Eisai is shutting down an oncology venture for good. Continuing the recent CDMO expansion spree, Wuxi Biologics is plotting a $1.4 billion R&D and manufacturing site in Singapore, just as Samsung Biologics paid $323 million to buy a piece of land for its second bio campus in Korea. Novartis has decided to abandon a PD-1 monotherapy filing in non-small cell lung cancer. And more.
1. SCOOP: Eisai closing oncology R&D wing H3 Biomedicine for good
Eisai is shutting down its H3 Biomedicine oncology unit. H3 is laying off 88 people stationed there, and its work will be transferred to Eisai’s Deep Human Biology Learning organization. Its lead program, H3B-6545 is in a phase 2 trial for breast cancer. “H3 has validated the founding concept for the company and this venture is complete,” Eisai said in a statement.
2. WuXi plots $1.4B production and R&D center in Singapore, where it will employ 1,500
WuXi Biologics said it will invest $1.4 billion over the next 10 years to erect a new site in Singapore to beef up its R&D and drug manufacturing capabilities. The new project is expected to add 120,000 liters of biomanufacturing capacity by 2026, and the site will employ 1,500 staffers once complete, WuXi Bio said. The new Singapore site follows a global investment spree in the U.S., Ireland, Germany and China.
3. For $323M, Samsung Biologics buys land for a 2nd manufacturing campus in South Korea
Fellow CDMO Samsung Biologics is also in an aggressive expansion mode. The company just revealed it has acquired additional land in Incheon for about $323 million to build its second bio campus. Covering an area of 357,366 square meters, the new site is 30% larger than the firm’s current campus. The site will bring 4,000 jobs by 2032 when it’s complete, Samsung said.
4. Novartis shelves a PD-1 bid in non-small cell lung cancer after FDA feedback
Novartis has decided not to file BeiGene-partnered PD-1 inhibitor tislelizumab as a monotherapy in newly diagnosed non-small cell lung cancer after hearing feedback from the FDA. The agency concluded that the data “didn’t adequately reflect the U.S. population in terms of the number of patients and the standard of care that was used in that BeiGene-driven first-line study,” Novartis CEO Vas Narasimhan said on a call.
5. Daiichi Sankyo willfully infringed Seagen patent in creating Enhertu, court rules
A Texas federal court has determined that Daiichi Sankyo should pay Seagen $41.8 million for willfully infringing a Seagen patent in AstraZeneca-partnered breast cancer drug Enhertu. The award is based on royalties owed in the past, and the court will also decide whether Seagen should pay for future royalties until the patent’s expiration in November 2024. Daiichi said it will contest the ruling.
6. Merck KGaA launches Asia startup scheme to locate next generation of partnerships
Merck KGaA has launched Uptune, a program offering funding of up to $100,000 to startups in Asia. It will support five early-stage companies working within healthcare, life science, electronics and smart manufacturing. It will also focus on supply chain innovation, data management, simulation and analytics for manufacturing, the German Merck said.
7. Kyowa Kirin axes Parkinson's med, saying development and regulatory hurdles are too daunting
Kyowa Kirin has capped development of its Parkinson’s disease candidate KW-6356 even though the drug showed promise in a phase 2 trial back in 2018. The Japanese company cited the “global regulatory landscape, development hurdles, and timelines for potential market entry” for the decision.
Takeda is paying F-star Therapeutics $1 million upfront and committed up to $40 million in milestones to tap two F-star antibody platforms to develop a bispecific antibody against an undisclosed immuno-oncology target. The deal adds on to Takeda’s existing gamma delta T-cell engager work in cancer.
9. Takeda shows HyQvia can help CIDP patients as a maintenance therapy, plots filings
Takeda reported a successful phase 3 trial showing HyQvia reduced relapse neuromuscular disability and impairment against placebo when used as a maintenance treatment for a rare autoimmune disorder called chronic inflammatory demyelinating polyradiculoneuropathy. The company now plans regulatory filings by the end of 2022.
Other News of Note
10. From AstraZeneca to Novavax: Serum Institute wins FDA nod to supply new COVID shot to US from India
11. Lilly taps Triastek to use 3D printing for gut-targeted drug delivery
12. Gene therapy player Frontera reels in $160M as FDA clears eye drug's first clinical trial (release)