News From Terre Haute, Indiana

March 22, 2006

Pfizer investing heavily in Valley as it prepares to release new inhaled-insulin drug Exubera

By Howard Greninger

Pfizer Inc. plans to hire more than 450 additional employees by 2009 plus invest $170 million in its Vigo County manufacturing facility for the worldwide production of its new inhaled-insulin drug Exubera, the company announced Wednesday.

“This is the most complex undertaking, from a technical point of view in product development, that we have ever undertaken,” said Nat Ricciardi, president of Pfizer Global Manufacturing, at the company’s facility south of Terre Haute.

“It is a signal of the type of trust and confidence that we have in the citizens of Terre Haute and Indiana to tackle this breakthrough technology. It is a vote of confidence of our people here and citizens of this state,” Ricciardi said.

Pfizer began construction of its manufacturing plant for Exubera in 1999 and already has invested $160 million.

Pfizer has built a 120,000-square-foot production, warehouse and office area and plans to add 60,000 square feet, costing between $65 million and $103 million.

The new plant will help attract and retain college graduates in the county, such as engineers from Rose-Hulman Institute of Technology, said Frank Foley, Pfizer’s site leader in Terre Haute.

“The typical operator-type rates, which is the majority of the positions, range from $18 [per hour] to $25 in terms of different levels of skilled technicians. Then [the salary of] a quality engineer or a scientific job is all over the map, but would be very competitive here,” Foley said.

The drug, now being warehoused in the Vigo County facility, is expected to be released to physicians and clinics worldwide this summer.

Economic incentives to Pfizer include up to $450,000 in training grants and up to $8.5 million in tax credits based on anticipated employment and capital investment from the Indiana Economic Development Corp.

Vigo County in November approved 10-year tax abatements on real property and personal property investments. The abatements are up to $72.1 million in real property improvements and up to more than $183 million in new equipment and machinery.

Pfizer’s 2,000-acre site currently has about 350 employees. Pfizer has been in Vigo County since 1948. The primary pharmaceutical products manufactured are the antibiotics Unasyn, Cefobid and now, Exubera.

Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs before eating, using a handheld inhaler. The inhaler weighs 4 ounces and when closed, is about the size of an eyeglass case.

It is the first inhalable form of insulin for controlling Type 1 and Type 2 diabetes in adults. Pfizer received European Union approval for the drug Jan. 26 and U.S. FDA approval Jan. 27.

Type 1, which affects 5 to 10 percent of people with diabetes, requires a person to take insulin to survive. Type 2 diabetes is when a person’s body does not make or use insulin well enough to manage blood sugar levels and requires a supplement of insulin.

Diabetes is an epidemic disease that affects more than 358,000 people in Indiana, nearly 21 million in the United States and as many as 200 million worldwide, said Jeffrey Kindler, vice chairman of Pfizer.

“The economic cost of diabetes in our nation nearly equals the economic output of Indiana,” Kindler said. “This is a medical breakthrough, the first new way to deliver insulin in 80 years. Among our many hopes for this medicine is the hope that Exubera will encourage people who are reluctant to seek treatment for diabetes to come forward and take better care of their health.”

“The hope that is Exubera starts right here … in Terre Haute,” Kindler said.

Insulin crystals are brought from Germany by plane and then transported by truck in stainless steel containers. In a rare viewing of its sanitized facility, the company had one production line operating to show its capabilities.

Six high-speed robotic arms called “Schubert SMB loaders” precisely package blister packs that hold the spray insulin powder. Each inhaler can provide six does of insulin. The packages on this line each contained 3 milligrams of insulin powder.

Ricciardi said Terre Haute’s airport could play a role in the company’s future as it considers transportation links to its plant. “To the extent that one can maximize the transportation hubs that exist, the better off we will be. Reducing cycle time in the processing is very important, so if there were to be a local airport that we can fly the product in, it would be very advantageous to us,” he said.

Airport Director Dennis Dunbar said the airport has been approved as an alternative landing site for a carrier that supplies Pfizer. “We would hope that as this product continues to develop, we would be utilized to help future growth,” Dunbar said.

Exubera could be a major competitor to Indianapolis-based Eli Lilly & Co., which produces the fast-acting insulin drug called Humalog. That drug generated $1.2 billion in sales last year. Analysts differ on how sales of Exubera will grow, but say sales could reach at least $1.3 billion by 2008.

The drug is not recommended for those with lung disease. Concern over harm to lungs delayed the FDA approval for nearly two years. Long-term studies showed the powder impaired lung function about 1 percent a year, but effects are reversible when the drug is no longer used.

Exubera was studied in more than 2,500 adults with type 1 or 2 diabetes for an average duration of 20 months. More patients reported overall preference for Exubera than the injected form, said Rick Chambers, spokesman for Pfizer.

“After you turn age 25, you naturally lose about 1 percent of your lung capacity annually as you age,” Chambers said. “This is a one-time decrease that reverses if the therapy is stopped.”

Ricciardi said Pfizer believes those in the medical community and patients will prefer a non-injection way to administer insulin to that of an injection. “That is part of the forecasting challenges that we have,” he said.

Gov. Mitch Daniels, who toured the facility, said the “eyes of the world are on Terre Haute … It is an event of worldwide significance.”

“These are the kind of jobs we seek in Indiana. It is not good enough in a state in which the average net income has drifted down to 90 cents that the average Hoosier earns for every $1 the average American earns. There has to be jobs that diversify our economy,” the governor said.

“This proves that Indiana is going to be a life science leader as well as a manufacturing and agriculture and agri-business leader,” Daniels said.

Howard Greninger can be reached at (812) 231-4204 or howard.greninger@tribstar.com.