US drug-development services company Aptuit has cemented its commitment to the Indian market by entering into a joint venture with Hyderabad-based Laura Labs.

Aptuit, which already runs an Informatics Development and Support group with 100 employees in Bangalore, has agreed to invest around $100 million over the next four years in the new contract drug-development company, Aptuit Laurus, and expects to take majority control of the joint venture by March 2009.

Incorporated as Aptuit Laurus Private Limited and trading as Aptuit Laurus, the joint venture will combine the US company’s global drug-development capabilities with Laura’s R&D and manufacturing expertise, as well as its new state-of-the-art facilities in Hyderabad and Vishakhapatnam. Aptuit Laurus will offer established and emerging pharmaceutical companies “integrated services, technologies and manufacturing capabilities that span the entire drug development continuum,” the partners said.

Both companies are relative newcomers on the contract research scene. Laurus, which specialises in process chemistry, formulation development and analytical services, was founded in late 2005 by chief executive officer Dr Satyanarayana Chava with two founders. Formerly chief operating officer at Matrix Laboratories, Dr Satyanarayana will lead Aptuit Laurus locally with his existing management team. The joint venture will be governed by a board of directors including three Aptuit designees, three members selected by the founder shareholders of Laura Labs, and one mutually agreed independent director.

Rapid growth

Aptuit has grown rapidly since its formation (originally as Global Pharmaceutical Development) in December 2004, powered by the acquisitions of Quintiles’ Early Development and Packaging units (closed October 2005), Almedica International (September 2005), InfoPro Solutions (March 2006) and Pharma Consulting (May 2006). With backing from leading private equity firm Welsh, Carson, Anderson & Stowe, Aptuit started with a handful of employees and now has a staff of more than 2,000 spread across 15 facilities worldwide.

Aptuit Laurus will initially provide services in early-stage drug discovery, medicinal chemistry, lead optimisation, process development, scale-up and process optimisation, safety and hazard assessment, formulation development and analytical chemistry. Headquartered in Hyderabad, the joint venture will draw on Laurus’ newly established 160,000 sq ft research and development facility in the ICICI Knowledge Park near the Indian city, as well as its large-scale manufacturing plant currently under construction on more than 34 acres of land in Pharma City, Vishakhapatnam.

Also entering the equation will be Aptuit’s Informatics Development and Support unit in Bangalore, set up as a centre of excellence for software design and development and as a production hub for Clinicopia, a clinical packaging and supply management product suite used by eight major pharmaceutical companies and Aptuit’s six global clinical packaging facilities.

On top of this, the US partner will invest around $100 million under the joint venture agreement to build on Aptuit Laurus’ development, manufacturing and informatics capabilities with a complete set of development services, including medicinal chemistry, preclinical studies, solid-state chemistry, consulting, clinical packaging and logistics, Phase I/IIa trials and large-scale production of dosage forms.

When these investments are completed, Aptuit Laurus will mirror the full suite of services available from Aptuit in North America and Europe, the companies noted. The joint venture will also offer expanded services in drug discovery and clinical research as well as access to “larger-scale manufacturing at the back-end of the product development lifecycle.”

Excellent fit

Michael Griffith, founder and chief executive officer of Aptuit, said Laurus “shares our strategic vision to build an end-to-end drug development services partner with high service levels and an emphasis on technology … It’s an excellent cultural fit, and provides a new set of choices for our 600 pharmaceutical company clients.”

Dr Satyanarayana added that the two companies’ “strengths are complementary, and we are very focused on the value and efficiencies to be gained for our customers in having access to a full range, development and manufacturing capabilities and services on a truly global scale."

The partners highlighted India’s “exceptionally” skilled workforce, competitive labour and material costs, well-established infrastructure for local and international regulatory approvals, and the largest number of Food and Drug Administration-approved manufacturing plants outside the US. They also pointed to the Indian government’s efforts to install and protect product patents, saying the joint venture would “play a vital role in creating, securing and safeguarding intellectual property for its clients.”

The initiative was not just about economies, the companies stressed. “We believe it is a mistake to enter India and China primarily in search of operational savings,” Griffith commented. “We have approached our expansion into India as a strategic priority which would go beyond this rationale in pursuit of high-quality science and a leadership role in the large and quickly evolving pharmaceutical consumer markets in these two countries.”