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Exelixis' Partner Ipsen Gets Approval for Cabometyx in Canada

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Exelixis, Inc. (EXEL - Free Report) along with its partner Ipsen Biopharmaceuticals Canada announced that Health Canada has approved Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adult patients, previously treated with vascular endothelial growth factor targeted therapy.

The approval was based on positive results from a pivotal phase III METEOR study. The analysis compared Cabometyx with Novartis’ (NVS - Free Report) Afinitor (everolimus) on patients suffering advanced RCC and who have also received a prior anti-angiogenic therapy. During evaluation, Cabometyx demonstrated a statistically significant and clinical improvement in the overall survival rate, progression-free survival and objective response rate.

The regulatory body in Canada granted a priority review status to Cabometyx, which expediated the review process of Ipsen’s new drug submission. The above approval looks to address an area of significant unmet need for adult patients with advanced RCC having experienced disease progression on first-line therapy and are left with limited treatment options.

Per the terms of the collaborative agreement, Exelixis is eligible to receive a $5-million milestone payment from Ipsen to be paid within 70 days following Cabometyx’s approval in Canada. In 2016, Ipsen was granted exclusive rights to commercialize and develop Cabometyx in the ex-U.S. markets as well as Japan.

Shares of Exelixis have plummeted 45.9% year to date, comparing unfavorably with the industry’s decrease of 4.8%.


Last week, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include new recommendations for Cabometyx. Following the update, Cabometyx is now recommended by the NCCN for treating advanced RCC, regardless of patient risk status (favorable-, intermediate- and poor-risk).

Moreover, the NCCN added Cabometyx as a Category 1 option for the treatment of patients with hepatocellular carcinoma (HCC) (Child-Pugh Class A only), who have been previously administered with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib), in its recent update on the Clinical Practice Guidelines for Hepatobiliary Cancers.

However, the drug is not yet approved for this indication. In May 2018, the FDA accepted the supplemental New Drug Application for Cabometyx in previously treated advanced HCC and assigned it with a Prescription Drug User Fee Act action date of Jan 14, 2019.

Cabometyx generated $270 million of net product revenues in the first half of 2018. The company experienced a 14% increase in the drug’s prescriber base during the second quarter of 2018 as compared to the first. Cabometyx sales are expected to rise further this year as the drug is now approved for first-line RCC, which will expand the eligible patient population in the United States.

Exelixis, Inc. Price and Consensus

Exelixis, Inc. Price and Consensus | Exelixis, Inc. Quote

Zacks Rank & Stock to Consider

Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Gilead Sciences, Inc. (GILD - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings estimates have been revised 7% upward for 2018 and 2.4% for 2019 over the past 60 days. The stock has gained 3.1% so far this year.

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