“The problem with CROs has been that they function as torso with no head – the head is pharma telling the CRO what to do. And CROs have, traditionally speaking, been okay with that,” Cyrus K. Mirsaidi, President and CEO, BioDuro, told us at the launch at BIO.
“So the impetus behind BioDuro was to provide an end to end solution; to have the ability to go form early research all the way to drug product.”
Prior to the company’s merge with Formex, BioDuro focused mostly on preclinical discovery and early clinical development. With the addition of Formex, the company gains 44,000 square-feet of cGMP manufacturing facility in San Diego and expertise in formulation, development, and manufacture.
As Outsourcing-Pharma.com previously reported, several CROs are entering the formulation market – as it is being touted as one of the fastest growing areas in pharma. Jim Miller, founder and president of PharmSource Information spoke in May at the newly launched CPhI Worldwide Finished Dosage Formulation (FDF) event in London, UK, commenting at the time that the demand for FDF is having a big effect on consolidation – as is exemplified with BioDuro’s acquisition of Formex.
The strategic merger between the two companies positions BioDuro as an end-to-end solution provider for drug discovery and development, API synthesis and optimization, formulation and cGMP manufacture of drug products.
According to BioDuro, together, the companies have completed 25 IND and NDA filings with 10 to 200-fold solubility enhancement on insoluble compounds performed.
Mirsaidi also said that the company has seen a lot of development in China. Currently, BioDuro is the fourth largest CRO in China, and of those four, is the only non-Chinese owned.
However, he added that there are still pieces that the company doesn’t have and will look toward acquiring soon – “one of them is GMP manufacturing of the active pharmaceutical,” he said.
According to Mirsaidi, the company will be making two acquisitions, one in China and one outside of China, and hopes to have something announced by the end of the year.