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Wired News – EU Approved Exelixis/Ipsen’s CABOMETYX in Europe for Intermediate - or Poor-Risk Advanced Renal Cell Carcinoma

Stock Monitor: Eyenovia Post Earnings Reporting

LONDON, UK / ACCESSWIRE / May 21, 2018 / If you want access to our free research report on Exelixis, Inc. (NASDAQ: EXEL), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=EXEL as the Company's latest news hit the wire. On May 17, 2018, the Company announced that the European Commission (EC) has approved the Company's partner Ipsen for CABOMETYX® (cabozantinib) 20 mg, 40 mg, and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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Under the terms of the collaboration with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in Q1 2018. The payment will be made by Ipsen within the next 70 days.

Expanded EC Approval to Include First-Line Treatment is Based on Results of CABOSUN Trial

CABOMETYX was approved in the European Union in September 2016 for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. The expanded EC approval to include first-line treatment is based on results of the CABOSUN trial, which met its primary endpoint of improved progression-free survival (PFS) compared to sunitinib in patients with previously untreated advanced RCC determined to be intermediate-or poor-risk by the International Metastatic RCC Database Consortium criteria.

CABOSUN was a randomized, open-label, active-controlled phase-2 trial conducted in May 2016 that enrolled 157 patients with advanced RCC determined to be intermediate-or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was PFS. Eligible patients were required to have locally advanced or metastatic clear-cell RCC.

FDA and CHMP Approved CABOMETYX® for Previously Untreated Intermediate- or Poor-Risk Advanced RCC

On March 23, 2018, Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® 20 mg, 40 mg, and 60 mg for the first-line treatment of adults with intermediate-or poor-risk advanced RCC. On December 19, 2017, the US Food and Drug Administration (FDA) approved CABOMETYX® for the expanded indication of patients with advanced RCC based on the results from the CABOSUN trial.

Post announcement of the news, shares of Exelixis surged in pre-market trade.

About Renal Cell Carcinoma

RCC is a kidney cancer that originates in the lining of the proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. RCC is the most common type of kidney cancer in adults. Initial treatment is most commonly either partial or complete removal of the affected kidney(s). Where the cancer has not metastasized or burrowed deeper into the tissues of the kidney, the five-year survival rate is 65%–90%, but this is lowered considerably when the cancer has spread. The body is remarkably good at hiding the symptoms and as a result people with RCC often have advanced disease by the time it is discovered.

About CABOMETYX® (cabozantinib)

Cabometyx® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL, and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance. Cabometyx® is available in 20 mg, 40 mg, or 60 mg doses. The recommended dose is 60 mg orally, once daily

Exelixis and Ipsen Collaboration

In February 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada, and Japan. This agreement was amended in December 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 09, 2016, EC approved Cabometyx® tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway, and Iceland.

Stock Performance Snapshot

May 18, 2018 - At Friday's closing bell, Exelixis' stock was slightly up 0.09%, ending the trading session at $21.58.

Volume traded for the day: 3.59 million shares.

Stock performance in the last month – up 2.32%; and past twelve-month period – up 2.62%

After last Friday's close, Exelixis' market cap was at $6.40 billion.

Price to Earnings (P/E) ratio was at 26.67.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.2% at the end of the session.


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