Fierce Pharma Asia—Eisai's Alzheimer's trial deaths; Moderna's first M&A deal; GSK, WuXi's bispecific pact

After a publishing break, we're now giving you three weeks of biopharma news related to Asia and Asian companies. Eisai continues to field questions around deaths observed in its closely watched clinical trial of Alzheimer's disease candidate lecanemab. Moderna is buying a Japanese DNA manufacturer. GSK is betting as much as $1.5 billion on T-cell engagers developed by WuXi Biologics. And more.

1. Eisai rebuts NEJM report that Alzheimer's med contributed to patient's stroke death

3rd patient death potentially tied to Eisai's Alzheimer's drug reported

Even as the FDA is slated to rule on Eisai’s Alzheimer’s disease candidate lecanemab, the Japanese pharma faces more reports of patient deaths in its clinical trial. One case was put on public display in The New England Journal of Medicine. A team from Northwestern University described the death of a 65-year-old patient who got lecanemab during the extension portion of the Clarity AD trial and a clot-busting treatment for strokes and then suffered multiple brain bleeds. In a rebuttal, Eisai refuted the idea that lecanemab caused the death.

2. Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M

Flush with cash from selling COVID-19 vaccines, Moderna has made its first acquisition. The mRNA specialist is paying $85 million to purchase Japanese DNA supplier OriCiro Genomics. OriCiro offers cell-free assembly and amplification of DNA, which Moderna CEO Stéphane Bancel said could reduce large-scale manufacturing time by up to 30%.

3. GSK pays WuXi $40M, bets $1.5B in biobucks for preclinical anti-cancer bispecific antibodies

GSK is making a bet on T-cell engagers, paying $40 million upfront to exclusively license one preclinical CD3 bispecific antibody from WuXi Biologics, with options on three more bispecific or multispecific candidates. Up to $1.46 billion in milestone payments are also up for grabs. The announcement came as more CD3 bispecifics, such as Roche’s freshly FDA-approved Lunsumio, are emerging across the industry.

4. Merck puts eye-popping $9.3B on the line in lopsided ADC deal with Kelun-Biotech

Meanwhile, the antibody-drug conjugate field is also getting hotter what with the success of AstraZeneca and Daiichi Sankyo’s Enhertu. Now, one Chinese company has attracted Merck & Co.'s interest for the third time. In a basket deal, Merck put down $175 million upfront to license seven ADCs from Kelun Biotech, with an eye-popping $9.3 billion earmarked for potential milestones.

5. Pfizer wins—again—in courtroom fight versus Astellas over Lexiscan patents

Astellas has lost again in its patent fight against Pfizer’s Hospira around Astellas’ cardiovascular scanning agent Lexiscan. A federal appeals court has upheld a lower court’s ruling that Pfizer’s generic didn’t infringe on Astellas’ patents. Lexisan reeled in $650 million during Astellas’ fiscal year that ended on March 31, 2022.

6. Astellas' 2nd phase 3 win in a month for cancer antibody tees up submissions to regulators

Meanwhile, Astellas’ potential first-in-class anti-CLDN18.2 drug zolbetuximab has chalked up a second phase 3 win. A combination of zolbetuximab and the chemo regimen CAPOX topped chemo alone at prolonging the lives of patients with newly diagnosed , CLDN18.2-positive, HER2-negative gastric and gastroesophageal junction in the GLOW trial. This adds to the phase 3 SPOTLIGHT win that tests a combo of zolbetuximab and the mFOLFOX6 regimen.

7. Takeda troops rare disease drug to regulators after glimpse at phase 3 data

Takeda is gearing up for an FDA filing for an enzyme replacement therapy, coded TAK-755, in the rare blood-clotting disorder of congenital thrombotic thrombocytopenic purpura. An interim analysis of a phase 3 trial linked the ADAMTS13 replacement therapy to a 60% reduction in the incidence of thrombocytopenia compared with existing standard of care.

8. Viking accuses Chinese biotech of 'ruse' to raid trade secrets and make off with NASH cache

Viking Therapeutics has sued Chinese biotech Ascletis BioScience for allegedly using Viking’s confidential information obtained under the disguise of a business collaboration to benefit its own nonalcoholic steatohepatitis program. The U.S. biotech argued that Ascletis’ candidate ASC41 was “unlawfully derived” from Viking’s trade secrets around its candidate VK2809.

Other News of Note

9. With BMS plant in hand, Korea's Lotte sets out to hit $940M in CDMO revenues

10. With bigger fish to fry, Eisai unloads US rights to epilepsy drug Fycompa to Catalyst

11. Fujifilm to acquire digital pathology company Inspirata in 2nd image deal in a week

12. Japan greenlights Sysmex's amyloid blood test for Alzheimer's disease