TS deal

[bradleysbest]

When will MNKD announce their 1st TS deal?

[dreamboatcruise]

Three nevers? I'm curious the rationale behind those. If I had created the poll it would not even have occurred to me to have that option. Though I would have put "2017 or beyond" as an option. Maybe "never" was selected because an option for beyond 2016 wasn't available.

[bradleysbest]

Was bored and got to thinking that Matt said a deal was not far off( after the 1st deal, every 6 months after). I could have made it 2017 or beyond but thought it would be interesting to see who does not think a TS deal will happen. Maybe we are on the "brink" and we just don't know it yet! Poll is all in fun while we "patiently" wait for Afrezza to dominte the diabetic market in the USA (and beyond).

[gomnkd]

Aug 3, 2015 10:54:26 GMT -5 dreamboatcruise said:

Three nevers? I'm curious the rationale behind those. If I had created the poll it would not even have occurred to me to have that option. Though I would have put "2017 or beyond" as an option. Maybe "never" was selected because an option for beyond 2016 wasn't available.

I voted for never as it was the closest. I'm sure my post will rile up FUD-vigilantes.

Reason 1: this platform was available for last 15 years, yet no one else had shown any interest to proceed.
Reason 2: You need a chronic disease that has a mass market for economics to work. (Think insulin).

           If you try to use it for pain, first you exclude the whole smoking population, ex-smokers, people with COPD etc. Next the cost of trials would be exorbitant (several 100's of MM). most pain is not chronic, and even if chronic, the target population will be very small. The competing drug will be so cheap that insurance wont pay for it. The docs will show the same reluctance as case of Afrezza.

Reason 3: Folks here talk about vaccine. Why would a BP produce vaccine using TI when 20-25% of population can't use it? How do you vaccinate smokers/COPD pts? You let them die? Do you expect a BP to come up with a parallel delivery? how about double costs, double sku's, production, marketing,....Just not economically feasible

Reason 4: Now, lets consider the chronic variety. You got two options, try on existing drugs (Afrezza) or develop a new drug.
               For existing drug, you do robust ph 3 trials, test for lung function and market it. You make docs use spiro and compete against cheaper existing drugs. The insurance co balks, the pay off is longer and thereby NPV to BP is just puny. Insurance co's give a rats behind about convenience. The exception is if we've a different PK profile that results in superiority. Good luck proving that. This option still remains a possibility. Any BP that has seen MNKD saga and FDA's reluctance will think twice.

               Last option,  a new drug. Problem with new API is that the co. has to start from Ph1,2,3, work on MOA, PK/PD, safety/efficacy ... It'll take 5+ years if they start now to market it. It is again the same spiro issue, unknown lung risk,... Just an uphill battle.

Reason 5: We are way too early in the market for lung delivery. it'll one day succeed, but the day is far into the future to add any value to MNKD. 

In summary, you need chronic disease, high patient pop, superior PK, diverse patient base and a deep pocketed BP for TI to succeed.

I hope I'm proved wrong big time.

[mrv]

gomnkd, your points are very logical. I would also add that Matt sounded more like a car salesman than a CFO, at the last cc, so I am skeptic to what he says, until proven otherwise.
However, just like you, I hope I am also proven wrong big time.

[joeypotsandpans]

Shouldn't it read 2nd TS deal? SNY was the first deal, it is important to keep in mind that Afrezza validates the technology so I discount the it's been around for the last 15 yrs. statement as once it was validated both by users and the FDA approval it changes the whole dynamics. As Afrezza becomes the top selling RAA (Ultra when eventually designated) then it becomes a whole different dynamic. Let's go back to DNDN, they essentially changed the landscape for cancer immunotherapy as far as validating the concept. Once they got FDA approval, how many companies accelerated their programs...dynamics change quickly after the pioneers settle the new landscape. As far as vaccines, I don't know how many third world countries citizens can afford cigarettes...of course those same citizens can't afford the vaccines but places like the Gates Foundation etc., certainly can.

[mnholdem]

I think gomnkd is over emphasizing the lung testing issue. First off, FDA never made lung testing mandatory with Exubera. Why Afrezza? Some would say to put up a roadblock, but I'll give the FDA the benefit of the doubt (barely) that post-marketing tests associated with Exubera may have prompted the change.

Regardless, lung testing for an inhaled insulin that is administered multiple times a day for long periods of time is a MUCH different scenario than the occasional puff for a migraine or other pain. I'm convinced that FDA would NOT make FEV1 lung testing mandatory for other TS drugs. So the majority of the target market could use a Technosphere-delivered API with a warning of possible bronciospasms for patients with COPD only.

Also, it is not too early for pulmonary drug delivery. In fact, there already are inhalable drugs on the market, that have been prescribed for years. There's even an inhaled powder that is used, ironically, for COPD.

-----

Regarding the poll, I don't think this time that MannKind will wait until its drugs are ready for NDA, before securing a distribution agreement with BP. The cost/profit share deal they made with Sanofi may become a template of sorts for future partnerships, with the partner either providing enough of an upfront payment for MannKind to fund FDA trials or the partner handles developmental costs in exchange for a bigger piece of the pie.

Since Technosphere and the four API that MannKind has selected are already FDA-approved, Hakan has stated that MannKind fully expects these drugs to be expedited through the FDA approval process. Tests to prove the efficacy of an API are already established, so FDA trials will primarily involve the PK/PD/dosing studies using Cricket or whatever inhaler is selected for each API.

I think it's entirely possible for MannKind to make a distribution/development deal in 2016, especially if Afrezza sales pick up significantly in 2015.

[dreamboatcruise]

gomnkd... I don't agree with you, but interesting perspective. I said 2016.

[mdcenter61]

I voted for 2016 but I must say that voting "never" did cross my mind, albeit not with the depth and logic in Go MNKD's post. Although its not an absolute that Afrezza's success will dictate whether or not another TS application will be imminent, I think its reasonable to assume that Afrezza's success is a huge factor in TS future; I also think its why Edstrom was waffling a bit in his first quarter CC in stating the hesitant "12 to 18 months" out statement rather than sooner. He knows that the market and prospective partners want to see how Afrezza sells and how widely accepted before putting out a lot of time and money in TS. In that I also hope I am wrong.

Ultimately, I do think Afrezza will be successful and that success should parlay into other TS applications. In that, I definitely hope and have bet I'm right accordingly! Its just going to take a lot more time than I originally thought.

[gomnkd]

mnholdem , a point to ponder. The impact of a new API on lung is unknown. Number crunchers in BP won't make a blanket assumption of "no lung testing" and shoot themselves in the foot if it is needed. We are talking about CEO changes, billion $ write offs etc when things go wrong. The last thing a CEO wants to see is to get kicked out.

My position on this has evolved considerably over time. I'll sell 100% of my shares if MNKD is going to develop anything on their own.

[bradleysbest]

My bad, 2nd TS deal.