of U.S. profits and losses received in connection with commercialization of COTELLIC® and eligible to receive royalties on sales of COTELLIC® outside the U.S.; the potential for increased COTELLIC® sales; Genentech's plan to start IMspire170 in the third quarter of this year; Exelixis' commitment to the discovery, development and commercialization of new medicines to improve care and outcomes for people with cancer; and the therapeutic potential and continued development of cabozantinib. Words such as "promising," "will," "eligible," "potential," "look forward," "planned," "committed," or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Exelixis' dependence on its relationship with Genentech with respect to COTELLIC® and ability to maintain its rights under the Collaboration Agreement; the risk that unanticipated developments could adversely affect the commercialization of COTELLIC® and/or the parties' willingness to perform their respective obligations under the Collaboration Agreement; the degree of market acceptance of COTELLIC® and the availability of coverage and reimbursement for COTELLIC®; Genentech's ability to conduct clinical trials of COTELLIC® sufficient to achieve a positive completion; risks related to the potential failure of COTELLIC® to demonstrate safety and efficacy in clinical testing; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Exelixis' quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC (News - Alert)) on May 1, 2017, and in Exelixis' future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Exelixis, the Exelixis logo, COMETRIQ®, COTELLIC® and ZELBORAF® are registered U.S. trademarks, and CABOMETYX is a U.S. trademark.
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