I have had the honor and privilege to interview Alfred E. Mann, CEO of Mannkind corp. I want to thank him for taking time from his busy schedule. This is an original interview and has not been posted anywhere else. I received his written answers on June 3rd 2010.
This June is a crucial month for Mannkind. The company is meeting with the FDA to address the issues raised in the complete response letter and the submission of additional data, that includes the bio-equivalency data for dreamboat inhaler.
1) Critics of inhaled insulin say, even with Afrezza, people with Diabetes still have to take injections. Is Mannkind planning to come up with basal inhaled insulin using the Technosphere particle in near future?
Mr. Mann: AFREZZATM addresses prandial (mealtime) glucose. But glucose is supplied by the liver between meals so in type 1 and late stage type 2 a person also needs a basal insulin. Basal insulin today requires one or two injections daily. However, for the 70% of type 2 diabetics who have not progressed to basal/bolus therapy. AFREZZA alone without basal injections has provided excellent control in a recent trial.
MannKind has been exploring various technologies to provide better basal insulins. We cannot yet speak about these.
2) Is there sufficient data to get approval in Europe,
and other countries for Afrezza? Japan
Mr. Mann: We have extensive data that is adequate for approval in most countries However, the European Union requires a separate ultrasound study for cardiovascular risk. That measurement is being done in one of our current studies but the data won't be available until next year. In the AFREZZA trials the CV risk for the US FDA was only 1.01 --- showing essentially no risk and far below the Agency's acceptable level of 1.30.
3) What is the time line for launch of Afrezza outside US?
Mr. Mann: We are planning to file for the EU next year. Many countries quickly follow US FDA approval and several of these are already in discussions with us. There are a few such regions in which partnerships could likely be finalized outside of a “global” partnership.
4) Has Mannkind found licensing opportunities for the Technosphere platform?
Mr. Mann: We are in discussions for several opportunities to deliver drugs with the Technosphere platform.
5) If Mannkind signs a partnership for Afrezza, will it include only the TI (Technosphere insulin) or both TI & the platform?
Mr. Mann: Our partnership talks on AFREZZA at this time are only for TI and not on the platform. We are in several separate discussions for use of Technosphere with other molecules.
6) You have seen the potential of Technosphere particle a decade back, given all the results of trials done so far, what aspect of TI surprised you the most?
Mr. Mann: I have long recognized that there is no need for complex titration of AFREZZA for different meal sizes. What has surprised me most is that in Study 119 it seems that in type 2 --- at least before end stage --- a person can take a dose of AFREZZA and will not have a hypo even if nothing is eaten.
7) Over the years, do you think FDA significantly tightened the regulatory processes and stacked the odds against start up biotech companies?
Mr. Mann: The FDA has certainly tightened the regulatory process, in my view beyond what is necessary. The absolute aversion to risk in the
is likely to choke off innovation. US
8) Critics say, even if FDA approves the drug, the sales of inhaled insulin won't be great. Are you still confident that Afrezza will see billion+ dollar sales?
Mr. Mann: We have had multiple market surveys performed with physicians that all refute the assertions from the naysaying analysts. In a survey performed last year with 613 physicians, about half in the US and half about equally divided in the five major European markets, there were almost uniform projections that about 25% or more of their patients would be appropriate for AFREZZA, and that they expected to adopt AFREZZA for most such patients within one year (over 90% of the estimates at one year).
9) Given the costs of running a public company, the hostile reception of Wall Street & others, if you have to do it all over again, would you have kept Mannkind private until FDA approval?
Mr. Mann: Being a public company certainly has its disadvantages, yet a benefit is that so many people are now aware of AFREZZA and this may expedite early use. Perhaps we would have been better off keeping the company private, but we cannot turn back the clock.
10) Do you think Mannkind’s oncology drug has better potential than Dendreon’s ProvengeTM?
Mr. Mann: As to our oncology program, our vaccines certainly have many potential advantages over ProvengeTM. Our vaccines are "off the shelf' and far less costly. Our early clinical trials are very promising and appear to be more effective, at least for certain cancers. On the other hand we are at least three years away from approval.