Recro Pharma was granted a March 2019 PDUFA date for its non-opioid pain drug after providing the FDA with additional data and answering manufacturing questions raised in a complete response letter. While it awaits the outcome, it is leaning heavily on its CDMO business and that arm of the operation has just completed an expansion that should help the drug developer boost its revenues.
Recro Gainesville, its CDMO subsidiary, has added a 24,000-square-foot facility that includes high-potent material processing space. The new facility sits near its existing 97,000-square-foot solid dose facility in Gainesville, Georgia.
“(O)ur revenue-generating CDMO division continues to exceed expectations, with $18.3 million in revenue generated during the third quarter,” Recro Pharma CEO Gerri Henwood said in an earnings release. “We are increasing our 2018 CDMO guidance and currently believe we will generate approximately $75 million in revenue. With the recent facility expansion, we significantly enhanced our development and high potency product services.”
The Malvern, Pennsylvania-based company in 2015 bought the DEA-approved plant and a number of pain drugs from Ireland-based Alkermes for $50 million in cash and up to $120 million in milestone payments. At the time, the facility had 165 employees.
Among the drugs that Recro bought from Alkermes was meloxicam IV/IM, for which the company has high hopes given healthcare providers’ building reservations about prescribing opioids. It is a non-opioid alternative for relief of moderate to severe pain.
Recro in May was issued a CRL that had CMC related questions on extractable and leachable data provided in the NDA. It also said that data from ad hoc analyses and selective secondary endpoints suggested that the analgesic effect would not meet the expectations of the FDA.