Welcome to this week's FiercePharmaAsia report, which includes stories about two Takeda R&D deals, pharma supply issues as China tackles pollution, Merck KGaA's manufacturing expansion plan in Asia, and more.
1. Takeda rides the neuro R&D Wave with latest biotech pact
Takeda has teamed up with Wave Life Sciences to work on antisense oligonucleotides in neurological disorders. The first part of the collaboration will see Wave focus on programs in Huntington’s, ALS, FTD and SCA3, with the option to co-develop and co-commercialize them. For the second part, Takeda gains exclusive rights to a few preclinical programs targeting areas like Alzheimer’s and Parkinson’s.
2. Deal-hungry Takeda forges another R&D alliance
In another R&D alliance formed this week, Takeda teamed with the University of Washington and Fred Hutchinson Cancer Research Center in Seattle. A joined research committee comprised of scientists from the three organizations will select several ongoing research projects to support.
3. China's pollution crackdown creating pharma supply issues, Stada executive says
China has been targeting manufacturing plants in a fight against air pollution, and that has created supply problems for the pharmaceutical industry. One way to cope with that, according to a Stada executive, is to bring more production in-house “for better availability, better costs, reliable quality and for better logistics.”
4. Merck KGaA to build manufacturing facilities in China, South Korea and India
After opening a $188 million facility in Nantong, China, Merck KGaA is expanding further in Asia. It plans to invest $47 million on projects in South Korea, India and China over the next two years. A 109,000-square-foot manufacturing and distribution center in Incheon, Korea, will be fully operational late 2019, and there will be another similar center in Mumbai.
5. Plant where Biocon and Mylan will produce their Lantus copy spanked with FDA Form 483
Following an EU nod, Biocon and Mylan hope to get their Lantus copycat approved in the U.S. as soon as possible. But that effort hit a roadblock in the form of an FDA Form 483 issued to the manufacturing facility in Malaysia where the insulin will be produced. The partners previously ran into manufacturing issues at another Biocon plant which makes the insulin injectors.
6. ‘Exorbitant’ 2,000% margins drive India to mull further device price caps
Indian authorities have already imposed price caps on stents, and now they’re considering extending price limits for more medical products. That came as officials found that the patients vs. distributors price margins reached over 2,100% for an infusion set at a hospital, plus many other 1,000%-plus examples on other pieces of medical equipment.
7. Sanofi again denies Dengvaxia refund request as Philippine officials prep lawsuit
Sanofi just rejected a second request from the Philippine government for a refund of unused Dengvaxia, and the Department of Health now plans to bring legal action against the company. The government said the vaccine is “a defective product,” but Sanofi argued that it never promised a vaccine that’s 100% effective.
8. USV sterile injectables plant overcomes issues that resulted in warning letter
About a year after the FDA issued a warning letter to USV Private’s finished injectables plant, the Indian drugmaker has finally redeemed itself. In a closeout letter, the FDA said USV’s corrective actions appear to have addressed the violations.