ALAMEDA - Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.

Takeda's application is based on the results of two clinical trials in patients with advanced HCC who had received prior systemic therapy: CELESTIAL (XL184-309), a global, randomized, placebo-controlled, double-blind phase 3 clinical trial, and Cabozantinib-2003, a phase 2 clinical trial conducted in Japan. The CELESTIAL trial was the basis for the CABOMETYX approvals in the U.S. and the EU for the treatment of patients with HCC who have been previously treated with sorafenib.

'Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related death worldwide,' said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. 'The approval of CABOMETYX in Japan is an exciting next step toward bringing this treatment to liver cancer patients who otherwise have limited treatment options following prior systemic therapy. We're proud to collaborate with Takeda as we work to bring this treatment to patients in Japan.'

Per the terms of Exelixis and Takeda's collaboration and license agreement, Exelixis is eligible to receive a $15 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable HCC, which is expected to occur in the fourth quarter of 2020. In January 2020, Takeda's application for approval to manufacture and sell CABOMETYX as a treatment for patients with unresectable HCC that had progressed after prior systemic therapy in Japan triggered a $10 million milestone payment. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan.

Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

About HCC

Liver cancer is a leading cause of cancer death worldwide, accounting for more than 700,000 deaths and 800,000 new cases each year.1 In the U.S., the incidence of liver cancer has more than tripled since 1980.2 HCC is the most common form of liver cancer, making up about three-fourths of the estimated 43,000 new cases in the U.S. in 2020.2 HCC is the fastest-rising cause of cancer-related death in the U.S.3 Without treatment, patients with advanced HCC usually survive less than 6 months.4

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of CABOMETYX for patients with liver cancer and Exelixis' and Takeda's collaboration to bring CABOMETYX to HCC patients in Japan; Exelixis' eligibility to receive a $15 million milestone payment from Takeda upon Takeda's first commercial sale of CABOMETYX for unresectable HCC, which is expected to occur in the fourth quarter of 2020; Exelixis' eligibility for future development, regulatory and first-sale milestones, plus sales revenue milestones and royalties on net sales under its collaboration with Takeda and Exelixis' plans to reinvest in its business to maximize the potential of the company's pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX in Japan; Exelixis' dependence on its relationship with Takeda, including Takeda's investment in the resources necessary to successfully commercialize CABOMETYX in Japan; Exelixis' and Takeda's ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for their products or to enter into and maintain agreements with third parties to do so; Exelixis' and Takeda's continuing compliance with applicable legal and regulatory requirements; the continuing COVID-19 pandemic and its impact on Exelixis' and Takeda's commercial activities; Exelixis' ability to protect its intellectual property rights; Exelixis' dependence on third-party vendors for the development, manufacture and supply of cabozantinib; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions and other factors affecting Exelixis and its commercial programs and partnerships discussed under the caption 'Risk Factors' in Exelixis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis' future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Contact:

Susan Hubbard

Tel: (650) 837-8194

Email: shubbard@exelixis.com

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