HIV Drug Firm - Call to Pool Patents

posted: 07/09/2009

Leading UK and international organisations have written to Britain's largest drug company urging it to pool its patents on HIV medicines to help save millions of lives in developing countries.

A letter from 15 organisations, including the Stop Aids Campaign, Médecins Sans Frontières, Unicef and Christian Aid, calls on GlaxoSmithKline (GSK) to join a patent pool being put together by UNITAID, which aims to improve access to drugs for HIV, malaria and tuberculosis (TB) in poor countries.

The patent pool would allow cheap copies and combinations of HIV treatments to be made without legal restraint or delays from the manufacturers, whose monopolies are protected for 20 years.

The letter follows Andrew Witty, the chief executive of GlaxoSmithKline, saying that all he knew of UNITAID was what he had read in the papers. UNITAID’s mission is to help increase access to treatment for HIV, malaria and  tuberculosis, for people in poor countries, by getting speedy price cuts for tests and medicines.

On a trip to Katine in northern Uganda, Witty made clear his reservations about a patent pool for HIV drugs, although he said: "I'm not saying no to anything because nobody's actually put in front of me a really concrete proposition." He added that GSK was already doing a lot to help those with HIV in developing countries, including funding research into drugs for children, and he was willing to let generic companies make cheap copies of its HIV drugs under licence.

Witty went to Katine to explain how his own plans to help the developing world would work in one corner of Africa.

He has cut the prices of GSK drugs in poor countries to no more than a quarter of the level in the west and promised to reinvest 20% of profits on those drugs in the developing world. He has also launched a patent pool of his own, with more than 800 compounds and molecules that might be useful to researchers into neglected diseases. HIV, he insists, is not a neglected disease.

Much more still to do

In response, the 15 organisations wrote in their letter: "GSK's insistence that a patent pool for HIV is unnecessary is surprising given the woeful lack of innovation into HIV treatments suitable for children, and the obvious need for new safer and more effective fixed dose combinations for adults." The group also urged Witty to meet UNITAID.

Alan Smith, chair of the Stop Aids Campaign, said: "The UNITAID patent pool is our best hope of increasing access to life-saving medicines on the scale that is needed to achieve universal access.

"It is crucial that Andrew Witty and GSK … engage in an honest and positive manner with the UNITAID taskforce."

A letter from Unitaid to the Guardian on 15 October reinforced the need for a HIV patent pool:

'Unitaid welcomes GlaxoSmithKline's renewed interest in the Unitaid patent pool initiative for HIV/Aids medicines and its openness to taking a flexible approach to managing intellectual property (Letters, 10 September); and GlaxoSmithKline urged to pool its patents on HIV drugs, 7 September). Wherever multiple patents owned by different companies are required to make a product, patent pools may offer a useful solution. Pills that combine three medicines into one tablet to treat HIV/Aids are a good example of such products.

The World Health Organisation recommends the use of such pills because they make it easier for patients to take their treatment and reduces the risk that viral resistance will render the drugs useless. However, patents from two to three different companies are usually required, meaning that single-company initiatives will not do the trick. The Unitaid pool will facilitate the development of combination pills and children's formulations of HIV/Aids medicines for use in developing countries, based on voluntary patent contributions from pharmaceutical companies. Those companies will receive royalty payments for doing so. The pool will also enable robust competition among drug producers to ensure that international resources to fight Aids, currently under severe strain, are spent as efficiently as possible.

The situation is urgent. An estimated 6 million people needing access to Aids treatment, including hundreds of thousands of children, still do not receive it. This number will only grow in the years to come. We ask GSK and other Aids drug patent-owners to work with us to make this initiative a success.' Ellen 't Hoen, Senior adviser IP & medicines patent pool, Unitaid
 

UNITAID

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Drug Firms Merge HIV Arms

posted: 17/04/2009

Glaxo-SmithKline (GSK) and Pfizer are to merge the HIV arms of both these international drug companies, in a move to better develop and market HIV drugs. This follows an announcement in February that GSK was going to reduce the prices of its drugs, including those for HIV, across the developing world.

Britain's biggest drugs company, GlaxoSmithKline, is to pool resources for treating HIV with its USA rival Pfizer, in a bid to reinvigorate financial returns from tackling the global epidemic.

GSK and Pfizer announced that they intend to create a new company, headquartered in London but as yet unnamed, to manage their HIV operations with initial working capital of £250m.

The lion's share of the business will be owned by GSK, which will take 85% to reflect its portfolio of big-selling HIV drugs such as Combivir and Kivexa. The other 15% will go to Pfizer, which will contribute potentially promising new treatments.

Delivering new drugs

GSK's chief executive, Andrew Witty, said the "clear focus" of the joint venture would be in delivering new drugs to build on what he described as the drugs industry's remarkable success in tackling HIV over the last two decades.

Witty recalled that as recently as 1990, it was extremely difficult to conduct clinical trials in HIV because people rarely lived long enough to complete studies. He said: "I think it's one of the finest performances of the pharmaceuticals industry to have transformed an incredibly frightening infectious disease into something more manageable."

The new company will have 11 drugs on the market and a further six in clinical development. It will have a market share of 19% and annual sales of £1.6bn.

Once the global leader in HIV drugs, GSK has slipped to second place behind a USA rival, Gilead, and has seen sales stutter. Revenue from GSK's HIV treatments fell by 5% to £1.5bn last year, while sales of the company's entire pharmaceuticals portfolio slipped 3% to £20.3bn. It has few new HIV drugs in the pipeline, but Pfizer has several.

Pfizer has a relatively newly launched HIV drug, Selzentry, and is working on several more in trials.

"Both companies are facing some pressures in the HIV area," said Damien Conover, an analyst at the Chicago research firm Morningstar. "Selzentry is not doing as well as it probably could if it had more resources behind it."

Cautious welcome

Charities supporting people living with HIV greeted the tie-up with cautious optimism. Sir Nick Partridge, chief executive of the Terrence Higgins Trust, said his organisation "welcomes any move which will strengthen HIV research and development and benefit people living with HIV".

Partridge said that 33 million people lived with HIV worldwide: "We need to be making constant advances to stay one step ahead of the virus."

The new company will be run by Dominique Limet, a former head of GSK's French operation who presently runs the group's personalised medicine strategy.

Under the arrangement, either GSK or Pfizer could be rewarded with a greater ownership stake depending on whose laboratories come up with promising treatments in the future.

GSK's chief executive Witty, who is sceptical about multimillion-dollar mergers among drugs firms, suggested that this tie-up could be an example of how collaboration could be made to work elsewhere in future. "It's not necessarily a template but it will apply elsewhere," he said. "This structure is a good example of the way we want to create value and generate efficiency in our business."

He pledged that the new company would adopt "enlightened mindsets" towards the pricing and availability of HIV drugs in sub-Saharan Africa and other developing countries.
 

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Drug Firm's Bold Promise

posted: 16/02/2009

The new chief executive of pharmaceutical giant GlaxoSmithKline (GSK) says the company will cut prices for its drugs in the developing world.

Andrew Witty said GSK would cut the cost of drugs in the 50 poorest nations to 25% of price in the UK and US. He also said the firm would share knowledge of patents and reinvest profits in local clinics.

Charities have long campaigned for such a policy as patents prevent cheaper generic versions of drugs.

Mr Witty told the Guardian newspaper drugs companies had a duty to help the poor. He said: "We work like crazy to come up with the next great medicine, knowing that it's likely to get used an awful lot in developed countries, but we could do something for developing countries.

"Are we working as hard on that? I want to be able to say yes we are, and that's what this is all about - trying to make sure we are even-handed in terms of our efforts to find solutions not just for developed but for developing countries."

Formulas and processes owned by GSK under patent will be shared with researchers and 20% of the firm's profits in the developing world will be reinvested in hospitals and clinics there.

Move welcomed by HIV and health campaigners

Health campaigners have said more still needs to be done but they welcomed the initiative. Oxfam said affordable HIV treatment, for instance, could stop 6,000 people dying every day in countries affected by the HIV/Aids epidemic.

Charity World Vision's director of advocacy Mike French said: "Slashing drug prices is good. But without the necessary health infrastructure many won't be able to access those drugs. Therefore, investment by GSK, along with the knowledge pooling, make this a landmark announcement.

"This is a gutsy move in a commercial world. Witty has demonstrated a willingness to make saving lives a business goal along with making money."

George House Trust Chief Executive Michele Reid responded, saying:
"Andrew Witty has taken a bold first step in the right direction. We hope that other international drug companies will soon match and then outbid GSK's move. They can and need to do more if we are to see real change in the developing world for people living with HIV."

"In the future, rather than selling their own HIV drugs to the developing world for a bit less, we'd like to see the pharmacos allowing the generic companies to produce drugs more cheaply."

"We also need Witty's "patent pooling" idea to include HIV drugs, so we can have faster development of new HIV treatments. This is a good start, but let's hope it leads to saving lives on the ground, which should be everyone's driving ambition in the HIV drugs marketplace."
 

Could do better - check the small print

Critics of the drug companies acknowledged yesterday that GSK was making strides, but said it could go further. It's proposal to give away 20% of profits in the 60 least developed countries is not what it seems - GSK currently has operations in only 18 of them and earns around £30 million a year from them.

"I recognise the fact that GSK is seeking to meet concerns," said Michelle Childs, director of policy and advocacy at Médecins sans Frontières, who welcomed the move to open to pool patents on chemical compounds that could help the development of treatments for neglected diseases. But, she said, she would challenge GSK to go further.

Need for HIV patent pool and cheaper drugs from generic manufacturers

"He is saying there is no need for a patent pool for HIV. Our position is that there is an urgent need for a patent pool for HIV because of the rising prices of new first and second line drugs for patients who develop resistance."

Buying cut-price drugs from GSK would not necessarily be the best move for the poorest countries, she added.

Generic companies were capable of producing drugs at lower prices than big pharma could manage, because of the lower costs of manufacture. GSK's combination HIV drug Combivir had been reduced from $730 (£506) in 2001 per patient per year and now sells at $197 in the least developed countries.

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letters from Stop Aids Campaign and others in response