NICE guidelines highlight the importance of HepCgen's HCV genotyping service

- Successful positioning reflected in completion of 2^nd round funding -

Southampton UK, December 11, 2003 …… HepCgen, specialising in diagnostics and treatments for chronic liver disease, has received further endorsement of its centralised hepatitis C (HCV) genotyping service through a NICE announcement released on 8 December, confirming that genetic information, in this case the genotype of the virus, is the most critical determinant of efficacy in the treatment of HCV. Treatment centres can have the immediate capability to comply with NICE’s appraisal, without purchasing their own equipment, by sending their samples to HepCgen.

NICE’s guideline report was released on the same day as Dr Allen Roses, Worldwide Vice President of Genetics at GlaxoSmithKline, sparked controversy with his disclosure that most drugs work in fewer than one in two patients.  This is mainly due to a patient's genes interfering with treatment and further highlights the importance of tailoring treatments to the genetic profile of the patient or the pathogen infecting them, as is the case with HCV.  HepCgen has developed proprietary molecular diagnostics to determine the genotype of HCV in the patient’s blood.  The Company can also confirm the presence of HCV and measure how much virus the patient has in their blood, a critical method for monitoring response to treatment. These high profile industry communications emphasise the importance of HepCgen’s role in the treatment of HCV and fits the Company’s working model of providing relevant genetic information to enhance the efficacy of current treatments and develop novel treatments based on the genomics of the virus.

NICE’s new guidelines endorse combination therapy with peginterferon alfa and ribavirin, and emphasise the need for HCV genotyping to tailor treatment to the individual.  The report proposes that patients with genotypes 1,4,5 or 6 be treated for 48 weeks and those with genotype 2 or 3 for 24 weeks, with any indeterminate HCV strains treated like genotype 1.  It is generally accepted that there are 300-400,000 HCV infected individuals in the UK, of which 49% have HCV genotype 2 or 3 who, if identified, would only require 24 weeks rather than the full 48 weeks treatment.  HepCgen estimates that if treatment was implemented according to the current NICE guidelines, the NHS would save over half a billion pounds in medication costs alone.

“Funding greatly limits treatment in this country and compared to the 15,000 patients treated in France, Germany and Italy respectively, the UK currently funds less than 2,100 patients per year”, stated HepCgen’s CEO, Paul Colford. He continued, “Given the extent of the disease, which is four-five times more prevalent than HIV, and the current funding crisis, we presently look upon our service as enabling the NHS to do far more with less.”  HepCgen contends that this is the essence of personalised medicine and has confirmed that its largest customers happen to be the companies that make these medicines. “Big pharma is embracing this technology in the UK because more patients can be treated appropriately if these tests are used.”

HepCgen founder, Dr William Rosenberg, commented, “As a physician, if you have to wait three weeks for a genotype or viral load result, not only is the result worthless but the patient potentially could be exposed to unnecessary side-effects from treatment, as well as the anxiety of waiting for the result. Furthermore, there is a significant cost to the NHS in prolonging a therapy that could have been justifiably discontinued.”

Paul Colford added, “Our facility has enormous capacity, rapid turnaround times and is significantly less expensive compared to current systems available for individual hospitals to purchase.  Our service allows testing centres to implement NICE guidelines immediately, with no capital cost and no disruption to current working practices.”

HepCgen’s timely positioning as a pivotal player in the treatment of HCV in the UK is reflected in the successful completion of £1.6m in second round financing.  The heavily oversubscribed financing activity, generated by both private and institutional investors, capitalises the Company at £4.8m and enables HepCgen to expand its team of experts and roll out its commercial and R&D programmes much faster than originally anticipated. 

The Company’s pipeline of hepatitis C therapeutics includes programmes targeting the stimulation of dendritic cells, which have been found to be dysfunctional in chronic HCV and could account for the altered immune response.  Dr Rosenberg and his team hope to be able to modify these defective cells in patients with HCV to restore effective immune function, in a similar method to that being used to treat some forms of cancer.

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For further information, please contact:

At HepCgen: Paul Colford, CEO, tel: 023 8079 8945, email: paul.colford@hepcgen.com

Dr William Rosenberg, University of Southampton, tel: 023 8079 6883, wmr@soton.ac.uk

Media enquiries:

Sue Charles, CEO Northbank Communications, tel: 020 7886 8152, email: s.charles@northbankcommunications.com

James Parkinson, Northbank Communications, tel: 01260 296 506, email: j.parkinson@northbankcommunications.com

Notes to editors:

1. HepCgen Ltd, founded by liver disease specialist Dr William Rosenberg, specialises in diagnostics and treatments for chronic liver disease, focusing on hepatitis C viral infections.  The company has developed proprietary tests that aim to help tailor treatments to individual patients and to identify those who are unlikely to respond to treatment early on. HepCgen’s tests provide medically actionable data i.e., the technology developed takes genomics-based, or nucleic acid based diagnostics to a practical level, where results can be measured in hours, not weeks. The Company raised £350,000 from IP2IPO, a majority owned subsidiary of Evolution Group plc, the investment bank and fund management group and has subsequently completed £1.6m in second round financing from institutional and private investors.  
2. Hepatitis C is a blood borne virus and anyone who has ever injected drugs or who received contaminated transfusions before donated blood was screened for the virus are at risk. Infected Mother to baby transmission is thought to occur in approximately 6% of cases, this increasing to 15-20% when there is HIV co-infection. Estimates vary from 200,000 to over 400,000 people may be infected.  Only 1 in 10 people are currently aware they are infected. In 2003, it is estimated over 5000 new cases of Hepatitis C will be diagnosed.  Currently over 40% of referrals to UK hepatologists involve Hepatitis C. Of those patients who know they are infected, hardly a fraction can receive the latest treatment due to lack of funding.
3. The UK government has promised to take action to tackle this condition but since the Department of Health published a consultation document in August 2002, the action promised at the end of last year has not surfaced.  
4. The Chief Medical Officer’s Infectious Diseases Strategy has recently highlighted Hepatitis C as a cause of major long-term sequelae including cirrohosis, and liver cancer, with considerable treament and costs.  Hepatitis C is the principle cause for liver transplantation in the UK.  
5. NICE released their final appraisal determination, “Interferon alpha (pegylated and non-pegylated) and ribavirin in the treatment of chronic hepatitis C” on 8 December 2003 and the full guidance is planned to be reviewed in November 2004.  
6. On 30 June 2003, a reception was held at the House of Commons to inaugurate the first Annual National Hepatitis C Awareness Day. Hosted by Neil Gerrard, MP and Chair of the All Party Parliamentary Group on AIDS, the meeting was attended by over 100 delegates from across London and both Houses. A Best Practice Guide for London on Hepatitis C was officially launched. Ken Livingstone, Mayor of London, provided a statement saying, “I’m delighted to send a message of support to the launch of the Hepatitis C Best Practice Guide for London.  Hepatitis C is a significant public health issue for the capital.”  
7. The expected increase in diagnosis of this condition in the UK could well outstrip resources to treat hepatitis C.  HepCgen has built a high capacity testing service with a state-of-the-art laboratory utilising the latest real-time nucleic acid testing technology.