India a potential center for orphan drug development and demand

Print 09 December 2015

India may be sitting on a pharmaceutical gold mine. It has more than 7 times the number of people affected by rare diseases than the United States, a less expensive workforce for making drugs and an often-criticized price-control system that, by definition, does not affect orphan drugs.

One India-based company sees a profitable outcome for its orphan drug, a sign the nation could become a major source of the often-overlooked treatments as other drugmakers watch to see if the optimism is justified and lasts, the Deccan Herald reports.

Earlier this year, Stempeutics Research, a joint venture between Cipla and the Manipal Education and Medical Group, received orphan-drug status from the European Union to develop its Stempeucel for treating Buerger's disease that attacks blood vessels in the legs. The disease already has that designation in the United States and Japan.

Despite the time and cost to produce a stem-cell based drug that attacks the disease instead of just its symptoms, Stempeutics says it expects to be able to reduce its drug dosage to just one a day, half the dosage of competitors in development.

The smaller dosage would still be expensive for patients, but would undercut the prices in the other two markets: $25,000 to $30,000 in Europe and $60,000 to $90,000 in the U.S. A lower price also could be allowed simply because the India market for treating the disease is twice that of its two competing countries that count 100,000 cases each. One estimate is a price of $1,500 per vial.

India offers the advantage of cheaper drug development, orphan drugs often have already produced or at least studied relatives, and many of them, like Stempeucel, are curative, thus reducing the burden on healthcare systems. And, it has a lot more potential patients.

Ten percent of the American population has one of the 7,000 rare diseases estimated to be on the planet, or just over 32 million, well below the 0.01% to qualify for an orphan drug designation. All of India, a country of 1.25 billion people, is estimated to have only 7.2 million, lower still, the newspaper said.

But, the head of an India activist group told the Deccan Herald, "We don't even have a clear design of the pattern of diseases, which makes it difficult to enlist orphan diseases."

That still leaves India an attractive market not only for India drugmakers but foreign companies as well.

Other negatives for India include its current focus on producing generics, APIs and other research services for innovative drugmakers. It also cannot afford to spend much per capita, and most of the patients for an orphan drug are not likely to afford it. India additionally has no regulatory provision for such a drug yet, the newspaper said.

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