Specialty pharmaceutical company NeurogesX Inc. raised $20 million through a private equity financing to wrap up pivotal trials of its pain product, Transacin, in HIV-associated neuropathy and postherpetic neuralgia.

This financing is an extension of the company's Series C round, which brought in $35 million in February 2004. Funds are expected to "take us through all of 2006 and into early 2007, and allow us to finish the clinical development of Transacin," said Anthony DiTonno, president and CEO of the San Carlos, Calif.-based company.

"It will take us right up to the doorstep of filing a [new drug application]," he added.

Before filing for approval in the U.S., however, NeurogesX anticipates submitting a marketing authorization application in Europe, likely in the third quarter of 2006. That application would be based on results from a Phase IIa/III trial of Transacin, which met its primary endpoint, showing a statistically significant pain reduction in patients with HIV-associated neuropathy (HIV-AN) over a 12-week period, as well as data from a Phase III study in postherpetic neuralgia (PHN) initiated in June. (See BioWorld Today, June 16, 2005.)

"We expect to see top-line data from [the PHN] trial in the June-July period," DiTonno said, adding that the study is about 50 percent enrolled.

The European label likely would be very broad, he told BioWorld Today, "whereas in the U.S., the FDA is very indication-centric," meaning NeurogesX must file NDAs for Transacin in both indications.

That filing is expected to follow the completion of a second Phase III trial in PHN and a confirmatory Phase III study in HIV-AN, both expected to begin in early 2006. The FDA previously granted the drug both orphan and fast-track status for the treatment of HIV-AN.

Transacin, formerly NGX-4010, is described as a high-concentration trans-capsaicin dermal patch. It is designed to act on where the pain originates, and unlike existing opioid drugs, it has been shown to work without the systemic side effects, such as drowsiness or constipation.

The product also is being evaluated in a third pain indication: diabetic neuropathy. A Phase II trial showed "efficacy very similar to what we saw in HIV-associated neuropathy and postherpetic neuralgia," DiTonno said. "And we expect to fire up some pivotal trials in diabetes in the middle of 2006."

At this time, NeurogesX has not partnered Transacin, though the company anticipates finding a partner for ex-U.S. sales. Inside the U.S., it intends to establish its own specialty sales force of 75 to 100 people to cover the HIV-AN and PHN markets. DiTonno said the company might look for a co-promotion partner if the drug is later approved for the diabetes market.

Early in its development pipeline, the company has a second-generation product aimed at delivering even higher concentrations of capsaicin than Transacin. That product is designed to work more rapidly and more efficiently without the use of a patch, DiTonno said, adding that an investigational new drug for that product is expected to be filed around the middle of next year.

Investors participating in the financing round include MC Life Science Ventures, a subsidiary of Tokyo-based Mitsubishi Corp. and Mitsubishi International Corp.; MunMun International Ltd.; Saudi Venture Development Co.; ARCH Venture Partners, of Chicago; Alta Partners, of San Francisco; Montreux Equity Partners, of Menlo Park, Calif.; Global LifeScience Ventures, of Munchen, Germany; and Walden International Venture Partners, of San Francisco.

To date, the company has raised about $85 million.

In other financing news:

• Biopure Corp., of Cambridge, Mass., filed for a proposed public offering of 8.8 million shares of common stock and warrants to raise funds for general corporate and working capital purposes. The company also plans to grant underwriters an option to purchase an additional 1.32 million shares and 1.32 million warrants to cover overallotments. Biopure, which focuses on oxygen therapeutics, markets two products: Hemopure (hemoglobin glutamer - 250, bovine) for human use, and Oxyglobin (hemoglobin glutamer - 200, bovine) for veterinary use. Dawson James Securities Inc. and Noble International Investments Inc. are the managing underwriters of the offering.

• Neuren Pharmaceuticals Ltd., of North Sydney, Australia, privately raised A$6.36 million (US$4.7 million) to accelerate its clinical program for its neuroprotective drug Glypromate, and advance other products in its pipeline. The company placed 12 million fully paid ordinary shares at A53 cents per share, and reported that the placement was significantly oversubscribed. Funds will be used to support development of Glypromate, which is in a Phase IIa safety study as a protection from neurocognitive disturbance following coronary artery bypass grafting surgery, and is expected to begin Phase III testing next year. Proceeds also will go toward work on NNZ-2566, which is in Phase I development to treat a range of acute neurological conditions. The placement was co-managed by Taylor Collison Ltd. and Patersons Securities Ltd.

• Point Therapeutics Inc., of Boston, said underwriters of its previously announced public offering exercised their option to purchase an additional 1.21 million shares of common stock to cover overallotments. Aggregate net proceeds from the offering totaled about $25.8 million. The company recently started a Phase III program to evaluate its lead product, talabostat, in metastatic non-small-cell lung cancer. (See BioWorld Today, Nov. 23, 2005.)