Sarepta Therapeutics is acquiring a multifunctional manufacturing facility in Massachusetts, which it plans to use to manufacture investigational exon-skipping therapies for Duchenne muscular dystrophy (DMD). The total price tag for the facility plus planned enhancements is $25 million, and the RNA-based therapeutics developer expects the transaction to close in July.
Sarepta says the 60,000 square-foot facility, which was built in 1996 and upgraded in 2006, meets cGMP standards and can support around 40 technicians and support staff when fully operational. The acquisition also includes 26 acres of land for potential expansion.
In addition to manufacturing drug supply to support trials of exon-skipping therapies for DMD, the firm plans to use the facility to enhance and scale its processes for manufacturing phosphorodiamidate morpholino oligomer (PMO) chemistries for RNA therapeutics as well as research and develop future potential products and modified PMO chemistries.
Around a month ago, Sarepta announced plans to submit a NDA to the FDA by year’s end for eteplirsen for DMD. Eteplirsen is Sarepta’s lead exon-skipping drug candidate in development for the treatment of patients with DMD who have a genotype amenable to skipping of exon 51.
"While we scale up to address the potential U.S. commercial demand for our lead product candidate eteplirsen in the event of an approval next year, the addition of internal resources will enhance our ability to advance the development of our broader exon skipping platform and explore the potential of our technology platform in other therapeutic areas," Sarepta's president and CEO Chris Garabedian said in a statement.