Genentech returns rights to Hanmi Pharm's targeted cancer drug after decade-long partnership

Hanmi Pharm will reclaim global rights to its oral targeted anticancer drug belvarafenib (HM95573) a decade after licensing them to Genentech, a subsidiary of Roche, in a deal worth up to $910 million.

Hanmi Pharm said the move is a routine contractual wind-down that had been anticipated for years, and that its domestic Phase 2 clinical trial for melanoma will proceed without disruption. The company also said it plans to deepen its partnership with Genentech, anchored by a deal signed last month to license an obesity treatment candidate worth up to 3 trillion won ($2.21 billion).

Hanmi Pharm disclosed Tuesday that Genentech had notified it of the contract termination and return of rights under the belvarafenib technology transfer agreement signed Sept. 28, 2016. The termination takes effect 90 days from the notification date, on Dec. 27, and the two companies plan to carry out a smooth handover of responsibilities and rights by that date.

Under the original agreement, Genentech secured exclusive global development and commercialization rights outside South Korea. The total deal was valued at $910 million, comprising an $80 million upfront payment — worth about 88 billion won at the time — and $830 million in milestone payments. The remaining milestones will lapse upon termination, but Hanmi Pharm has no obligation to return the $80 million it has already received, leaving the company with no direct financial impact.

Hanmi Pharm described the disclosure as "a contractual wind-down of something Genentech had already made official years ago when it decided not to continue development — an outcome that was fully anticipated."

Separate from the return of global rights, Hanmi Pharm will continue developing belvarafenib independently. The company has been advancing a Phase 2 trial in South Korea — rights it retained from the outset — targeting melanoma, a form of malignant skin cancer, with an oral anticancer drug. It also has the option to recover global clinical data accumulated by Genentech and use it to explore expanded indications or pursue a new global out-licensing deal.

Hanmi Pharm reaffirmed its commitment to drug development, saying that "just as with efpeglenatide — which was returned by Janssen and then out-licensed to Merck in the United States — and epeglenatide, an obesity drug set for domestic launch this year, a rights return in drug development is not an end but an opportunity to create new innovation." Efpeglenatide is a treatment for MASH, or metabolic dysfunction-associated steatohepatitis.

The two companies' collaboration is expected to shift from oncology to next-generation obesity treatments. Hanmi Pharm signed a technology licensing agreement with Genentech on Aug. 24 for HM17321, an obesity treatment candidate designed to selectively reduce fat while preserving muscle mass, in a deal worth up to $2.3 billion, or between 3.2 trillion and 3.5 trillion won.

Hanmi Pharm said it plans to build on its long-standing relationship with Genentech to further solidify the obesity drug partnership.