New Hep C drug means treatment for the masses

By Anna Lewcock

- Last updated on GMT

Related tags: Hepatitis b, Interferon, Hepatitis c

Philanthropic researchers in the UK have developed a brand new drug
for Hepatitis C that dodges restrictive patents held by pharma
heavyweights.

The standard treatment for Hep C is a combination of broad-spectrum antiviral ribavirin, and the protein interferon-alpha which has been chemically modified to extend the period of time it can survive in the body. It is this modification of the interferon that is covered by patents held by pharmaceutical big shots Hoffman-La Roche and Schering Plough.

The alteration involves attaching a large sugar polymer (polyethylene glycol, known as PEG) to the surface of the interferon (a process known as pegylation) in order to increase the size of the protein. This means the molecule beomes large enough to withstand rapid metabolism and excretion by the body.

However, researchers at Hammersmith Hospital and the London School of Pharmacy developed a new method of pegylation by which the PEG is anchored within​ the interferon molecule itself, thus avoiding infringement of the existing patents. The new technique has been patented by Imperial College London.

The new pegylation method exploits the chemistry of the disulphide bond of the interferon molecule, making the process more efficient and also therefore more cost-effective.

The traditional pegylation process has been a real moneymaker for pharmaceutical companies, with the standard course of treatment for a single Hepatitis C patient costing around £7000 (€10,377).

Altruistic researcher Prof Sunil Shaunak and collaborator Prof Steve Brocchini, however, have no intention of raking in the cash from their discovery. A full course of treatment with the new drug will cost one quarter of the current therapy, making it much more widely available to the 200m Hep C sufferers worldwide, only 20 per cent of whom can currently afford treatment.

"People in Academic Medicine have a choice,"​ says Prof Shaunak.

"They can use their ideas and creativity to make large sums of money for small numbers of people, or they can look outwards to the global community and make affordable treatments for common diseases."

PolyTherics Ltd, a spin-out company from Imperial College London and the London School of Pharmacy, agreed a technology transfer agreement with Indian pharmaceutical Shantha Biotechnics enabling the company to licence the pegylation technology and initiate an accelerated drug development project in May 2005.

Shantha has a reputation for manufacturing affordable healthcare products whilst remaining able to stay afloat financially. The company's Hepatitis B vaccine costs around $1.25 (€0.95) per course, in comparison to the multinationals' $125 price tag.

The new pegylation technology is already being used in the development of Shantha's Interferon Alpha 2b therapeutic protein.

The new Hepatitis C drug is due to enter fast-track clinical trials in India in 2008, funded by the Indian government.

The researchers hope that the new pegylation technology will be applied to a wide range of proteins in an attempt to develop new versions of drugs that are cheaper and address current medical needs.

"We have to continue to innovate or we'll be overrun,"​ says Prof Brocchini.

The team have already worked on a handful of other technologies to try and produce more cost effective drug treatments. One of their current projects involves working with amphotericin B in an attempt to develop a cheaper treatment for visceral leischmaniasis, which costs hundreds of pounds for the first treatment alone.

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