One patient death in a phase 3 clinical trial clouds the outlook for Eisai and Biogen's closely watched Alzheimer's disease drug lecanemab ahead of an FDA decision. GSK is barred from participating in China's volume-based procurement program targeting off-patent drugs for 18 months after a manufacturing problem. Daiichi Sankyo boosted its sales projection for Enhertu, now expecting the AstraZeneca-partnered antibody-drug conjugate to cross the blockbuster threshold in fiscal year 2022. And more
1. Eisai's Alzheimer's hopeful lecanemab may have contributed to patient death: report
A patient death has been reported in a phase 3 trial of Eisai and Biogen’s Alzheimer’s disease candidate lecanemab, casting a shadow over the Aduhelm follow-up drug after the companies reported positive efficacy results. Eisai acknowledged “at least a reasonable possibility lecanemab may have contributed to the” hemorrhage but figured other factors such as use of anticoagulants might have played a part, Stat reported.
2. GSK hit with bulk-buy ban in China after quality shortfall
China has blocked the import and sale of GSK’s enlarged prostate drug Avodart and pulled the med from the country’s volume-based procurement program. The country also barred the British pharma from the annual bulk purchase program for 18 months until April of 2024. The chain reaction was triggered by manufacturing inspection shortfalls uncovered during an inspection of a contract manufacturer’s plant in Poland.
3. Daiichi Sankyo dials up Enhertu projection, hastens oncology focus with selloffs
Daiichi Sankyo now expects AstraZeneca-partnered Enhertu to cross the blockbuster threshold in its 2022 fiscal year, which ends in March 2023. After a strong quarter fueled by a string of new approvals, Daiichi has dialed up its full-year Enhertu sales expectation to 195.2 billion Japanese yen ($1.31 billion), a big increase from the previous 128.4 billion yen forecast.
4. Lilly gives up on $40M BCL-2 buy as part of latest pipeline cull
Eli Lilly has dumped two clinical-stage candidates. One of them, a BCL-2 inhibitor coded LOXO-338, was licensed from Fosun Pharma two years ago for $40 million upfront. Once billed as a potential competitor to AbbVie and Roche’s Venclexta, the drug was undergoing a phase 1 trial in patients with blood cancers. Fosun has its own phase 1 trial underway in China.
5. SK bioscience plans global expansion push focused on vaccine manufacturing, gene therapy and more
SK Bioscience has unveiled a new global growth strategy, hoping to expand its capabilities in vaccine R&D and manufacturing. It plans to use its SKYCovione recombinant protein vaccine to address the endemic phase of COVID. The South Korean company will also scout for purchases in cell and gene therapies and other advanced platform technologies. Further, SK plans to expand its CDMO business, including extending a partnership with Novavax.
6. Avanir, Strides are laying off US employees as Sanofi eyes early retirements in Korea: report
Otsuka’s Avanir Pharmaceuticals is laying off 109 employees amid an integration with its parent. And India’s Strides Pharma Science is putting 88 jobs at its manufacturing site in New York on the chopping block, citing a “business restructuring.” Meanwhile, Sanofi has rolled out voluntary early retirement to trim its workforce in South Korea.
7. Amicus' Pompe approval hopes stall after COVID scuttles WuXi FDA inspection
Amicus Therapeutics’ Pompe disease candidate AT-GAA is further delayed at the FDA because the agency couldn’t inspect a WuXi Biologics manufacturing site, which makes the biologic component of the drug in China. An eventual U.S. approval for AT-GAA is a question of “when” not “if,” Amicus CEO Bradley Campbell said.
8. New York Yankees legend Bernie Williams gets personal about liver care in Eisai-backed campaign
Baseball legend Bernie Williams has joined the liver cancer advocacy group Blue Faery, the Global Liver Institute and Lenvima maker Eisai in launching the “One Liver to Love” initiative. The campaign features a video in which Williams talks about his personal experience with liver diseases and advocates for liver health.