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Genaissance, Sensing Strong PGx Appetite In Japan, Pens Theranostic Deal With Sankyo

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Genaissance said this week that it intends to create a companion diagnostic test to guide therapy in a collaboration with Japanese pharmaceutical company Sankyo.

"It fits very nicely into the company that Genaissance is going to be acquired by â€" Clinical Data," Jerry Vovis, executive vice president and chief technology officer of Genaissance told Pharmacogenomics Reporter. "One of the reasons that they saw value in Genaissance is that they were looking for the next generation of diagnostic tests."

The acquisition, first announced in late June, is scheduled to close this week.

Under the terms of the drug-diagnostic agreement, Sankyo will pay Genaissance an undisclosed amount for genotyping clinical samples with its HAP technology, and analyzing the genetic and clinical data for genetic markers of drug response related to a single compound under development at the Japanese pharma. Genaissance also has "certain rights" for the co-development and co-commercialization of a companion genetic test, the companies said in a statement. The deal sees Genaissance capitalizing upon what Vovis sees as a willingness among Japanese pharmaceutical companies to implement pharmacogenomics at a point in their pipelines that should result in diagnostics and drug-diagnostic combination product sooner.

Should the companies' research prove fruitful, the usual course of action is for the companies to submit a combination product to the Japanese drug regulator â€" which has been the Pharmaceutical and Medical Devices Agency since 2004 â€" and later to the US Food and Drug Administration for clearance, said Vovis. But neither company will say much about what sort of diagnostic might emerge, nor even what area of medicine the combination product will address.


"We've been working on trying to partner with Japanese pharmaceutical companies in this area for a long time, and what you're now seeing is the Japanese pharmaceutical industry [recognizing] that pharmacogenomics has value in terms of their drug-development programs."

Some clues may lie in the firms' areas of concentration, however â€" both have strong cardiovascular experience, for example, and both have already offered glimpses into their plans for the future.

The deal is similar to an agreement that Genaissance signed with Japan-based Otsuka Pharmaceutical late last month, although that statement mentioned diagnostic products related to drug response, rather than companion products. According to a representative of Otsuka's US subsidiary, the company's strengths are largely concentrated in gastrointestinal, cardiovascular, and neurological medicine.

Asked whether the two deals had anything in common, Vovis said, "The only connection is that we've been working on trying to partner with Japanese pharmaceutical companies in this area for a long time, and what you're now seeing is the Japanese pharmaceutical industry [recognizing] that pharmacogenomics has value in terms of their drug-development programs."

Large pharmaceutical companies in the United States don't appear to be pursuing pharmacogenomics as aggressively as Japanese companies and their smaller US counterparts, Vovis said. Big pharmas in the United States are applying pharmacogenomics far upstream in the drug-development pipeline, before clinical trials, "whereas midsize pharmaceutical companies, and the Japanese [companies] seem to see value in applying it on products that are entering or going into clinical trials," he said. "So in many ways, you can look upon that as being ahead of the game, because they're putting it further downstream, and they're likely to see applications coming out earlier."

Like Genaissance, Sankyo is in the middle of a merger, albeit a bit further along. On Sept. 28, Sankyo and Daiichi Pharmaceutical established the joint holding company Daiichi-Sankyo. By next month, the two arms of the holding company plan to begin merging their development pipelines, and by April 2007, the process should be complete for all business units.

Genaissance's deal is with the Japanese Sankyo, rather than its US-based subsidiary, and it centers around Sankyo's portion of what will soon be the Daiichi-Sankyo pipeline. That being the case, it becomes a little easier to deduce where a new drug-diagnostic combination product may enter the market.

Sankyo divides its research into three domains, "franchise research," "challenge research," and "principal research." The franchise area is the company's traditional realm of expertise, and is largely composed of cardiovascular drugs, such as the antihyperlipidemic statin drug, Mevalotonin, and antihypertensives Olmetec and Calblock.

The Meat and Potatoes of the Future

In company literature, Sankyo emphasizes its "principal" research domain â€" those health areas likely to grow given current trends: metabolic disorders, such as diabetes; bone and articular disorders, such as osteoporosis; and immune system and allergic disorders, such as hay fever and asthma. In the principal area, the company currently markets a diabetes drug called Fastic, and a nonsteroidal anti-inflammatory analgesic called Loxonin, and in the pipeline are at least 13 more drugs in these categories.

Genaissance has conducted a large amount of research into genes involved in drug response, and should its collaboration with Sankyo involve the Japanese pharma's principal area, a diagnostic product coming out of the deal will almost certainly draw from this work.

Genaissance advertises that its HAP technology has already been used to identify more than 8,000 genes in its HAP database that code for drug targets, play a role in drug metabolism, or otherwise affect drug response, such as receptors, transporters, G-Protein coupled receptors, and tumor suppressors.

There is reason to think the compound supported by Genaissance's research may be amenable to the companion-diagnostic approach, said Vovis. "In terms of economic information that's available [concerning] the disease area and presumed mode of action, it would appear that [a diagnostic] would have a chance of being beneficial to the product."

Is This the Heart of the Matter?

Although it may not be the area that Sankyo is focusing on for the future, the most conspicuous overlap between the two companies is clearly in cardiovascular research, Sankyo's "franchise" area. Genaissance has increasingly applied itself in the cardiovascular arena, with its Familion genetic test, its pending acquisition by cardio specialist and clinical-chemistry company Clinical Data, and a few of its other offerings.

The Familion test, one of two genetic tests the company offers, is intended to spot patients at risk of experiencing long-QT syndrome, a potentially fatal abnormal heart rhythm sometimes triggered by the administration of certain drugs. Although it is certainly important to identify patients at risk of the condition, Genaissance can just as easily add new genetic markers to the existing Familion test, which already has implications for many drugs. Here are three lists of drugs for which long-QT can be a problem. Most of the cardiovascular drugs on these lists belong to the anti-arrhythmic type, rather than the antihypertensive category for which Sankyo has several drugs in the pipeline and on the market.

Clinical Data sells small- and mid-size lab equipment for blood-chemistry analysis, coagulation, and hematology, but it sells no molecular diagnostics. "We sell into the physicians' office laboratory market and the clinic and hospital markets around the world," Mark Shooman, Clinical Data senior vice president and CFO, told Pharmacogenomics Reporter in June.

Neither Shooman nor a company attorney were available for comment before deadline, a Clinical Data spokesperson said this week. Asked whether Clinical Data and Genaissance had begun to work on any projects together, Vovis wrote in an e-mail message that until the firms' Oct. 6 merger, "each company remains as a separate entity."

Other cardio offerings from Genaissance can be found in its services and intellectual property. The company performs in-house testing in its CLIA lab for Factor V Leiden, which is linked to thrombophilia, and it offers tests for polymorphisms in six CYP450 genes, some of which affect cardiovascular-drug metabolism, such as CYP450 2C9, which is largely responsible for warfarin breakdown.

â€" Chris Womack ([email protected])

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