Aptuit Establishes New Company in India

(Greenwich, CT), a contract drug-development company, has been actively building its capabilities through a series of key acquisitions. Its latest move is the formation of a new entity, Aptuit Laurus (Hyderabad, India), which Aptuit formed through a phased acquisition with Laurus Labs Limited (Hyderabad) in June. The deal positions Aptuit in the growing market for pharmaceutical outsourcing in India.

Aptuit Laurus targets pharmaceutical outsourcing in India

Aptuit Laurus will be comprised of a 160,000-ft² research and development facility in Hyderabad, a large-scale manufacturing plant for drug substances that it is currently under construction in Pharma City, Vishakhapatnam, and Aptuit's existing informatics development and support group in Bangalore. The Pharma City plant is scheduled for completion in 2008.

"We have been interested in investing in India for over 10 years," says Michael Griffith, CEO of Aptuit, adding that in Laurus, Aptuit found a company that will meet the pharmaceutical industry's demand for outsourcing services in India and Asia. "We see the Indian pharmaceutical outsourcing industry increasing its share of the global market from roughly 10% today to as much as 50% during the next five to 10 years," adds Griffith.

To further underscore the growing importance of Asia in the pharmaceutical outsourcing market, Griffith points to potential shifts. "If you look at a list of leading global providers of pharmaceutical services today, we think that fewer than 20% of those companies will be on that list 10 years from now," he says. "We think that many of the leaders on that list will be replaced with leadership coming out of Asia."

Aptuit says it plans to invest approximately $100 million during the next four years to build upon Aptuit Laurus's development, manufacturing, and informatics capabilities with the addition of a complete suite of development services including: medicinal chemistry, preclinical, solid-state chemistry, consulting, clinical packaging and logistics, Phase I/IIa research , and large-scale dosage-form manufacturing. When these investments are completed, Aptuit Laurus will mirror the capabilities of services offered by Aptuit in North America and Europe. In addition, the new company plans to offer expanded services in discovery and clinical research and access to larger-scale manufacturing at the back-end of the product development life cycle.

Satyanarayana Chava, founder and CEO of Laurus Labs, was named president of Aptuit Laurus in June 2007 with the formation of the new company. Chava founded Laurus with two colleagues in late 2005. Chava was formerly chief operating officer of Matrix Laboratories (Secunderabad, India).

In August, Andhra University in Visakhapatnam, India and Aptuit Laurus signed a memorandum of understanding to mutually collaborate in the areas of research, training, consultancy work, and technology management.

Aptuit builds through acquisitions

The venture with Laurus to form Aptuit Laurus is the latest of a series of deals made by Aptuit to strengthen its drug-development services portfolio. Since its founding as Global Pharmaceutical Development in 2004, Aptuit has built its business largely through acquisitions with each deal positioning the company in a given aspect of the drug-development continuum. Since 2005, the company completed six acquisitions as follows:

• SSCI in 2007

• EaglePicher Pharmaceutical Services in 2007

• Pharma Consulting in 2006

• InfoPro Solutions in 2006

• Almedica International in 2005

• Early-development and packaging (EDP) business of Quintiles Transnational in 2005.

With SSCI, Aptuit gained solid-form research capabilities, and EaglePicher Pharmaceutical Services gave the company small-molecule synthesis capabilities, including those for high-potency actives. From InfoPro Solutions Aptuit obtained an informatics suite, "Clinicopia," for clinical-trials management, information technology staffing, and infrastructure that will serve as the information spine for Aptuit across all business lines. Pharma Consulting expanded the company's consulting capabilities in drug development. And the acquisition of Quintiles EDP added capabilities for Aptuit in preclinical technology, pharmaceutical sciences, and clinical packaging and logistics (CPL). Almedica further added to Aptuit's capabilities and capacity for CPL and provided a foundation for information technology infrastructure.

Aptuit builds API capabilities

A key move made by Aptuit was the acquisition of EaglePicher Pharmaceutical Services, which provided Aptuit drug-substance manufacturing capabilities to complement its existing capabilities in dosage-form manufacturing, clinical packaging, and informatics.

With the acquisition of EaglePicher Pharmaceutical Services, Aptuit has a total reactor capacity of 2,500 gallons, which includes specialized technologies in radiolabeling, high-potency API manufacturing, and cryogenics. Aptuit is investing in the former EaglePicher facilities in Harrisonville, Missouri. The investment includes upgrades to quality systems and laboratory capabilities, the addition of dryer capacity, and some additional production capabilities such as hydrogenation. The target completion date for the larger volume capacity of API manufacturing capability is August–September 2008. Aptuit also is investing in radiolabeling capability, kilo-scale laboratories, and additional process-development capabilities at its facilities in Kansas City, Missouri. The radiolabeling and kilo laboratories in Kansas City are scheduled to be on line in December 2007–January 2008.

In all, the company is spending approximately $140 million in internal capital for projects and also plans to invest an additional $100 million in Aptuit Laurus. The privately held Aptuit has raised as much as $750 million as of April 2006.