August 6, 2003.
By Bill Berkrot.
Genaera Corp. is betting its experimental treatment for the most common cause of age-related blindness is more fun than a needle in the eye.
The tiny Pennsylvania biotechnology company this week released promising results from a small, early-stage trial of its drug, squalamine, for treating the more severe wet form of age-related macular degeneration (AMD).
And while Genaera still has a long regulatory road ahead, company executives believe they have a very strong selling point compared to potential competition from industry giants in a market that could be worth billions of dollars.
About 500,000 new cases of wet AMD are diagnosed annually worldwide and that number is expected to soar as the baby-boom generation ages.
Squalamine, which demonstrated improvement or no deterioration of vision in 97 percent of the 40 patients in the recent study, is administered intravenously.
AMD drugs in later stages of development by Pfizer Inc. and another by Genentech are delivered by injection directly into the eye.
"We feel strongly that this will be a huge advantage," Genaera Chief Executive Roy Levitt told Reuters.
"We're very excited about differentiating the product we have in development from those in development that require an injection into the eye on a regular basis," Levitt said.
All three are anti-angiogenesis drugs that work by cutting off nutrients to the abnormal blood vessels that grow beneath the retina, causing the loss of eyesight.
Experts say there is dire need for new drugs because current treatments for wet AMD are very limited in effectiveness. While they can slow progression of the disease, they do not reverse it and it often returns with a vengeance.
"The early data from squalamine is remarkable because it shows that anti-angiogenesis can not only preserve vision in patients with AMD, but it can also restore vision as well," said Dr. William Li, president and medical director of the Angiogenesis Foundation.
"All these drugs show incredible promise," said Li, including Macugen, being developed by Pfizer and Eyetech Pharmaceuticals Inc., and Genentech's Lucentis.
AMD is the leading cause of blindness among adults over age 50 with about 25-30 million people affected globally.
"In an aging society this is literally an epidemic that is heading toward us," Li said.
Jason Kantor, an analyst for WR Hambrecht, called the new class of drugs "a $2 billion market opportunity."
Clearly, Pfizer is betting on a big money maker. The world's largest drug maker paid privately held Eyetech $100 million up front to acquire the Macugen marketing rights with another $645 million in potential milestone payments.
Genentech has a deal with Swiss drug maker Novartis, and Genaera is in talks with major drug companies with the resources that could help it compete with Pfizer's sales clout and likely earlier entry into the market.
Hambrecht's Kantor believes Genaera's intravenous (IV) treatment should have some competitive advantage. "But I don't think it's a foregone conclusion that weekly IV will dominate the market," he said, citing the inconvenience of regular doctor visits.
"There will be a continual race to develop oral drugs or eye drops," Kantor predicted.
Li agreed that finding a more convenient option that can prevent or reverse age-related blindness is the goal.
"The holy Grail of the whole ophthalmology field will be to ultimately develop an anti-angiogenic treatment that is safe and effective and can be delivered as an eye drop to prevent blindness," he said.
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