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British Startup Enlists Roche, Schering Into HCV PGx Program; US May Be Next Market

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A tiny British startup has launched a novel nationwide genotyping service designed to pinpoint a patients’ hepatitis C subtype, and help physicians treating these patients determine which regimens to pursue.

If adopted, the program, developed by the company HepCgen, may reduce the cost of treating patients with the disease in the UK — which is five times more prevalent than HIV in the country — and relieve some pressure from the country’s cash-strapped National Health Service.

Though not entirely new, the concept has two novel aspects that will likely be a boon for the company and its nascent pharmacogenomics platform. First, HepCgen has enlisted as makeshift payors a couple of the world’s largest makers of HCV drugs. Second, the company’s RT-PCR technology delivers results to physicians in a fraction of the time required by other diagnostic-service providers.

And HepCgen founder William Rosenberg, a renowned hepatologist from Britain’s University of Southampton, estimates the firm’s HCV test can save the NHS £500 million ($812 million) a year. As a result, he is positioning the program to plant similar stakes in neighboring European markets and the United States.

“Hepatitis C is an enormously important disease to treat effectively,” HepCgen CEO Paul Colford told SNPtech Reporter this week. “It is important that, once identified, diagnosis and treatment commence without delay.” The genotyping program “speaks to the interest that the companies have in ensuring the proper patient is getting the proper drug,” he said. “This model helps everybody.”

Today, HCV is a bunker buster on health-care costs in most countries. In the UK, between 200,000 and 400,000 people are believed to be infected with the virus. However, only around 20,000 to 30,000 are in secondary care, 2,000 of whom are undergoing treatment.

In the United States, the virus has infected 4 million people, as many as 10,000 of whom die each year from the disease and its myriad complications. A report by the Tufts University School of Medicine, recently published in the American Journal of Public Health, predicts that the country will spend $11 billion between 2010 and 2019 in direct HCV-related health-care costs.

There are six known HCV genotypes, though two of them — 1a and 1b — are believed to be the most prevalent, according to the US Centers for Disease Control and Prevention. Patients with these strains, which account for between 65 percent and 75 percent of the total HCV population, are considered the lowest responders to traditional HCV drugs, interferon and ribavirin. Consequently, efficacy rates fluctuate between 12 percent and 56 percent across all genotypes, the CDC said.

Though existing HCV patients represent a strong market for HepCgen, the company hopes physicians in the UK will also use its service to help them determine what drug — and how much of it — to prescribe to newly diagnosed patients. This market, according to Colford, is ballooning at a rate of more than 5,000 new patients each year.

From its base on the University of Southampton campus, HepCgen genotypes sera collected from HCV patients at some 20 hospitals and other health-care facilities around the UK. The company, a four-month-old university spinoff, is able to determine HCV genotype as well as a patient’s viral load.

The young firm had a bit of a head start. “A lot of the genotyping work [HepCgen currently performs] was already being done at the university,” said Colford. “They had already set up these impromptu arrangements with other centers that knew that they could do very specific genotyping. It was based on word-of-mouth interest, and we soon found out that [the business strategy] would make a very interesting roll-out.”

HepCgen currently uses its own primers and probes on a Roche TaqMan platform [Applied Biosystems owns the TaqMan trademark in the research marketplace and owns a license from Roche to perform TaqMan chemistry]. In fact, HepCgen “will shortly be Roche’s sole [and] first TaqMan-48 site in the UK,” Colford wrote in an e-mail message. He added that HepCgen will soon begin comparing the TaqMan platform with Roche’s Amplicor technology for the Swiss company’s TaqMan HCV viral load assay. Colford called the Roche assay “a beautiful product.”

HepCgen has applied its own technology for CE Mark approval, which Colford said should be finalized in December. He also believes the technology can pass muster with the US Food and Drug Administration’s pre-market approval process. He added, however, that the firm would enter the US market only if it had a commercial partner.

These days, HepCgen, which employs five full-time people, is looking to conserve cash; beside revenue from the genotyping service, the company raised £350 million from IP2IPO, a subsidiary of British investment bank Evolution Group. Genotyping revenue comes from arrangements HepCgen penned with at least two big pharma companies that have an HCV product on the market — Roche and Schering-Plough. These firms, eager to ensure that patients are prescribed the proper drug — or at least are prescribed their HCV drug — reimburse HepCgen for the cost of “a lot” of the procedures, said Colford.

The firm charges British health-care providers £65 for each genotyping test and £90 to determine viral load. Colford said the tests are sold together for £135. He said HepCgen “strives” for 48-hour service: It typically processes a patient sample the morning after it receives, and has “full results” that afternoon.

“We would like to expand our services throughout Europe, as countries like Italy, Germany, and France are treating over five times the number of patients the UK chooses to, and will tremendously benefit by either using HepCgen services or licensing this technology,” Colford said.” However, he said that turnaround time for European customers will likely be longer because of the relative difficulty getting samples shipped to the UK. Consequently, Colford said, HepCgen is “considering opening a facility in key European markets.” He said he’d like to offer the service in the United States, too.

Colford stressed that HepCgen is not a one-trick pony. Through its diagnostics experience and the probe it designed, the company intends to use the data to create a DNA vaccine. “That work has undergone significant peer review in England, and it looks extremely promising,” he said.

— KL

 

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