Sarepta intends to use the 60,000 square-foot facility to further enhance and scale its proprietary manufacturing processes for PMO (phosphorodiamidate morpholino oligomer) chemistries.
The PMO manufacturing process involves a series of controlled chemical steps that differ from the typical living cell process used to manufacture a biologic or recombinant protein-based drug. The production of PMO subunits involves the conversion of RNA subunit five-sided rings into six-sided morpholine rings following a number of chemical reactions.
The facility will be used to manufacture drug supply to support clinical trials of Sarepta’s exon skipping therapies for DMD, as well as research and development of future potential products and modified PMO chemistries. The transaction is expected to close in July.
Sarepta spokeswoman Maria Favorito told us that the company also does small-scale manufacturing at its Corvallis, Oregon research facility, in addition to working with a number of CMOs worldwide.
“This strategic acquisition complements our existing internal manufacturing capability and global network of suppliers,” said Chris Garabedian, president and chief executive officer of Sarepta Therapeutics. “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 seems poised to submit an NDA to the US FDA for eteplirsen by the end of 2014.
Constructed in 1996, the multi-functional facility was upgraded in 2006, and has been qualified under Current Good Manufacturing Practice (cGMP) regulations. When fully operational, the facility supports approximately 40 technicians and support staff. The 26 acres of land also allow for future potential expansion.