Astex bags milestone after Novartis cancer drug approved

Astex Pharmaceuticals has pocketed a milestone payment from Novartis after the cancer drug the companies worked on together a decade ago secured FDA approval. The milestone was triggered when FDA signed off on the use of Kisqali as a first-line treatment for HR-positive, HER2-negative advanced breast cancer.

Approval of Kisqali comes 11 years after Novartis struck a $520 million (€489 million) deal with Astex to gain the rights to two cell-cycle inhibitors and form a collaboration to discover similar candidates. That led to the publication of a paper on the crystal structure CDK4 by a team mostly made up of people from Astex’s site in Cambridge, U.K. 

The approval of CDK4/6 inhibitor Kisqali, née LEE001, is the culmination that work.

“We are absolutely delighted that Novartis has received this first approval of a cancer drug arising from our productive collaboration. This milestone further validates the power of our Pyramid platform and the excellence of our science. It’s a moment to celebrate when such ground-breaking scientific work results in a new treatment option for women with advanced breast cancer,” Astex CEO Harren Jhoti said in a statement.

The approval gives Astex its second milestone from Novartis of the past six months. Novartis last handed cash to its partner at the end of October when Kisqali was filed for approval with FDA. Astex, which is part of Otsuka following a 2013 buyout, hasn’t disclosed the size of the milestones.

How much more Astex earns from the program will depend on Novartis’ future regulatory and commercial successes. Astex is set to pocket additional milestones if Novartis gets Kisqali approved in Europe and Japan. And it will receive royalty payments on the annual sales Novartis racks up in trying to steal market share away from Pfizer’s Ibrance.

Novartis won approval for Kisqali on the strength of phase 3 data. The data showed that combining it with its own Femara cut the risk of disease progression or death by 44% compared to the latter drug alone. This led FDA to grant approval for use of the drug in combination with an aromatase inhibitor, such as Femara.