Welcome to this week's FiercePharmaAsia report, which includes a Parkinson's co-development deal between AstraZeneca and Takeda, an EU approval for Samsung Bioepis' Humira biosimilar Imraldi, a rumored Daiichi Sankyo takeover deal, and more.
Takeda is paying AstraZeneca up to $400 million to co-develop the latter’s preclinical Parkinson’s candidate, an alpha-synuclein antibody dubbed MEDI1341. Once AZ moves the drug through phase 1, Takeda will take over the responsibility for development. The deal follows AZ’s strategy to split the risks and rewards of developing drugs in high-stake CNS indications.
About a month after launching a Remicade biosimilar in the U.S. with partner Merck, Samsung Bioepis just gained an EU approval for its Humira copycat Imraldi. The biosim was approved for all of the available indications and will be marketed in Europe by Biogen. Amgen also has EU and U.S. approval for its version called Amjevita, but has been holding off a launch as litigation by AbbVie persists.
Did Daiichi Sankyo receive a buyout bid from AstraZeneca last year? A story from Nikkei Business said it turned away AZ’s offer, but the Japanese drugmaker said that it is “not the fact.” It’s not clear, however, whether there was talk of any sort. The Nikkei story previously sent Daiichi’s shares up by as much as 13% and triggered a trading halt on the Nikkei exchange.
Seven months after Daiichi received a CRL for CL-108—a fixed-dose combination of hydrocodone, promethazine and acetaminophen—and a lead prospect of a collaboration it had formed with Charleston Laboratories, it has decided to end that $650 million deal. The decision came after Daiichi reviewed its portfolio and the U.S. market and will post financial consequences.
England’s cost watchdog, the National Institute for Health and Care Excellence, has decided to back Takeda’s non-Hodgkin’s lymphoma med Adcetris based on a confidential discount agreement. That means the med is entitled to reimbursement in England. But NICE only recommends the med for patients who have no restriction or minimal restriction in physical activities.
The FDA has sent a warning letter to Hetero Labs’ finished products plant in Telangana, India, citing concerns about sanitation, quality controls and handling of customer complaints. The warning letter didn’t mention data integrity, though a previous Form 483 noted that employees were found shredding documents in the middle of the night.
In a reverse of common order of conducts, the FDA is banning all of Mahendra Chemicals’ products produced at its API plant in Ahmedabad, India, after a warning letter sent to it two years ago. Back in July 2015, the warning letter scolded the drugmaker for forging manager signatures.