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MannKind Corporation Will Submit for FDA Approval for It’s SUPRA Inhaled Insulin

It has been described by Jay Skyler, a leading diabetologist, as the first in a new class of diabetic therapies, “Supra-Rapid Acting Insulin’s”, that can change the way diabetes is treated. MannKind’s investigational inhaled insulin product is based on its proprietary insulin Technosphere® formulation and MedTone® inhaler. The Technosphere® Insulin System has some important differentiating characteristics, which makes it not only a leading product in inhaled insulins, but a whole new class. This therapy consists of a proprietary dry powder formulation of insulin that is inhaled into the deep lung using our proprietary inhaler. Alfred E. Mann, states that, “We believe that the performance characteristics, unique kinetics, convenience and ease of use of the Technosphere Insulin System may have the potential to change the way diabetes is treated.”

Note: Just last Friday, MannKind Corporation was awarded the 2006 Frost & Sullivan Award for Product Innovation for its lead product, the Technosphere® Insulin System.

Alfred E. Mann, Chairman of the Board and Chief Executive Officer presented at the Wachovia Securities Small and Mid-Cap Healthcare Conference last week.

He stated that they will submit in 2008 for final approval for the new inhaled Supra-Rapid Acting insulin. It will be for prandial insulin deliver for Type 1 and Type 2 diabetics.

Alfred E. Mann stated that this is a whole new class of drugs to treat diabetes. For the first time you do not have to titrate the insulin, nor count your carbs and it will not cause hypoglycemia no matter how much you use. Doctors will not be afraid to use it, because of its ability not to cause hypoglycemia. Because it is not necessary to titrate, there will be no need to check blood sugars prior to inhaling before eating a meal. It will it probably not even be necessary to educate the patient on the precautions of using insulin.

In particular, we have observed in our clinical trials to date that the Technosphere Insulin System produces a profile of insulin levels in the bloodstream that approximates the insulin profile normally seen in healthy individuals immediately following the beginning of a meal, but which is absent in patients with diabetes

Sit down to a meal, put a cartridge in and press a button and puff. Usually just one cartridge. It will be the first in a totally new class of medications. All other insulin’s are hexameric that need to be broken down in the body, not so with monomeric, which makes it much quicker to react and has a much shorter duration. It will peak in 12-14 minutes and its duration will last only 3 hours, which is the time the food is entering the blood. What is really unique is that it will not cause WT. GAIN. No snacks required!

In our clinical trials to date, we have observed no difference in pulmonary function between patients treated with Technosphere Insulin and patients treated with standard diabetes care. However, the longest study that we have completed so far is a six-month trial.

In a survey of 425 doctors, 9% said they would even recommend it before diet and exercise. They feel that 42% of those requiring insulin will be on this new Supra Insulin.

With the first Phase 3 trial being completed, they have yet to take on a partner.

In September 2006, MannKind completed patient enrollment in a pivotal, two-year, Phase 3, safety study of Technosphere Insulin that will compare the pulmonary function of diabetes patients randomized to either Technosphere Insulin or standard diabetes care. MannKind are continuing to enroll patients in three other major Phase 3 clinical trials two of which are pivotal efficacy trials. They anticipate that their entire clinical trial program, including several special population studies, will involve more than 4,500 patients.

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