ZymoGenetics announced Thursday the launch of a 400- to 600-patient clinical trial of rhThrombin, a topical treatment designed to stop bleeding...
ZymoGenetics announced Thursday the launch of a 400- to 600-patient clinical trial of rhThrombin, a topical treatment designed to stop bleeding during surgery.
The results could pave the way for the Seattle biotechnology company to seek its first product approval from the Food and Drug Administration, a filing expected late next year.
“This is of course a very important milestone in the development of ZymoGenetics,” said President and Chief Executive Bruce Carter on a teleconference with analysts.
The announcement matches company forecasts for progression of its lead product candidate, which is targeted for approval in 2007. ZymoGenetics’ stock ticked down 2 cents to close at $16.45. It has traded between $14.57 and $24.69 in the past year.
The company’s recombinant human Thrombin, derived from human proteins, would compete with standard Thrombin products, which are isolated from bovine plasma. The bovine version has caused negative reactions, including severe bleeding and death, in some patients who had multiple treatments, causing the FDA to put a “black-box” warning label on the product.
ZymoGenetics’ trial is designed to show that its product can stop bleeding during surgery as quickly as bovine-derived Thrombin and without exposing the patient to antigens that can provoke a dangerous immune-system response.
“We don’t anticipate we’ll have a black-box warning,” said Doug Williams, ZymoGenetics executive vice president and chief scientific officer.
Pacific Growth Equities analyst Greg Wade said doctors will take note of that difference, which could help the company penetrate the market and charge a higher price.
“Doctors always want to reduce risks whenever possible,” said Wade, who owns ZymoGenetics shares and whose firm has co-managed stock offerings for the company.
King Pharmaceuticals’ bovine Thrombin costs between $100 and $150 per surgery and had 2004 sales of $175 million. Banc of America Securities projects potential rhThrombin sales at $49 million in 2008 and $92 million in 2009. BAS also owns shares in ZymoGenetics and does investment-banking business with the company.
The trial, to be performed at 35 sites, will be “significantly cheaper” than many other late-stage clinical trials because it will measure whether the treatment stops bleeding within 10 minutes. A follow-up with patients 28 days later will check for immune-system response.
Trials that require months of treatment and follow-up testing can cost between $30 million and $40 million.
Benjamin J. Romano: 206-464-2149 or firstname.lastname@example.org