Despite a recent regulatory setback, ZymoGenetics executives were optimistic Tuesday about prospects that their bleeding-control product will receive approval next week from the U.S. Food and Drug Administration and will be ready to hit the market.
“Nobody has seen anything coming out of the FDA causing us any concern,” Chief Executive Bruce Carter told a room packed full of analysts and investors at the JP Morgan Healthcare Conference in San Francisco.
ZymoGenetics’ lead product, an artificial form of thrombin, was expected to get an FDA blessing in October. But the agency requested more data on the company’s manufacturing process before it would grant approval. A final decision is expected on January 17.
The product, known as rThrombin, will face stiff competition from rival compounds based on human or bovine blood. A “citizens’ petition” challenging the drug was filed with the FDA by one of ZymoGenetics’ competitors, but Carter dismissed concerns that it might prompt the agency to withhold its approval.
“We haven’t been asked any questions by the FDA on anything that came out of the citizens’ petition,” Carter said.
The company warned investors that it might take several months to produce a splash on the thrombin market, as it seeks to convince doctors to adopt the product. “Don’t be disappointed by the sales in the first and second quarters,” he said. “We believe it will take us a little time.”
ZymoGenetics is Seattle’s largest independent biotech.