Recro spins out Baudax to boost CDMO focus

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Radachynskyi)
(Image: Getty/Radachynskyi)

Related tags: CDMO, CMO, FDA approval, Crl

Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.

Baudax Bio entered the trade capital market as an independent company on November 22, with an aim to continue developing Recro’s acute care settings business, allowing the latter company to build on its future growth as a contract development and manufacturing organization (CDMO).

Gerri Henwood, CEO of Recro, who is also taking on the position of CEO at Baudax, stated that the newly-established company holds a portfolio of candidates, with its lead product being meloxicam, a nonsteroidal anti-inflammatory analgesic administered intravenously.

The company will seek approval for the drug ‘in the near-term’, Henwood noted, adding as well that it ‘may seek to expand’ its pipeline over time.

Recro filed a new drug application for meloxicam in 2017​, following completion of two Phase III clinical studies. However, the US Food and Drug Administration responded with two complete response letters​, which included concerns related to the onset and duration of the product.

The FDA granted an appeal​ to Recro, with Baudax now working on a ‘comprehensive’ response for the agency, which will include proposed labeling and certain other information.

Recro provided Baudax $19m (€17.25m) to support its future efforts on pursuing approval, concurrently stating that the separation will enable the parent company to enhance its operations as a CDMO.

The company recently reported​ a 37% year-over-year revenue growth, generating $4.8m in cash from operations in the third quarter of 2019.

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