Inhaled Insulin - Alkermes/Lilly, Mannkind (MNKD)
Given the market conditions, consider this an exercise in cognitive dissonance or willful denial or some other overused term. But the topic here is biotech and life sciences, where successes typically overcome all market conditions.
The demise of Novo Nordisk's (NVO) inhaled insulin program -- using technology developed by Aradigm (ARDM.OB) leaves two serious inhaled programs left for investors to scrutinize.
Eli Lilly (LLY) and Alkermes (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, 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's an easy-to-use disposable device (that 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. 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 Mannkind (and many analysts) counters 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 (another article) 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.
Comments (1)
Mr. Shulman,
Your article asked a good question. Inhaled insulin or oral insulin? The market seems to be answering the question for us as are many scientist. The answer has been reported over and over and is simple. The lungs are meant for gases and not proteins. Pfizer and Novo have both recognized it. Oral applications are a much better way to go.
Generex Biotechnology has got the best approach and is selling their oral insulin spray (Oral-Lyn) in third world countries with Phase III starting this quarter.
The worldwide market for insulin is projected to be $12 billion by 2010. A 5% share of the market would generate $600 million/year.
As you say in your article an oral insulin would be a revolutionary product -- in the hands of the right marketing company. Generex in the right hand would be a blockbuster.
Have fun,
Monte
Posted by Monte Nelson | January 24, 2008 9:29 PM
Posted on January 24, 2008 21:29