Charles River Laboratories International, Inc. (NYSE: CRL) shares were positive at first Monday, on bringing to light an important milestone in its strategic collaboration to manufacture CASGEVY (exagamglogene autotemcel [exa-cel]). CASGEVY is approved in some countries for certain eligible patients.
The news follows Charles River’s Memphis center of excellence passing back-to-back audits from both the U.S. Food and Drug Administration (FDA) and the Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA). The Memphis facility was the first North American contract development and manufacturing organization (CDMO) to be approved by the EMA to commercially manufacture an allogeneic cell therapy drug product.
“Our team in Memphis is proud to receive regulatory approval to manufacture CASGEVY,” said CEO James C. Foster. “We are pleased to reach this milestone working hand-in-hand with Vertex to manufacture the world’s first gene-edited therapy. There is a tremendous patient need for this therapy and we look forward to working with Vertex to help bring this treatment to patients.”
SCD is an inherited blood disease impacting millions of people worldwide. SCD affects hemoglobin, a part of the blood that carries oxygen around the body. People who suffer from this condition require lifelong treatment and significant use of health care resources, ultimately resulting in reduced life expectancy. Vertex collaborated with CRISPR Therapeutics to leverage the use of a gene-editing technology, known as CRISPR/Cas9, to discover and develop CASGEVY.
CRL shares picked up $1.21 to $232.01.
