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Genaissance Deal With Sciona Underscores Trend to Marry PGx With Consumer Products

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Genaissance Pharmaceuticals, a pioneer in using haplotype technologies to draw drug-discovery alliances with some of the biggest names in pharma, now has its sights on a new market: Walgreens. Or Rite-Aid. Or Boots, or any other store around the world that sells vitamins or nutritional supplements to consumers.

Genaissance is the latest in a handful of pharmacogenomics companies to have meandered into this enormous health-care backwater, lured by enormous markets — consumers spend around $30 billion on vitamins each year — and a world with almost no regulatory obstacles.

“The whole vitamin and nutrition business [is opting for the] mass-personalization approach, where they can link [their product] to some kind of predictive claim,” said Kevin Rakin, president and CEO of Genaissance. “That’s very intriguing to us.”

So intriguing, in fact, that the company agreed to partner with a vitamin newcomer — UK-based Sciona — and help it enter the nascent world of nutritional genomics.

Terms of the multi-year agreement call for Sciona (pronounced see-OH-na) to receive a license to Genaissance’s haplotype technology and software, specifically the hap markers that in theory will enable it to “customize” health and wellness products for its customers. These customers, in turn, would manufacture and distribute the vitamins and nutritional supplements to retail outlets worldwide.

For its part, Genaissance will get a 30-percent equity stake in Sciona as well as royalties when its products appear in Sciona offerings. In addition, since Sciona is an early-stage company, Genaissance will support it by allowing its researchers to use its backroom for genotyping and association studies.

One of Sciona’s immediate goals is to use the hap markers, such as those governing metabolizing enzymes, to help its customers determine dosing regimens or combination products.

Today, Sciona sells a first-generation product based on publicly available SNPs, “and they’ve done pretty nicely with [the offering],” Rakin told SNPtech Reporter. He said this product offers users “some basic diet and lifestyle advice, and now [Sciona] wants to get to the next stage.”

A typical Sciona collaboration would look like this: A vitamin distributor would ask it to develop a product to help lower an individual’s cholesterol by increasing the body’s metabolism of lipids. First, Sciona would perform gene-association studies to find markers linked to lipid metabolism. For this, its researchers would work with Genaissance to identify associations between Genaissance’s haplotypes and the effect certain nutritional components have on lipid metabolism. The next step would be to develop over-the-counter components that would influence this metabolism, and package the product as a nutritional supplement to consumers.

Sciona CEO Chris Martin said some products would require consumers to be tested for specific biomarkers. He said buccal swabs would be sent to a CLIA-certified lab at Genaissance’s New Haven, Conn., facility. Martin also said Sciona may be able to “optimize the active ingredients” of a vitamin or nutritional supplement so it can work “across all common” genotypes. In this case, consumers would not require DNA tests because the product will “work in the vast majority of the population.” An attractive quality of these arrangements is that these tests, because they are associated with OTC products, require only limited regulatory approval.

Martin said Sciona is currently researching six “sporadic” disease areas associated with old age. “Clearly, our customers are looking [for] nutritional interventions that can be made which will improve metabolism and prevent disease.” Genaissance will work with Sciona on each of these disease states over time, said Martin.

He said it would take several years for R&D to wind down — associations must be found, gene-expression studies need to be performed, and intervention trials need to be performed — but expects a multi-billion-dollar market waiting for him.

Critics have suggested that deals like this will dilute the significance of pharmacogenomics and engender cynicism. If these technologies are principally used for developing drugs for “serious” diseases, critics argue, why should companies divert their resources to OTC supplements sold to healthy people? Rakin dismissed this criticism, saying “there is a marketplace for each of those. There is a percentage of people who are sick … and need prescription products, and there is a percentage of people who are well, and would like to enhance their wellness. I see a very clear compartmentalization here.”

In fact, Rakin said Genaissance had considered getting into this space itself, but decided against it. “We were faced with a challenge, because we were intrigued by this market, but didn’t see how we could pursue it with our limited resources because of our core focus on prescription products,” he said. Instead, the company last year hired a consultant who looked at the market and brought Genaissance and Sciona together.

To be sure, the Sciona deal for Genaissance is the latest in a short string of similar deals of pharmacogenomics companies aligning themselves with the OTC set. In September, for instance, Interleukin Genetics and the University of California, San Francisco agreed to look for mutations linked with osteoporosis in order for Interleukin’s new owner, Amway, to try to turn the data into consumer gold [see 9/11/03 SNPtech Reporter].

In addition, in February, Perlegen Sciences penned a multi-year agreement with consumer-products giant Unilever to use whole-genome-association technologies to develop new lines of “personalized” products ranging from shampoos to snacks and sunscreens [see 2/28/03 SNPtech Reporter].

The alliance of consumer products and pharmacogenomics has also created a stir in mainstream media, which might hip consumers to pharmacogenomics. For example, a recent article in the Toronto Star said nutritional genomics “promises to reduce the risk of afflictions as varied as arthritis, menopausal hot flashes and heart disease” — a bit breathless, but the fact that these products are not hindered by costly or burdensome regulatory hurdles means they will likely appear more quickly on the market.

“We could be choosing our breakfast food based on our genes,” Peter Singer, director of the University of Toronto’s Joint Centre for Bioethics, was quoted in the article as saying. “If you have the low-fat gene you’ll opt for the bran with raisins, but with the [low-carbohydrate] gene your choice might be bacon and eggs.”

The article goes on to say that companies already offer “personalized nutritional advice” based on a dozen mutations. Sciona, for one, has amassed seven genes — CYP1A1, GSTM1, GSTP1, GSTT1, MTHFR, MnSOD, and ALDH2 — that its customers could use to help consumers adjust their eating and drinking habits.

“Such ‘boutique’ services now costing roughly $600 could explode as the science improves and the public takes notice,” according to the Toronto Star. This notice is significant because exuberant reports such as this have previously been reserved for stories on Herceptin and Xeloda.

—KL

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