United Press International - July 14, 2005
Charles Q. Choi

The gel alone could have a potential worldwide market exceeding $1 billion, said Anne-Marie Corner, senior vice president of women's health at specialty biopharmaceutical firm Cellegy in Brisbane, Calif., a $41 million market-cap company specializing in women's health.

Corner and others attended the CE Unterberg, Towbin Emerging Growth Opportunities Conference this week in New York City. Unterberg, Towbin provides market analysis and capital to companies in the healthcare, technology and other industries.

"Talk about a medical need that's also a social need," said Angela Larson, a specialty pharmaceuticals analyst at Unterberg, Towbin. "You very seldom see something in the pharmaceutical industry like this that can change world dynamics, that's going to save so many lives."

Cellegy has more than 3,000 patients enrolled in two separate phase III HIV-prevention trials in Africa, and also has a phase III contraception trial under way in the United States. Cellegy hopes to complete those trials in late 2006. With funding from the U.S. Agency for International Development, the company will provide the gel at cost-plus to the developing world.

"The fact they've funded a 3,000-women study in Africa is clearly a serious commitment to the product's development," Larson said.

Emerging specialty pharmaceutical company Durect in Cupertino, Calif., a $257 million market-cap firm, is developing a viscous biodegradable gel that enables the controlled release of any drugs dissolved in it.

"We're developing a relative of Novocain with an extended release technology," said James E. Brown, Durect's chief executive officer. "Instead of lasting four hours, it last four days."

The market to help fight pain after surgical operations could by itself exceed $1 billion. "There are more than 70 million surgical procedures performed each year in the United States that often require post-operative pain medication," Brown said.

This pain reliever could also reduce hospital stays by one to three days.

"I've been told it could actually turn out to have an $8 billion impact on the hospital market, by saving in nursing time and drug orders," Brown said. The extended-release pain medication should reach the end of phase II trials later this year.

Another product in Durect's pipeline of five products is a patch for treatment of chronic pain with a week's duration. Worldwide sales of Duragesic, the current leading patch for chronic pain -- which provides only three days of relief -- exceeded $2.1 billion in 2004. The product is manufactured by Janssen, a subsidiary of Johnson & Johnson.

Durect's patch is currently in phase II trials.

"Durect's very exciting. They have next-generation state-of-the-art technologies," Larson said. "Still, when you have five products in a pipeline, one of them is going to fail. So when that hits, it's going to be difficult. It's not that they're doing anything wrong, there are no obvious red flags, but you do have to anticipate one could fail. Investors have to be aware of that."

Oxygen-therapeutics company Biopure in Cambridge, Mass., a $32 million market-cap company, is developing medication that can deliver life-saving oxygen in the face of ischemias, or cutoffs in blood and oxygen to limbs and organs. The most familiar examples of ischemias are myocardial infarctions, or heart attacks.

"There's a real unmet medical need here. There are 2 million myocardial infarctions per year in the U.S. and Europe combined," said Zafiris Zafirelis, Biopure's president and CEO.

"The market's probably over $1 billion in the U.S. alone for acute coronary syndrome," Zafirelis said. "For limb ischemia, the market's probably a half billion."

Acute coronary syndrome includes heart attacks and unstable angina.

Biopure's lead product, originally designed as a blood substitute, is derived from cow hemoglobin, giving the company a vast raw-material source.

"The product is 1,000 times smaller than red blood cells. This means it can bypass constrictions red blood cells could not go, to deliver oxygen," Zafirelis said.

The product's ability to last three years at room temperature makes it attractive to the military, he added. Biopure is collaborating with the U.S. Navy to bring a product to market for out-of-hospital treatment of traumatic injuries and has received $18.5 million in federal funding to date.

"The market is $200 million for trauma indications," Zafirelis said.

In South Africa, Biopure has completed a phase II trauma trial and has initiated a phase II limb ischemia trial. In 2005 Biopure plans to submit a plan for a U.S. pilot study to the FDA for treatment of ischemia this year and move forward with the Navy on a trauma clinical trial.

"Having the Navy as their partner is very attractive, but they will have to get over the FDA's concerns before an investor can be too serious," Nelson said.

Charles Choi covers research and technology for UPI Science News. E-mail: sciencemail@upi.com

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