BioDuro said today its U.S. operations have been merged with those of the contract development and manufacturing organization Formex, in a deal whose price was not disclosed.

The merger is designed to support BioDuro's global expansion of services to provide end-to-end solutions—from integrated drug discovery and development, API synthesis and optimization, to formulation and cGMP manufacture of drug product.

The combined companies will operate under the corporate structure of BioDuro, which is headquartered in San Diego. Formex’ formulation and manufacturing group will continue to operate in San Diego as a wholly owned subsidiary of BioDuro.

BioDuro is a global CRO focused on preclinical chemistry, biology, and fully outsourced integrated drug development services for pharmaceutical partners.

BioDuro's global operations include a 100,000-square-foot facility in Beijing that is focused largely on biosimilars, synthetic, medicinal, and computational chemistry; as well as a 92,000-square-foot facility in Shanghai that houses BioDuro's drug screening, DMPK, and integrated biology, as well as GLP bioanalysis, PK/PD, biomarker, and translational research.

In merging with Formex, BioDuro gains access to a 44,000-square-foot, cGMP manufacturing facility in San Diego. According to BioDuro, the facility’s expertise includes the formulation, development, and manufacture of drug product; use of advanced and proprietary technologies to enhance bioavailability of poorly soluble compounds; translation of clinical candidates developed by BioDuro's preclinical group into more efficacious clinical trial material, use of gram-scale quantity of API for initial formulation, and scalable operations designed to provide clients with Phase I-III and commercial manufacture of drug product.

The combined company will maintain a 1:4 ratio of Ph.D.-to-non-Ph.D. scientific staff. That staff, according to BioDuro, has experience in managing drug discovery and development programs for pharma partners that include repurposed drugs, biosimilars, and novel therapeutic programs.

BioDuro said the merger is being led the chairman of both companies, Masood Tayebi, Ph.D. Formex’ current CEO Cyrus K. Mirsaidi, will lead the combined companies as president and CEO, while a longtime BioDuro executive, TJ Deng, Ph.D., will continue as general manager, China operations.

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