AFREZZA™ is a novel, ultra rapid acting mealtime insulin therapy developed by Mannkind Corporation and marketed by Sanofi. Visit the official site www.afrezza.com for more information. The investor/patient should not rely on this blog as it could be inaccurate & incomplete. The blog was originally written for investors to get a better understanding of the drug while it was in the development stage. As Afrezza is approved, the author does not wish to post anymore.
There are quite a few positive developments for Mannkind corp in Q3.
The major uncertainty was the financing. The stock was under pressure in anticipation of some dilutive financing. The news of senior debt issue of $370.0 million was a welcome relief to the common shareholders. The interest rate on this debt is not yet made public. The debt issue should be enough to cover the costs of the new Phase 3 trials.
Here is the break down of the net cash used in operating activities. Given the recent right-sizing, the cash burn rate should be lower than the past years. The net cash used in operations for the first 6 months of 2011 is ($67,447,000).
Moving on to the second uncertainty, Mannkind has had successful meetings with the FDA, confirming the protocols for Type 1 & 2 studies.
Study 171 (Link to clinicaltrials.gov website MKC-TI-171) is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients will be optimized on their basal insulin regimen, subjects will be randomized to one of three arms: a control arm, in which patients utilize injected rapid-acting insulin at mealtimes, or one of two AFREZZA arms, one each for the MedTone and next-generation device. After the mealtime insulin is titrated, there will be a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter.
Estimated Enrollment: 471
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Study 174 will assess AFREZZA using the next-generation inhaler in patients with type 2 diabetes who are inadequately controlled on metformin with or without a second or third oral medication. Patients will be randomized to treatment with AFREZZA or placebo in a randomized fashion. The study will have a titration period, followed by a 12-week observation period to assess HbA1c levels.
I couldn’t locate this study in clinicaltrials.gov. Al Mann has this to say in latest PR "We are very encouraged and pleased with this outcome. Our attention now turns to the execution of these trials. The protocol for Study 171 has already been sent to Institutional Review Boards and the protocol for Study 174 is being finalized and will be distributed to our sites shortly."