Biotech Values

[DewDiligence]

ALKS, LLY Not Fazed by Inhaled Insulin Developments

[Maybe they are, but they’re not acknowledging it.]

http://www.boston.com/business/healthcare/articles/2008/01/18/

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January 18, 2008

Cambridge biotech company Alkermes Inc. said it plans to continue working with partner Eli Lilly and Co. on an inhalable form of insulin for diabetes patients, even though two other drug makers scrapped work on competing products in the past few months.

In October, Pfizer Inc. shelved its Exubera inhaled insulin product, despite spending close to $3 billion developing and marketing the product. The company said too few patients preferred using the device to giving themselves insulin injections. On Monday, Novo Nordisk A/S of Denmark halted development of its own version of inhalable insulin, AERx, after studying Pfizer's Exubera failure

"People had expected something that was simpler than an insulin pen, and they actually ended up with something that was much more complicated," said Mads Krogsgaard Thomsen, Novo Nordisk's chief science officer, in a conference call with analysts.

Doctors and patients said that Exubera was bulkier than injection needles and difficult to use. Thomsen said a breakthrough would be needed to persuade customers to switch to an inhalable version of insulin - something AERx could not deliver.

Some physicians have questioned the safety of inhalable insulin, saying it is unknown what effect the drug could have on the lungs.

Despite the doubts, Alkermes and Eli Lilly said they plan to go forward with their version of inhalable insulin, called Air Insulin.

David Broecker, chief executive of Alkermes, recently told investors that Air Insulin is "better and simpler than the Exubera device."

Rebecca Peterson, a spokeswoman for the company, said Air Insulin users will simply need to insert a capsule, press a button, and breathe. The device is also much smaller than Exubera. Alkermes also said it and Eli Lilly are hoping to produce medical data that highlight the device's benefits.

Air Insulin is currently in late-stage clinical trials for type 1 and type 2 diabetes, and results are expected this year. Tim Coulom, spokesman for Eli Lilly, said the company plans to file an application with the Food and Drug Administration in 2009 for permission to start marketing the device.

The company is not alone. Mannkind Corp., a biotech in Valencia, Calif., is also developing a palm-sized inhalable insulin system, called Technosphere. And Novo Nordisk executives said this week they still hope to develop a new generation of lung treatments for those with diabetes and other chronic diseases.

If successful, new diabetes drugs have the potential to generate billions of dollars in sales. In the United States alone, about 21 million people are thought to have diabetes. Many of them take insulin regularly to help control their blood-sugar levels. Typically, diabetes patients' blood-sugar levels are not regulated naturally because their pancreases does not make enough insulin or their cells do not use it properly.
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