Encysive Pharmaceuticals (ENCY)

[Gd2Aussie3]

Here's one on ENCY going Global. Enjoy.
http://www.dallasfed.org/fed/annual/2006...
New Hope for Fighting Disease

Pulmonary arterial hypertension, a rare disorder involving extremely high blood pressure in the lungs' smallest arteries, afflicts an estimated 100,000 people in the U.S.—a number too large to ignore but too small to entice most drug companies.

Going global proved the way around this dilemma for Encysive Pharmaceuticals. By expanding the number of potential patients, the international market gave the Houston-based firm the critical mass it needed for Thelin, its brand name for sitaxentan sodium.
Bruce Given
Bruce Given

"If you are going to put in all the effort to build out an infrastructure, you really have to have enough patients to make it worth your while," says Encysive president and CEO Bruce Given.

Pulmonary arterial hypertension is one of 5,000 so-called orphan diseases, those afflicting fewer than 200,000 people in the U.S. The larger market size inherent in globalization makes it far more likely that companies will embark upon the risky business of finding new treatments. "There are some orphan indications so small that to attain enough patients for regulatory filings, there is no other choice than to go global," Given says.

Developing drugs is extremely expensive. For every 1,000 that are synthesized, 100 go to animal testing, 10 to clinical trials and only one makes it to the marketplace. Without enough patients, pharmaceutical companies can't justify the time and expense needed for research and the approval process.

Encysive is currently selling Thelin in Europe and awaiting Food and Drug Administration approval in the U.S. Approval is also pending in Canada and Australia, and the company is casting its eyes toward Latin America and perhaps beyond.

Going into Europe doubled the potential market to 200,000 patients, big enough to make Thelin a viable drug. Encysive markets Thelin directly in Europe and plans to do the same in the United States and Canada. Elsewhere, it will probably partner with a big pharmaceutical company, which will handle distribution and pay Encysive royalties.

"I don't care who you are," Given says. "If you are in the business of developing a drug, you are doing so for a worldwide market. Increasingly, this includes looking for patients in places like India and China, which was not often done in the past."

Global markets will ease the way for future generations of orphan drugs. An increasingly integrated world economy may even become crucial to mainstream treatments.

"As regulatory authorities continue to seek greater assurances that drugs are safe and effective prior to approving them, patient numbers in dossiers are generally increasing," Given says. "As such, even in larger indications, companies often find it necessary or advisable to go global to enroll enough patients in their trials to meet regulatory expectations in a reasonable period of time.
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G' day Mates,

Aussie