ZymoGenetics' Thrombin drug closer to market

ZymoGenetics took a big step Tuesday toward delivering its first marketable drug, a protein to stop surgical bleeding that could be used in hundreds of thousands of surgeries a year.

The Seattle biotech company said after markets closed that its brand of Thrombin, made through gene-splicing to be virtually identical to a human clotting protein, reached its goals in a pivotal study of 411 patients.

ZymoGenetics' Thrombin proved it was as effective at stopping bleeding as the standard clotting protein made from cow blood. More importantly, it proved to be safer.

The study showed that 1.5 percent of patients taking ZymoGenetics' drug developed antibodies against it, which can be dangerous, compared with 22 percent who developed antibodies against the cow-blood product.

The next steps for ZymoGenetics are to release more details at a medical meeting Sept. 17 in New Jersey and the next day at a meeting with investors in New York.

Chief Executive Bruce Carter said the company is on schedule to apply for Food and Drug Administration approval by the end of the year and to bring it to the U.S. market in 2007.

ZymoGenetics stock rose $1.46 after the news, closing at $20.70 in after-hours trading.

ZymoGenetics


Founded: 1981

Chief executive: Bruce Carter

Employees: 500

Located: Seattle's South Lake Union neighborhood

What it does: Has completed development of a protein drug to stop surgical bleeding and plans to apply for FDA approval by year-end. The company also has drugs in earlier stages of human testing for autoimmune diseases and cancer.

Cash and investments: $310 million as of June 30

Cash spending rate: $125 million to $140 million in 2006

Source: Company reports, Securities & Exchange Commission

"We couldn't be more thrilled," Carter said.

He said his company believes it can dominate the market. History has shown that biotech drugs quickly supplant animal-derived ones.

One famous example was when human-engineered insulin replaced pig-derived insulin for diabetics.

Bernadine Leung, an analyst with Infinium Securities in Toronto, said the study results had been expected. Small studies have suggested ZymoGenetics' Thrombin was safe, and other studies have shown cow-derived Thrombin creates antibodies in at 40 percent or more of patients.

Antibody reactions, which can cause severe bleeding, have prompted the FDA to require a warning on the label of the cow-derived product.

In a survey by Infinium, doctors said they would prefer a human-engineered protein over drugs made from human or animal blood, which could harbor contaminants.

Company surveys reveal the same preference, but not many doctors realize they are using a drug derived from cows, Carter said.

Despite the FDA's strong warning, the cow-derived product, made by Tennessee-based King Pharmaceuticals, had $221 million in sales in 2005.

Leung said she doesn't expect ZymoGenetics' Thrombin to crush the competition overnight, but that it should generate $500 million a year in U.S. sales after four years, and $600 million to $700 million a year when sales peak, expected in 2014.

It could create big returns. ZymoGenetics has spent $45 million developing Thrombin over the past 18 months, according to filings with the Securities & Exchange Commission.

The price hasn't been set, but Carter said the company believes it can charge a premium over the cow-derived drug and also coax more surgeons to use the new drug.

ZymoGenetics plans to hire a sales staff next year, with about 50 people making pitches to at least 1,200 hospitals a year.

Abbott Laboratories makes the drug under contract, and ZymoGenetics said it has enough capacity to meet demand.

ZymoGenetics is searching for a partner to sell the drug in Europe.

The company also plans to develop a Thrombin spray to help burn victims and tests to show whether it is effective in children, Carter said.

Luke Timmerman: 206-515-5644 or ltimmerman@seattletimes.com