Exelixis: Great News Towards Great Changes

Exelixis’ (EXEL) quarterly results beat analysts’ expectations, which was the least of our concerns. The details of the firm’s actions during the past year, however, confirmed our conviction that the recently approved products will be taken care of responsibly by the firm that created them and believed in them against all pessimistic opinions.

Indeed, more important than the firm’s current revenues and spending was the firm’s ability to strike a deal regarding the marketing of cabozantinib outside the U.S. and Canada at the exact right time.

Prior to the announcement of financial results, Exelixis and Ipsen (Euronext: IPN; ADR: IPSEY) jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib, Exelixis’ lead oncology drug. Under the agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan.

This news was refreshing. 

This agreement includes rights to COMETRIQ®, approved in the European Union (EU) for adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).

The firms agreed to collaborate on the development of cabozantinib for current and potential future indications. And, again, Exelixis will maintain exclusive rights for cabozantinib in the U.S. and Canada, while discussions on commercial partnering in Japan are taking place.

Exelixis will receive a $200 million upfront payment while remains eligible to receive regulatory milestones, including $60 million upon the approval of cabozantinib in Europe for advanced renal cell carcinoma (RCC) and $50 million upon the filing and approval of cabozantinib in Europe for advanced hepatocellular carcinoma (HCC). The firm will get additional regulatory milestones for potential further indications.

That’s not all.

The agreement also includes up to $545 million of potential commercial milestones and provides for Exelixis to receive tiered royalties up to 26% on Ipsen’s net sales of cabozantinib in its territories.

Expressing enthusiasm about cabozantinib’s robust results, Ipsen Chairman, Marc de Garidel, said: “The robust results from the METEOR study in advanced renal cell carcinoma demonstrate that cabozantinib has the potential to become a key oncology product in Europe. This transaction will help Ipsen accelerate the growth of the company and strengthen its oncology footprint in Europe. We are excited to bring cabozantinib to patients and clinicians around the world.”

Cabozantinib could be approved also for advanced hepatocellular carcinoma (HCC). Results from the CELESTIAL clinical trial, which is Exelixis-sponsored phase 3 pivotal trial are anticipated in 2017.

Also, earlier-stage studies are being conducted through collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP), and its ongoing Investigator-Sponsored Trial (IST) program. More than 45 ongoing or planned studies including trials in advanced RCC, bladder cancer, colorectal cancer, non-small cell lung cancer, and endometrial cancer are being conduced.

Exelixis believes that Ipsen’s partnership will accelerate cabozantinib’s commercialization in its territories, while Exelixis remains focused on our launch in the United States. Exelixis and Ipsen are committed to exploring and potentially developing cabozantinib in a variety of cancer settings.

Cabozantinib is a small molecule drug that inhibits the activity of tyrosine kinases including VEGF receptors, MET, AXL, and RET. Following positive results from the METEOR global phase 3 pivotal trial, the tablet form of cabozantinib is the subject of pending U.S. and EU regulatory applications for use as a treatment for advanced RCC in patients who have received one prior therapy.

In the EU, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment. With this designation, the MAA is eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA).

METEOR — a global, randomized open-label trial that compared cabozantinib to everolimus, a standard of care therapy in 658 patients with advanced RCC whose disease progressed following treatment with a VEGF receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial’s primary endpoint is progression-free survival (PFS), and secondary endpoints include overall survival (OS) and objective response rate (ORR).

As published in the New England Journal of Medicinethe trial met its primary PFS and secondary ORR endpoints. Cabozantinib demonstrated a 42% reduction in the rate of disease progression or death as compared with everolimus, with median PFS of 7.4 months versus 3.8 months for everolimus.

Following a pre-planned interim analysis that showed a strong trend in OS favoring cabozantinib but did not reach statistical significance, Exelixis undertook a second interim analysis after consulting with regulatory authorities. The results of this second interim analysis demonstrated a highly statistically significant and clinically meaningful increase in OS for cabozantinib.

Cabozantinib’s safety profile was similar to that of other VEGFR TKIs in this patient population. The incidence of adverse events (any grade), regardless of causality, was 100% with cabozantinib and more than 99% with everolimus. Serious adverse events occurred in 40% of cabozantinib patients and 43% of everolimus patients. The rate of treatment discontinuation due to adverse events was low (~10%) in both treatment arms.

To read more about the drug’s efficacy and safety clickHERE

Prohost Observations

This news is exactly what we wished to hear. The firm has brought in a reliable partner at the right time, which also indicates of how important cabozantinib will be in the war against resistant cancers. Regarding the market’s volume, according to the American Cancer Society’s 2015 statistics, kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Clear cell renal cell carcinoma (RCC) is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.

Cabo, as we mentioned above could also be approved in liver cancer and other solid tumors. Needless to remind that recently, another product from Exelixis, COTELLIC was granted U.S. approval in November 2015 as a treatment for patients with a BRAF V600E or V600K mutation-positive advanced melanoma, in combination with Roche’s drug vemurafenib, also known as Zelboraf®. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and currently shares equally in U.S. marketing and commercialization costs. COTELLIC is also approved in the EU, Canada and Switzerland, and Exelixis will receive low double-digit royalties based upon sales outside the United States.

Great News for cancer patients in the U.S. and Europe. Good news for Exelixis and for those shareholders who remained believers in the firm in spite of the negative campaigns against it. All we can see now is a bright future for Exelixis.

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