Firms to vie for inhaled-insulin sales
Costly, but seen as hope for patients wary of injections
By Val Brickates Kennedy, MarketWatch
Last Update: 12:05 AM ET May 7, 2005 [ Page 1 | 2 ]
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BOSTON (MarketWatch) -- A handful of drug manufacturers hope to make living with diabetes a little easier -- not to mention capitalize on a potential $3 billion market -- by taking insulin out of syringes and putting it into inhalers.
In the coming months and years, pharmaceutical giants such as Eli Lilly (LLY: news, chart, profile) , Pfizer (PFE: news, chart, profile) and Sanofi-Aventis (SNY: news, chart, profile) will seek approval for these new insulin-delivery devices -- similar to the contraptions used by asthma patients. The first products could hit the market by early 2006.
Not only could inhaled insulin make the drug more palatable among diabetics skittish about injections, but it might also bring a new market into play. The caveat, however, is cost.
'From a reimbursement perspective, there's little argument to be made for a product that's five times the price.'
Ian Sanderson, SG Cowen
According SG Cowen analyst Ian Sanderson, inhaled insulin would cost $4 to $4.50 a day right now, compared with 85 cents to $1 for the injected version. Sanderson's figures are based on four treatments per day of each type of insulin.
Experts have said insurance reimbursement also could be a problem, though that won't be resolved until carriers evaluate the drugs.
"What would discourage higher market penetration would be price and safety," according to Sanderson. "From a reimbursement perspective, there's little argument to be made for a product that's five times the price."
But Sanderson said the current U.S. market for insulin products is $2.7 billion, with overseas sales amounting to another $3.2 billion. He sees inhaled insulin eventually penetrating up to 20% of the Type 2-diabetes market, with peak sales of about $2.8 billion overall.
Is time ripe?
With skyrocketing obesity rates leading to a record number of diabetes cases, the time may be ripe for this new form of insulin treatment. Diabetes, a disease where the body loses its ability to process blood sugars, long has been fought via injections of insulin, a hormone.
The thought of self-injections four times a day, though, is daunting for some diabetics, and many end up foregoing insulin treatment. If blood sugars are not kept in check, diabetes can lead to blindness, cardiovascular problems and kidney failure.
Cost may be a minor concern for those who seek a more user-friendly alternative in inhaled insulin. Because it's less onerous than a syringe, drugmakers and physicians alike hope this new delivery system appeals not only to current insulin users but patients afraid to take the plunge.
"It will certainly encourage people to go on insulin, because there's this fear of needles, especially by older people," said Dr. Martin Abrahamson, acting chief medical officer at the Joslin Diabetes Center in Boston.
Abrahamson said the drug could aid diabetics by encouraging them to go on insulin earlier in the progression of their disease.
"Insulin is still the most efficient way to lower blood sugars," he said.
Affecting 6.3% of population
According to the American Diabetes Association, 18.3 million U.S. residents -- 6.3% of the population -- have the disease, which worsens over time.
The illness has two forms. Patients suffering from Type 1, also known as juvenile diabetes, cannot produce any insulin and thus depend on shots from an early age.
Type 2 patients, also known as adult-onset diabetics, gradually lose the ability to process insulin. About 90% of all diabetics have Type 2, often triggered by such factors as family genetics, age and, in particular, obesity. This form of the disease first is treated with nutrition and diet, and then later with oral medications.
Eventually, 25% to 30% of all Type 2 diabetics will need to go on insulin, but many refuse to take that step. Most experts believe inhaled insulin would be best suited, at least initially, to this patient population.
"There's big resistance from Type 2-diabetic patients to go from oral agents to insulin," said Dr. Enrico Cagliero of the Diabetes Center at Massachusetts General Hospital in Boston. "Patients seem to be more open to inhaled insulin."
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Pfizer and Sanofi-Aventis have teamed up with Nektar Therapeutics (NKTR: news, chart, profile) on Exubera, which recently became the first inhaled-insulin product to file for U.S. regulatory approval.
"This product is for everyone who is on insulin and people on oral medications who are failing," says John Patten, co-founder and chief medical officer of Nektar.
"This disease is taking a terrible toll. Diabetics are losing their limbs, their eyesight and their kidneys," Patten said. "And one of the reasons it's doing this is because people don't like to take insulin shots."
The Exubera application was accepted by the U.S. Food and Drug Administration on March 2 for the treatment of Type 1 and Type 2 diabetes. If the review goes smoothly, Exubera could be approved by late 2005.
Other contenders
Other contenders include Lilly, teaming with Alkermes Inc. (ALKS: news, chart, profile) ; Novo Nordisk, with Aradigm Corp. (ARDM: news, chart, profile) ; and biotechnology group MannKind Corp. (MNKD: news, chart, profile) . All of their products are entering late-stage development.
The Lilly-Alkermes version is called Human Inhaled Insulin Product, or HIIP. According to Lilly, the companies should wrap up their Phase II clinical trials midyear, making a 2008 U.S. filing possible.
Danish firm Novo Nordisk, a major player in the international diabetes market, has paired up with Aradigm to develop its product, AERx iDMS.
The companies recently placed their Phase III clinical trial on hold to re-examine dosages because it was found that the drug was leaving the body too quickly. Novo Nordisk recently said it would make a decision on how to proceed with the remaining Phase III trials at year's end.
A fourth product, the Technosphere Insulin System, is being developed by MannKind. The company said Technosphere, in Phase III clinical testing, could be ready for an FDA-approval filing in early 2008.
So far, MannKind has developed the product without a major pharmaceutical partner, no small feat for a company attempting to develop a mass-market drug.
'I think there's room for several products. We'll see how patient preference drives market share.'
Douglas Muchmore, Eli Lilly
"We're not excluding the idea of a partnership. We've been entertaining the idea of entering into some partnership," said Hakan Edstrom, MannKind's chief operating officer. "But when we're looking at partners, we're being stringent."
Each product uses a different delivery mechanism, but the FDA could end up approving all of them if each is found to be safe and effective.
Respiratory concerns
While most data show inhaling insulin is as effective as injecting it, some medical professionals still wonder whether long-term use could negatively impact lung function, especially in patients with respiratory problems.
Smokers, for example, absorb inhaled insulin at different rates than nonsmokers. As a result, Pfizer and Nektar seek approval of Exubera for nonsmokers only.
"There appears to be no significant decrease in lung function," said Joslin's Abrahamson. "But that's a clear factor the FDA would take into account. There would have to be no effect on lung function."
At least some analysts have said they believe the FDA will have enough concerns that the agency will ask companies to run additional safety trials, which would be likely to delay approvals.
Others said they expect the FDA to approve the products, but with restrictions advising they not be used on patients with lung problems, at least until more long-term data are available.
"It's still too early to tell the safety profiles of each," said Robert Hazlett, an analyst for SunTrust Robinson Humphrey.
Comparisons
Do any of the products hold an advantage?
"The products all have different attributes," said Douglas Muchmore, a leading diabetes researcher for Lilly. "I think there's room for several products. We'll see how patient preference drives market share."
While Lilly and Novo have larger stakes in the worldwide diabetes market, Pfizer and its mammoth sales force targeted at general practitioners could easily grab a large slice of the pie with an early launch of Exubera.
"With a 2 1/2- to 3-year lead time, Pfizer will have a blockbuster product on its hands," Hazlett said.
'With a 2 1/2- to 3-year lead time, Pfizer will have a blockbuster product on its hands.'
Robert Hazlett, SunTrust Robinson Humphrey
Pfizer and Nektar, though, face formidable competition if Lilly and Alkermes also receive approval. Lilly's device already gets attention for being noticeably more compact than that of Pfizer, a potentially huge selling point among convenience-minded consumers.
MannKind's Technosphere system reputedly works faster than the other three, due to its drug-delivery formulation. That quality, according to analysts, could give the drug an edge with certain patients.
And the Novo Nordisk-Aradigm device has its own advantages. Using a liquefied version of insulin and a battery-powered device, AERx can deliver more minutely metered doses of the drug, a potential advantage for some patients.
AERx also keeps a dosing log, which could come in handy for patients who need monitoring or more precise measurements.
"Aradigm's device having some electronics has some advantages," Hazlett said. "They'll be a decent presence in the market."
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