Are Flamel Technologies (Nasdaq: FLML ) investors finally seeing the long-awaited other shoe drop? Or is this news just part of a barrage of falling footwear? Three generic drug companies have announced they have received approvals for their versions of the beta-blocker Coreg, made by Flamel's partner GlaxoSmithKline (NYSE: GSK ) , which brought in $1.65 billion in sales for the pharmaceutical company over the past year.
Caraco Pharmaceutical Laboratories (AMEX: CPD ) , Mylan Laboratories (NYSE: MYL ) , and Teva Pharmaceutical (Nasdaq: TEVA ) all announced in succession that they had received FDA approval for carevdilol, the generic version of Coreg. The drug treats left ventricular dysfunction after heart attacks and hypertension.
It's not like the news was unexpected, though; in fact, this prospect has been part of the weakness Flamel's stock has experienced since it reached the mid-$30s at the beginning of the year (when Glaxo launched its once-a-day version of the drug). Those were heady times for the tiny Motley Fool Hidden Gems recommendation, which makes the technology that makes once-a-day dosing feasible. Coreg CR is the only drug in production utilizing Flamel's micropump technology. A successful showing might encourage other drug companies to apply the technology to their formulations.
Yet unfortunately for Flamel, Glaxo came under fire for its Avandia medication, leading it to divert salespeople who should have been out promoting Coreg CR to quell unrest with the other medication. When those fires were doused, Glaxo said it was redirecting its focus back to Coreg, but the window of opportunity to make a splash was quickly closing -- the patent on Coreg expires this month.
Some investors believe that window slammed shut a few weeks ago, when a study was published in the Journal of Cardiac Failure showing that once-a-day dosing had little impact on patients' compliance when taking their medications. The point is that patients took their meds when they were supposed to, regardless of how often they had to. Coupled with the impending generics release, Flamel's stock plummeted 25% on the news and is down nearly 75% from its highs.
There are still a few opportunities here for Coreg CR -- and Flamel investors. For one, it's still unknown how much of an impact the generics will have on CR's sales. The generics are still in the twice-a-day version (Coreg CR remains patent-protected), but how doctors prescribe the medication and how insurance companies pay for it will play a large role in whether Coreg CR is successful.
The second hope, as Foolish biotech commentator Brian Lawler has noted, is the COSMOS hypertension study, which seeks to prove Coreg CR is more effective than AstraZeneca's (NYSE: AZN ) Zestril. That would be an important finding, since industry research analysts at Datamonitor expect the antihypertensives market to reach $40 billion by 2016. The COSMOS study is still ongoing, and results from it may not be published for some time.
To remain a viable investment, though, Flamel will need to ink the handful of deals it has hinted at having in the works. Yet that's part of the attraction of its technology and its stock. Its micropump and complementary Medusa technology can assist pharmaceutical companies in extending patent protection on expiring blockbuster drugs, prolonging their shelf life from attack by generics -- assuming they don't get the boot from other issues and crises along the way.
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