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Alkermes, Lilly, Mannkind: Inhaled Insulin Just Got Interesting

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.

Mannkind: Overlooked Biotech With Excellent Prospects (Part VI)

AW-
I'd like to read your thoughts, if you are willing to share them, regarding TI's prospects in light of recent news that the FDA is considering tougher standards, regarding impact on cardiovascular disease, for new and current diabetes drugs, potentially increasing time and cost needed to reach approval.

From the WSJ, "Still, this draft of questions to be considered at next week’s [first week in June '08] panel meeting suggests that the discussion could be pretty wide-ranging. The first question on the list gets to heart of the matter: 'What specific cardiovascular assessments should be required as part of the approval process for drugs and biologics developed for the treatment of type 2 diabetes, and why?'"

Mannkind: Overlooked Biotech With Excellent Prospects (Part VI)

Thanks for your efforts AW. Your writings gave me a good head start on my own DD. Your conclusions are in line with my own. I am impressed enough that I bought today at $2.86.

Although I wonder, as did RJ Steffens, the extent to which dilution will affect an investment in MNKD, I am hopeful that the strong market differentiators apparently possessed by TI will prove a strong enough incentive to lure a good partner for distribution on good terms. The position of Sanofi-Aventis and the three other strong potential partners in this market, combined with the benefits statement for TI compared to the alternatives (for example, predicted market killer Byetta generates nausea and sweats) give confidence that a good marketing partner can be attracted on good terms. The majority owner being so heavily invested personally, the extent of that investment, the total concession of the inhalable insulin market by larger competitors, and the drawbacks to alternatives give me hope that the Zack's report mentioned above is overly pessimistic.

It is also interesting to see the angst your report generates amongst touts and investors in alternatives. So far my DD supports your position over the mostly emotional response your article has elicited.

Success to everyone.

Generex Biotech: A Breath of Fresh Insulin

Author's comments, regarding Mannkind "persisting despite it all," belie an ignorance of the differences between Mannkind's approach and the failed approach employed by Pfizer for Exubera, or a willing obtuseness rooted in a long position in Generex.