– The second approval of a cancer drug for Exelixis
– The approval of Exelixis/Roche drugs combination will save lives.
– The melanoma the combination drugs treat is a killer with bad prognosis
– The terms of Exelixis/Roche agreement are favorable
Reiterating our enthusiastic feeling about the future of Exelixis (EXEL), our feeling has transformed into reality and here we are, Swissmedic, the Swiss licensing and supervisory authority of Switzerland, has approved Exelixis drug cobimetinib for use in combination with Roche’s drug vemurafenib as a treatment for patients with advanced melanoma.
Cobimetinib trade name in Switzerland is Cotellic™.
The drug will be mainly used on melanoma patients having the BRAF V600 mutation, as the granted approval was based on data from the coBRIM phase 3 pivotal trial of cobimetinib and vemurafenib conducted in patients with previously untreated unresectable, locally advanced or metastatic melanoma with a BRAF V600 mutation.
Expected Upcoming Worldwide Approval
The approval is the first for Exelixis drug cobimetinib and the second following the firm’s drug Cometriq (cabozantinib) for progressive, metastatic medullary thyroid cancer.
The cobimetinib combination is expected to get more approvals. Here are some filings for approval of the combination:
– Genentech filed its New Drug Application (NDA) for cobimetinib with the FDA in December 2014 and the Prescription Drug User Fee Act date is November 11, 2015.
– Roche filed a Marketing Authorization Application with the European Medicines Agency in late 2014, and Roche anticipates a regulatory decision before the end of 2015.
After discovering and advancing cobimetinib to investigational new drug (IND) status, Exelixis entered in 2006 into a worldwide collaboration with Genentech. 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 eligible to receive royalties on sales of cobimetinib outside the United States.
This is good news.
The Better News
In case cobimetinib will be approved in the U.S., Exelixis will be 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. And, in November 2013, Exelixis exercised its option to co-promote cobimetinib in the United States and, under the terms of the agreement, the company is prepared to field up to 25 percent of the U.S. sales force.
Here is what Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis said in this respect after congratulating his employees, past and present, who contributed to the program since its inception. “Our agreement with Genentech and Roche enables Exelixis to participate meaningfully in the product’s commercialization. This includes receiving royalties on ex-U.S. sales and sharing in the profits in the U.S., where our team is fully prepared to co-promote cobimetinib with Genentech pending regulatory approval. 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 the compound’s discovery and clinical development.”
This news constitutes in our opinion the beginning of a chain of achievements and approvals for Exelixis lead pipeline products – the nearest to be approved now is cabozantinib for metastatic renal cell carcinoma (mRCC), which the FDA awarded a breakthrough designation a few days ago.
The Swiss approved cobimetinib/vemurafenib combination for advanced melanoma having the BRAF V600 mutation will be life saving from a melanoma that is the less common, but the more serious type of the skin cancer.
In recent years, significant advances are made in the treatment of metastatic melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years. It is projected that approximately half of all melanomas, and eight percent of solid tumors, contain a mutation of the BRAF protein.
The BRAF V600 mutation-positive form of melanoma is associated with high-risk characteristics of the disease, including early onset, the absence of chronic skin damage, and decreased survival. That’s why the approval of this combination was essential and would lead to saving lives of many patients whose melanoma has the BRAF V600 mutation.
In the future, cobimetinib might be saving many lives of patients suffering from other cancers having the same mutation.
This is indeed excellent news for EXEL.
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