Eisai said uptake of its Biogen-partnered Alzheimer's drug, Leqembi, will likely miss an early launch target. Takeda cut several cancer candidates in its latest pipeline clear-out. Roche's subcutaneous C5 inhibitor won its world-first approval in China. And more.
1. Eisai, Biogen likely to miss early launch goal for Alzheimer's drug Leqembi
As of Jan. 26, only 2,000 Alzheimer’s disease patients in the U.S. were receiving Eisai and Biogen’s Leqembi, far below the 10,000-patient target Eisai had previously set for the end of March. About 8,000 U.S. patients are currently waiting to get on treatment, Eisai’s Alzheimer’s disease chief, Keisuke Naito, said. Eisai will be able to administer Leqembi to these patients once diagnosis and treatment pathways are in place, he said.
2. Takeda drops cancer candidates, axing immunocytokine and CAR-Ts amid shifting treatment landscape
Takeda has axed modakafusp alfa, which consists of two interferon alpha-2b molecules fused to an anti-CD38 antibody. The decision was based on existing data, the evolving multiple myeloma treatment landscape and long development timelines, Takeda’s R&D head Andy Plump, M.D., Ph.D., said. The company also ended development of three phase 1 autologous CAR-T candidates.
3. Roche's subcutaneous answer to AstraZeneca PNH drugs wins world-first approval in China
China has become the first country to approve Roche’s C5 inhibitor crovalimab, a subcutaneous challenger to AstraZeneca’s infused Soliris and Ultomiris. The approval was for paroxysmal nocturnal hemoglobinuria patients age 12 and older who have not received a complement inhibitor. Crovalimab has succeeded in three phase 3 trials, including one in China.
4. Astellas' sales expectations are up for Padcev, down for Veozah
Astellas has raised its peak sales estimate for Pfizer-partnered Padcev following the FDA’s approval for use of the antibody-drug conjugate alongside Merck’s Keytruda in first-line bladder cancer. The company now expects sales of Padcev to peak at between 400 billion to 500 billion Japanese yen ($2.7 billion to $3.4 billion). On the flip side, Astellas has lowered its fiscal-year sales projection for newly launched menopausal drug Veozah.
5. Despite Vyvanse's loss of exclusivity, Takeda treads water thanks to launch momentum
Takeda’s revenues for the nine months ended Dec. 31 reached 3.21 trillion yen (about $22 billion). The company achieved flat year-over-year sales after the ADHD drug Vyvanse lost patent protection in the U.S. in August. The Japanese pharma recently launched a pen form of its popular inflammatory bowel disease drug Entyvio, which saw sales grow 7% during the nine months.
6. Former CRISPR Tx CMO finds new home at Takeda
Also at Takeda, former CRISPR Therapeutics chief medical officer, Phuong Khanh Morrow, M.D., has taken on the role of head of oncology at the Japanese pharma. She succeeded Chris Arendt, Ph.D., who recently transitioned to become Takeda’s chief scientific officer.
After WuXi AppTec landed in the crosshairs of a new U.S. bill dubbed the BIOSECURE Act, the CRO giant’s leadership has penned an open letter. The company called the draft bill “misguided,” adding that it’s taking measures to correct the bill’s “unfounded and misleading claims.” The House committee behind the bill is planning to hold a hearing on China biotech competition, Axios reported.
8. I-Mab sheds China footprint to complete transformation into US-based biotech
As geopolitical tension becomes a thorny issue among biotechs with Chinese backgrounds, I-Mab has decided to separate its Chinese operations so it can become a U.S.-focused biotech. The Nasdaq-listed company will hand its work in China to an affiliate and a group of China-based investors in exchange for $80 million and the right of first negotiation on the ex-China rights to three future drug candidates.
Other News of Note:
9. Samsung Biologics, LegoChem partner to propel ADC development and production
10. Kyowa Kirin pays $100M to partner with BridgeBio on potential dwarfism drug
11. Empower bolsters compounded drug manufacturing capacity with purchase of Eugia site in New Jersey