LONDON (Thomson Financial) - Australian biotechnology company Phosphagenics Ltd said it has received ethics approval for a Phase 2 clinical trial of its patented transdermal insulin delivery system, TPM/Insulin on patients with Type 1 diabetes, with the trials due to start in April.http://www.forbes.com/markets/feeds/afx/2008/03/19/afx4791567.html
(and with some mint flavoring it could freshens your breath too!)
WORCESTER, Mass., March 25, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has received a Purchase Order for 210,000 canisters ofGenerex Oral-lyn(tm), the Company's proprietary oral insulin spray product, from Shreya Life Sciences Pvt. Ltd. ( www.shreya.co.in), the Company's distributor in India. This is the first Indian commercial order for the Company's flagship product. Generex Oral-lyn was approved for sale in India in late 2007 and is the first non-injectable buccal insulin to receive Indian approval. Generex Oral-lyn is delivered into the mouth via the Company's proprietary RapidMist(tm) device. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not enter the lungs.
The only insulin formulation that does address cranial level separately from fasting modes is Technosphere Insulin. No other insulin even comes close. Good control cannot be achieved through cranial kinetics that is at least those achieved as good as Technosphere Insulin is. So please don’t compare Technosphere Insulin to Exubera.
Exubera was simply a relatively inconvenient means to deliver insulin with no clinical advantage, and at higher costs and with questions about safety. And don’t even compare Technosphere Insulin to any other inhalable insulin. The Lilly Alkermes product has a tail long after a cranial glucose challenge. They assert that the long tail helps to address basal requirements. As I have said earlier good control requires independence so their approach is unlikely to offer any clinical advantage.http://seekingalpha.com/article/69624-mannkind-corporation-q4-2007-earnings-call-transcript?source=homepage_transcripts_sidebar
I think there is more than simple needle phobia required to make any of these a contender. Simply put the needle isn't the only pain about insulin.
Getting the right amount, in a reliable way, with a known absorption profile is the real pain. I am not so sure that wall street market analysts get that. OK I am sure they don't get that even if MannKind tried to talk about it.
Importantly, Technosphere Insulin has the potential to prove really valuable in treating type 1 and the entire spectrum of type 2 diabetes, even pre-diabetes. Our target markets include type 2 patients who are currently using conventional therapies other than insulin, even including those currently using diet and exercise therapies but who are having difficulty achieving proper blood glucose control.
Read any T1 forum like CWD, Type1Parents or ADA. You don't hear a lot of griping about needles. But they sure can get fired up about what a pain in the arse NPH is.
You also hear a fair amount of concern about long term consequences. Now the long term is something Wall Street has NO CLUE about. They live even more glued to quarter to quarter numbers than someone obsessed with their A1C check ups.
We manage A1C for the long term. So we think about the long term consequences of therapy. We get smoking has long term lung problems and worry about inhaled insulin delivery.
To their credit MannKind is all about how they don't see it hurting lungs.
We previously announced the clean results of a two-year lab study and now a six-month study with no evidence of microscopic tumors. These and other extensive laboratory and animal studies have demonstrated that FTKP and Technosphere Insulin do not and I repeat do not affect lung tissue. We have seen none of the effects, even any that are minor, that have been seen with some pulmonary insulin.I think the average parent is going to require more than two years before the put something in their kids lungs. Now a needle phobic type 2 may be a more attractive market.