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Proteome Sciences Gears Up to Commercialize Stroke Biomarkers as Stock Slowly Edges Up

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Proteome Sciences laid out plans this week to hit the high-throughput diagnostics market hard with its panels of stroke biomarkers, as it continues to recover from an April stock tumble.

The Surrey, UK-based company, which employs 40 scientists in the UK and Germany, is listed on the Alternative Investment Market of the London Stock Exchange. The company’s stock took a sharp nosedive in April in the midst of a shaky biotech market — a dive that did not have any clear connection to company activities, according to Proteome Sciences’ CEO Christopher Pearce, and several British news reports.

Now Pearce is banking on the most high-profile segment of the company’s portfolio — biomarkers — to help it gain altitude. The company has been issued patents for diagnostic and therapeutic applications of biomarkers for lung cancer, esophageal cancer, breast cancer, colon cancer, neuroblastoma, and glioma; as well as Alzheimer’s disease and stroke, according to Pearce. It is the stroke biomarkers that are the furthest along the commercialization path. Using “a combination of technologies for discovery” — including 2D gels, SELDI, mass spec technologies, and other commercial front-end technologies, as well as some proprietary front-end chemistries — the company has identified eight biomarkers indicative of stroke, Pearce said. At the Fifth World Stroke Congress held last week in Vancouver, Canada, Proteome Sciences presented data from a validation study where it used a panel of five of the biomarkers to test for stroke in the serum of patients at various time points after they experienced an episode, ranging from one hour to 24 hours. The biomarkers were able to distinguish stroke from non-stroke, as well as stroke from heart attack, and ischemic stroke from hemorrhagic stroke, Pearce said. “The exact numbers differentiated depending on in which combinations [the biomarkers] were used … but we have some with 100 percent sensitivity and some with 100 percent specificity,” he said.

The company has an exclusive licensing deal with diagnostics company Biosite, in which Biosite will develop a point-of-care diagnostic using antibodies that Biosite has made against the biomarkers.

Now, Proteome Sciences is taking its markers to the much larger high-throughput diagnostics stage. Pearce said the company is currently in talks with a number of the “major diagnostics players in the world,” and he hopes the company will be able to capitalize on relationships with as many of these players as possible. “We have been approached by proposals on an exclusive basis, but at the moment we’re currently also very much exploring the non-exclusive basis as well,” he said. “So our deal is to try to conclude arrangements on a nonexclusive basis with a range of these players, so that we can get reasonably maximum penetration.”

Pearce said that diagnostics companies developing tests with its markers “don’t have to redesign the system to accommodate them.” Since Proteome Sciences already has in hand antibodies against the biomarkers, “the antibodies we have will just slot straight into any of the existing technology platforms there are at the moment,” including 96-well plate and array-based systems, he said.

Pearce said that the company is also in the process of trying to decide how best to commercialize its many cancer markers as well. “We are in discussions with a number of prospective licensees in the individual cancer types … [which] break down into two different applications: the people into diagnosis aren’t typically the people producing drugs and vaccines and vice versa,” he said. “So the process to commercialize those is underway, but, at the same time, we’ve been approached as to whether we want to put together” a specific cancer proteomics center. Such a vehicle, he said, would “be an integrated cancer proteomics [center] going right through from diagnosis through to possibly therapeutic applications.”

As part two of its commercialization strategy, Proteome Sciences is looking to commercialize a set of reagents that it developed at the Frankfurt R&D business formerly known as Xzillion Proteomics, which it bought from Aventis in 2002 (see PM 9-9-02). The family of reagents, called Sensitizer, can be used for quantitation, Pearce said.

The third element of the company’s strategy is to form partnerships with “major pharma and biotech companies on specific [R&D] projects and programs together” using ProteoShop, the proteomics workflow it has put together with its proprietary chemistries and a variety of commercially available but modified instruments, Pearce said.

With these three elements in motion, Pearce is confident that the company “has established very much a leadership position” that will carry it through into 2005. Proteome Sciences is not looking to become an instrument vendor or a diagnostics company, however. “We’re a pure research house — nothing more, nothing less,” Pearce said.

Meanwhile, the company’s stock has risen from a low of 85.5 pence per share in April, having begun a recovery in May following an announcement that the company’s biomarkers for stroke were encouraging. The stock closed at 128.5 pence on June 30.

Pearce told ProteoMonitor this week that “the company has been one of the top performing stocks in terms of share price performance over the last three to four years in Europe consistently,” and that while the stock did have troubles in April, its figures for 2003, which the company released this week, were encouraging despite increased losses. Proteome Sciences reported a loss of £6.8 million for the year 2003, compared with £4.1 million in 2002, with cash on hand as of Dec. 31, 2003 of £6.2 million. The company took in £170,000 in revenue in 2003.

“We’re very well-funded as a company, we have a very low and predictable cash burn … below the levels of expected cash burn,” Pearce said of the 2003 figures. “Looking to the future, [even] assuming no revenue coming through, the business is very well-funded.” Pearce is confident that significant revenues will come in soon. “We have a very active pipeline of products that will be coming through ... in 2004 leading into 2005. This will shift the equilibrium of our business to generating a sustainable and growing revenue and royalty stream,” he said.

— KAM

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