Exelixis Bolsters Pipeline in Deal with India’s Aurigene

Exelixis, based in Alameda, California, inked a collaboration, option and license deal with India’s Aurigene Discovery Technologies Ltd. Aurigene focuses on oncology and inflammatory diseases. Exelixis is working to build its pipeline behind its flagship product Cabometyx (cabozantinib), and this deal will give it access to up to six Aurigene programs.

Under the terms of the deal, Exelixis is paying Aurigene $10 million up front for exclusive options to license three existing programs. The two companies will then launch three drug discovery programs led by Aurigene on mutually agreed-upon targets. For these, Exelixis will pay $2.5 million per program.

Exelixis will also help pay for the research for the discovery and preclinical development for all six programs. As the work continues, Exelixis will have the chance to exercise an exclusive option for each program up to the point of Investigational New Drug (IND) acceptance. At that point, if Exelixis chooses to option a program, it will make another payment and take over the program’s clinical development and commercialization including international manufacturing efforts. Aurigene will then be up for various milestones based on development, regulatory and sales progress in addition to royalties.

Aurigene will hold limited development and commercial rights for India and Russia.

“Aurigene has a proven track record in discovery collaborations with 14 partnered programs currently in clinical trials, including 10 trials in the United States,” stated Peter Lamb, Exelixis’ executive vice president, Scientific Strategy, and chief scientific officer. “Our collaboration has the potential to enhance Exelixis’ early-stage pipeline with promising therapeutic candidates while mitigating financial risk for Exelixis through a success-based payment structure. Aurigene’s small molecule discovery expertise complements our internal discovery capabilities and gives us access to an expanded range of targets and mechanisms, including covalent inhibition and induced protein degradation.”

Aurigene is a wholly-owned subsidiary of Dr. Reddy’s Laboratory. It is based in Bangalore, Hyderabad and Kuala Lumpur. The company focuses on cancer and inflammatory diseases, in particular oral immune checkpoint inhibitors, precision oncology and the Th-17 pathway. It has three programs in clinical development, its PD-L1/VISTA antagonist CA-170 is in Phase II in India, its CDK7, CDK12 inhibitors, CD47 immune checkpoint inhibitor, and SMARCA2/4 degraders are in preclinical development.

Aurigene has collaboration deals with Agios Pharmaceuticals, Curis, Orion Corporation, Pierre Fabre, Debiopharm Group, Forest Labs, Merck Serono and several others.

Exelixis also reported its second-quarter financials yesterday. For the quarter, it reported total revenues of $240.3 million, compared to $186.1 million in the same quarter in 2018. The revenues reflect the growth of its Cabometyx for patients with advanced renal cell carcinoma (RCC) and its U.S. launch of the drug for hepatocellular carcinoma who have been previously treated with sorafenib. It was approved for that indication by the U.S. Food and Drug Administration (FDA) in January 2019.

“The second quarter of 2019 was highlighted by the strong and sustained momentum of our business,” stated Michael M. Morrissey, president and chief executive officer of Exelixis. “We achieved notable revenue growth for the Cabometyx franchise, supporting our strategy of reinvestment in long-term growth opportunities through our internal discovery and targeted in-licensing activities, including today’s announcement of our partnership agreement with Aurigene.”