Gilead has already entered into generic licensing deals with three Indian pharma majors - Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab - for the drug. The Indian firms will make generic versions of Viread and distribute it to 95 low-income countries around the world in a couple of months.
"Our endeavour is to provide the widest possible access to our drugs for HIV/AIDS patients. Gilead has devised a tiered product pricing based on a country's economic status and HIV prevalence," Gilead's senior vice-president Gregg Alton told IANS from San Jose, California.
More than 5.1 million people are believed to be infected with the HIV virus in India - the second largest number of infected people after South Africa.
"Viread will be available at $365 per year in India. For African countries where the economic status is lower, we have priced the drug at $203 per year, making it close to 37 cents a day for patients," he said.
There has been much speculation in recent months with claims that Viread had been overpriced, selling at $5,700 in the developed world.
Alton said, "That pricing information is inaccurate, while we have the right o protect our intellectual property in developed markets, our tiered pricingfor countries like India and Thailand will ensure that Viread will o well and provide better health status for patients."
Compared with generic versions currently available from pharma major Cipla, priced at over $1,200 per year, the new pricing is bound to come as a relief.
Viread (tenofovir disoproxil fumarate) is on its way to becoming the frontrunner drug across Europe for HIV/AIDS due to its low toxicity and resistance levels observed in patients. The tablet-a-day dosage of the drug also helps in better regimen and compliance among HIV/AIDS patients taking it.
On why the three generic Indian manufacturers agreed to take a license when
Gilead does not actually have a patent, Alton said, "There are several reasons for these license agreements. We will transfer technology and know-how to our partners for them to be able to produce larger, better and higher quality batches of Viread."
The technology transfer is expected to increase efficiency and drive down costs.
"We believe that we are the innovators of one of the foremost drugs in the battle against HIV/AIDS and are hopeful that our patents will be issued in India as they have in many other countries across the world."
Under the terms of the agreement, the generic companies will have the right to manufacture and market both the API (active particle ingredient) and the tablets in perpetuity.
While the rights to sell API will be limited to other pharmaceutical companies in India, tablets can be distributed in India, Thailand, Africa and 43 other countries.
This offers the Indian licensees a huge business opportunity given the size of the market. In Africa alone, 45,000 patients are currently on Viread, of an estimated infected population of 30 million. In India, about 40,000 patients are under treatment on the anti-retroviral drug.
In return, the Indian manufacturers will pay Gilead a five percent royalty, which is well within the World Trade Organization norms, as compared with industry practice of much higher royalty rates.
Alton said his company was in discussion with other Indian pharmaceutical majors even though some of them have filed oppositions to the Gilead patent filings.
He said: "We are in very advanced stages of discussions with other pharmaceutical companies, including Ranbaxy and Cipla, and are very positive that they will see value in our offer."
Source: Indo-Asian News Service