why push the US market first?

[dinvestor89]

Question:  With the FDA's expensive and long approval process, why did afrezza decide to seek US penetration first?  Why not choose an easier market to penetrate?
(Yes Afrezza is technically approved, but with a black box warning and not yet approved for children  (something I believe will be a big market), also I believe there are further FDA tests that need to be conducted)

My guess is, if it works in America it'll work everywhere?  But I feel we could have focused easier markets with less regulation.  Curious other peoples thoughts on this?

This was my first investment, and I'm keeping my money here until MNKD gets sold, falls apart, or allows me to retire at an early age.  Haha

[dreamboatcruise]

Apr 7, 2017 13:31:32 GMT -5 dinvestor89 said:

Question:  With the FDA's expensive and long approval process, why did afrezza decide to seek US penetration first?  Why not choose an easier market to penetrate?
(Yes Afrezza is technically approved, but with a black box warning and not yet approved for children  (something I believe will be a big market), also I believe there are further FDA tests that need to be conducted)

My guess is, if it works in America it'll work everywhere?  But I feel we could have focused easier markets with less regulation.  Curious other peoples thoughts on this?

This was my first investment, and I'm keeping my money here until MNKD gets sold, falls apart, or allows me to retire at an early age.  Haha

Simple... they can charge way more in U.S. than elsewhere.   Might also be that they would view additional risk in other markets.  For instance in much of EU you not only have to get the drug approved for use, you then have to convince the national health systems to cover it in order to be successful.  And if health systems did adopt it, they might be very strict about using it only in a step scenario or only for patients who really "can't" do injected for some reason.  We're struggling in U.S. to get adoption but at least it isn't an all or nothing scenario as it would be in countries with nationalized medicine.

Just my random thoughts on that issue, but perhaps also relevant to issue of attracting marketing partners internationally.

[matt]

There are few markets with less regulation than the US that also present significant market opportunities. Most countries with a stream-lined approval process will rely on an FDA or EMA approval in lieu of their own process, but you still have to have FDA or EMA approval first and, for most drugs, there is little difference between what the FDA and EMA will require for approval.

dreamboatcruise hinted about pricing with national health systems, which is only partly true since most countries have a dual public/private market with differing prices, but even when private reimbursement is available it is almost always less than in the US. Germany, Netherlands, Austria, some of the Nordic countries reimburse on the order of 80% of US price for many scripts, but the rest of Europe is more price sensitive with the Mediterranean countries very price sensitive. About the only large country with prices higher than the US is Japan, but then the approval process is similar to FDA with significant added costs and a much longer time line.

The fact that the world contains 7 billion people while the US only has 300 million is true, but the idea that foreign countries are easier to penetrate or that untold riches await those willing to hop on a plane is largely an illusion. I have spent a good part of my career doing business development both here and abroad (I have 3 million frequent flyer miles to prove it) and I can tell you that the grass is not always greener on the other side of the ocean. Far from it.

[dreamboatcruise]

matt... funny, I nearly added a note at the bottom of my post saying we need Matt to weigh in. I should have just waited.

[dinvestor89]

Cool.  Thanks for the info.  I suspected there were reasons for choosing the US, was just curious as to what they were.

[sayhey24]

Apr 7, 2017 13:31:32 GMT -5 dinvestor89 said:

Question:  With the FDA's expensive and long approval process, why did afrezza decide to seek US penetration first?  Why not choose an easier market to penetrate?
(Yes Afrezza is technically approved, but with a black box warning and not yet approved for children  (something I believe will be a big market), also I believe there are further FDA tests that need to be conducted)

My guess is, if it works in America it'll work everywhere?  But I feel we could have focused easier markets with less regulation.  Curious other peoples thoughts on this?

This was my first investment, and I'm keeping my money here until MNKD gets sold, falls apart, or allows me to retire at an early age.  Haha

Simple, Al underestimated the push back from the FDA due to Big Pharma pressure.  All he was trying to get was approval on monomer human insulin, the same insulin secreted by the pancreas.  He never expected the first CRL let alone the second. Hey, R human insulin was already approved.  All he needed was "device" approval not drug approval.  It turned into a big mess.

The plan once approved was to work the kinks out of the new manufacturing process and pilot afrezza on a small scale while having the marketing partner do additional trials and get EU and other approvals.  They would then announce the Gen2 inhaler for the big product launch after sale to the partner.  For the first approval they didn't even have the current three production lines.

The Pfizer decision to drop Exubera was a real curve ball.  The hope was Pfizer would make the market for afrezza and since afrezza was so much better it would take all Exubera sales.  SNY picked up the afrezza deal and Stefan Schwarz immediately knew to really penetrate and change the PCP T2 market he needed to take a different approach - his words not mine.