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.