Two companies working on premature ejaculation products and other complementary programs decided to merge operations in an effort to reach the market in 2007.

New York-based Enhance Biotech Inc. signed a definitive agreement to join with Ardent Pharmaceuticals Inc., of Research Triangle Park, N.C., issuing an undisclosed amount of stock.

Focused on the discovery and development of delta receptor compounds, privately held Ardent has a pipeline of preclinical and clinical candidates in the areas of moderate to severe pain, urinary incontinence, premature ejaculation, depression and cardio protection. It has a library of about 1,000 delta receptor compounds that demonstrate specific opiate receptor activity.

It's a good match, said Chris Every, CEO of Enhance, a virtual company with four employees.

"Our view is it really brings together two portfolios that fit really well together with crossovers that strengthen us," he told BioWorld Today.

The new entity will make its headquarters in Research Triangle Park, where Ardent has 15 employees, all of whom will remain. It will be called Enhance Biotech, and will continue to have corporate offices in New York and London.

The shareholders of Enhance will retain 55 percent of the merged company's stock, while Ardent shareholders will acquire 45 percent of the company. Every will continue as CEO for the new company, while Ardent's chairman, president, founder and CEO, Ken Chang, will become chief science officer and president of Asia-Pacific operations. Enhance's current chief financial officer and vice president of business development, Phillip Wise, will assume the CFO position for the merged company. The parties also expect to form a new board of directors that includes members from the existing boards plus some new independent members.

Every said the merger brings together two companies with a large market potential and deep pipelines. Ardent, he said, is recognized for its expertise in chemistry, pharmacology and clinical development.

"Their lead compounds are now either in or very close to entering clinical trials in potential blockbuster indications," Every said, "which we believe will be extremely attractive to potential large pharmaceutical partners."

Ardent also will bring to the new company state-of-the-art laboratory and technical trial facilities, as well as expertise in the U.S. FDA process.

"We're getting early stage laboratory resources for preclinical and early clinical work," Every said. Enhance previously had outsourced such work.

While Enhance in-licenses its products at the preclinical or Phase I stages then develops them through Phase III and partners them for marketing, Ardent has taken a different approach.

"They've got the longer-term developments of new chemical entities," Every said.

Ardent has two products, DPI-3290 and DPI-125, in the clinic for the acute treatment of moderate to severe pain. DPI-3290 has completed a large Phase II trial for acute post-operative pain. The candidate has demonstrated substantially less respiratory depression and vomiting than historical fentanyl controls. A follow-on drug, DPI-125, might possess a better safety and efficacy profile than DPI-3290. It is being explored for the treatment of chronic pain.

"If you look at their strengths in pain, that's something new for us and becomes one of our lead product areas," Every said.

At the earlier stage, Ardent is studying DPI-221 for urinary bladder function, and various candidates for premature ejaculation, depression and cardiac ischemia.

Founded in 1996, Ardent acquired its technology and library of compounds affecting the delta receptor site from the former Glaxo Wellcome plc, of London.

Enhance's own pipeline includes products that focus on sexual dysfunction and dermatology. Its lead product, LI-301, is in a dose-ranging study for premature ejaculation as it prepares for Phase III trials. Both LI-301 and another late-stage product for fertility could reach the market in 2007, Every said. The company also has studied products for depression, anti-aging, cellulite and skin disorders. The company's stock last traded (OTC BB:EBOI) at $2.65.

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