West Coast Editor

Less than five months after Neose Technologies Inc. signed a deal with Wyeth to provide Phase III quantities of Wyeth's drug for myocardial infarction, P-selectin glycoprotein ligand (rPSGL-Ig), Wyeth is stopping development of the compound because of disappointing Phase II data.

The decision represented no failure of Horsham, Pa.-based Neose's technology, but investors severely penalized the company anyway. Neose's stock (NASDAQ:NTEC) closed Friday at $11.56, down $9.26, or 44.5 percent.

"These things happen," said Matt Kremer, senior director of corporate communications for Neose. "They are in Phase II clinical trials, and we were informed they would not be taking it forward, and so we had to disclose. Our technology was not used to make any Phase II material."

Wyeth's move "doesn't have a large near-term impact," Kremer told BioWorld Today. "The drug was still years away. It was going into Phase III, and myocardial infarction trials [often include] many thousands of patients and long follow-up."

Although Neose will miss out on an undisclosed amount of research and development support and potential milestones, Kremer added, the company had $65 million in cash at the end of the first quarter and "we don't need to finance in the near term."

Specifically, the deal entered in December with Madison, N.J.-based Wyeth, formerly named American Home Products Corp., entailed the license of Neose's GlycoAdvance technology (designed for correcting incomplete or incorrect glycosylation encountered in the manufacture of recombinant glycoproteins) to Wyeth for commercial production of the drug for myocardial infarction.

"There may be additional indications, and the agreement we have with Wyeth has not been terminated," Kremer said.

It was the first major GylcoAdvance deal for Neose, which is focused on synthesizing and making complex carbohydrates.

"Our technology is the use of enzymes to finish carbohydrate structures on glycoproteins," Kremer explained. "As you push cells to overproduce a protein, if it's glycosylated and includes carbohydrates structures - produced in a mammalian system - what happens is, they overwhelm the Golgi apparatus [a cell structure that processes proteins synthesized in the endoplasmic reticulum], the proteins don't get fully glycosylated and they have a much shorter half-life."

He compared the Golgi apparatus, "where the carbohydrates get put on," to Lucille Ball's character in the "I Love Lucy" episode where she is working in a chocolate factory and must eat the candies that she can't wrap, as they move past her quickly on the assembly line.

"She can't keep up, and that's what happens to the Golgi [apparatus] - it can't keep up," he said. "Putting sugars on is a very complicated process."

Neose's technology can add "any number of sugars," Kremer added, thereby increasing protein half-life by two or three times.

Other Neose platforms are GlycoTherapeutics, intended to develop and produce carbohydrate-based therapeutics, and GlycoActives, to develop carbohydrate-based food and nutritional ingredients.

Kremer said Neose is optimistic about finding other partners that can see through the Wyeth misfortune.

"Glycosylation, as an issue in biotechnology drug development and manufacturing, has received little attention," he said. "People have talked about alternative ways of making proteins, but the carbohydrate area is one where we have very strong intellectual property, and it's critical in making these drugs."

No Comments