Eisai's Alzheimer's disease drug Leqembi won't get any special Medicare coverage—for now. AstraZeneca signed a deal worth up to $1.1 billion for a Chinese antibody-drug conjugate candidate. Mitsubishi won $940 million in Gilenya royalties in an arbitration feud with Novartis. And more.
1. Eisai's Leqembi shunned as CMS keeps strict Alzheimer's drug restrictions in place
The Centers for Medicare & Medicaid Services (CMS) rejected a petition to reconsider its Medicare coverage policy for Eisai’s Leqembi. Despite phase 3 data showing Leqembi can alleviate cognitive decline in Alzheimer’s disease patients, CMS argued that there isn’t “evidence meeting the criteria for reconsideration.” Eisai, in response, said it had anticipated CMS would only weigh coverage changes after a full FDA approval.
2. AstraZeneca doubles down on hot cancer target, paying $63M for ADC months after bispecific deal
AstraZeneca is reaching out to an Asian company for an antibody-drug conjugate once again. In a heavily backloaded deal, the British pharma is paying $63 million upfront for KYM Biosciences’ Claudin 18.2 ADC candidate, with up to $1.1 billion earmarked for potential milestone payments. KYM is a joint venture between Chinese companies Keymed and Lepu Biopharma.
3. Novartis loses $940M arbitration case against Mitsubishi Chemical over Gilenya royalties
Mitsubishi Chemical Group has won a $940 million Gilenya royalty arbitration case from Novartis. In handing Mitsubishi the win, the arbitration tribunal denied Novartis’ claims that certain provisions in the two companies’ license agreement were invalid. As a mainstay multiple sclerosis therapy, Gilenya generated $2 billion in sales last year.
4. Astellas has menopause accelerated approval ambition thwarted by FDA at last minute
Astellas may have used a priority-review voucher for nothing. The FDA has extended the review of Astellas’ menopause drug fezolinetant by three months as the agency takes more time to complete the assessment. The drug previously failed a study in Asian patients after showing it can reduce hot flashes in two global phase 3 trials.
5. Kinnate buys OrbiMed and Foresite's stakes in cancer venture, paying $24M to go solo in China
Kinnate Biopharma has bought its partners out of a Chinese joint venture. The venture, Kinnjiu Biopharma, was established in May 2021 with help from OrbiMed and Foresite Capital Management to take care of Kinnate’s lead RAF program, exarafenib, in China. Kinnate is paying $24 million to acquire the 42% of the joint venture shares it didn’t already own.
6. Daiichi Sankyo, Seagen continue Enhertu patent fight in new US PTO review (release, PDF)
The legal fight between Daiichi Sankyo and Seagen around the antibody-drug conjugate technology used in Daiichi’s AstraZeneca-partnered Enhertu hasn’t stopped. After losing $41.8 million to Seagen in a Texas federal court last year, Daiichi has convinced the U.S. Patent and Trademark Office to launch a post-grant review of the Seagen patent.