Originally published May 7, 2008 at 12:00 AM | Page modified May 7, 2008 at 4:02 PM
FDA asks ZymoGenetics to revise new product's press release
ZymoGenetics was told to clarify a press release suggesting its new Recothrom blood-clotting product caused fewer antibody reactions than a competitor derived from bovine blood.
Seattle Times business reporter
The U.S. Food and Drug Administration says ZymoGenetics omitted important facts when announcing the launch of its first commercial product, Recothrom, and it asked the company to revise the press release.
The Seattle company's product is a genetically engineered form of thrombin, a protein that helps control surgical bleeding. In a Jan. 17 press release, ZymoGenetics said its product was shown to be as effective as a competitor derived from bovine blood, and had a "lower incidence of antibody formation."
In a letter posted on the FDA's website Wednesday, the agency called that statement "false or misleading," because it suggested that bovine thrombin's antibodies are less safe than Recothrom. In clinical trials, the agency noted, the antibodies did not lead to adverse events in patients treated with the bovine product. Both products had similar instances of adverse events, the FDA said.
In response to the FDA letter, ZymoGenetics added a three-sentence footnote with the missing information. The information is already present in the company's promotional materials, said spokeswoman Susan Specht. "This will not change the sales materials," she said.
The FDA action underscores the fierce competitiveness of the medical market — and how closely federal regulators watch over it. ZymoGenetics has asserted that genetically engineered products, also called recombinant, are less risky than those derived from bovine or human blood, which could contain impurities.
The company said Tuesday that its Recothrom sales had reached $1 million in the first quarter of its launch.
"We believe the launch is going well, and we're seeing strong interest in the marketplace, reflecting an appreciation for the advantages of a recombinant topical hemostat," said Chief Executive Bruce Carter.
Kevin DeGeeter, an analyst with Oppenheimer & Co, said in a note that Recothrom adoption is "taking longer than previously thought," and called the launch "soft."
Many hospitals targeted by ZymoGenetics are stocking both Recothrom and its bovine competitor made by King Pharmaceuticals.
McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million, but said the product's long term potential remained unchanged.
"We're still seeing a $300 million to $400 million product in three to five years," Latta said. "But clearly it will take a while to get there."
Ángel González: 206-515-5644 or agonzalez@seattletimes.com
Copyright © 2008 The Seattle Times Company
Landmark Smith Tower mostly vacant
Toyota's Toyoda scolds execs for emulating U.S. car companies' mistakes
Money Makeover: Financial makeover: A "go-getter" goes after her spending habit
Do your homework before buying brokered CDs
Mutual-fund deposits shift into low gear

2009 fireworks time lapse
With strict parking rules enforced at this year's July 4th celebration on Wallingford Ave North, less cars and more spectators filled the streets.
Entertainment | Top Video | World | Offbeat Video | Sci-Tech
shopping

events for Sunday, Jul. 5th
- Posh on Main Semiannual Sale
- REI Summer Sale and Clearance
- Kuhlman Summer Sale
- Evo Independence Sale
editors' picks
More shopping guides- Plasma and LCD beware; OLED screens ready to go mainstream
- Former NFL MVP McNair killed
- Russell Branyan, Mariners fight off the Red Sox
- Palin takes to Web for hints of political future
- Fourth of July festivals and fireworks in Seattle, the suburbs and beyond
- The Blotter | Man pistol-whipped after argument at nightclub
- Desert-lobster dispute turns pair into sagebrush heroes
- Landmark Smith Tower mostly vacant
- Close-up | Prison guards intercept carrier pigeon with a cellphone
- Property taxes: Appeals shoot up in King, Snohomish Counties
- Palin resigning as Alaska governor
767 - Seattle Mariners at Boston Red Sox: 07/04 game thread
244 - Reports: NKorean missile arrives at launch site
100 - Former NFL MVP McNair killed
85 - Hatred for the NBA runs deep, but don't take it out on the players
83 - Palin links resignation to 'higher calling' and blasts media in Facebook posting
74 - Tukwila residents rally against light-rail noise
63 - Mariners score unlikely win over Red Sox in battle of bullpens
58 - Property taxes: Appeals shoot up is King, Snohomish Counties
50 - Tent City on campus: UW stalls decision
38
- Plasma and LCD beware; OLED screens ready to go mainstream
- Merchant Marine veterans fight for recognition
- Property taxes: Appeals shoot up in King, Snohomish Counties
- Close-up | Prison guards intercept carrier pigeon with a cellphone
- Pre-grill drill: marinate steaks
- Hard times for tourist towns means good deals for travelers
- Concert Review | Green Day blasts off 4th weekend with KeyArena show
- Lake Washington's sockeye run may hit a record low
- Amtrak cleared for 2nd daily train to Vancouver, B.C.
- Yakima teacher reprimanded for sending 5-year-old student home with bag of feces in backpack
