Aptuit Plans Investment in API Infrastructure

CPhI Worlwide, Paris, (Oct. 5)-Following its recently announced acquisition of EaglePicher Pharmaceutical Services (Lenexa, KS, www.eaglepicher.com), Aptuit, Inc. (Greenwich, CT) plans further investment in infrastructure and staff in building its capabilities in manufacturing active pharmaceutical ingredients (APIs).

Aptuit announced the acquisition of the assets and operation of EaglePicher in late September 2006. “This acquisition is the first of its kind for Aptuit and will create the foundation for our API and drug substance manufacture capabilities,” says Stu Needleman, Aptuit’s senior director, active pharmaceutical ingredient development. “Drug development begins with the synthesis of a molecule and without a solid foundation in APIs, the rest of the drug development process can be difficult. Adding capabilities to our offerings was one of the key pillars we set out to incorporate from the inception of the company.”

Following the close of the acquisition, Aptuit will have total reactor capacity of 2,500 gallons, which includes specialized technologies in radiolabeling, high-potency API manufacturing, and cryogenics. Aptuit also is planning investment in the former EaglePicher facilities in Harrisonville, Missouri. “The investment will upgrade quality systems and laboratory capabilities as well as add dryer capacity and some additional production capabilities such as hydrogenation,” says Needleman.

“We also plan to make upgrades that will offer additional radiolabeling capability and capacity, GMP kilo-scale laboratories, and additional process development capabilities,” adds Needleman. “We are currently reviewing whether these upgrades will be made to the Lenexa, Kansas facility or our current Kansas City facility, but we'll be making this decision and moving forward shortly.”

Marcello DiMare, who was appointed last week to the newly created position of senior director of chemistry development, will focus on building Aptuit’s custom synthesis and process development business, which will center on post-discovery preclinical and clinical trial custom API synthesis and supply. Aptuit plans to add 12 to18 chemists to fill out the company’s newly designed good laboratory practices (GLP) laboratories and will work on integrating Aptuit’s custom formulation capabilities with the newly acquired API assets of EaglePicher.

Since its founding as Global Pharmaceutical Development in 2004, Aptuit has built its business largely through acquisitions. The acquisition of EaglePicher is its fifth since 2005. 

In 2005, Aptuit acquired the early development and packaging (EDP) business of Quintiles Transnational (Research Triangle Park, NC, www.quintiles.com) and Almedica International. In 2006, it added InfoPro Solutions (Bangalore, India) and Pharma Consulting, Inc. (Harvard, MA). Each acquisition added a piece to the company’s capabilities in drug development services.

“Quintiles EDP added capabilities in preclinical technology, pharmaceutical sciences and clinical packaging and logistics (CPL),” explains Needleman. “Almedica added significant capabilities and capacity for CPL as well as a foundation of information technology (IT) infrastructure. With InfoPro, we gained industry-leading IT professionals and the ‘Clinicopia’ product suite for clinical trials management. The Clinicopia suite will eventually serve as the information spine of Aptuit across all business lines and provide transparency and real-time data access for customer projects. And the acquisition of Pharma Consulting expanded our consulting capabilities to help customers navigate the potential pitfalls of the drug development.”  

To date, the privately held Aptuit has raised as much as $750 million to support these acquisitions (including EaglePicher) and other investments. Aptuit expects to generate revenues of $250 million in 2006 and plans to invest $60 million over the next two years to enhance its existing offerings across all business lines, adds Needleman