With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain.
Vertex has inked a long-term supply agreement with Swiss manufacturing bigwig Lonza to crank out global commercial supply of Casgevy, Lonza said in a release Tuesday.
Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands. The CDMO eventually plans to expand production of the gene-editing therapy to its U.S. plant in Portsmouth, New Hampshire, as well.
While the Geleen cell facility recently won a good manufacturing practices (GMP) license from the FDA, European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), the Portsmouth site isn’t expected to kick off operations until next year, Lonza said.
Financial terms of the deal were not disclosed.
“Manufacturing a first-of-its-kind therapy like Casgevy is complex and requires advanced technology and capabilities,” Morrey Atkinson, Ph.D., EVP and chief technical operations officer, head of biopharmaceutical sciences and manufacturing operations at Vertex, said in a statement. “The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure Casgevy will be available for the patients who need it.”
Casgevy, which Vertex shares with CRISPR Therapeutics, made history late last year when it picked up approvals, first in the U.K. and then in the U.S., as a potential one-time treatment for the debilitating blood disorder sickle cell disease (SCD).
Shortly thereafter, the personalized medicine scored a second FDA green light to treat transfusion-dependent beta thalassemia.
Casgevy is the first approved medicine to leverage the CRISPR gene-editing system, which earned its inventors a Nobel Prize in 2020.
To ensure that it can maintain supply of Casgevy, Vertex has also enlisted the help of prominent CDMO Charles River Laboratories and RoslinCT, the contract manufacturing arm of the renowned Roslin Institute, which famously cloned Dolly the Sheep back in 1996.
While it's still early days for Casgevy’s launch, Vertex said it was pleased with the drug’s commercial trajectory so far when it announced second-quarter earnings in August.
At the time, around 20 patients had started their treatment journey via the cell collection process, Vertex said of Casgevy, which the company referred to as a “potential multi-billion opportunity.”
Vertex and CRISPR have priced their one-time therapy at $2.2 million.