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Friday, July 3, 2009

Discovery Labs won't pursue Surfaxin if FDA requires new study

When bad news strikes Discovery Laboratories Inc., the company always seems to lose half of its market value.

Shares of the Warrington biotechnology company sank 53 percent on April 25, 2006, when it announced a significant delay in winning approval for its first product, called Surfaxin.

On May 2, 2008, shares fell 50 percent after the Food and Drug Administration issued an “approvable letter” for Surfaxin. While the name of that document sounds positive, it actually means a company has more work to do before its drug can be sold commercially.

Plus, that was Discovery Laboratories’ third approvable letter for Surfaxin, which is a respiratory treatment for premature infants.

Shares declined nearly 50 percent on April 20 after the company said the FDA had once again requested more information, and a June 2 meeting was set to hash out their differences.

Yesterday, it happened again after the firm discussed the outcome of that meeting. Given that Discovery shares fell 52 percent to 51 cents, you already know that the company failed to persuade the FDA staff to see things its way.

The bottom line: Surfaxin most likely will not be approved without a new limited clinical trial.

While Discovery Labs said it might appeal the decision through the FDA’s formal dispute-resolution process, the company does not want to spend millions on new tests.

Management told analysts in a conference call it would rather focus on two other products at earlier stages of development.

In a statement, Discovery chief executive officer Robert J. Capetola described plans to begin late-stage clinical tests on Surfaxin LS and Aerosurf in 2010.

But as of March 31, the company had only $19.1 million in cash. In a Securities and Exchange Commission filing, Discovery did say it had “committed equity financing facilities” that could enable it to raise up to $77.3 million.

Kimberly Lee, an analyst with Wedbush Morgan Securities Inc., downgraded her recommendation to “sell” on Discovery shares. Lee said she saw too many issues for it to overcome: financing, regulatory, and development risks. She projects the company will run out of cash during the third quarter, unless it finds a way to access funds through those CEFFs.
Posted by Mike Armstrong @ 9:10 AM  Permalink | File Under: Pharma, Biotech | Post a comment
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About Mike Armstrong
Mike Armstrong, a business editor and writer for nearly two decades, is the Inquirer's business columnist and PhillyInc blog editor. Contact Mike via e-mail or at 215-854-2980
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