GSK Consumer Healthcare, the world's largest pharmaceutical OTC company, is soon to roll out a blockbuster product in the burgeoning erectile dysfunction drug market.
The new OTC gel, an invention of UK's leading sexual health company Futura Medical, would create an unparallel competition in the erectile dysfunction drug market, which is a strictly regulated prescription segment in India.
GSK had recently entered into an agreement with Futura Medical to co-develop the drug for treatment of erectile dysfunction. If successful, the drug, MED2002, would be the world's first non-prescription pharmaceutical treatment for erectile dysfunction.
In India, the Rs 100 crore ED market is dominated by Pfizer's Viagra and other 15 odd local generic brands launched by Indian pharma majors. This is allowed to be prescribed only by specialists in cardiology, endocrinology and psychiatry in India.
Analysts said since GSK product is to hit the OTC segment, it will surely open up a floodgate in India, where these patients are often reluctant to have medical consultation.
The ED market in India is growing at more than 30 per cent with an estimated number of 12.5 million men suffering from various kinds of erectile dysfunction.
According to data cited by Futura, it is expected that the number of men with ED will double from its current level of 152 million worldwide to 322 million by 2025 due to ageing populations.
"It is too early to comment on the launch and the sales impact of this product in India though we are aware of the co-development programme by the parent company for the OTC Gel for erectyle dysfunction," said a GSK Consumer Healthcare India spokesperson.
Early this month, Paul Berman, vice-president of business development and strategic planning at GSK Consumer Healthcare Europe, was quoted by foreign media stating that; "This is a very exciting new business opportunity for GSK Consumer Healthcare, one that meets a significant unmet need in the marketplace, and the prospect to be the first regulatory approved non-prescription erectile dysfunction product is compelling."
Under the terms of the GSK-Futura agreement, GSK will pay 65 per cent of the clinical development program costs for the drug and Futura will pay the remaining 35 per cent.
The co-development program, to be run and managed primarily by GSK, is expected to comprise up to three studies involving approximately 1,500 men with ED and several additional safety studies to support the existing studies already completed by Futura. The drug is also likely to be human-tested in India as part of the global trials.
The agreement also includes license terms that are not yet legally binding, under which GSK would have global distribution and marketing rights for MED2002 as well as first refusal on two other products currently in the early stages of development: a non-prescription treatment for arousal and desire disorders associated with female sexual dysfunction and a non-prescription treatment for premature ejaculation.