Synriam, Ranbaxy’s new anti-malarial drug combination, is the first new drug R&D project by an Indian generics company that’s yielded a marketable drug. That’s big in itself as various media reports have acknowledged.
To me, its key value lies not so much in its “firstness.” Its value is even greater as a case study – with one or more Indian entities at the centre – that holds multiple lessons on the nature of R&D, on the value of partnerships, on the role of governments, on the need for a competitive and heterogenous drug industry where everybody doesn’t think like everybody else. And so on.
Am sure that there are other drugs that’ve hit the market globally that can illustrate some of this even better but this is a story that India can own given that it’s played such a pivotal role in it.
So without further ado let me quickly go to key takeaways from Synriam :
1. It takes a village
“It takes a village to raise a child,” it’s been said, a reference to the involvement of the entire community and not just the parents. Evidently, a similar sentiment can be expressed about putting a new drug on market. At the end of its trajectory, Synriam had had at its back at least three universities, two companies, one non-profit, one government. Not to mention the many centres where it was tested. And all these across five continents.
Synriam’s journey began as a collaboration between Geneva-based non-profit Medicines for Malaria Venture and institutions such as the University of Nebraska, Monash University, and the Swiss Tropical Institute. (For a list of inventors read spicyip’s post here). Roche was briefly a pharmaceutical partner but then gave up malaria research. Ranbaxy stepped in (with funding commitment from MMV). Then after initial trials, MMV opted out of funding though it transferred development and marketing rights to Ranbaxy. The company then roped in India’s department of science and technology as a development partner. Other institutions such as Bangkok’s Mahidol University and India’s Malaria Research Centre were also involved in the project.
2. What’s “valuable” research?
There’s been some debate on whether this is really a “new” chemical entity. In the larger scheme of things, what it “is” is a lot less important than what it “does.” Synriam is a combination of a known drug piperaquine with arterolane a synthetic alternative to naturally-derived artemisinin which (in combination with other drugs) is the preferred malaria treatment globally. There are several artemisinin derivatives already available but arterolane stands out because it’s source is synthetic as opposed to natural i.e. the sweet wormwood. This can make a world of a difference by substantially reducing dependence on the wormwood crop the supply of which has not always kept pace with demand bumping up raw material cost and creating shortage. It also offers hope in the event of artemisinin-resistance.
3. It takes all kinds
Synriam shows once again why plurality of agenda, of geography etc is vital for drug R&D to thrive. The drug came to Ranbaxy after two Big Pharma cos – Roche and Lilly (the only ones besides Ranbaxy who understood the chemistry, according to a 2005 Fortune magazine article) had turned MMV down for different reasons. Roche because it discontinued malaria research and Lilly because it couldn’t work within MMV’s budget. Ranbaxy -like other Indian companies doing new drug R&D- was focused on disease areas that would ideally appeal to Big Pharma. This was because it was wooing these moneybags to licence out any promising research that came out of its lab. Malaria was not one of them. Luckily for Synriam, Ranbaxy also wanted to build its own development skills. It saw an opportunity to learn by working with MMV and its partners. And being based in the developing world, it could do R&D for much less than, say, someone like Lilly could. The priorities of Ranbaxy, an emerging generics powerhouse with new drug R&D ambitions coupled with the Indian cost advantage to keep the project afloat.
4. Public-private partnerships (PPP) are working
MMV, which funded a good portion of the R&D, is a PPP. Ultimately, so is Synriam. Clearly, there’s a lot more than can be done in the field.
There are still more hoops to jump. Synriam, cleared for sale in India, has to be approved for marketing in various malaria-endemic countries and be accepted for wide-scale procurement by agencies such as the World Health Organisation. When MMV dropped the project in 2007 it had said that the drug “might not fulfill all of the very rigorous potency, efficacy, safety and cost criteria of MMV-sponsored products.” It will take a second look now.
In the meantime, while Synriam won’t be a blockbuster that can bankroll future R&D at Ranbaxy it holds valuable lessons nevertheless. And as I wrote in an article in Businessworld in 2007, “If successful.. this will also send out a strong political signal about an Indian company working to cure a disease that affects large numbers of Indians.” That’s a big plus.