Glaxo Makes Like Ponce de Leon With Sirtris Buy
You can't fault GlaxoSmithKline for temerity. The U.K. drugmaker's unexpectedly large $720 million bid for Sirtris Pharmaceuticals represents a gutsy bet that the Massachusetts biotech really has a handle on a class of drugs that slow aging. Not that anyone at either company is eager to describe their work that way, of course.
Late in 2006, Sirtris got a big boost when a team led by its scientific co-founder David Sinclair reported in Nature that resveratrol, a compound most commonly found in red wine, extended the life of mice on a high-calorie diet, much the way it had in yeast, worms and flies. A year later, the company announced that it had developed a new series of compounds that activate the same gene as resveratrol, only with roughly 1,000 times resveratrol's original potency.
That's pretty heady stuff for your average biotech. In fact, Sirtris has tended to shy away from public discussion of the potential anti-aging properties of its drugs, and instead describes them as ways to combat "diseases of aging" such as diabetes. For instance, it's been testing its original resveratrol analogue as a treatment for type 2 diabetes in an early-stage, "phase I" trial in human volunteers.
Although Glaxo plunked down a big wad of cash for Sirtris -- $720 million is not only a huge amount for a biotech whose first drug hasn't even reached what the industry likes to call "proof of principle," it represents an 84 percent premium over Sirtris' closing value on Tuesday -- the pharma is similarly reticent about the anti-aging potential of resveratrol and its derivatives, technically known as sirtuins. Here's how Glaxo put it in its press release:
Through the acquisition of Sirtris, GSK will significantly enhance its metabolic, neurology, immunology and inflammation research efforts by establishing a presence in the field of sirtuins, a recently discovered class of enzymes that are believed to be involved in the ageing process. Sirtris Pharmaceuticals has established a drug discovery capability to exploit sirtuin modulation for the treatment of human disease, an approach that has the potential to generate multiple clinically and commercially important products. Their focus to date has been on the development of SIRT1 activators for the treatment of Type 2 Diabetes Mellitus (T2DM).There are two reasons for this, one good and one, well, sly at best. The good reason derives from the fact that the Food and Drug Administration has made it clear over time that it has no interest in approving drugs that don't treat actual diseases. Any drug designed to improve "normal" functioning -- presumably including reducing the potential effects of aging -- simply doesn't fit the agency's paradigm unless it's dressed up as a disease treatment. And so that's exactly what Sirtris, and now Glaxo, intend to do.
The second reason, of course, follows directly from the first. Given the amount of press attention resveratrol has gotten over the past couple of years -- everyone seem to have heard that red wine could help you live longer, right? -- getting approval to sell a resveratrol-based drug would very likely create immediate, and potentially huge, off-label demand for it.
Managing that sort of situation can be dicey for a drugmaker, as off-label promotion is a pretty serious no-no in the eyes of the FDA. But so long as Glaxo let resveratrol's enthusiasts do its talking for it, the returns could be tremendous -- certainly enough to make $720 million look like pocket change. Assuming, that is, the drugs actually work, which is never, ever a given in this business.