Saturday, September 17, 2005

Linking competencies.

The question is whether one is assigning the right competency to the right party.

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An antidote to neglected diseases - PUBLIC-PRIVATE PARTNERSHIPS: Alliances of drugmakers, governments and charities are reviving research into overlooked health problems, writes Andrew Jack.

By ANDREW JACK
1229 words
16 September 2005
Financial Times
London Ed1
Page 14
English
(c) 2005 The Financial Times Limited. All rights reserved

Basel may be the commercial centre of Switzerland's pharmaceutical industry, but new not-for-profit medicine groups are taking root in nearby Geneva with important lessons for drug development - and even for their for-profit counterparts.

Since 2000, the Medicines for Malaria Venture (MMV) and the Drugs for Neglected Diseases initiative (DNDi) have been established in the city alongside the World Health Organisation's own programme for tropical disease research.

They are among a growing number of innovative public-private partnerships (PPPs) that are giving fresh impetus to the development of drugs to treat "neglected" diseases.

During the latter half of the twentieth century, political decolonisation and corporate consolidation undermined previous efforts to find cures for malaria, tuberculosis and other diseases primarily affecting the less lucrative markets of the developing world. The result was that between 1975 and 2000, just 13 drugs were developed for the WHO's list of 10 neglected diseases, which also includes leprosy and dengue.

Since the turn of the millennium, times have changed again, with fresh public pressure on governments to assist the developing world and improve its public health. But if the response by policymakers has been well meaning,it has also been largely misplaced.

Recent recommendations by governments and industry alike have focused on the need for financial incentives to create commercial markets and stimulate research and development by multinational drug companies.

Earlier this year, for example, the UK-inspired Commission for Africa called for "giving large pharmaceutical firms incentives to investigate diseases that affect Africa".

Discussions have focused on tax breaks for innovation, patent extensions conditional on neglected disease research, and "pull" incentives such as "advance purchase commitments" to motivate companies to develop for-profit drugs.

At the other end of the spectrum, some advocates have called for a fundamental overhaul of the existing patent system. They argue that the drugs companies benefit from monopoly profits while patent exclusivity is in place, but are not directing their research efforts into the areas of greatest health need.

Such calls for a radical overhaul caused Chris Hentschel, the head of MMV,to intervene in frustration at a seminar on the subject organised by Medecins sans Frontieres earlier this year, arguing instead: "Let's focus on what we know works."

An analysis published this month for the Wellcome Trust by the pharmaceutical research and development policy project at the London School of Economics suggests that he may be right. The work of MMV and similar PPPs are beginning to deliver promising results.

In the past five years alone, the study estimates that 63 drugs have entered the pipeline, with 18 new products in clinical trials.

"Everything we believed when we started out was wrong: that there were no projects on drugs for neglected disease; that big pharma wanted to work on them alone," says Mary Moran, who led the study. "PPPs work. They are cheap, effective and the best outcome for public health."

Progress has come despite the withdrawal of big pharmaceutical companies from developing world disease research. Just seven of the 12 largest groups remain involved, of which the four most visible are European - GlaxoSmithKline, AstraZeneca, Novartis and Sanofi-Aventis.

The first three have created dedicated research centres costing up to Dollars 20m (Pounds 11m) a year each, while other companies have taken a more sporadic and low-profile approach.

The large drugs companies that remain active today now explicitly recognise that their neglected disease work is conducted on a "no-profit no-loss" basis. While they may have an interest in using such drugs to help win broader access to countries that may in future provide markets for other commercial products, they appear primarily motivated by corporate social responsibility and efforts to minimise their reputational risk.

But the mechanism that has allowed three-quarters of the new neglected disease drugs to emerge since 2000 is the PPP, which brings a mix of public and private skills. Alongside MMV and DNDi, the study considered the US-based TB Alliance and the Institute for One World Health. It did not consider similar work in vaccine development.

The large pharmaceutical companies are best suited to discovery, using the techniques they employ for commercial drugs. But a PPP can help them focus on the most suitable products for neglected disease patients, and provide money and links to others in academia or business involved in the process of research.

In particular, by acting as an honest broker, the PPPs have been able to foster co-operation between traditional competitors. As a result, even drugs companies no longer directly involved in neglected disease work, including Roche, Merck and Abbott, are willing to offer scientific advice or access to their libraries of compounds.

Since they often employ former drug company staff, they can also bring expertise in selecting the best "candidate" drugs. PPPs' greatest assistance comes in clinical development, drawing on staff from the public sector to bring "political cover" and experience in negotiating testing and regulatory approval in the developing world.

The 46 neglected disease drugs developed in this joint way in the past five years have so far performed favourably compared with commercial medicines, with similar timelines. At a cost of Dollars 112m to date between them, their development has also proved extremely cheap.

In contrast to their larger rivals, some smaller pharmaceutical companies are willing to try to develop neglected disease drugs as commercial products. Their lower cost base allows them to focus on medicines with sales below the threshold sought by their larger rivals.

PPPs have also proved useful in these cases, although the study suggests that the mix does not always work well. It highlights at least one case where a company was unable to agree commercial terms to enter joint development for its product with the TBAlliance.

There are two challenges ahead for the PPP approach. The first is that most of the new treatments have yet to prove themselves to completion. The LSE study estimates that eight or nine should gain approval by 2010. That may be optimistic, since some of the most advanced are "low hanging fruit" which had already been partly developed.

PPPs must yet negotiate regulatory and safety hurdles, and tackle one obstacle that hindered the previous round of neglected disease drugs: they often remained too expensive to find a market in the developing world, even when sold at cost.

The second challenge is funding. As the report points out, the term PPP is in reality a misnomer, since the partnerships sometimes work without a private partner, and very often have minimal public backing.

Philanthropy has to date been a far more important source of finance than governments, with the Bill & Melinda Gates Foundation alone providing almost 60 per cent of all financial support to the organisations studied.

Four charities have paid or pledged Dollars 211m, while total government support is Dollars 44m. That has left the PPPs under-funded, with some clinical trials under way without sufficient money to guarantee completion.

As Mr Hentschel puts it: "For the first time in many decades, there are completely new malaria drugs in the pipeline. We are just hoping that the enthusiasm will not fade. We are not yet 100 per cent certain."

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