Don't Ignore This Potential Blockbuster

Investors may not be interested in hitting the foreign stock exchange or buying an over-the-counter ADR in order to invest in Roche (OTCQX: RHHBY), but that doesn't mean that they should ignore the news coming out of Switzerland either. The company's new diabetes drug, taspoglutide, could knock down sales of several of the drugmakers investors may own.

Yesterday Roche posted a media release that said, "Roche announced today that results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose (blood sugar) in these studies."

But close observers of the company already knew that.

Back in October, the company announced that taspoglutide beat Eli Lilly (NYSE: LLY  ) and Amylin Pharmaceuticals' (Nasdaq: AMLN  ) twice daily Byetta. And in December, Roche announced that the drug had fared better than Merck's (NYSE: MRK  ) Januvia in one trial and placebo in two others. Roche also said that taspoglutide was as good as sanofi-aventis' (NYSE: SNY  ) Lantus in a fifth trial.

Five trials, all accounted for. Why Roche is pushing the drug hard in the media, I'm not sure, but it should give competitors an idea of how in love Roche is with the drug and how much money it might be willing to plough into the marketing of taspoglutide.

There are still three more phase 3 trials to go. The competitive nature of the diabetes market is one of the reasons for the large number of trials -- the head-to-head trials should help sell drugs -- but we can also thank side effects of GlaxoSmithKline's (NYSE: GSK  ) Avandia. The FDA wants diabetes drugs thoroughly tested before they're approved.

Taspoglutide, which is injected once a week, is in the same class of injectable drugs as twice-daily Byetta, once-daily Victoza from Novo Nordisk (NYSE: NVO  ) , and the yet-to-be-approved once-weekly version of Byetta. Assuming it's approved, the latter will be taspoglutide's biggest competition given the same dosing schedule -- and who doesn't like fewer shots -- but we probably won't see a head-to-head trial until one of the drugs is already approved.

Reading between the lines though, it's tempting to say that once-weekly Byetta might be superior, since Lilly and Amylin showed that it was superior to Lantus, but taspoglutide was only "non-inferior" to Lantus. Be careful though, until Roche releases the full data set -- probably at the American Diabetes Association meeting in June -- we won't know to what extent it's lowering glucose levels in diabetics.

Long story short, keep your eye on this one even if you're not invested.

Novo Nordisk is a Motley Fool Global Gains selection. Investing internationally doesn't have to be scary and it can certainly be profitable. Click here to grab a 30-day trial subscription to the newsletter where you'll see all of our current picks for a global economy.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Motley Fool owns shares of GlaxoSmithKline and has a disclosure policy.


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  • Report this Comment On February 12, 2010, at 3:45 PM, Canalkid2 wrote:

    Sometimes you can learn more from what a company does not say, than from what they do. One must also wonder what the motivation was for Roche to make so much of their incomplete phase III clinical trials for this drug, given that much of the information was not new. Even under optimistic scenarios, Roche is probably 2-3 years away from FDA approval in the US. Close scrutiny will be given to new drugs that do not have established safety records. Note that Novo's Liraglutide was delayed nearly a year and ended up with labeling that carried stern warnings. Given the safety concerns expressed by their advisory panel review, they fared better than expected. I'm not quite ready to jump on the Roche bandwagon quite yet, and I doubt that most savvy investors will be either.

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