AGC Biologics has been tapped to manufacture Provention Bio’s long-awaited Type 1 juvenile diabetes treatment that had been in development for more than 36 years before getting FDA approval late last year.
AGC will produce Tzield (teplizumab-mzwv) at its Seattle protein biologics facility, the CDMO said in a Jan. 24 press release. The company was heavily involved with the advancement of the treatment through early manufacture and validation batches, and U.S. regulatory approval.
Financial terms of the contract weren’t disclosed.
The company’s Seattle facility, which has been producing biologics for 30 years, runs multiple mammalian manufacturing lines and a variety of scales.
“This is an important milestone for the Type 1 diabetes community, and we hope the launch of this therapy can truly make an impact on patients and families seeking innovative treatments for the delay of Stage 3 T1D,” Ashleigh Palmer, Provention Bio’s chief executive, said in the release.
Work on the treatment began in 1986 and culminated with a green light for Tzield from the FDA in November. The immunotherapy, which delays the progression of Type 1 diabetes, will be available to patients age 8 and older who are in stage 2 of the disorder. It is the first drug approved to delay progression of Type 1 diabetes.
More than 1.8 million Americans have Type 1 diabetes, an autoimmune disease caused by the destruction of beta cells, according to Provention.
In October, Provention inked a deal with Sanofi to market the drug in the U.S. Under terms of the agreement, Sanofi will pay $35 million to Provention and an additional $20 million to secure the right to first negotiation on exclusive global marketing rights when other governments approve Tzield.