Fierce Pharma Asia—Takeda's gene therapy pivot and pay-for-delay lawsuit; Astellas' write-offs

Takeda has decided to stop preclinical work on adeno-associated virus-based gene therapies and in rare hematology areas. The Japanese pharma company also faces a new U.S. anticompetition lawsuit around gout drug Colcrys. Astellas has taken impairment losses on FibroGen-partnered Evrenzo and two other collaborations. And more.

1. Layoffs loom as Takeda trims early-stage efforts in AAV gene therapy, rare hematology

Takeda has decided to stop early research work in adeno-associated virus-based gene therapies and in rare blood disorders. With the pivot, some employees are expected to leave the company, according to a Takeda spokesperson. Takeda is talking with its AAV partners about next steps for the programs and will maintain some level of investment in nonviral gene therapies, the spokesperson said.

2. Takeda hit with another pay-for-delay lawsuit, this time on gout drug Colcrys

A group of drug purchasers and distributors has sued Takeda for allegedly using patent settlements with generic drug makers to delay price declines on the gout drug Colcrys. If it weren’t for the alleged conspiracy, Endo's Par Pharmaceutical could have launched a cheaper copycat in 2016, the plaintiffs argued.

3. Astellas takes $340M charge on Evrenzo, joins GSK in nixing cell therapy collab with Adaptimmune

Faced with lower-than-expected sales, Astellas is taking an impairment loss of about $340 million related to FibroGen-partnered anemia drug Evrenzo. The Japanese pharma also ended a regenerative hearing loss program licensed from Frequency Therapeutics after a phase 2b flop. In addition, Astellas terminated a partnership with Adaptimmune around off-the-shelf T-cell therapies.

4. Merck and Eisai's Lenvima-Keytruda combo flunks first-line melanoma trial

Eisai’s Merck-partnered Lenvima chalked up two more failures in its combination with Keytruda. The pair stopped a phase 3 trial for the combo in first-line melanoma after an independent data monitoring committee found it wasn’t likely to beat Keytruda alone. The combo also failed to top Bayer’s Stivarga or Taiho’s Lonsurf in previously treated colorectal cancer in separate a phase 3 trial.

5. Eisai's Alzheimer's drug Leqembi gaining ground with US neurologists, but most waiting on full approval: Spherix

In a recent survey of neurologists by Spherix, a “healthy proportion” of respondents have started prescribing Eisai and Biogen’s Leqembi. Still, most “intend to wait” until the drug gets a full FDA approval. Once that comes through, nearly all respondents “expect to prescribe” Leqembi within the first year of approval, Spherix found.

6. Otsuka, Lundbeck head into key FDA panel meeting with agency support for their Rexulti application

The FDA appeared to lean toward an approval for Otsuka and Lundbeck’s Rexulti for treating agitation in Alzheimer’s disease patients. In briefing documents prepared ahead of an advisory committee meeting, the FDA’s reviewers recognized that the drug significantly reduced agitation in two phase 3 trials. A third trial failed on the primary endpoint but showed a “nominally significant” effect compared with placebo, the FDA said.

7. Trailing AstraZeneca and Merck, Junshi reports phase 3 ovarian cancer success for Lynparza rival

Junshi Biosciences said its Impact Therapeutics-partnered PARP inhibitor, senaparib, extended the time before progression or death when given as a first-line maintenance therapy to BRCA-positive ovarian cancer patients. The company didn't reveal detailed data, but the trial win sets up Junshi to compete with at least four other PARP inhibitors in China.

8. Genexine's anemia drug matches Roche-CSL product in phase 3, laying groundwork for Asia filings

South Korea’s Genexine said its long-acting erythropoiesis-stimulating agent, GX-E4, matched up to Roche and CSL Vifor’s Mircera in non-dialysis chronic kidney disease patients with anemia. Genexine and its Indonesian partner KG Bio plan to complete several phase 3 studies this year and start filing for approvals in Asian countries.

Other News of Note

9. In debt again, Glenmark seeks buyer for its stake in API business: report

10. Korea's UNDBIO earmarks $100M to build insulin plant in West Virginia

11. With Brukinsa launch, BeiGene seeks to avoid protracted pricing squabbles in Europe: exec

12. Takeda gets FDA expansion of HyQvia to treat kids with primary immunodeficiency