OPKO Health, a multinational biopharmaceutical and diagnostics company, has acquired EirGen Pharma, a specialty pharmaceutical company focused on the development and commercial supply of high-potency, high-barrier-to-entry pharmaceutical products for sale in the U.S., Canada, Japan, Australia, most European countries and more than 40 others around the world.

EirGen, based in Waterford, Ireland, was founded by two former executives of IVAX Pharmaceuticals, Tom Brennan and Patsy Carney. The company, situated in a state-of-the-art high containment R&D, and manufacturing facility, is approved by the FDA, EMEA (European Health Authorities) and the PMDA (Japanese Health Authorities). High-potency drugs such as those used for cancer chemotherapy typically are unsuitable for manufacture in normal multi-product facilities due to cross contamination risks.

To date, EirGen and its commercial partners have filed 10 product applications with the FDA and five each in Europe and Japan. EirGen has a strong R&D portfolio of over 20 niche, high-barrier-to-entry drugs and, with access to additional capital that OPKO will provide, together with the benefits of Irish government programs to encourage R&D in Ireland, EirGen will rapidly expand its drug portfolio.

“EirGen Pharma is one of the leading developers and suppliers of high-potency niche pharmaceutical products in the world,” said Phillip Frost, M.D., OPKO’s chairman and CEO. “As FineTech, OPKO’s Israeli active pharmaceutical ingredient manufacturing subsidiary, is also focused on high potency drugs, an immediate business synergy is expected. EirGen also offers the significant benefit of potentially being able to manufacture OPKO’s current and future products in our own facilities, which we expect will result in even higher gross margins. The superb management, R&D, manufacturing and product distribution teams, along with state of the art facilities, together, will create an important, tax efficient base of operations for OPKO.”