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Wired News – Exelixis’ Partner Ipsen Gets EMA Validation of the Application for a New Indication for CABOMETYX

Stock Monitor: ChemoCentryx Post Earnings Reporting

LONDON, UK / ACCESSWIRE / April 02, 2018 / Active-Investors.com has just released a free research report on Exelixis, Inc. (NASDAQ: EXEL). If you want access to this report 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 March 28, 2018, the Company, which is a commercially-successful, oncology-focused, biotechnology organization, announced that its partner, Ipsen, has received the European Medicines Agency (EMA)'s validation of the application for a new indication for CABOMETYX® (cabozantinib) for previously treated advanced hepatocellular carcinoma (HCC). Register today and get access to over 1000 Free Research Reports by joining our site below:

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About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer in adults, and it is the most common cause of death in people with cirrhosis. Liver cancer accounts for over 700,000 deaths every year and the incidence of liver cancer has more than tripled in the US since 1980.

However, this patient community has very little treatment options. Patients suffering with HCC normally survive for less than 6 months without treatment.

About CABOMETYX® (Cabozantinib)

CABOMETYX® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL, and RET. Cabozantinib constrains the activity of these receptors, which are involved in normal cellular function and pathologic processes, such as tumor angiogenesis, invasiveness, metastasis, and drug resistance.

About the CELESTIAL Study

The CELESTIAL trial was a randomized, double blind, placebo-controlled study for evaluating the safety and efficacy of Cabozantinib in patients with advanced HCC. The CELESTIAL trial was conducted at over 100 sites in 19 countries. The trial enrolled a total of 760 patients with advanced HCC who received prior sorafenib, may have received up to two prior systemic cancer therapies for HCC, and had adequate liver function. Exelixis completed the enrollment for this study in September 2017.

In the CELESTIAL trial, patients were randomized 2:1 to receive 60 mg of Cabozantinib once daily or placebo. Patients were stratified on the basis of etiology of the disease (hepatitis C, hepatitis B, or other), geographic region (Asia versus other regions), and presence of extrahepatic spread and/or macrovascular invasion (yes or no).

However, cross over was not allowed between the study arms during the blinded treatment phase of the trial. The primary endpoint was overall survival (OS), while the secondary endpoints included objective response rate and progression-free survival. Exploratory endpoints included patient-reported outcomes, biomarkers, and safety.

Filing Based on Positive Results from CELESTIAL Trial

The filing for the new indication of Cabozantinib is based on positive top-line data from the global pivotal Phase-3 CELESTIAL trial. This trial met its primary endpoint of overall survival, with Cabozantinib providing a statistically significant and clinically meaningful improvement in OS versus placebo in patients with advanced HCC, and who had been previously treated with sorafenib (pre-specified critical p-value ≤ 0.021).

Milestone Payment for Exelixis

The marketing authorization from the EMA marks a significant milestone in Exelixis' collaboration and development program with Ipsen. This will allow the Companies to extend the usage of Cabozantinib to additional patient populations outside of the currently approved indication.

As per the terms of the Collaboration and License Agreement with Ipsen, Exelixis is entitled to receive a milestone payment of $10 million subsequent to the acceptance of this filing. As per the new revenue recognition standards adopted by Exelixis in the first quarter of 2018, the Company will not record this amount as revenue but expects Ipsen to make the payment in the second quarter of this year.

FDA Granted Orphan Drug Designation to Cabozantinib

On March 06, 2017, the US Food and Drug Administration (FDA) granted an orphan drug designation to Cabozantinib for the treatment of advanced HCC. However, Exelixis declared on October 16, 2017, that the independent data monitoring committee for the CELESTIAL study has suggested that the trial should be stopped for efficacy after the review at the second planned interim analysis.

Submission of sNDA for Cabozantinib

On March 15, 2018, Exelixis declared that it had completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Cabozantinib for previously treated advanced HCC. The submission was based on the findings from the CELESTIAL trial. If the sNDA gets approved, it will allow the drug sponsor to make changes to the previously approved product label, including modifications to the indication.

Stock Performance Snapshot

March 29, 2018 - At Thursday's closing bell, Exelixis' stock slightly dropped 0.94%, ending the trading session at $22.15.

Volume traded for the day: 4.84 million shares, which was above the 3-month average volume of 2.89 million shares.

Stock performance in the past twelve-month period – up 4.83%

After last Thursday's close, Exelixis' market cap was at $6.62 billion.

Price to Earnings (P/E) ratio was at 44.84.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.5% at the end of the session.

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