Alkermes, Lilly, Mannkind: Inhaled Insulin Just Got Interesting

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 (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 (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 (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.

Comments

[jimmy Turano:]

Mr.Shulman, your article regarding inhaled Insulin
was quite interesting. I didn't know that there are two programs left to consider. Now that NVO is out and broke their agreement with 'NSTK' on Jan.16th
according to yesterdays press release, do you think
in your opinion that 'nstk' doesn't have any chances left in the inhaled insulin programs?
Even though the stock price is down almost 80% in the past 12 months, you must admit the company has been around for 24 years already and management still keeps filing for shelf registrations and somebody keeps buying it.

2008 Jan 23 06:42 AM

[Jolly_Rancher:]

Very poorly researched article. Lily terminated the inhaled insulin program March 2008. www.biospace.com/news_... Mannkind has the last inhaled insulin program because Afresa is the only one that actually works. Mannkind has the ENTIRE market.

Jan 26 10:21 AM

[aracer:]

Mr. Shulman -

Thanks for the heads up. I did a quick search on Lilly and Alkermes to get teh latest and it looks like Lilly pulled the plug on the AIR program with Alkermes. It also doesn't show up in Alkermes pipeline on their website. If I read it correctly the were not seeing a clear clinical benefit, which would mean they would not get insurance reimbursement, so the cost of further testing outweighed the upside. Here is the article:

I also looked up Nastech while I was at it

www.in-pharmatechnolog...

Mannkind does appear to have clinical benefits over current treatments. Their CEO says their therapy can "produce exceptional control of postprandial excursions, with very little, if any, risk of hypoglycemia, no need for complex meal titration, and no weight gain, even generating weight loss for prior insulin users." That would be a pretty nice set of clinical benefits. It looks like Phase 3 data is back and they report the therapy safe and efficacious with an NDA filing planned soon.

While I was at it I looked up NSTK for Jimmy. It looks like they changed their name and symbol. They are now MDrNA trading as MRNA and they no longer have any diabetes compounds in their pipeline, as they are now focusing on RNA compounds.

Jan 26 10:26 AM

[Jolly_Rancher:]

OOps. My apologies. I notice the date of your article is 2008 rather than 2009. You were right then that these were the only two therapies remaining at that time. Lily killed the program in March.

Jan 26 10:54 AM

[Obi.Wan:]

XOMA 052 will revolutionize diabetes care, insulin will no longer be required as it treats the actual source of the problem. Review the clinical trials, it's the future of diabetes management.

Nov 10 10:11 AM