Layoffs hit NeurogesX after FDA rejects pain patch for HIV patients

NeurogesX Inc. will cut 57 percent of its workforce after the Food and Drug Administration Wednesday rejected the use of the company's Qutenza pain patch for some HIV patients.
The San Mateo company (NASDAQ: NGSX) said the restructuring will lower its quarterly cash burn to $5.5 million to $6.5 million in 2012. The move comes as NeurogesX expects lower revenue from Qutenza and as it hopes to push another pain treatment, NGX-1998, through a Phase III trial by the end of the year.

Biotech's battle: Rebuild industry for next wave of drugs

Maybe it’s overdramatizing to say it feels like we’re passing through history, but as a number of Bay Area biopharma companies approach the cusp of drug approvals, it feels like we may not pass this way again.
It’s something to consider as the state’s biomedical industry players meet this week for the CalBio 2012 conference in San Francisco.
Maybe it’s my limited experience, but the sheer volume of drugs from Bay Area companies that are in front of the FDA in early 2012 seems unprecedented. After watching capital dry up for four years, just getting to this point seems a victory for some companies.
But for today's small life sciences companies to deliver big-time drugs in the coming years will take a new model for funding.

Slew of Bay Area drugs awaiting approval

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A bounty of new drugs from the labs of Bay Area companies could win Food and Drug Administration approval in the next few months.
At least 10 drugs — from an obesity treatment to cancer drugs — are candidates for FDA approval by the end of June. Industry observers said they didn’t know how that number compares with any previous six-month period.
One thing is sure: After the economic downturn pushed many investors away from the capital-intensive drug-development business, the cadre of potential new drugs represents a victory of sorts. Many drug developers — especially smaller ones — have carried their drugs within sight of the finish line by sheer will or grit.

FDA panel recommends agency reject NeurogesX HIV pain patch

An FDA advisory panel unanimously recommended Thursday that the agency reject an HIV pain patch from NeurogesX Inc. not be approved.
Qutenza, the patch from the San Mateo-based company (NASDAQ: NGSX), already is used for pain related to shingles, but NeurogesX is seeking Food and Drug Administration approval for its use in nerve damage associated with the AIDS virus.
The 12-member panel’s unanimous decision does not mean the FDA will reject the drug, but the agency typically follows the advise of its committees of experts.
The FDA is scheduled to make a final decision on the Qutenza on March 7.

FDA review of NeurogesX HIV pain patch hits stock hard

FDA reviewers raised questions about a pain patch that NeurogesX Inc. wants to sell for HIV-associated nerve damage, sending the San Mateo company’s stock down 24 percent lower by mid-Tuesday.
The Food and Drug Administration’s staff said in briefing documents Tuesday that a study of the pain patch, called Qutenza,, failed to show superiority for the 60-minute application of the patch compared to low-dose capsaicin in a control group.
A 30-minute application was superior, the reviewers said.

Scenes, thoughts from the J.P. Morgan Healthcare Conference

If the Occupy Wall Street folks wanted to shut down biotech’s biggest wheeling-and-dealing session, the 30th annual J.P. Morgan Healthcare Conference, couldn’t they just contact the San Francisco fire marshal?
The Occupy movement supposedly was the reason J.P. Morgan asked the Westin St. Francis for additional security for the conference this week. Badge-checkers were at their usual stations inside the hotel but also were moved outside of the hotel, creating more logjams than usual on the sidewalk along Union Street.
Folks staying at the hotel had to show their room keys, so the security crush significantly cut down “clock tower” meetings in the hotel’s lobby. Coupled with the unusually good January weather, Union Square became the preferred chat-up locale, to the point that the park was overrun by posses of (mostly) men in black suits.
All in all, the mood seemed less dreamy, more serious. Even last year, life sciences companies still in shock from the financial crisis seemed like zombies: “Must focus portfolio … arrrrrgh … Be virtual … ugh.” They walked the talk, but they didn’t really seem to mean it. This year, the companies indeed were focused, their milestones tangible.

NeurogesX picks former Poniard boss as president, CEO

Former Poniard Pharmaceuticals CEO Ron Martell replaced the retired Tony DiTonno as president and CEO of pain treatment developer NeurogesX Inc.
Martell’s base salary is $460,000, compared to a 2010 base salary of $440,214 at Poniard. He also will receive an annual target performance bonus at NeurogesX of 50 percent of the base and an option to buy 500,000 shares.

NeurogesX hires Stephen Peroutka as chief medical officer

NeurogesX Inc. hired Stephen Peroutka, M.D., as chief medical officer. He replaces Jeffrey Tobias, M.D., who quit Oct. 16 but who still works as a consultant for up to $7,200 per month.
Peroutka has already started part time work at the San Mateo company (NASDAQ: NGSX) as a consultant, but will come on board full time Nov. 9.

NeurogesX chief medical officer resigns, heads to Jazz Pharma

Dr. Jeffrey Tobias, chief medical officer of pain drug developer NeurogesX Inc. since 2005, will resign effective Oct. 16
It is the second high-level departure this year for San Mateo-based NeurogesX (NASDAQ: NGSX). President and CEO Anthony DiTonno said in April that he would retire by the end of the year.

NeurogesX seeks to expand pain patch use

NeurogesX Inc. wants to expand the market of its Qutenza pain patch to include people with HIV-associated nerve pain.
The San Mateo company (NASDAQ: NGSX) said Thursday that it filed a supplemental new drug application with the Food and Drug Administration. The application includes a request for priority review, which would cut the agency’s review time from 10 months to six months.

NeurogesX CEO Anthony DiTonno to retire

NeurogesX Inc. President and CEO Anthony DiTonno, who led the company through FDA approval of its Qutenza pain patch, will retire by the end of the year.
“I have been CEO of NeurogesX for more than eight years and we have accomplished the objectives I established for myself when I joined the company in March 2003” as chief operating officer, DiTonno said in a press release Friday by the San Mateo company (NASDAQ: NGSX).

NeurogesX loses $12M in Q4, $44M in 2010

Pain treatment company NeurogesX Inc. lost $12.4 million in the fourth quarter and lost $44.5 million in 2010.
The San Mateo company (NASDAQ: NGSX), led by CEO and President Anthony DiTonno, lost $5.1 million in the fourth quarter of 2009.