Viridian Therapeutics has spent years moving its thyroid eye disease (TED) hopeful, veligrotug, through clinical trials and is now at the FDA’s doorstep, with an approval decision expected next month. Ahead of the potential launch, Viridian is getting its commercial supply plan in order.
Earlier this week, Viridian linked up with Chinese pharma manufacturing juggernaut WuXi Biologics on a long-term supply pact for the drug, according to a May 26 filing with the Securities and Exchange Commission (SEC). The deal calls on WuXi Bio to supply drug substance and drug product for commercial use for an initial period of 5 years, after which the agreement could be extended.
Notably, Viridian said WuXi Bio will be a “non-exclusive supplier” and that it could tap other CDMOs to assist with veligrotug supply. In addition, the agreement could come to an early end if “there is a change in applicable laws that materially and adversely impacts WuXi’s Biologics ability to perform services,” according to the filing.
That clause could come into play amid the rhetoric in Washington surrounding China’s biotech rise in recent years. While Wuxi Bio was once a named target in the China-targeting Biosecure Act, that threat has eased in the final version of the legislation, which did not name the company.
Meanwhile, some industry watchers are now looking to curb China’s rise on the drug development front, including through a new pitch related to the COINS Act.
Nevertheless, in addition to the Viridian pact, Wuxi Bio in February secured work with Vertex Pharmaceuticals on the latter company’s trispecific T-cell engager for B-cell mediated autoimmune diseases.
As for Viridian, the Waltham, Massachusetts-based biotech has posted a series of phase 3 wins in recent years and is awaiting a June 30 decision target date for its TED prospect. If approved, the medicine would go up against Amgen’s entrenched Tepezza, which generated $1.9 billion worldwide last year.
The Viridian-WuXi deal calls on the Massachusetts biotech to provide its CDMO with volume requirement forecasts, a portion of which will be “considered a binding and non-cancellable commitment,” according to the SEC filing.
The supply pact features volume-based pricing for veligrotug supply, plus service fees and other costs, though the parties didn’t share specifics.