The last few days have witnessed at least a dozen news reports on the launch of Ranbaxy’s new anti-malarial drug – Synriam. Several of the news reports such as the one over here and here give the impression that this drug launch is the first of its kind in India. The Business Line report in particular claims that Ranbaxy has spent invested $30 million to develop this drug. A part of this claim can be traced to Ranbaxy’s press-release which claims that Synriam is India’s ‘first new drug’. Image from here.
However several other papers have reported that Ranbaxy’s ‘Synriam’ is not a brand new molecule but a fixed-dose combination (FDC) of two existing drugs. In particular, the DNA report by Priyanka Golikeri reports that the drug is arterolane maleate +piperaquine phosphate. She also reports that Cipla has also has launched another anti-malarial FDC drug which is also a combination of two existing drugs: artesunate + mefloquine. The DNA news report appears to be corroborated by a quote in the Ranbaxy press-release itself: “The new drug, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg drug, in line with WHO recommendations.”
While this achievement in creating a new FDC is commendable, it is certainly not the first time that an Indian company has developed a FDC, as is being projected in some of the news reports. Cipla and Ranbaxy and in fact most of the Indian drug industry has been extremely adept at developing FDCs. In fact Cipla is credited with pioneering FDCs in the battle against AIDs/HIV. One of its first such FDCs was Triomune, a FDC of three anti-retroviral (ARVs): Lamivudine, stavudine and Nevirapine. The FDC was credited with greatly increasing compliance amongst the HIV patient community since it did away with the need to take the three drugs independently.
It is interesting to note that both the Ranbaxy and Cipla FDCs to combat malaria, where done in combination with the Department of Science & Technology (DST) and the Drugs for Neglected Diseases Initiative (DNDi), respectively. The Business Line reports that the DST primarily funded Ranbaxy’s phase III clinical trials for the new drug in South Asia, South-East Asia and Africa. The amount released for the clinical trials, according to the Business Line was Rs. 5 crores (i.e. roughly one million US dollars). Before the DST, Ranbaxy was reportedly working with the Medicine for Malaria Venture (MMV). The partnership with MMV was broken off a few years ago.
Although details are unavailable on the exact nature of the agreement between DNDi and Cipla, I’m guessing it is more of a marketing arrangement because as per the Wikipedia page for DNDi, the artesunate + mefloquine FDC was developed in the year 2008 itself and already being manufactured by a Brazilian government owned pharmaceutical company.
The major cost in developing FDCs, is the clinical trials, especially for drugs aiming for the WHO pre-qualification regulatory approvals. A seal of approval from WHO would mean that the drug will be bought in bulk by the several international aid agencies that carry out anti-malarial programs in Africa and Southeast/South Asia where malaria is rampant. Once the cost of clinical trials is covered by the DST, it is unlikely that Ranbaxy would have had to invest any significant sum in the development of the drug. Public private partnerships such as this negate the need for monopoly IP measures such as patents or data exclusivity, since the public sector is in effect subsidizing the private sector in drug development. It is also not the first time that somebody proposed this model of developed. Jerome Reichman, for instance has long called for a ‘public goods’ approach clinical trials where the cost is borne by the government in a bid to reduce demands for monopoly IP protections by pharmaceutical companies. You can read his paper over here. (Image from here)
Returning to the issue at hand, although, both Ranbaxy and Cipla claim that their drugs are a part of their corporate social responsibility agenda, I’m guessing that they stand to make killer profits from these drugs simply through economies of scale. Both drugs appeared to be priced quite cheaply, the Ranbaxy drug for instance is just Rs. 130, but the number of new malaria cases in the world every year is estimated to be at around 250 million. You do the math! This is not to say that profits are bad but instead point out how the profit motive is always effective in delivering results. In case you are wondering as to why both companies launched their drugs in tandem, it was most probably because April 25th is World Malaria day.
How do you know that the partnership with MMV was broken off? MMV owns the patent to arterolane, so Ranbaxy has to have a license to be able to market this drug.
Hi Akshat – It was widely reported in the media that MMV and Ranbaxy broke off their agreement some years ago. Here is an article on this point: http://www.business-standard.com/india/news/ranbaxy-malaria-drug-in-final-trial-stage/357117/
You should be able to find several other articles on this point.
Cheers,
Prashant
Prashant, you are completely wrong when you say that arterolane maleate is not an NCE. Have you checked this out yourself or are you relying on media reports? Can you show one country in the world where it has been approved or marketed before? In malaria treatment, monotherapy is not almost never recommended and it is very common to develop FDCs directly, even when one of actives is the an NCE. As such Indian scientists are not seen to be innovative, as alluded to in your recent post on Prof Desiraju’s Nature article. It certainly does not help to be belittling work by Indian scientists just so you make a point. Please check your facts before you cast aside such work.
Hi Anon,
Read my post again – I never said that arterolane maleate is not a NCE. I’ve only said that Synriam is not a NCE and Ranbaxy’s press release seems to be quite clear that Synriam is a FDC and the impression given by the press release is that the invention lies in creation of the FDC. No where does Ranbaxy claim that their invention lies in the development of a NCE, although I’m not denying that this could be the case.
Also, I never ‘cast aside’ or belittled Ranbaxy’s achievement. In fact I used the word ‘commendable’ – I was only critical of some of the media reports which seem to indicate that this was the first time that an Indian company invented a FDC.
As for the rhetoric over it being an Indian drug, I think we need to collect more information before jumping to any conclusions. From the information that I have been able to gather, Ranbaxy is pretty much a Japanese company, the drug in question is reportedly being manufactured by Ranbaxy in its Chinese plants and the drug itself was discovered initially by a Swiss non-profit – MMV, with a team consisting largely of foreign scientists. If I have tracked the right patent for the drug in question then in that case it is quite clear that only 2 of the 9 inventors of this drug are Indians, while one is of Indian origin. I could be wrong on this patent and I’m waiting for confirmation on the patent covering the drug.
From what I gather Ranbaxy took over only at the stage of clinical trials. And yes, they deserve credit for taking the risk of investing and conducting large scale clinical trials but even for the clinical trials they received funding from the govt. So there really wasn’t much risk.
Which ever way you look at it Ranbaxy does deserve credit for cracking this new public private mode of development.
Regards,
Prashant
You are correct on the patent. Ranbaxy currently licenses the patent. One of the inventors is from the University of Nebraska Medical Center. This American Doctor led the international team of researchers who, with support from the Medicines for Malaria Ventures, developed the antimalarial drug. Ranbaxy then took charge of the operation when the drug was ready for clinical trials. Synram is the name given to RBx11160, which was originally known as OZ277. A simple google search can point you in the right direction.
Dear Prashant,
You are completely wrong Ranbaxy was associated with this product development stage.
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