Eyetech Pharmaceuticals Inc. picked up $54.2 million - the second part of the $108.5 million it raised in its Series C financing a year ago - for completing enrollment in its two Phase III trials of Macugen in wet age-related macular degeneration.
The Series C round, made public in August 2001, sketched the financing in two portions - the $54.3 million Eyetech received when the round closed, and the $54.2 million just now handed over after completed enrollment. But with Eyetech's product aimed at wet AMD, an indication with a large patient population, the second tranche was never really in question, said David Guyer, Eyetech's CEO. (See BioWorld Today, Aug. 10, 2001.)
"This basically was a C-2, a second half of [the round] based on enrollment," he said. "To us, part of the excitement was that enrollment closed early. Last week, more than 75 people were recruited in the European trial alone."
Previous public guidance from the company estimated the end of enrollment at the end of 2002. There are 1,196 patients now enrolled at 117 sites worldwide, evaluating vision stabilization and/or improvement associated with Macugen as a stand-alone treatment, as well as in combination with photodynamic therapy for patients eligible for such therapy. The standard endpoint is measured in patients one year after enrollment. Although unwilling to talk about a timeline for regulatory filing, Guyer pointed out that Macugen is fast-tracked by the FDA for both wet AMD and diabetic macular edema.
Eyetech has not said what it would do with an approved Macugen, but as potential approval nears, Eyetech is fanning out its marketing cards.
"We are presently evaluating the various different options of partnering," Guyer told BioWorld Today.
Macugen, formerly EYE001, was licensed in as NX 1838 from Gilead Sciences Inc., of Foster City, Calif., in April 2000 in a deal valued at at least $32 million. The product is an aptamer designed to bind and neutralize vascular endothelial growth factor (VEGF). VEGF can cause abnormal blood vessel growth, and blood vessel growth behind the retina can cause blindness when the vessels leak. Privately held Eyetech, of New York, also is conducting Phase II trials of Macugen in diabetic macular edema. Those trials "are going very well. We are seeing a significant portion of patients gaining vision," Guyer said. Phase III trials are expected to be initiated in 2003. (See BioWorld Today, April 7, 2000.)
The company has products in preclinical development, as well as "a very active drug delivery system," Guyer said. Eyetech in July opened a new research lab, headed by Anthony Adamis, Eyetech's senior vice president of research.
VEGF and its targets have potential in other areas, specifically cancer, something Eyetech is aware of, but Guyer said Eyetech is "focused directly on the eye right now." The company might license the product out for other indications in the future, he said.
With the second tranche of the $108.5 million in pocket, Eyetech appears well funded, especially for a private company. Its late-stage product is something that usually waters the mouths of investors, putting Eyetech in an enviable position of having what it might take to go public, but not needing to float in today's difficult market.
"We think we are very fortunate having raised enough cash to get us through our Phase III trial," Guyer said. "We feel we are lucky enough to pick our opportunity [for an initial public offering.]"