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John
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GlaxoSmithKline agrees royalty-free licensing deal for HIV drug

Deal comes as MPs call for a 'patent pool' for HIV drugs

GlaxoSmithKline has granted South Africa's Aspen the right to make its HIV drug abacavir in a royalty-free licensing deal, on the day that a group of MPs called on manufacturers to put their HIV medicines in a "patent pool" to reduce prices.

Aspen will manufacture a cheaper, generic version of abacavir, also known as Ziagen. The deal was announced by GSK chief executive Andrew Witty on a visit to Kenya today and forms part of the company's efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.

The world's second-largest drugmaker also announced a new £50m fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV. A further £10m will go to support public-private partnership work in developing Aids medicines for children.

While welcoming the initiatives, MPs and campaigners said GSK, and other pharmaceutical companies, must do more. David Borrow, who chairs the all-party parliamentary group on Aids, said: "GSK is taking positive steps, but they are broadly unilateral, which will limit their impact. We would like to see them sign up to the Unitaid patent pool, a proposal which the Department for International Development and all the major UK charities, like Oxfam, support."

Unitaid is the leading international organisation pushing for a patent pool that would allow generic firms to produce HIV medicines cheaply for developing countries.

Borrow stressed the importance of reducing the price of second-line treatments, a combination of new drugs given to patients who have become resistant to the drugs initially administered to them. Second-line treatments cost seven times as much as first-line drugs.

"The most effective way to reduce prices would be a patent pool approach, rather than individual deals between companies," said Borrow.

The parliamentary group on Aids today published a report entitled The Treatment Timebomb, which said that by 2030 more than 50 million people will need HIV treatment compared to just 9 million today.

While GSK took the lead in February, announcing it would place many drug patents for tropical diseases into a free pool, Witty rejected calls for the inclusion of HIV drugs. "The patent pool on neglected diseases was because there was really no research going on in that area – HIV is not a neglected disease," he said. "I can't see how a patent pool in this particular area would change things dramatically."

Dr Tido von Schoen-Angerer, director of Médecins Sans Frontières' Campaign for Access to Essential Medicines, said: "Some have been quite positive about it. It's a bit difficult to see why GSK is hesitating on this."

So far Glaxo is the only major drugmaker that has committed to pool some patents, although it was joined in the initiative last week by US biotech Alnylam Pharmaceuticals.

http://www.guardian.co.uk/business/2009/jul/14/glaxosmithkline-aspen-hiv...

 

John
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"Treatment Time Bomb" APPG HIV & Glaxo
anonymous (not verified)
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Drug firms 'must pool patents'

Drug firms must allow the generic production of their HIV medication if the deaths of millions of people are to be avoided, British MPs warn.

The All Party Parliamentary Group on Aids wants to see a patent pool in which firms would give up their rights in exchange for a royalty fee.

They describe a "treatment timebomb" in which the number of people with HIV will increase fivefold by 2030.

Growing resistance to basic drugs mean millions need more expensive ones.

"We are sitting on a treatment timebomb," said David Borrow, chair of the group of MPs who wrote the report.

"We must reduce the price of second-line medicines and less toxic first-line medicines before millions need them. We cannot sleepwalk into a situation where we can only afford to treat a tiny proportion of those infected."

Governments around the world, including the UK, have signed up to the goal of 'Universal Access to HIV treatment, prevention, care and support' by 2010.

But the report warns that the world is not on track to meet this target, noting that only a third of the 9m people who need it have access to HIV treatment.

Good will

The majority of people who are being treated in the developing world are treated with a combination of cheaper drugs which can have serious side effects. Because of this they are barely used in the West.

The pharmaceutical industry has an opportunity to act now to help prevent future human catastrophe
Mike Foster
International Development Minister

Three years ago, the World Health Organisation recommended a shift away from these medications to less toxic ones based on either Zidovudine or Tenofovir.

But these remain significantly pricier than the older ones: currently the Tenofovir-based combination is more than twice as expensive as the traditional combination.

This is despite the fact, the report notes, that a voluntary license scheme for this drug has allowed eleven different generic manufacturers - all in India - to produce it.

A much broader form of licensing is being proposed by Unitaid, the UN body on drugs for killer diseases.

This would involve drug firms voluntarily putting their patents into a single pool in return for a royalty. Manufacturers or researchers who wish to use the relevant patents are then able to do so for a fee.

International Development Minister, Mike Foster, said: "The simple fact is that the HIV epidemic continues to outstrip our best efforts. Five people are infected with HIV every minute and for every two people put on treatment, there are 5 people newly infected with HIV.

"The pharmaceutical industry has an opportunity to act now to help prevent future human catastrophe. It is time for them to state their clear commitment to make new HIV medicines affordable to those who need them most, by working with Unitaid to develop a patent pool"

GlaxoSmithKline (GSK) is cited by the report as saying it did not at present see the point of putting its HIV patents in a pool.

"For HIV, we believe that extensive research is already underway, and thus it is not a neglected disease. Millions of dollars are ploughed into research into HIV every year by the pharmaceutical industry.

"To improve access, we already have an extensive voluntary licensing programme for HIV across Sub Saharan Africa, involving eight licensees. These licensees are free to develop FDCs [Fixed-Dose Combination retovirals] and paediatric versions and we believe this is a much simpler approach than the creation of a patent pool."

Gilead, which makes Tenofovir, has said it is interested in the idea.

"We believe if structured appropriately, Unitaid's patent pool can play a critical role in expanding access to antiretroviral treatment for patients around the world by encouraging the development of new fixed-dose combinations and pediatric formulations, lowering prices, while respecting intellectual property," said the company's senior vice president Gregg Alton.

http://news.bbc.co.uk/1/hi/health/8150457.stm

anonymous (not verified)
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NEW DEAL 'COULD SECURE CHEAPER HIV DRUGS'

10/08/2009

Former US president Bill Clinton has announced a new deal that could help to boost the supply of affordable HIV and AIDS treatment to many developing countries.

The new agreement with UK-based companies - Mylan and Matrix - will lead to four antiretroviral drugs being sold for less than $500 (£300) for a year-long course of treatment.

It is expected that the drugs - atazanavir, ritonavir, tenofovir and lamivudine - will be sold as three pills, with tenofovir and lamivudine combined into a single tablet, at an annual cost of $475.

According to the Clinton Foundation, the new deal could help to achieve around $400 million in savings over a five-year period and could play a vital role in tackling the global HIV/AIDS crisis.

"Today's announcement will help ensure we can sustain treatment over a lifetime and better treat patients with both HIV and TB, two key steps in turning the tide of the global HIV/AIDS pandemic," commented Mr Clinton.

UNAIDS estimates that around 22 million people in the sub-Saharan region of Africa are currently living with HIV/AIDS.

Written by John Curtis.

http://www.vso.org.uk/news/19303774/new-deal-could-secure-cheaper-hiv-drugs

anonymous (not verified)
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Many more receiving HIV therapy

Falling prices and increased testing have led to a marked rise in the number of people in the poorest parts of the world receiving treatment for HIV.

The number of people on antiretrovirals had risen by 1m by the end of 2008, a 36% increase from the previous year, the World Health Organisation reports.

But despite the progress, less than half of those needing treatment get it.

The majority of pregnant women still go untreated, and their infants are infected via "vertical transmission".

Nevertheless testing of pregnant women is continuing to rise in line with rates overall.

Testing is the gateway to treatment, and in many areas facilities providing this service increased by about 35%, noted the Towards Universal Access report which looked at 158 countries.

"An Aids free generation is no longer an impossibility - the elimination of vertical transmission is in sight," said Jimmy Kolker, head of the HIV/Aids division at UNICEF.

Just the same

Drug prices have also fallen by between 10% and 40% - the result of a combination of a factors, including greater co-operation by the pharmaceutical companies and the prevalence of generic drugs.

There is currently momentum behind the establishment of a patent pool, which would allow the creation of cheap copies of drugs and would be one way of getting newer and more effective second-line treatments into the developing world.

Prevention services still fail to reach many in need
Margaret Chan
WHO

The report highlighted the problems of access to these treatments: the majority of people who are being treated in the developing world receive a combination of cheaper, older drugs which are barely used in the West because of their sometimes serious side-effects.

Three years ago, the World Health Organisation recommended a shift away from these medications to less toxic ones based on either Zidovudine or Tenofovir.

But these remain significantly pricier than the older ones: currently the Tenofovir-based combination is more than twice as expensive as the traditional combination.

Cash flow

But by current reckoning, at least 5m people with HIV do not have access to even the most basic treatment.

The pace of new infections also continues to outstrip the number treated: for every one person being put on a therapy regime, three people contract the disease.

The report highlighted particular concerns about access to high risk groups, such as gay men and sex workers. It noted that as many as 6m drug users are infected worldwide, but less than 40% are reached by HIV prevention programmes.

There are also concerns that recession will hit the international funds flowing into countries where the need is great.

"This report shows tremendous progress in the global HIV/Aids repsonse," said WHO director general Margaret Chan.

"But we need to do more. At least 5m people living with HIV still do not have access to life-prolonging treatment and care.

"Prevention services still fail to reach many in need. Governments and international partners must accelerate their efforts to achieve universal access to treatments."

http://news.bbc.co.uk/1/hi/health/8282825.stm

 

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