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Azopharma Integrates Units, Expands Services

Azopharma Product Development Group (Booth 1801) has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.

The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.

At a press event during AAPS, a spokesman for the company said that Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.

Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.

Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.

Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.