Pharmaceutical companies are looking to put the failure of Exubera, the inhaled-insulin product, behind them for now. But many companies are still working to develop drugs that are delivered through the lungs.
Doctors have been treating asthma with inhalants for decades, and other inhaled drugs are now under development for other pulmonary diseases, like cystic fibrosis or infections of the lung, and a faster-onset version of an existing migraine drug.
“This is a way to deliver high concentrations of medication to the target organ,” said Kevin Corkery, senior director of the pulmonary business unit at Nektar Therapeutics.
Last week, Nektar abandoned its Exubera inhalable insulin program after onetime partner Pfizer Inc said clinical trials discovered that 6 of 4,740 patients given Exubera during a study developed lung cancer.
Because relatively few patients developed the disease and all had been cigarette smokers, it’s impossible to know if Exubera caused their cancer, Pfizer said. But after reviewing the data with the U.S. Food and Drug Administration, the company said it decided to add a warning about the lung-cancer cases to Exubera’s prescription label.
Nektar is developing inhalable dry powder versions of anti-infectives for treating pneumonia in the lung as well as aerosolized forms of antibiotics for patients with cystic fibrosis, a genetic disease that clogs the lungs and other organs.
Pfizer stopped marketing Exubera last year when the drug reported only marginal sales despite the pitch of being more convenient than traditional insulin injections.
The decision cost the company a $2.8 billion pretax charge.
Eli Lilly and Novo Nordisk also ended inhaled insulin development programs this year after Pfizer reported their losses.
However, Tiny MannKind Corp said this week that it remains committed to its experimental inhaled insulin, Technosphere, which it believes holds advantages over the other products.
“The safety issues related to inhaled insulin really center on the fact that it is a growth factor going into the lung,” said Tim Nelson, chief executive at MAP Pharmaceuticals Inc. His company is developing an inhalable migraine drug and an asthma drug for toddlers and preschoolers.
Insulin and related substances called insulin-like growth factors have been shown to increase the risk of developing cancer.
Exubera has always been associated with slight impairment of lung function, requiring physicians to carefully screen and monitor patients for lung disease like asthma and emphysema.
According to Nelson, MAP’s products do not hold that kind of risk.
Results from a pivotal-stage trial of a low-dose aerosol form of a steroid used to treat asthma in children too young to use inhalers are expected later in the year.
“MAP’s technology will deliver about half as much steroid to children under age 5 in three to four minutes, compared with the 10- to 15-minute process they are now subject to,” Nelson said.
The active ingredient in MAP’s migraine drug (MAP0004) is dihydroergotamine, which has been used intravenously for 60 years by hospitals for treating severe migraines.
“The IV infusion can cause nausea and cardiovascular problems, but MAP’s inhaled drug is not associated with those side effects,” Nelson said.
Nelson also said MAP0004 can calm migraine pain in as fast as 10 minutes, compared with 45 minutes to two hours for commonly-prescribed migraine pills.
“We’re treating migraine upstream … there is a much broader spectrum of efficacy,” Nelson said.
The company’s migraine program is expecting the first Phase III results in late 2008.
Morgan Stanley has estimated peak annual sales for MAP0004 of around $250 million and said UDB could see sales of $500 million a year.
Nektar and partner Bayer AG are talking with U.S. regulators about the design of a Phase 3 trial of its aerosolized powder form of the antibiotic amikacin.
An inhaled version of vancomycin for treating antibiotic-resistant, hospital-acquired pneumonia is also in thw works.
The company has partnered with Novartis and Bayer to develop inhalable dry powder versions of anti-infectives tobramycin and ciprofloxacin for cystic fibrosis patients.
Gilead Sciences Inc, the world’s second-most highly valued biotech company, will hear in September whether the U.S. Food and Drug Administration will approve its application for cystic fibrosis drug aztreonam lysine for inhalation.
Analysts estimate that Gilead’s drug will see sales of more than $500 million a year.
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