Advinus Therapeutics, promoted by the Tatas, focuses on new drug discovery and development of pharmaceutical and agrochemical products. Advinus has set its sight on pharmaceutical R&D with no generics or API focus. In 2006, a survey conducted by New Jersey based management-consulting firm Proximare, named Advinus as India's best emerging CRO in drug discovery services.
Advinus is exploring opportunities in companies based in the US and Europe which are looking at cost-effective, high-quality solutions for their R&D programmes. In 2006 the company entered into drug discovery and clinical development collaboration with Merck & Co. In the same year it also entered into alliance with Ahmedabad based Veeda CR to leverage each other's capabilities to create an integrated drug discovery through Phase 2 platform. Dr Kasim A Mookhtiar is chief scientific officer and head, Drug Discovery,Advinus Therapeutics Pvt Ltd. In an e-mail interview with Gireesh P K, Dr Mookhtiar explained the various developments occurring in the Indian pharma and outsourcing industry. Excerpts
Several global MNCs are now seeking alliance with Indian firms to outsource some aspect of their pre-clinical research work. Why this increased interest of late?
Global MNCs are exploring many options to increase the success rate of finding new therapies for many diseases. This includes accessing global talent for the research that is required to discover and develop new medicines in a cost effective manner. The key drivers are:
■ The higher hurdles for safety set by regulatory authorities such as the FDA and lower productivity of internal research organizations in terms of approvals of new medicinal entities (NMEs).
■ The high cost of discovering and developing new drugs in the developed countries.
India's strength in science and technology is well known. Its prowess in pharma research is already being accessed by MNCs. First it was in the active pharmaceutical ingredient (API) manufacturing and formulation space. It then went up the value chain to contract research for medicinal chemistry and clinical trials/ clinical data management. These areas are growing strongly and will continue the momentum. Now MNCs are starting to explore the final frontier in innovative pharma research - generation of intellectual property via the discovery of new drugs- in collaboration with Indian companies like Advinus.
What are the capabilities in terms of pre-clinical drug R&D, Indian firms like Advinus offer to outsourcing companies?
Many companies offer contract research services in the area of medicinal chemistry. Of late, biological assay development and testing has also been included in the services offered. Advinus is unique in that it offers a full range of capabilities required for drug discovery and development. On the research front, Advinus and some other companies are willing to work in collaboration with the MNCs, where the Indian partner will discover a potentially new drug, while the MNC partner will carry out the late stage clinical development and commercialization of the product. Advinus also offers all the capabilities required for converting the potential drug candidate to an investigational new drug (IND). The company carries out early clinical trials upto human proof-of-concept through its strong alliance with Veeda Clinical Research. This includes, process research and scale up synthesis, formulation and stability testing, analytical chemistry and bioanlytical services, full fledged drug metabolism and pharmacokinetics (DMPK) and state of the art drug safety evaluation. Advinus is very much exceptional in offering these end-to-end drug development capabilities.
MNCs based in advanced markets like US&EU used to be a bit wary of the quality of work done in Indian drug research front. How has this apprehension been changing?
While there has been considerable caution on the part of MNCs about the quality of work in the past, this concern has declined considerably. This is clearly proven by the fact that a number of discovery collaborations between MNCs and Indian companies have been announced recently. To name a few, the Advinus Merck alliance and the GSK-Ranbaxy agreements are some of the alliances forged recently.
India is part of the WTO and has signed the trade related aspects of intellectual property rights (TRIPS) agreement. Thus, from Jan 1, 2005, intellectual property protection in India has become harmonized with the rest of the world. Since Indian companies are now partnering in intellectual property generation, the quality of work must be of the international standards for it to be recognized globally. This has resulted in a significant change in the comfort levels of MNCs about doing IP based works in India.
What are the models of pre-clinical R&D outsourcing currently in vogue in India?
While contract research or full time equivalent (FTE) based agreements are growing strongly, risk-reward sharing agreements have started appearing. This is a phenomenal turn of events because it is a great recognition of the scientific talent in India as well as the increase in trust and confidence in Indian companies by the global pharma industry.
What is the potential of pre-clinical R&D off shoring to India?
The current level of outsourcing to India is about USD 200 million. My expectation is that it is going to grow more than at least five folds in the coming years.
What are the plans of Advinus to leverage the outsourcing trend?
Advinus is ideally placed to leverage this trend. With its highly experienced scientific and business teams, Advinus has demonstrated its appeal to potential clients and partners. In the short period it has been in existence (less than 2 years), it has built an enviable list of MNC and international biotech clients in addition to domestic pharma clients for its drug development services. Advinus has also entered into a ground-breaking alliance in drug discovery with one of the leading research based multinational pharma company Merck. Advinus will continue to pursue this model and then serve the global pharmaceutical and agrochemical industry with its services. The company will also continue to contribute its own intellectual property by way of new drugs through its drug discovery programs and alliances.