Dive Brief:
- Contract manufacturing organization Rentschler Fill Solutions has signed a deal to make the drug product for Mepsevii, Ultragenyx Pharmaceutical's injectable treatment for people with a rare genetic disorder.
- The deal gives Ultragenyx access to Rentschler Fill Solutions' Austrian facility for aseptic filling of biopharmaceuticals, which the Rentschler has set up as a center for fill and finish solutions.
- Mepsevii is the first and only drug approved for the treatment of children and adults with mucopolysaccharidosis VII, also known as Sly Syndrome.
Dive Insight:
Mepsevii (vestronidase alfa) is a recombinant form of beta-glucuronidase. It was Ultragenyx Pharmaceutical's first approval, in November 2017, and brought along a valuable rare pediatric disease priority review voucher.
"Identifying a reliable and proactive drug product CMO partner for Mepsevii was critical for Ultragenyx," said Dennis Huang, head of technical operations at the biotech.
Mepsevii was developed in collaboration with the biopharmaceutical CDMO Rentschler Biopharma, which also has an existing partnership with Rentschler Fill Solutions.
"This project reaffirms our strategic partnership with Rentschler Fill Solutions, announced a year ago, as we are able to meet our clients' needs not only as a solution provider for clinical trials but also for market supply in growing international markets," said Frank Mathias, CEO of Rentschler Biopharma.
The benefits of the agreement aren't just one way. Working with California-based Ultragenyx also provides Rentschler Fill Solutions with market validation of its facilities' usefulness.
Earlier this year, Ultragenyx picked up approval for Crysvita (burosumab-twza), the company's second approved drug and the first Food and Drug Administration-approved treatment for a rare inherited form of rickets.