India is beginning to reap the benefits of amending its Patents Act to allow product patents two years ago in line with the global trends. The increased IPR protection, coupled with the availability of a large talent pool of life science researchers, is making big pharma companies take a fresh look at the country. Many have already voted with their investments, setting up research centers in the country in recent months. BioSpectrum provides an overview of the latest R&D entrants into India.

Actis Biologics
California-based Actis Biologics Inc.’s Indian arm, Actis Biologics Pvt Ltd, a joint venture with entrepreneurs in India, is focused on target discovery of new molecules through collaborations and/or internal research or to in-license promising targets, then add value to the targets by accelerating the progression through the biopharmaceutical product life cycle while reducing costs by a significant margin. The Indian arm will be its hub for clinical research and development activities. Actis Biologics Pvt Ltd has incorporated under it ventures like Kohinoor Biotech to focus on a Ribozyme tech platform; Aum Life Sciences to focus on development of various Recombinant proteins and MABs; Mercury Biotech for development of genetherapy-based products; and Deep Biotech for the development of various immunotherapies using a novel Cytokine. Actis Biologics Inc., which was founded by Sanjay Saxena, a expat Indian and Mr Dave Toman, a molecular biologist and former scientist of Aventis as well as MD Anderson, has over 40 patents to its name.

Albany Molecular Research Inc (AMRI)
Albany Molecular Research Inc. (AMRI) is a chemistry-based drug discovery, development and manufacturing company, focusing on small molecule prescription drugs. AMRI recently announced the signing of a definitive agreement to acquire from the Runwal Group the assets of Ariane Orgachem Pvt Ltd in Aurangabad, Maharashtra and Ferico Laboratories Ltd in Navi Mumbai. AMRI also obtained additional land in Aurangabad and plans to invest approximately $15 million to expand and upgrade its manufacturing capabilities over the next three years. AMRI’s research center, Albany Molecular Research Hyderabad Research Centre Pvt Ltd. (AMRHRC), is located in Hyderabad, Andhra Pradesh and provides custom synthesis of scaffolds and building blocks, besides preparation of reference standards. A second laboratory for preparing larger amounts of pharmaceutical intermediates, starting materials and other compounds is also operational.

EI DuPont India
DuPont has located its first plant biotech research center outside the US at the DuPont Knowledge Center, in Hyderabad, India. Twenty DuPont crop genetics scientists have already begun working out of leased facilities near the site where the new $25 million DuPont Knowledge Center is to be built. By 2007-end, DuPont expects the number of crop genetics scientists on site to grow to nearly 100 as part of its $100 million reinvestment plan to increase its speed-to-market for new seed products. The plan includes adding more than 400 positions, mainly in research and development, at Pioneer.

The new DuPont R&D center, the DuPont Knowledge Center, will be set up on 15 acres of land in the ICICI Knowledge Park in Hyderabad and is expected to accommodate more than 300 scientists and other employees. The Center is expected to be built and operational in less than 15 months.

Aptuit Laurus
Aptuit Inc and Laurus Labs announced the formation of a new contract drug development company, Aptuit Laurus, in June this year. The JV will combine Aptuit’s global offerings in drug development with Laurus’ R&D and manufacturing expertise and newly built state-of-the-art facilities. The combined company will provide integrated services, technologies and manufacturing capabilities that span the entire drug development continuum.

The new entity, Aptuit Laurus Private Limited, is based in Hyderabad, Andhra Pradesh with additional facilities in Visakhapatnam and Bangalore. Aptuit Laurus will initially provide services in early-stage drug discovery, medicinal chemistry, lead optimization, process development, scale-up and process optimization, safety and hazard assessment, formulation development and analytical chemistry.

Aptuit has committed to invest approximately $100 million over the next four years to build upon Aptuit Laurus’ development, manufacturing and informatics capabilities.

BioCin
BioCin is a new Hyderabad-based company engaged in the manufacture of a range of high quality PCR reagents and tools for molecular biology research. BioCin’s products are claimed to offer high throughput, speed, better sensitivity and yield offering a complete solution to PCR optimization. The company plans to develop a range of recombinant bio-pharmaceuticals through proprietary rDNA technology that will make a revolutionary impact in the area of human healthcare by enabling production of safe, pure and effective rDNA expression products.

Evotec-RSIL
Evotec-RSIL Ltd is a joint venture between Evotec AG and Research Support International Ltd (RSIL), a subsidiary of DIL Ltd for the design, synthesis, and management of compound libraries. The joint venture combines Evotec’s expertise in library design, synthesis, analysis, purification and project management with RSIL’s science expertise. Evotec-RSIL Ltd has its facilities located in Thane, near Mumbai. It has core expertise in high throughput synthesis of lead finding libraries, parallel synthesis of focused libraries, profiling of virtual libraries using proprietary software to select compounds for synthesis, in silico ADMET tools for compound selection and high throughput analysis of customer libraries.

i3 Research
i3 Research is a full-service CRO focused on oncology, central nervous system, and respiratory and infectious diseases. i3 Research provides specialized CRO services in all phases of research, all over the world, and has recently entered India. In India, i3 provides clinical research and data services offerings for India-specific and global trials. In addition to project management, monitoring, regulatory and quality assurance services, its data services offerings include data entry and programming, data management, biostatistics and statistical programming.

INC GVK BIO
Hyderabad-based INC GVK BIO is a joint venture between North Carolina-based INC Research, a therapeutically focused contract research organization with a trusted process for delivering reliable results and operating in 23 locations worldwide and GVK Biosciences (GVK BIO), a premier contract research organization, providing an integrated platform of research services across the pharma R&D value chain. The joint venture gives INC Research the capability to run full service, Phase I-IV clinical trials in India for its pharma and biotech customers, utilizing clinical research resources at GVK that are fully dedicated to INC GVK Bio India projects. The joint venture provided an opportunity for GVK BIO to gain access to INC Research’s global reach while leveraging on its India-based clinical research capabilities.

Rheoscience, India
Rheoscience develops innovative therapeutics for diabetes, obesity and other serious metabolic disorders. Built around a selected group of leading metabolic diseases researchers from Novo Nordisk, the University of Copenhagen and the Center for Clinical and Basic Research (CCBR), Rheoscience is targeting areas of significant unmet medical needs. Rheoscience’s lead product is the oral anti-diabetic drug Balaglitazone, which is in Phase III clinical trials for the treatment of type 2 diabetes, a disease that affects approximately six percent of the global adult population aged 20-79 years.  Balaglitazone is being co-developed with Dr Reddy’s Laboratories in India.

“Our Indian presence will not only enable us to tap into Indian strengths in innovation, but will also allow us to use the capabilities of Indian contract research organizations for conducting effective R&D programs on behalf of biopharmaceutical companies that wish to take advantage of these resources but do not have the reach to do so effectively,” said Dr Philip Just Larsen, CEO.