Welcome to this week’s FiercePharmaAsia report, which includes stories about Gilead's first foreign manufacturing plant underway in China, Takeda's IBD med collaboration with Finch Therapeutics, its superheroes comic book ad winning #FierceMadness, and its 180 Ariad job cuts after the $5.2 billion buyout, plus Astellas' €500 million Ogeda acquisition.
Gilead is in the process of building its first foreign manufacturing facility in China. The new site will be based in Hangzhou, the capital city of Zhejiang Province near Shanghai. This, together with a new exec poached from Roche, could be seen as part of Gilead’s effort to bring its hepatitis drugs to China, a market with big potential but which the company hasn’t yet tapped into with those meds.
Takeda has signed a deal with Massachusetts-based biotech Finch Therapeutics to jointly work on FIN-524, a microbial cocktail—currently in preclinical stage—for inflammatory bowel disease. Takeda is forking over $10 million for exclusive worldwide rights to develop and sell the meds, along with follow-on products, while Finch is in line for biobucks if everything goes well.
On that note, Takeda’s superheroes comic book ad for IBD, a collaboration with Marvel and Crohn’s and Colitis Foundation of America, just beat Boehringer Ingelheim’s “Red Fish” Pradaxa ad in the final round of FiercePharma’s very own #FierceMadness DTC ad contest. It features the first-ever pharma company-sponsored superhero, named Samarium, suffering with IBD.
Astellas has struck a deal to buy Belgium-based Ogeda for €500 million ($534 million) upfront. Coming together with the takeover is a nonhormonal treatment for menopausal hot flashes. The biotech, formerly known as Euroscreen, reported positive data for the drug named fezolinetant, also known as ESN364, from a phase 2a trial earlier this year.
But it’s not all good news coming from the Japanese pharma this week, as it cuts about 180 jobs from Ariad headquarters after its $5.2 billion buyout of the biotech in January. Fair warning was given when Takeda stressed the importance of cost synergies when it announced the deal. Fifty of those let go could land at Takeda’s CRO partner PRA Health Sciences, while others are encouraged to seek jobs at the drugmaker’s global operations.
Next-generation sequencing player ArcherDX and Shenzhen, China-based precision medicine company HeliTec are teaming up to develop NGS-based cancer diagnostics in China. The pair will work on NGS-based tech and aim to get cancer diagnostic kits through the CFDA.
Takeda has finished enrolling 20,100 children aged 4 to 16 for a gigantic phase 3 dengue vaccine study in eight endemic countries in Latin America and Asia, in just about seven months. Investigators are looking to determine whether Takeda’s TAK-003 can protect against dengue of any severity from any serotype regardless of previous exposure to the virus.
For the second time in about six weeks, India’s Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with the problems the agency had outlined in a warning letter two years ago. The FDA issued a Form 483 with two observations during a return visit to its API plant in Srikakulam.
A New Jersey man wanted for smuggling unapproved foreign drugs into the U.S. has been deported back to the U.S. after he was located in China by local authorities last month. He is charged with smuggling misbranded drugs, conspiracy and other charges, which could carry sentences of three to 20 years in federal prison, and all carry fines of up to $250,000.
India’s Alkem Laboratories could finally deliver some good news after a year of nothing but FDA citations of its plants. The Indian drugmaker said that the FDA has signed off on Alkem’s plans to upgrade operations at its API plant in Ankaleshwar, India, which had been cited in a Form 483 with three observations last year.
Four out of six won’t cut it. India’s Indoco Remedies seemed to have failed to correct two of the six observations the FDA nailed to its sterile and solid dosage manufacturing site in a Form 483. Now, the drugmaker has been served with an FDA warning letter.