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San Diego (CNN/Money) – Diabetics could spend years waiting to inhale.
Billions of dollars could be made from insulin that is inhaled, not injected, say analysts who follow the industry, but health concerns could delay its entry into the market.
At least eight drug makers are developing insulin that can be absorbed into the blood through the lungs to treat diabetes.
With Exubera, Pfizer, the world's largest drug company, and Sanofi-Aventis, the third-biggest, were the first to file with the Food and Drug Administration for regulatory approval of inhalable insulin.
Some analysts believe Exubera will be a blockbuster. But the drug, which was developed by Nektar Therapeutics (Research) and then licensed to Pfizer (Research) and Sanofi-Aventis (Research), has been held up for years.
Pfizer and Sanofi filed Exubera's application with the FDA in this past March. But analysts said that the FDA could spend more than two years evaluating the drug, because of a lack of long-term tests establishing whether Exubera would cause respiratory problems for smokers and its effect on children.
Diabetics cannot produce enough insulin to turn sugar into energy, so they usually inject insulin into the blood. Some diabetics can also take pills, which deliver less insulin.
Exubera is a dry, fine-powdered insulin that is inhaled into the lungs and then absorbed into the bloodstream.
Dr. Bill Canovatchel, senior medical director for Pfizer and the company's team leader for worldwide diabetes, acknowledged that Exubera does not have long-term testing that specifically addresses the drug's effect on smokers and children. But he noted that Pfizer has still done considerable testing.
"We have submitted a rather extensive and comprehensive submission," said Canovatchel.
Dr. Jay Skyler, a University of Miami professor of medicine and an associate director at the Diabetes Research Institute, said that Exubera and other inhaled insulin products could benefit from longer-term studies.
But Skyler said that Exubera still deserved FDA approval. "Inhaled insulin is effective, has no serious health issues and should receive regulatory approval," said Skyler. "I suspect the FDA will examine [Exubera] carefully because it's the first of its kind to go through there, but I think it meets the regulatory hurdles."
Skyler was speaking Saturday at the American Diabetes Association's annual conference.
Big market seen
Bernstein Research projects Exubera sales to hit $600 million worldwide in 2011. Bernstein set its sales figure low because it factored in the possible effect on smokers, which could lead to a restrictive label.
Also, Bernstein analysts think the FDA might take a long time to test Exubera because it might be regarded as a convenience, rather than serving a medical need.
Other analysts are more bullish. David Steinberg of Deutsche Bank North America projects that Exubera will enter the market by mid-2007, making $250 million in sales that first year. The drug will make $1 billion in 2008, achieving blockbuster status, and drug sales will peak at $2 billion to $3 billion, said Steinberg.
Steinberg said that 13 percent of all patients with type 2 diabetes, the most common form of the disease, will eventually use Exubera. More than 90 percent of the 18.2 million diabetics in the United States have type 2 diabetes.
The numbers of diabetics are expected to grow as the population ages and becomes more obese, exasperating a health problem that some analysts call "diabesity."
Andrew McDonald, analyst for ThinkEquity, has projected sales at $500 million to $1 billion once the drug enters the market.
"[Exubera] offers patients a treatment option they've never had," said McDonald. The analyst noted one drawback: When it comes to delivering insulin into the bloodstream, inhaling isn't as effective as injecting. As a result, inhalable solutions require more insulin and will likely be more expensive to produce. But, says McDonald, Pfizer may be able to charge a higher price for it.
Other companies are trying to close in on Exubera's lead. Eli Lilly & Co. (Research), Alkermes (Research) and Mannkind Corp. (Research) are also developing dry powder insulin products.
Novo Nordisk (Research) and Aradigm Corp. (Research) are developing inhalable liquid insulin. Exubera is at least two years ahead of its competitors-in-testing.
These companies will most likely learn from Exubera's lead as it runs into regulatory hurdles. "There will be a lot of post-market surveillance," said McDonald. "There's going to be questions about inhaled insulin over the next three to five years."
Skyler has provided research support for most of the companies in this story. The other analysts interviewed for this story do not own stock in these companies. Deutsche Bank owns some Pfizer stock but Bernstein and ThinkEquity do not have relations with the companies.
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