- A Roivant Sciences Ltd. subsidiary has selected Avid Bioservices Inc. to manufacture its rare disease treatment headed for in-human studies.
- Avid is now responsible for providing the commercial supply of Enzyvant's RVT-801, a recombinant human acid ceramidase enzyme replacement therapy under investigation as a treatment for Farber disease. The drug will be produced at Avid's recently expanded facility in Myford, California.
- The 42.000-square-foot Myford site sports monolithic modular clean rooms, dedicated support utilities and flexible solutions. In September, Avid brought online a pair of 2000-liter, single-use bioreactors that the contract develop and manufacturing organization (CDMO) has said can quicken batch turnaround and reduce the risk of product cross-contamination.
Avid has been, well, avid about building out a place for itself in the CDMO market. In the last two months, the company changed its name from Peregrine Pharmaceuticals Inc. and sold off its cancer assets to Oncologie Inc. for $8 million upfront.
CDMOs need clients, however. In its most recent quarterly filing, Avid detailed how one of its two key goals for fiscal year 2018 is to diversify its customer base. The company is already experiencing some success in its pursuits, having secured four new customers from January through October last year. And Enzyvant adds to the list.
There's still plenty of work to be done, however. Avid is entering the CDMO arena at a time of widespread consolidation.
Just last week, Charles River Laboratories International Inc. snatched up MPI Research Inc. for $800 million — combining the capabilities of two well-know contract research organizations. In 2017, Thermo Fisher Scientific Inc.'s $7.2 billion acquisition of Pantheon NV and InVentiv Health Inc.'s merger with INC Research to form Syneos Health brought two more behemoth companies into the CRMO market.
But the stiff competition hasn't deterred Avid. On the contrary, Enzyvant noted in a Wednesday statement that it had considered a "large field of internationally recognized" CDMOs to produce RVT-801 before selecting Avid.
"We presented Avid with very ambitious timelines for RVT-801 manufacturing work and we were extremely impressed with the ability of their team to work creatively with us to design and deliver a program that meets our needs and contributes significant value," Alex Tracy, VP of pharmaceutical development and manufacturing for Roivant, said in the statement.
Avid and Enzyvant didn't disclose financial terms of the deal, though the companies did reveal they've been commencing successful technology transfer and clinical manufacturing since mid-2017. The next steps require Avid to complete process characterization and optimization, and then process validation for creating RVT-801.