Pfizer insulin wins US approval
The Pfizer Inc product, Exubera, was approved for adults with either Type 1 or Type 2 diabetes.india Updated: Jan 28, 2006 12:46 IST
The first inhaled version of insulin won US approval on Friday, offering an alternative for some of the daily shots millions of diabetics use to control blood sugar and prevent complications from the disease.
The Pfizer Inc product, Exubera, was approved for adults with either Type 1 or Type 2 diabetes. Industry analysts forecast sales will top $1 billion a year.
More than 5 million Americans use insulin daily to help manage blood sugar levels and prevent complications such as heart disease, blindness and limb amputations.
Exubera is not a substitute for all of the insulin shots many of them need. The new product is a short-acting powder form of insulin that can be taken before meals. Many patients, including nearly all Type 1 diabetics, still will need to get long-acting insulin by injection, Food and Drug Administration officials said.
Exubera "will not replace all injectable insulin and should not be used by smokers," stressed Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Smokers should avoid Exubera because more of the inhaled insulin gets in their blood, putting them at risk for an overdose.
FDA officials also advised against use by patients with asthma or other chronic lung conditions until more research determines if inhaled insulin is safe for them.
The Exubera inhaler, invented by Nektar Therapeutics Inc, weighs about four ounces and is about the size of an eyeglass case when closed, Pfizer said.
Side effects include coughing, shortness of breath, sore throat and dry mouth.
Pfizer promised further studies of long-term safety. Some patients in clinical trials experienced a small decrease in lung function but it did not worsen over two years of study.
The company said Exubera would be available by mid-year and could lead more diabetics to consider insulin.
"Many people who could benefit from insulin are fearful of injections, so they delay treatment five years or 10 years, placing them at risk for serious complications," Dr William Cefalu, chief of nutrition and chronic diseases at Pennington Biomedical Research Center in Baton Rouge, Louisiana, said. Cefalu was one of the researchers on Pfizer's studies.
Dr. Richard Jackson, a senior physician and investigator at the Joslin Diabetes Center in Boston, said interest in needle-free insulin may be less than expected.
"There's a common misperception that the problem with taking insulin is it's a shot and shots hurt ... I can tell people insulin injections are painless or nearly so" thanks to insulin pens and other devices, he said.
Analysts predicted big sales for the novel therapy.
"I think this could be a $1 billion-a-year-drug and is the kind of product Pfizer needs," said Oppenheimer & Co analyst Scott Henry.
Henry said eventual sales will be limited, however, by the lack of long-term safety data.
Although Pfizer has revenue of more than $50 billion a year, Henry said Exubera and other new drugs collectively could help stabilize the company's finances and boost its lackluster stock price.
Henry said Pfizer shares were trading for only about 12 times the company's annual earnings per share. But he said he expects shares to reach "at least 14 times earnings" in the next year.
Several other companies are developing inhaled insulin products, including Eli Lilly & Co. and Alkermes Inc, which are partners in one project, and Mannkind Corp, Kos Pharmaceuticals Inc and Novo Nordisk.
Pfizer shares gained 3.8 per cent to close at $25.99 on the New York Stock Exchange. Nektar shares jumped more than 5 per cent after the Exubera news but closed up just 13 cents at $20.75 on Nasdaq.