In an interesting agreement in the anti-retroviral drugs (ARVs) space, Gilead Sciences Inc (GILD), an original drug maker, has struck a licensing deal with four Indian generic drug manufacturers to bring low cost ARVs into the market.

The unique feature of the agreement is that three candidate drugs in the phase-III trial stage from Gilead Sciences will be on offer to these Indian companies — Hetero Drugs, Matrix Labs, Ranbaxy and Strides Arcolab – at a royalty, post their approval by the US Food and Drug Administration (USFDA).

While the US-based Gilead Sciences will bear the entire costs of trials and development of these drugs, the Indian companies would be readying with manufacturing capacity and marketing them.

The four Indian companies are major players in the global ARVs market (used in treatment of HIV). At present, more than 1.1 million patients in the developing countries receive Gilead HIV medicines produced by Indian partners since 2006.

Announcing the agreement at a news conference here on Tuesday, Mr Gregg H. Alton, Gilead's Executive Vice-President for Corporate and Medical Affairs, said the move was to expand the global access program of the company and provide accelerated access to its drugs. “Our goal is to provide low cost versions to developing countries without delay,” he said.

Gilead's original licensing agreement provided Indian manufacturers with non-exclusive rights to produce active pharmaceutical ingredients (APIs) and finished product and sell generic version of Viread and Truvada in 95 developing countries, including India.

Licensing terms

The expanded agreements include future rights to produce and sell generic versions of three Gilead HIV therapies. Elvitegravir, Cobicistat and Quad are investigational products and are at end stage clinical trials. The agreement also allows sale of Viread and Truvada in 16 more countries.

Licensees will also receive a complete technology transfer of Gilead manufacturing process to support their efforts to obtain local regulatory approvals and scale up production.

It is estimated that approvals could be got in the next 18 months to 36 months.

About 6.6 million patients receive HIV therapy in the developing world. Of this, nearly one-fourth receive either branded or generic versions of Gilead (which has a portfolio of 13 ARVs). Even the prices of the ARVs have been brought down to $6.15 per patient per month from $17.

HIV treatment needs to continue to grow, with as many as 15 million people requiring treatment now. An estimated 30 million could require treatment within the next five years.

Dr Arun K. Purohit, Vice-President & Head Global Therapy Management of Ranbaxy said, “The agreement is different as it starts quite early in the development stage of the HIV drugs. About 1.1 million patients in developing countries are on our drugs as per estimates,” he added.

Hetero Drugs, whose revenues from ARVs are close to $200 million has significant share of the global ARV market. Through the alliance it is targeted to reach about 15 million patients and hence, a sizeable market exists ahead, said Mr Bhavesh B. Shah, Vice-President, International Marketing.

Mr Hari Babu of Matrix Labs said one out of every three in the developing countries get a Matrix product in HIV treatment. Its parent Mylan Inc. recently got into a licensing agreement with Bristol Myers Squibb related to expanded access in the sub-Saharan Africa and India for a ARV.

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