MannKind: Afrezza Is Blooming With Scientific Chatter
Jun. 4, 2018 5:06 PM
Afrezza is the Scientific Chatter
Heretofore the clinical significance of Afrezza among endocrinologists and the diabetes community was largely unappreciated. As it may be, things have taken a turn for the better for MannKind and Afrezza—thanks to world-renowned diabetes expert and Chief Medical Officer for MannKind Corporation, Dr. David Kendall. Dr. David Kendall and his team of global diabetes experts have set out on a mission to not only see that Afrezza becomes the Standard of Care, but to be a solution for the global diabetes epidemic.
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Afrezza was the, "shot heard around the world" after Dr. Kendall's scientific revelations with Afrezza. The preliminary data regarding the 65 Afrezza studies was so compelling that Dr. Kendall could only describe it as, "veins of gold". Which to me, simply means scientific data with colossal value.
The veins of gold within the 65 Afrezza studies also reflects a rather large body of previously unpublished clinical information. Dr. Kendall indicated in MannKind's recent Q1 2018 Earnings Call that he and the global diabetes experts, the MannKind Scientific Advisory Board, were closely and carefully examining this new and exciting scientific information as they march forward towards making Afrezza the Standard of Care.
Potential 2018 MannKind Non-Dilutive Sources of Capital and Catalysts
1. MannKind will receive a $2.2 million upfront payment from Cipla within 30 days of entering the agreement, with the potential to receive additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India.
2. There have been almost 200 patients referrals to MannKind Care's since April 1 and many of these have not yet converted into prescriptions. (5/9/18)
—In 2018, approximately eight out 10 patients who are referred to MannKind Care get their prescriptions filled, so we're certainly going to watch this closely in the future but we wanted to share some early trending with you today.
3. The TreT, a Treprostinil Phase 1 single ascending dose study has started, and we are excited about that. As you may have seen last week, the United Therapeutics did a deal for $200 million for a pump. We believe this asset is a significant opportunity for us. We can put a Phase 1 readout that will be Phase 3-ready as soon as we get those results. We believe it's a three-player market with intense competition for differentiation. And we remain committed that Treprostinil will demonstrate that we believe this will show differences in potential dosing and convenience in this category.
—Readout Program on track to for this year ~ Q3 - Q4
4. TreP Phase 1 "SAD" Clinical Trial
—Estimated Primary Completion Date: September 2018
—Estimated Study Completion Date: December 2018
5. Levin (initiating mealtime Afrezza in uncontrolled T2D) Clinical Trial
—Estimated Primary Completion Date: September 15, 2018
—Estimated Study Completion Date: September 15, 2018
6. A-One (T2D) (Afrezza One Drop) Clinical Trial
—Estimated Primary Completion Date: September 30, 2018
7. Pediatric PK Study Part 3 is on track to start this year ~ Q3 - Q4
The Plan
I'm really going to be excited about the people, the culture and the foundation that we will be building at MannKind to ensure that Afrezza becomes the standard of care the meal-time insulin.
—Pat McCauley
So we are focused on continuing to make Afrezza a standard of care.
—Mike Castagna
Another question I often get is what's holding doctors back, why have they not used it. The reality is we've had 65 trials done in the history of the company to get to the point of approval in subsequent last couple of years. The majority of those trials were never published. And so when payers and database searches people look for PubMed to say what is the clinical data behind the product, they don't find a lot of our information. And what we've discovered is when we share our information with the doctors and why we believe the drug should be the standard of care, they're amazed at how data we have. They're amazed at the lung function data, and they really are a little bit surprised.
—Mike Castagna
One of the challenges we've had since we got the product back from Sanofi is really planning for the long-term. And with the capital raised last year and the recent capital raise, we've been able to continue to lay out our plan for the next 18 to 24 months, and execute against that plan. And you will see some of that in the upcoming slides. What that means is we can have evening symposiums, we can have CME events that we can sponsor, we can have booths at all the key conferences, and really [indiscernible] on that scientific chatter around the brand that's been missing since day of launch. So that will give the air coverage to the sales force. We'll continue to bring thought leaders onboard, and David will share the direction we're going in that environment.
—Mike Castagna
We are pleased to convene this board and will be working with them not only looking at the existing data from the 65 trials that have been completed, but looking very carefully and judiciously at any future trials that may be necessary, and most useful in assuring the safe, effective, timely, and appropriate use of Afrezza. An example of some of the outcomes of the work that was started, both before my arrival here at MannKind and our understanding of Afrezza, as a clinical aspect as Mike referred to earlier, is the scientific chatter.
—Dr. David Kendall
We have scientific information being presented at the ADA. We hope to have additional scientific information presented at each of these meetings, and many of the abstracts that have been developed by our medical team are currently under review, and we hope will be accepted for presentation at these upcoming meetings. So the scientific chatter is growing, and we believe making this scientific information available to clinicians to understand dosing, the effectiveness, safety and appropriate use can do nothing but support the commercial efforts that Pat and his team have put forth to better serve the diabetes population will require more effective meal time insulin therapy.
—Dr. David Kendall
We had previously announced the acceptance of both an oral presentation and a poster presentation from the so-called STAT study, a study that was first developed in collaboration with Satish Garg and colleagues at the Barbara Davis Diabetes Center looking at continuous glucose monitoring. And these results will be available in the poster sessions beginning on Saturday of the scientific sessions with an oral presentation being presented on Monday of the scientific sessions. I'm also very pleased to announce that a team here within our medical group took the opportunity to look at data performed from a trial in Type 1 diabetes and assess not just the rates of hypoglycemia, but adjusted total and severe hypoglycemia rates comparing Technosphere Insulin with Insulin Aspart. And these data will be presented as one of approximately 100 late-breaking poster presentations at the American Diabetes Association.
—Dr. David Kendall
Conclusion
For life repays what you put in.
—Al Mann
Let Mikey click it.
