S. Harachand07.23.07
Discovery Dalliance
Innovators land in Indian shores
By S. Harachand
It is curious to see the rather silent drug discovery scene in India turn increasingly noisier by the day. Traditionally a hotbed of intense generic activity, the Indian drug industry hardly figured in the global atlas of the so-called innovators. Even then, quite a few companies -- both big and small -- are putting the R&D arena on fire through some big-ticket deals.
Most of these collaborations are long-term pacts with discovery-led drug behemoths. The deal signed between Eli Lilly Suven Life Sciences on G-protein coupled receptors for CNS disorders is a striking example. A small-time player based in southern India, Suven got European patent (EPO) for a class of selective 5-HT compounds useful in treating neuro-degenerative disorders. Suven will receive milestones as well as downstream payments from Lilly if the identified candidates are selected for further development. GPCR based drugs constitute some of the top-selling medicines today.
The U.S. company also has a research association with Nicholas Piramal. As per terms, the Mumbai-based firm will conduct non-clinical studies and human clinical trials as far as Phase III for one of Lilly's molecules for metabolic disorders. Lilly is expected to pay $100 million in milestone payments for the drug, plus royalties when commercialized. "In case the drug fails to get past the Phase II trials, we would get back a portion of the payment," stated Ajay Piramal, Nicholas' chairman. The deal entails a provision to work on four more yet-to-be-decided molecules, as well, according to Mr. Piramal.
Accessing Skill Base
Last fall, Merck & Co. signed an agreement to outlicense two of its metabolic drug candidates to Advinus Therapeutics. The latter will get $74.5 million per target as milestone payment for doing research and preclinical studies while Merck will retain the right to advance the promising candidates into late-stage clinical trials and commercial development. Advinus, promoted by India's largest corporate house, Tata Group, is also eligible for royalties on sales if any of the drugs developed reach the market.
Wyeth, another U.S. drug major, picked up an alliance with GVK Biosciences on a range of research services in the synthetic chemistry area early last year. The five-year deal, engaging nearly 150 synthetic chemists is said to be in region of $40 million. Commenting on the tie-up, Wyeth executive vice president and head of discovery research Frank Walsh said the deal with the south Indian company would "truly be an exciting opportunity to expand Wyeth's drug discovery capabilities by accessing the ever-growing chemistry skills base in Asia."
European drug majors like GSK and AstraZeneca also have Indian partners in discovery. The British drug giant sources services including lead optimization, candidate selection and proof of concept studies for a variety of anti-infective, metabolic, respiratory and oncology products from Ranbaxy. AstraZeneca has found a joint funding partner in the west Indian Torrent Pharma for a hypertension treatment.
Rising Comfort Levels
Even as more and more MNCs start looking for suitable collaborative partners, the growing legion of drug discovery service providers makes an impressive line-up with different working models. Like Advinus, there are quite a few players such as Syngene, Jubilant Biosys, Aurigene, Chembiotek, GVK Bioscienes, Reliance Life Sciences, and more, offering integrated platforms across the R&D value chain.
Escalating costs are considered the prime reason forcing innovators to foster such ventures in developing countries. Drug development expenses have gone up steeply in the past 12 years. Higher safety hurdles set by regulatory bodies and lower productivity of internal research also made them explore options for bettering success rates of new therapies.
Recognized skills in medicinal chemistry along with recent policy revamp in the country favouring intellectual properties help Indian firms gain an edge. Since Indian companies are now partnering in intellectual property generation, the quality of work must reach international standards in order to be recognized globally. This has resulted in a significant change in the comfort levels of MNCs about doing IP based works in India, experts opine.
"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," noted Advinus' chief scientific officer, Dr. Kasim Mookhtiar.
Going by the current trend, said the U.S. expatriate scientist, research outsourcing is going to grow more than fivefold in the coming years from its current $200 million.