MannKind ASM Notes
posted on
May 17, 2012 06:18PM
Edit this title from the Fast Facts Section
5/17/201210am to 11:30am PT
MannKind Annual Meeting of Stockholders
Notes:
Many more people attending than normal – approximately 50 in the room
Al Mann chair of the meeting
~Read the purposes and protocol of the meeting.
Introduced the board of directors present at the meeting: Hakan Edstrom, Abraham Cohen, Ronald Consiglio, Michael Friedman, Kent Kresa, David MacCallum, Henry Nordoff
145 million shares represented at the meeting.
James Shannon resigned from the board at the request of GSK.
~There was no discussion regarding any of the proposal items.
~All proposal items were approved.
~FDA created the guidelines along with MannKind for the two trials now underway.
~Condition of superiority for one trial not required for approval.
~Al returned from China with a request for comparison of Afrezza to Exhubera by the Chinese Vice Chairman Health Ministry … he provided results of the comparison during his formal Afrezza presentation.
Afrezza Presentation (power point slides) by Al Mann
~Briefly mentioned other applications for Technosphere drug loading such as pain medication (i.e. morphine) but said could not discuss these in detail at this time.
~Same as Q1 presentation words focused on diabetes is a huge problem and opportunity and clinician acceptance rate for their practice if approved.
~4 slides added to show comparison of Afrezza to Exhubera for Chinese Vice Chairman of Health Ministry.
20 different characteristics analyzed.
Afrezza clearly superior overall.
Use of graphics (colored arrows) to create comparison of 20 characteristics.
Difficult to distinguish amount of superiority for each characteristic due to presentation approach.
Q & A
1.What is the FDA’s opinion of HbA1C?A: Al thinks he knows but they do not share their opinions and response with MannKind.Improved HbA1c not required by FDA for approval.FDA and MannKind structured the trial (type II) to reduce the HbA1c to provide entry into early diabetes onset.Afrezza slows (or maybe stops) diabetes progression by reducing glucose production which reduces insulin sensitivity.These are the elements which create body organ deterioration.
2. What is FDA’s attitude toward Afrezza?A: Meeting with FDA last Friday indicated very positive responses to each and every matter discussed.After l left the meeting, I am cautiously optimistic for approval.
3. According to the recent Q1 conference call, enrollment for the superiority trial is now not meeting management's estimates due to what appears to be challenging criteria.What are the primary reasons for the exclusions?A: The trial selection requires >7.5 HbA1c for inclusion.We have had a larger than expected number of participants between 7.0 and 7.5 which would not qualify for the trial threshold.(This would also impact the superiority result).Afrezza does not produce a negative component to the averages.Only a slight improvement to the numbers which is insufficient in itself to provide superiority.The trial must improve the fasting glucose as an additional component of the trial (using E Diary compliance checks) to achieve superiority.Afrezza allows the improved fasting glucose to occur simply because of hyperglycemia elimination/reduction.
4. What is the status of European Union submission for Afrezza?A: Regional submissions may be a better step after FDA approval.EU is approximately 1 year after USA approval.The Arab countries may be better and quicker.They also have the money to pay for the treatment.
5. What concern do you have regarding patent expiration?A: We have some 366 approved patents and another 200+ in the approval request process.Some extend until 2030 but I do not know the answer for each patent.
6 .Just prior to the last NDA due date, a hedge fund manager wrote and received attention by a number of FDA executives.Have you discussed this with the FDA and whether it may have impacted their decision regarding Afrezza approval? A: I can’t say very much about this matter except that the FDA last Friday was very positive on all matters regarding Afrezza.
7. Do you stillintend to partner Afrezza?If so, why has a big pharma not concluded a partnership with MannKind by now?A: Yes we are still pursuing partnership opportunities with Afrezza.I don’t understand why we are not getting more traction on the partnership matter.
After Q & A time limit - Me with Matt Pfeffer and 2 other attendees
8. Is dilutive financing still being discussed?A: We continue to review all potential sources of financing.