The United Nations-backed Medicines Patent Pool, Shilpa Medicare and Gilead Sciences have entered into an agreement to increase the access to medicines for HIV/AIDS treatment.

The Karnataka-based Shilpa Medicare will now be able to produce five key HIV medicines for sale in over 100 countries depending on the medicine.

The agreement covers tenofovir,emtricitabine, cobicistat, elvitegravir and a combination of the four known as “the Quad”, Medicines Patent Pool (MPP) said.

“There is a 3-5 per cent royalty payable by Shilpa to the patent-holder, Gilead, depending on the medicine,” an MPP spokesperson said, adding that MPP did not receive royalties from such agreements.

Four-medicines-in-one

The technology transfer, as a result of the agreement, will allow Shilpa to make its chemically similar version of these drugs at a lower price. The four-medicines-in-one Quad, is an important drug that simplifies treatment delivery, MPP pointed out.

Quad had received approval from the US Foods and Drug Administration in August 2012.

However, there is no commitment on price, the spokesperson said, adding, “he price is set by the market.” But experience over the last 10 years in HIV medicines shows that competition is the best way to reduce prices on HIV medicines, and increase availability.

In the past, five other generic manufacturers — Aurobindo, Shasun, Laurus, Hetero and Emcure have tapped into the pool, producing medicines licensed to MPP by Gilead Sciences.

In an agreement earlier this year, Aurobindo tapped the pool for HIV medicines for children. Aurobindo was the first generic company to take a licence from MPP for the paediatric product, licensed to MPP by ViiV Healthcare in February.

How it works

MPP negotiates licences into the “pool’’ from patent holders, and in turn licenses out to generic companies to make and sell HIV medicines to people who need it and at affordable prices.

“The in licence from Gilead has now been licensed out 6 times (Shilpa is the 6th). The in licence from ViiV, which concerns medicines for children, has now been licensed out once, to Aurobindo. Aurobindo has taken two sets of licences from the MPP — and now, through us, can manufacture both medicines patented by Gilead and medicines patented by ViiV,” the spokesperson said.

New entrants

Shilpa Medicare’s associate company,Reva Pharma, will assist in marketing Shilpa’s anti-AIDS products .

On Shilpa not being a known producer of HIV/AIDS medicines, the MPP spokesperson said: “Shilpa is a new player that has decided to enter the field of HIV production. Encouraging new players to the HIV medicines field is one of the MPP’s mandates — having more players in the HIV space helps increase the production of needed HIV medicines, and stimulates competition that keeps prices affordable.” Shilpa could not be reached for comment.

After companies express interest on tapping into the patent pool, they are evaluated on different criteria, particularly quality, the spokesperson explained.

The pool works with generic manufacturers who have been approved by a stringent regulatory authority, such as the US FDA, or the WHO pre-qualification programme. There is also a licence management process that helps ensure MPP licences result in impact, through quarterly reviews, for instance, he said.

The patent pool involves voluntary participation of patent-holders, such as large drug makers. Depending on the medical need, generic drug companies are allowed access to the patent of a particular medicine, on the payment of a royalty to the patent-holder.

jyothi.datta@thehindu.co.in

(This article was published on June 26, 2013)
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