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June 2016

BioDuro Launches as Unique Contract Research and Drug Manufacturing Organization

Establishes a contract services organization to meet today's demand for better and accelerated drug discovery and development to improve efficiency in establishing drug candidate success

SAN DIEGO, June 6, 2016 — BioDuro, LLC, a global contract research organization (CRO) focused on fully outsourced turnkey discovery and development services in Oncology, Inflammatory Disease, Metabolism and CNS for pharmaceutical partners, announced today the formal launch of the BioDuro organization, having merged with Formex to become an end-to-end solution provider for integrated drug discovery and development, API synthesis and optimization, formulation and cGMP manufacture of drug products.

Cyrus K. Mirsaidi, President and Chief Executive Officer, BioDuro, stated, “I am thrilled to introduce this truly unique organization to the global contract research and manufacturing markets. We have delivered on a strategic objective to establish a contract organization that meets market demand for full service drug discovery, development, formulation and manufacturing, to increase probabilities for drug candidate success.  We have made significant investments in the combined company for expansion, training, and highly differentiated platforms, and are committed to grow and increase our service offerings both organically and through acquisitions to broaden our value offerings for our partners and clients.”

BioDuro recognizes the increasing pressures on the pharmaceutical industry to reduce discovery and development time and cost, and offer ways to improve weak success rates while speeding the course of development. BioDuro, a U.S. owned research and development contractor founded in 2005, with laboratories in San Diego, Beijing and Shanghai, is a full-service preclinical research and clinical development service provider that offers discovery and development solutions from lead identification and optimization through to dosage form development and manufacturing. Until the company’s recent merger with Formex, BioDuro focused primarily on preclinical discovery, and early clinical development of pharmaceuticals.

With the addition of Formex, customers gain access to a 44,000 square-foot, purpose-built cGMP manufacturing facility in San Diego, with proven expertise in formulation, development, and manufacture of drug product. Using advanced and proprietary technologies, the newly merged companies offer services to enhance the bioavailability of poorly soluble compounds, to provide seamless translation of high value clinical candidates developed by BioDuro’s preclinical group into more efficacious clinical trial material (CTM), using gram-scale quantity of API for initial formulation, while providing scalable operations that will offer clients Phase I-III clinical development as well as clinical and commercial manufacture of drug product.

BioDuro’s global operations include a 100,000 square-foot facility in Beijing, focused largely on biosimilars, synthetic, medicinal and computational chemistry, formulation development and analytical support for conducting bioequivalence studies in support of CFDA filings, and a 92,000 square-foot state-of-the-art facility in Shanghai, which houses BioDuro’s drug screening, DMPK, integrated biology and a turnkey 18,000 square-foot vivarium, as well as Good Laboratory Practices (GLP), bioanalysis, PK/PD, biomarker and translational research.  The combined teams of highly experienced staff, with a 1:4 ratio of PhD to non-PhD scientific staff, have successfully managed many drug discovery and development programs for pharma partners, including repurposed drugs, biosimilars, and novel therapeutic programs.

BioDuro
The strategic merger of BioDuro with Formex provides end-to-end solutions for integrated drug discovery and development, API synthesis and optimization, formulation and cGMP manufacture of drug products. The companies have completed 25 IND and NDA filings with 10 to 200-fold solubility enhancement on insoluble compounds performed. Using advanced and proprietary technologies, the newly merged company offers services to enhance the bioavailability of poorly soluble compounds, to provide seamless translation of high value clinical candidates developed by BioDuro’s preclinical group into more efficacious clinical trial material (CTM), using gram-scale quantity of API for initial formulation, while providing scalable operations that will offer clients Phase I-III clinical development as well as clinical and commercial manufacture of drug product, with purpose-built cGMP manufacturing in San Diego. www.bioduro.com

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