NeurogesX slashes staff, shifts R&D direction after FDA slaps down app

Posted under Blog, Companies, Diagnostics, Funding, HIV, Medical Devices, Medical Supply, NeurogesX, NGX-1998, Pharmaceuticals, Qutenza, Startups, Universities, Videos by John Carroll

As expected, the FDA has rejected NeurogesX's application to expand the use of Qutenza, which clearly came as no surprise to management. After getting raked over the coals by regulators and then unanimously voted down by an expert panel, which failed to see anything like the efficacy data it needed for an endorsement, NeurogesX ($NGSX) management was ready with a restructuring plan this morning. The San Mateo, CA-based biotech says it is axing more than half its staff, switching focus to another program and scrounging for cash.

A total of 43 staffers are getting pink slipped, leaving 32 workers to set up a late-stage study of NGX-1998. Sales and marketing personnel appear to be taking the brunt of the cuts as NeurogesX looks for alternative marketing strategies. And management added that it plans to hunt for a partnership or raise capital to fund a planned Phase III for NGX-1998.

The biotech company says the Complete Response Letter from the FDA includes a demand for at least one "adequate" study of Qutenza to back its pitch to approve it for HIV-related pain. And while the company vowed to sit down with regulators to better understand their position, the developer says it will not invest any more cash on researching Qutenza.

"Our priority is to preserve our resources to enable us to move NGX-1998 rapidly into Phase III development," says CEO Ronald Martell. "Accordingly, we intend to reduce our marketing and sales activities significantly. Our corporate focus remains firmly fixed on the value that we believe NGX-1998 can bring to our shareholders. We regret that this decision will affect those individuals who have worked diligently to commercialize Qutenza and we thank them for their service to the company. NeurogesX remains committed to ensuring the availability of Qutenza for PHN patients in the United States, and we are seeking alternatives strategies, including potential partnerships, to increase awareness of Qutenza as an effective therapy for PHN patients."

- here's the press release

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NeurogesX slammed again as FDA panel spurns pain patch
NeurogesX hammered as regulators question HIV-pain app

NeurogesX slammed again as FDA panel spurns pain patch

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, NeurogesX, Pharmaceuticals, Qutenza, Startups, Universities, Videos by John Carroll

NeurogesX ($NGSX) finds itself on the ropes this morning, with its badly battered shares taking yet another beating after an FDA panel unanimously shot down an attempt to get an approval to use its pain patch for HIV-related neuropathy.

Earlier in the week, regulators issued an internal assessment that NeurogesX never laid out a clear set of data supporting the efficacy of the patch, and that's exactly the Achilles heel that the panel zeroed in on. The experts also decided that the risk/benefit profile was acceptable to HIV patients. Though no surprise, the panel vote triggered another selloff of shares, with the stock plunging 31% to a rock-bottom 55 cents a share.

The final decision has yet to be made, but the chances of an FDA approval at this stage are negligible. Nevertheless, the company is confident in the product.

"We will continue to work closely with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our sNDA," said NeurogesX CEO Ronald Martell. "We remain confident that Qutenza(R) has the potential to address significant, unmet medical needs and to improve the quality of life for patients with HIV-PN. We would like to thank the FDA and the Advisory Committee members for their careful and thoughtful deliberation on this matter."

- here's the press release
- get the report from Bloomberg

Related Article:
NeurogesX hammered as regulators question HIV-pain app

NeurogesX hammered as regulators question HIV-pain app

Posted under Blog, Companies, Diagnostics, Funding, HIV/AIDS, Medical Devices, Medical Supply, NeurogesX, Pharmaceuticals, Qutenza, Startups, Universities, Videos by John Carroll

Shares of NeurogesX, already badly beaten up over the past year, tanked after regulators raised questions about the efficacy of its pain patch for HIV-related pain. Its stock ($NGSX) dropped to as low as 75 cents a share and then recovered somewhat by midmorning as analysts sifted through the agency's remarks, which are intended to help shape an expert panel review coming up Thursday.

Wedbush analyst Gregory Wade tells Bloomberg that he was none too surprised to see the critical remarks. And even though he doesn't believe that the in-house regulatory review of the application will prevent a vote in its favor, any approval still wouldn't do much to improve the company's prospects.

About 1 in 3 HIV patients suffers from HIV-related neuropathy, notes NeurogesX. But one of the regulators doesn't believe that they'd be well served by Qutenza.

"It would not be in the best interest of these patients for us to approve a product for which substantial evidence of efficacy has not been demonstrated, or one for which the benefits do not clearly outweigh the risks," said Bob Rappaport, director of the agency's division of anesthesia, analgesia and addiction products, according to the Bloomberg report.

- here's the article from Bloomberg

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