March 21, 2006
Inhaled insulin a boon to diabetics, Terre Haute
Pfizer's Exubera, to ship from Indiana soon, expected to be among hottest drugs in decades
By Jeff Swiatek
jeff.swiatek@indystar.com
TERRE HAUTE, Ind. -- One of the most significant advances in eight decades of insulin treatments is piling up in a two-story warehouse here, bound in a few months for diabetics around the globe.
in the works: Production team members test and package items at Pfizer's Terre Haute plant. Insulin crystals are shipped from Germany and spray-dried, loaded into foil blister packs and packaged for delivery. The first inhaled version of insulin will be available to patients this summer. - ALAN PETERSIME / The Star
Exubera at a glance
• What it is: Inhaled insulin.
• Launch: Midsummer.
• Manufacturer: Pfizer Inc.
• Made: Terre Haute, Ind.
• Employees: About 200.
• Plant cost: About $170 million.
• Economic incentives: 10-year county property tax abatements.
• Product development cost: More than $1 billion.
• Developer of inhaler device: Nektar Therapeutics.
• Potential sales: $1.2 billion by 2008.
Sources: Pfizer, W.R. Hambrecht & Co.
It's the world's first inhaled, needle-free insulin. And it's seen as one of the most anticipated prescription products in decades.
Called Exubera, the inhaled insulin took 15 years to develop. Starting a few weeks ago, it began rolling off production lines in a tightly guarded manufacturing campus run by Pfizer Inc., a large New York drug maker, and established here 58 years ago.
Sales to patients will start in midsummer, Pfizer says.
Exubera brings luster to Pfizer's Terre Haute operations, which in the past turned out lesser drugs, including animal health products.
Pfizer has invested $170 million in the plant and hired 200 employees over several years to run it.
"This will be one of the biggest product launches ever in diabetes," said Kelly Close, a diabetes products consultant in San Francisco. "It'll be huge."
It also represents a major competitive challenge for Indianapolis-based rival Eli Lilly and Co., the nation's longtime leading seller of insulin.
With its convenience and ouchless inhaled technology, Exubera figures to steal away market share from Lilly and two European insulin suppliers, Novo Nordisk and Sanofi-Aventis. Lilly's popular Humalog, a fast-acting insulin that generated $1.2 billion in sales last year, could be hardest hit by Exubera.
Lilly has an inhaled insulin of its own in the works, but it's still in testing and won't be ready for market for another two or three years.
Pfizer site leader Frank Foley said the number of employees at the Terre Haute plant would grow, depending upon demand for the drug.
Pfizer also is looking at spending an additional $65 million to $103 million to expand the plant, said spokesman Richard Chambers.
Making this western Indiana city the sole production site for one of the highest-profile drugs ever is "thrilling" for the area, said Curt Stephens, vice president of Wabash Valley Packaging Corp. in Terre Haute, which sells corrugated boxes to Pfizer to pack Exubera. "This seems like a real home run. It's exciting to think about the possibilities that exist."
Inhaled insulin could make up a third of the market for fast-acting insulins by 2010, predicts investment firm W. R. Hambrecht & Co. Insulin has been taken only by injection since it was first sold in 1923 to help diabetics control their blood-sugar levels.
Diabetics who inject several times a day are the most likely users of the inhaled version.
Pfizer bought its way into the insulin business, long controlled by Lilly and Novo, by partnering with French company Sanofi-Aventis, which was testing an inhaled insulin. Nektar Therapeutics, of San Carlos, Calif., developed the inhaler, which resembles a large asthma inhaler.
Pfizer recently bought out Sanofi-Aventis' share, including the Frankfurt, Germany, plant that makes the insulin crystals used in Exubera. It's the largest insulin plant in the world, and for good reason -- inhaled insulin requires 10 times the volume of insulin per dose, since 90 percent of it is waylaid in the mouth and elsewhere before being absorbed in the lower lungs.
Worry about possible harm to the lungs delayed Food and Drug Administration approval of Exubera two years. Long-term studies showed the powder does impair lung function, but only by about 1 percent; the effect doesn't accumulate, and it is reversible after a person stops use, said Dr. Neville C. Jackson, Exubera development team leader.
During the delay, Pfizer held up hiring and purchase of equipment at the Exubera plant.
That all changed when FDA approval was given in late January.
"We're full speed ahead right now," said Foley, a 40-year-old, Irish-born process engineer who in 2000 got the job to direct the insulin plant. New York-based Pfizer built it in Terre Haute because the site had plenty of empty acreage and ready labor exists in the area, Foley said.
Exubera is generating such excitement that Pfizer has taken the rare step of opening the plant to the media and other selected visitors.
"This is such a great product, and there is such a great buzz about it . . . we want to share it," said Foley, punching in a security code to enter the tan, warehouse-sized building where the drug is made.
On Wednesday, Gov. Mitch Daniels is scheduled to take the tour.
Inside the metal-clad, 120,000-square-foot building, outfitted with robotics and sanitized to the hilt, the product takes shape. The insulin crystals are shipped from Germany by plane and truck in stainless steel canisters. Pfizer did dozens of test shipments to figure out the best way to ship the insulin.
It may sound inefficient to use insulin from Europe, but, in fact, the shipping costs make up only a small part of total production costs, with each incoming shipment holding enough insulin for millions of doses of the inhaled product, Foley said.
"It's not like we're rolling up truckloads of product three times a day," he said.
The Exubera plant is closer to a manufacturing assembly operation than a traditional drug plant that does production by the batch. Robotic machinery handles high-speed packaging lines, including filling the foil blister packs that hold spray-dried insulin powder.
The inhaler, which is assembled separately at two other plants, uses a blast of compressed air to release the dose in a cloud of dust that's inhaled by the user.
The plant contains enough space for at least six packaging lines. Once production picks up, the lines will run round-the-clock five days a week, said Foley, standing next to a line that just finished a run of product for the United Kingdom and Ireland.
One challenge: getting the doses precisely right. Each blister contains 1 or 3 milligrams of insulin powder.
Pfizer's marketing department has its own challenge: guessing patient demand for Exubera.
The drug maker doesn't want to run out of supplies of what's sure to be among the most heavily promoted new drugs in pharmaceutical history. |
