The Food and Drug Administration says ZymoGenetics omitted important facts when announcing the launch of its first commercial product, Recothrom...
The Food and Drug Administration says ZymoGenetics omitted important facts when announcing the launch of its first commercial product, Recothrom, and it has asked the company to revise the news release.
The Seattle company’s product is a genetically engineered form of thrombin, a protein that helps control surgical bleeding. In a Jan. 17 news 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 Web site 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.
Most Read Business Stories
- REI picks new satellite office ‘surrounded by trail networks’
- Judge upholds Seattle eviction regulations, rebuffing landlords' lawsuit
- Fry's Electronics executive accused of embezzling $65 million
- Funky electronics chain Fry's is no more
- Alaska Airlines ordered to pay $3.2M to family of woman who died after escalator fall
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 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,” 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. He added: “We’re still seeing a $300 million to $400 million product in three to five years. … But clearly it will take a while to get there.”
ZymoGenetics selling vacant lot
ZymoGenetics wants to sell a vacant lot near its Eastlake headquarters, the Seattle biotechnology company said in a regulatory filing.
The transaction to sell the land is “still in negotiation, not settled,” said spokeswoman Susan Specht on Wednesday, but a sale would be “a nice chunk of change.”
The land, previously tagged for future expansion, has a carrying cost of $4.5 million, according to a filing with the Securities and Exchange Commission. The 0.3 acre lot at 1150 Eastlake Ave. E., purchased in 2001 for $1.4 million, is across Eastlake and a little southwest from the company’s main building, according to King County Assessor records.
It’s not the first time that ZymoGenetics has shed real estate. In 2002, the company sold its state-of-the-art headquarters for $52 million, and now leases the building, a historic power plant near Lake Union.
The lot the company is now selling is its only remaining land asset, Specht said.
“We’re not in the real-estate business,” she said.
Ángel González: 206-515-5644 or firstname.lastname@example.org
Seattle Times reporter Eric Pryne contributed to this story.