Alkermes, Lilly, Mannkind: Inhaled Insulin Just Got Interesting

Includes: ALKS, LLY, MNKD
by: Michael Shulman

Given market conditions, consider this an exercise in cognitive dissonance or willful denial or some other over-used term. But the topic here is biotech and life sciences, where successes typically overcome all market conditions.

The demise of Novo Nordisk’s (NYSE:NVO) inhaled insulin program - using technology developed by Aradigm (NASDAQ:ARDM) - leaves two serious inhaled programs left for investors to scrutinize.

Eli Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) have developed a product called AIR Insulin that is in phase III clinical trials. Lilly is a market leader in diabetes and insulin products and understands diabetics and the doctors treating them (unlike Pfizer (NYSE:PFE), who blew the commercialization of Exubera, now off the market) and Alkermes is the most successful drug delivery company in the world. If inhaled insulin is to be successful in the marketplace, it will be this tandem that delivers the success. It is an easy to use disposable device (it lasts a month) and is built around the same measurements or units of insulin that is injected.

The other player in advanced stages of development is Mannkind (NASDAQ:MNKD). They have a technology called Technosphere. The company was founded by the founder of MiniMed, Al Mann, who has reputedly put in something near a billion bucks to get the product to market. They still do not have a Big Pharma parent – a major issue – and they and many analysts counter by saying they have the best technology and delivery system for insulin.

What should investors do? Inhaled or oral insulin is a breakthrough product – actually while most scientists believe it will never be possible, an oral insulin would be a revolutionary product -- in the hands of the right marketing company. Pfizer had no idea what to do with Exubera (and is clueless about a lot of other things, but that is for another column) and Novo did not want to spend another half billion to get the product approved and onto the market. Lilly would if it continues to develop and otherwise back the product. No recommendations here – just keep an eye on this opportunity – and if Mannkind gets a partner, things could get very interesting.