Pain, which is an unpleasant feeling, is also complex when it is related to nerve tissue damage. This condition is known as neuropathic pain and there remains an unmet need for effective therapeutics to address the problem. According to Centers for Disease Control and Prevention, or CDC, every day, more than 40 Americans die from prescription painkiller abuse.
Focused on developing and commercializing novel pain management therapies especially for neuropathic pain is NeurogesX Inc. (NGSX), a San Francisco Bay Area-based biopharmaceutical company.
For readers who are new to NeurogesX, here's a brief overview of its product pipeline and the upcoming events...
The company's lead product is Qutenza (capsaicin) 8% patch, a dermal delivery system , approved by the European Medicines Agency in May 2009 and by the FDA in November 2009, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain that develops in certain patients following a herpes zoster (shingles) outbreak. Shingles is caused by varicella-zoster virus - the same virus that causes chickenpox.
Qutenza patch works by delivering a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, providing up to 3 months of relief following a single one-hour application.
As part of expanding the label for Qutenza, the company is also evaluating the drug as a potential treatment for patients with painful HIV-associated peripheral neuropathy (HIV-PN). Qutenza has received orphan drug and fast track designations from the FDA for potential use in treating HIV-PN. There are no FDA-approved drugs to treat HIV-PN which represents a significant unmet medical need in the HIV community.
In the early September, NeurogesX submitted a supplemental new drug application to the FDA seeking approval for a 30-minute application of Qutenza for the treatment of neuropathic pain associated with HIV-PN. The company has also requested a Priority Review designation for the Qutenza sNDA. Whether or not the FDA accepts for review the Qutenza sNDA will be known before the end of this month (Nov. 2011).
NeurogesX has a deal in place with Astellas Pharma Europe Ltd. , the European subsidiary of Tokyo based Astellas Pharma Inc., to market Qutenza in the European Economic Area including the 27 countries of the European Union, Iceland, Norway, and Liechtenstein as well as Switzerland, certain countries in Eastern Europe, the Middle East and Africa.
Also under development is NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia, which is under phase II study. NGX-1998 is being developed to provide safety, efficacy and tolerability that is at least comparable to Qutenza (capsaicin) 8% patch with a shorter treatment time. Top line results from the phase II study are expected by mid November.
The company also has a number of prodrugs of acetaminophen in preclinical testing.
A quick look at the company's balance sheet...
Since inception in 1998, NeurogesX has incurred losses each year. As on September 30, 2011, the accumulated deficit totaled approximately $295.8 million. The company's revenue is comprised of Qutenza product revenue and collaboration revenue from the Astellas agreement.
In the third quarter ended September 30, 2011, net loss narrowed to $11.4 million or $0.43 per share from $12.8 million or $0.72 per share in the third quarter 2010. Qutenza product sales rose nearly four-fold to $0.8 million in the third quarter of 2011 while collaboration revenue increased 15 percent to $2.1 million.
With $45.2 million cash on hand, NeurogesX believes it is better positioned financially with a more sustainable operating structure. Given that the company is reducing its headcount by nearly 30 people, the operating expenses for 2012 are expected to decrease by over 25%, or nearly $15 million from previously planned levels.
NeurogesX went public in May 2007 offering its shares at a price of $11.00 each. Over the past 52 weeks , the stock has hit a low of $0.66 and a high of $7.50. NGSX closed Tuesday's trading at $1.10, unchanged from the previous day's close.
For comments and feedback: editorial@rttnews.com