Gilead’s model to enhance availability of anti-AIDS drug

February 22nd, 2009 - 2:50 pm ICT by IANS  

New Delhi, Feb 22 (IANS) American bio-pharmaceutical major Gilead, that has entered into generic licensing deals with 10 Indian pharma firms to distribute its HIV drug Viread, is all set to roll out its key anti-AIDS drugs at affordable prices in India and 94 other resource-limited countries through its unique licensing model.

Under the model, Gilead has issued non-exclusive licences to the manufacturers to sell generic versions of the key anti-AIDS drugs Viread and Truvada, charging a five percent royalty on sales of finished products.

“The policy of allowing these companies to compete amongst each other will drive prices down to the benefit of consumers. The low royalty being charged by Gilead is also a key factor for the low pricing to be achieved by the Indian generic manufacturers,” Gregg Alton, Gilead’s senior vice president and general counsel, told IANS.

“The agreements include a full technology transfer, to enable faster ramp-up of production of high quality product, and allow the generic companies to manufacture commercial quantities of both active pharmaceutical ingredient (API) and finished products,” Alton said in an interview.

He also mentioned that when the Indian generic companies signed up for these licences a few years ago, there was no certainty on how the pricing and patent issues would pan out.

“However, these companies were convinced of the therapeutic value of these drugs and the potential and signed up to manufacture these drugs.”

Additionally, Gilead has also appointed Piramal Healthcare as its distribution partner for selling branded Viread (tenofovir disoproxil fumarate) in India. The transfer pricing to Piramal is likely to be around $17 for a month’s dosage.

“Availability of the branded and generic version of Viread at an affordable price is likely to greatly benefit India’s AIDS-afflicted. The drug is awaiting marketing approval with the Drugs Controller General of India,” said Alton.

More than 5.1 million people are believed to be infected with HIV in India - the second highest incidence of the disease after South Africa.

Through its unique licensing model, Alton maintained that Gilead has succeeded in driving the pricing closer to 40 cents a day and has bettered its own commitments. This is being considered a very welcome move by patient groups and NGOs, who were earlier opposing a patent in India for Viread.

Gilead’s application for a patent has been pending before the Indian patent office for over a year now. The firm believes that it has a right to protect its intellectual property.

However Indian pharma major Cipla has filed a pre-grant opposition against the patent application for Viread before the patents office.

Alton said: “We believe that protecting the intellectual property of companies who engage in drug research and development is a critical part of the treatment access equation.

“Intellectual property protection, when used responsibly, encourages research and discovery of newer and more effective molecules.

“Gilead respects Cipla’s right to oppose the issuance of a patent for Viread or any drug. But, more importantly, we reaffirm our desire to work with Cipla whether or not a patent is issued,” said Alton.

The 10 Indian generic companies are Alkem, Aurobindo, Emcure, FDC Ltd, Hetero, Matrix, Medchem, Ranbaxy, Shasun and Strides. They are free to set prices for their generic versions of the drugs.

“It is important that the patents are issued so that the licensees can exert their legitimate claim to selling generic versions of Viread and Truvada and expand upon this successful model to increase access to medicines,” Alton said.

(Murali Krishnan can be contacted at m.krish@ians.in)

– Indo-Asian News Service

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