1. 2009 Pfizer wanted just Mannkind Stock for the factory in Germany.
2. Sanofi had first right of refusal and swooped in and took that factory.
3. That factory wasn't for insulin API but Inhaled Insulin production.
4. Mannkind paid $3 million for $10 Billion sales worth of API Insulin from Pfizer.
5. When Sanofi bought the factory I said they will be the partner and indeed a Billion dollar deal happened
6. Mannkind has a factory to create inhaled pharmaceuticals and the Danbury factory is a double award winning
factory build with State of the Art Starrett and Harro Hofflinger equipment.
7. The inhalers won a Global Inhaler competition for the best inhaler over Merck and all others.
8. The Inhaled insulin Afrezza is the worlds only active Monomeric human insulin besides mother natures own and indeed is also the only insulin that
shows no amyloid deposition. (this is important as all hexomeric insulins SC or inhaled exhibited amyloid deposition but not Afrezza Monomeric Insulin) (yeah this is huge but under reported)
shttps://allmannkind.wordpress.com/2019/06/02/safety-of-technosphere-insulin-afrezza/
Test article and Technsophere
particle findings in the nasal cavity of rats were limited to the presence of
eosinophilic globules in the olfactory and respiratory epithelium that were considered
nonspecific responses to chronic, high level administration of particulate materials.
After 39-wks in dogs, there was a low incidence of minimal to mild alveolar
and/or bronchial interstitial neutrophil infiltrate in the lungs at the high Afrezza™
dose. This cellular infiltrate regressed completely during the 8-wk recovery period.
Based on evaluation of H&E stained tissues, there was no evidence of amyloid deposition
in any portion of the respiratory tract in either species. Inhalation of
Afrezza™ up to 104 wks in rats and 39-wks in dogs did not increase PCNA labeling
in alveoli, large bronchiolar or terminal bronchiolar tissues. Based on no test article-related adverse findings in the lungs or increases in cell proliferation in rats or
dogs, the no adverse effect level was established in both species as the highest studied
doses. Chronic inhalation of Afrezza™ was well tolerated and supports the safe
use of this NME in humans over extended periods.