Monday, March 03, 2008 11:36:25 AM
By Ángel González
March 3, 2008
Seattle Times business reporter
After launching ZymoGenetics' first commercial product as an independent biotech in January, Chief Executive Bruce Carter shadowed one of his salesmen in a visit to several Seattle-area hospitals. The veteran scientist said he discovered "a different world."
Research scientists are trained to be skeptical, whereas salespeople are "optimistic and gung-ho," he said. "I love being surrounded by optimists."
Carter is living a moment many biotech captains dream of, but most never achieve: the successful approval of a new therapeutic product. And he's assembled something most biotech execs don't need: a sales force.
Atop ZymoGenetics' landmark building between Lake Union and Interstate 5, a banner hung for several weeks, proudly proclaiming to passing drivers, "FDA approves recombinant thrombin."
It celebrated the Food and Drug Administration's approval of Recothrom — a genetically engineered form of the human blood-clotting protein thrombin, designed to stop blood loss during surgery.
Last year only 19 therapies passed muster with the agency, a 13 percent drop from the previous year, according to research firm Sagient Research systems. In the 27-year history of Seattle's biotech industry, few companies have launched products on their own.
"It's an elite group," said Jack Faris, president of the Washington Biotechnology and Biomedical Association. The region has produced only two big sellers: rheumathoid-arthritis drug Enbrel, developed at Immunex; and erectile-dysfunction treatment Cialis, by Icos.
Many analysts, however, are skeptical of ZymoGenetics's ability to quickly carve a place for itself against well-established competitors that manufacture thrombin from human or bovine blood. The company says its product is better because the bovine version in rare cases can cause adverse reactions, and human plasma could contain harmful viruses.
The launch hasn't stemmed a drop in ZymoGenetics' stock price that led to belt-tightening as the company strives to conserve its cash. The company's market value is half of what it was a year ago, and last month it announced the elimination of more than 80 jobs, including layoffs.
Until recently the area's largest independent biotech by market capitalization, ZymoGenetics has ceded its No. 1 spot to Bothell-based Seattle Genetics.
"It's perplexing," Carter said. "Our stock has been twice as high as it is now, and we've done nothing except make progress."
The layoffs have been "difficult for people to understand," he said. "We are celebrating one week; the next week you're laying off."
Rough seas are nothing new to ZymoGenetics, the doyenne of Seattle's biotech companies.
Paul Bishop, one of the scientists behind Recothrom, remembers joining the company at an unstable time.
"The day I started work was Black Monday," he said, referring to the 1987 stock-market crash that killed most investors' appetite for biotech and quickly resulted in the company's acquisition by Novo Nordisk, a Danish pharmaceutical giant. Novo spun off ZymoGenetics in 2000.
What's new is having the spotlight shift from researchers to salespeople. For years, ZymoGenetics passed its discoveries on to other pharmaceutical companies; but when the FDA finally gave its blessing Jan. 17 and champagne corks popped at ZymoGenetics, a newly minted sales team began making calls.
"I'm not going to be sitting here drinking champagne," said Mike Dwyer, who was hired in 2006 to build up ZymoGenetics' sales effort. He assembled a team of 48 sales reps who, along with 35 salespeople from its marketing partner Bayer, are working to get Recothrom in the hands of surgeons.
Within four days of launch, Dwyer's team had closed its first sale, to Englewood Hospital, in New Jersey. Within seven days, 50 wholesale distribution centers had the product on their shelves.
In advance of the FDA approval, ZymoGenetics' sales team underwent a four-week course at the company's headquarters, and a two-and-half day University of Virginia program where they could witness different types of surgery and talk to doctors about their use of blood products.
Dwyer says his salespeople focus on surgeons, clinical pharmacists and key players who make purchasing decisions for hospitals.
While their targets are easy to find — about 1,000 hospitals account for 90 percent of thrombin sales — getting ahold of busy surgeons is no easy task.
ZymoGenetics sales staffers sometimes must wait for them in hospital parking lots at dawn or follow them into locker rooms to deliver a quick pitch.
"We have to find creative ways to get there," Dwyer said.
McAdams Wright Ragen analyst Paul Latta predicts that after a slow ramp-up, Recothrom annual sales could reach $300 million within three to five years.
But first, Zymo's product must best King Pharmaceuticals, whose bovine thrombin dominates the marketplace, and Omrix, which launched a human plasma-based thrombin last year.
Bishop thinks artificial thrombin will prevail because it's less risky to patients than bovine and human-blood thrombin. "You can't really control what's in the plasma," he said.
David Miller, an analyst with Seattle-based Biotech Stock Research, said that, like other recombinant products, Recothrom has a better safety profile than plasma-derived competitors.
Initial skepticism
Despite its novelty, Recothrom has been coolly received by many influential analysts.
A recent research note by brokerage firm Oppenheimer said the recombinant product does not offer any real safety advantages over its bovine competitor, yet costs about $86 for a vial, compared with $45 to $50 for King Pharmaceutical's version sold in long-term contracts.
But CEO Carter said the premium paid for recombinant thrombin is negligible when compared with other surgical costs, and most doctors are ready to pay it.
Oppenheimer downgraded ZymoGenetics' stock from perform to underperform, and it reduced its 2008 Recothrom sales estimate from $41 million to $28 million.
ZymoGenetics declined to predict sales, but it says at least 40 hospitals are giving Recothrom a try. Carter said that in a short time Recothrom is already on the agenda of 80 pharmacy and therapeutics committees in hospitals across the nation.
Dr. Aryeh Shander, chief of anesthesiology at Englewood Hospital, said the new product's price was "reasonable."
The hospital is evaluating Recothrom, with the aim of replacing bovine thrombin.
"To us, it seemed like it was a no-brainer," Shander said.
Ángel González: 206-515-5644 or agonzalez@seattletimes.com
Copyright © 2008 The Seattle Times Company
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