10.20.21
Recro Pharma Inc., a contract development and manufacturing organization (CDMO) dedicated to solving formulation and manufacturing challenges, has been awarded a new development and manufacturing contract by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
The contract, “Dosage Form Development, Manufacture, and Stability Studies of NES-100 Nasal Spray,” focuses on NES-100, a novel nasal spray analgesic.
“This is a great win for the company and highlights the impressive capabilities and expertise possessed by our San Diego team in the development and manufacture of sophisticated therapeutic formulations. At the same time, this also showcases the significant traction that we are generating as we rapidly integrate our new West Coast operations and continue to grow the overall business,” said David Enloe, chief executive officer of Recro.
He continued, “We are pleased to have been selected by NIH for this important project and are grateful for the strong working relationship that has been established between the company and the agency in recent years. Our broad-ranging parent contract with NIH remains in effect for several more years and we look forward to applying for and winning additional key projects during that time.”
This project is funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN2712017000201.
The contract, “Dosage Form Development, Manufacture, and Stability Studies of NES-100 Nasal Spray,” focuses on NES-100, a novel nasal spray analgesic.
About the Contract
The new contract is an individual $1.87 million task order that falls under an existing NIH parent contract (N01TR-17-2003) that was previously awarded to IriSys, the San Diego-based CDMO that was recently acquired by Recro. Under terms of the new contract, the company will support Chemistry, Manufacturing and Controls (CMC) development of NES-100, a microparticle dosage form of leu-enkephalin (LENK) that is prepared by the encapsulation of LENK in a patent-protected molecular enveloped technology (MET) and delivered via a nasal spray device. The polymer particles encapsulating LENK are able to transport LENK to the brain via the intranasal route with little to no peripheral exposure.“This is a great win for the company and highlights the impressive capabilities and expertise possessed by our San Diego team in the development and manufacture of sophisticated therapeutic formulations. At the same time, this also showcases the significant traction that we are generating as we rapidly integrate our new West Coast operations and continue to grow the overall business,” said David Enloe, chief executive officer of Recro.
He continued, “We are pleased to have been selected by NIH for this important project and are grateful for the strong working relationship that has been established between the company and the agency in recent years. Our broad-ranging parent contract with NIH remains in effect for several more years and we look forward to applying for and winning additional key projects during that time.”
This project is funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN2712017000201.