Pfizer pitches inhaled insulin to consumers

Approved by the Food and Drug Administration in January 2006, the drug, called Exubera, has been largely spurned by diabetes specialists, generating only about $5 million in sales last year, or one-10th as much as some analysts forecast. Pfizer will start the advertisements in the second half of 2007.

Ads also are scheduled for magazines as part of a marketing strategy designed to overcome the product’s higher cost and the inconvenience of the device used to administer the drug, analysts say. The New York-based drugmaker is risking criticism by members of Congress and physician groups who say consumer advertising encourages excessive use of costly therapies.“Pfizer is now putting on a full court press, creating an expectation with" the ad campaign that “prescriptions should start going up," Jim Reddoch, an analyst with Freidman, Billings, Ramsey & Co. in Arlington, Virginia, said in a research report.

Doctors say the inhaler’s device, as big as a half-liter bottle, is unwieldy. Patients can pay about $600 a year more for Exubera than injectable forms of insulin, under certain health plans. Clinical trials have found the product can reduce lung function for some patients. Pfizer says the condition is reversible and is conducting a five-year study among users to monitor it.

Some analysts reduced by 50 % their 2010 sales estimates, which had reached as high as $1.8 billion when the drug was first approved. Pfizer wants Exubera to help offset revenue that will be lost when several big-selling medicines no longer have patent protection.

Pfizer’s 2006 earnings more than doubled to $19.3 billion, or $2.66 a share. The company’s share price fell 23 cents to $26.07 at the close of New York Stock Exchange composite trading yesterday and have increased 1.7 % in the past 12 months.“I’ve brought it up to a few patients, and many just aren’t that interested in it," says Christopher Saudek, a professor of medicine who specializes in diabetes at Johns Hopkins University. “It is a cumbersome device."

The television ads will target newly diagnosed diabetics who may not want to inject themselves daily, said Ian Read, president of Pfizer’s worldwide pharmaceutical operations. Patients who develop diabetes later in life may put off using insulin because of needle phobia, he said.“The heart of the issue in diabetes therapy is the delay in getting patients to begin taking insulin, a delay that often lasts more than eight years," Read said.

About 14.6 million Americans are diagnosed with diabetes, according to the American Diabetes Association. In the disease, the pancreas either doesn’t produce enough of the hormone insulin or the body doesn’t properly use it. Cells require insulin to turn glucose, or blood sugar, into energy. Untreated, diabetes can lead to blindness, kidney disease, nerve damage and risk of heart attacks and strokes.

Pfizer Chief Executive Officer Jeffrey Kindler at a January analysts’ meeting said it will take longer than 2010 to reach a goal of $1.9 billion in peak annual sales. Pfizer is testing smaller inhalers, though they probably won’t become available until at least 2010, analysts said. Pfizer needs to spur Exubera sales because Indianapolis- based Eli Lilly & Co. and Denmark’s Novo-Nordisk A/S are testing insulin inhalers that are smaller and less complex, analysts say.

Pfizer, which once expected to introduce Exubera by 2002, delayed seeking approval for the device for four years after finding a 1 percent reduction of patient lung function in a trial. While Pfizer has since said any impact on the lungs appears to be reversible, doctors are required to test patients to avoid giving it to those with reduced capacity.The drug’s packaging also says the product shouldn’t be used by smokers because that interferes with the lung’s ability to absorb insulin.

Pfizer also was forced to delay marketing the drug to primary care doctors by several months after last year’s approval because the new technology used to make the product wasn’t initially able to produce large quantities, the company said in an October regulatory filing.

Insurance coverage is another impediment, doctors say. Exubera costs patients $616 more a year than Lilly’s Humalog insulin injection pen under certain insurance plans that provide coverage for recipients of Medicare, the U.S. health plan for the elderly.“Insurers are trying to push people towards cheaper insulin," said Richard Hellman, president-elect of the American Association of Clinical Endocrinologists. “There are many people who would welcome it if it wasn’t for the cost."

Indianapolis-based Wellpoint Inc., the nation’s second- largest health insurer, charges customers more for Exubera than other insulin products because “no meaningful clinical studies are available to demonstrate that its use will result in earlier treatment, improved compliance, improved quality of life, or better long-term outcomes," says spokesman Jim Gavin.Because of the limitations, only about 900 Exubera prescriptions were written on average each week in January, said Wolters Kluwer Health, a unit of Amsterdam-based Wolters Kluwer NV that collects health-care data.Januvia, a new daily pill from Merck & Co. that boosts the body’s insulin production, had more than 28,000 total prescriptions filled the week ending 9 February, said a research report by Bear Stearns & Co. analyst John Boris in New York.

Some 2,300 Pfizer sales representatives have been promoting Exubera to more than 5,000 doctors. Analysts say they are skeptical that consumer ads will produce better results.“We are not aware of any pharmaceutical product that has ever become a blockbuster that was not endorsed by specialists," says Merrill Lynch analyst David Risinger, who last month lowered his initial 2008 sales projection to $175 million from $300 million.

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