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Post by dreamboatcruise on Feb 2, 2016 18:09:57 GMT -5
I agree with Matt. SNY tried a traditional approach and failed. They didn't sandbag it, meaning intentionally trying to bury it. I think the new CEO concluded it was more work than they were anticipating, a long haul and they needed to redirect their efforts to existing drugs that were 100% in their portfolio. Agree that Sanofi probably wasn't intentionally trying to bury Afrezza. However, Sanofi's efforts on Afrezza (granted a traditional approach) probably did not meet the "commercially reasonable efforts" standard set forth in the partnership agreement. This is pretty apparent when one compares the efforts Sanofi spent on Afrezza vs its efforts on Toujeo, both were launched by Sanofi around the same time. Big question is whether they put the same effort into getting formulary placement for Afrezza. Toujeo fared much better for whatever reason. With the poor formulary coverage it is easy for SNY to claim the rest of their efforts were in line with that reality. Who knows... MNKD might have even approved all the strategy in JAC, such as not running TV ads. Proving that SNY did not do as much for Afrezza formulary would be hard to prove as those negotiations with PBM are likely covered by non-disclosure agreements.
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Post by dictatorsaurus on Feb 2, 2016 18:12:49 GMT -5
I agree with Matt. SNY tried a traditional approach and failed. They didn't sandbag it, meaning intentionally trying to bury it. I think the new CEO concluded it was more work than they were anticipating, a long haul and they needed to redirect their efforts to existing drugs that were 100% in their portfolio. I have to disagree. Overall Afrezza is still largely unknown even among diabetics. Marketing would have taken care of that but there was no such thing. Few ads on Time magazine...seriously??? Where were the TV ads? Obviously Toujeo is worth 1000 TV ads so why not Afrezza? The drug was priced too high that most insurances didn't cover it. No EU application and other studies still not initiated. I'm sure others can point out many other red flags. If all that is not sandbagging then I don't know what is.
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Post by compound26 on Feb 2, 2016 18:18:30 GMT -5
Agree that Sanofi probably wasn't intentionally trying to bury Afrezza. However, Sanofi's efforts on Afrezza (granted a traditional approach) probably did not meet the "commercially reasonable efforts" standard set forth in the partnership agreement. This is pretty apparent when one compares the efforts Sanofi spent on Afrezza vs its efforts on Toujeo, both were launched by Sanofi around the same time. Big question is whether they put the same effort into getting formulary placement for Afrezza. Toujeo fared much better for whatever reason. With the poor formulary coverage it is easy for SNY to claim the rest of their efforts were in line with that reality. Who knows... MNKD might have even approved all the strategy in JAC, such as not running TV ads. Proving that SNY did not do as much for Afrezza formulary would be hard to prove as those negotiations with PBM are likely covered by non-disclosure agreements. If Sanofi priced Afrezza with a significant premium to RAA without a superiority trial and label improvement in the plan, that does not sound like a plan for success from the starting point. Looking with hindsight, had Sanofi even considered a superiority trial during the existence of the partnership? Does the December San Diego meeting give hint of a superiority trial? Then why the sudden termination of the partnership?
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Post by bioexec25 on Feb 2, 2016 18:27:22 GMT -5
Big question is whether they put the same effort into getting formulary placement for Afrezza. Toujeo fared much better for whatever reason. With the poor formulary coverage it is easy for SNY to claim the rest of their efforts were in line with that reality. Who knows... MNKD might have even approved all the strategy in JAC, such as not running TV ads. Proving that SNY did not do as much for Afrezza formulary would be hard to prove as those negotiations with PBM are likely covered by non-disclosure agreements. If Sanofi priced Afrezza with a significant premium to RAA without a superiority trial and label improvement in the plan, that does not sound like a plan for success from the starting point. Looking with hindsight, had Sanofi even considered a superiority trial during the existence of the partnership? Does the December San Diego meeting give hint of a superiority trial? Then why the sudden termination of the partnership? They priced Afrezza as if the superiority trial was already completed but the lawyers help saying it was defensible in court. They knew the pricing and the insurance was a concrete shoes into the bay yet legally defensible. As for the Dec meeting it just confirmed the full on attack Afrezza would have on their overall diabetes franchise. Picture the scenes from Independence Day. Fans and investors line up underneath the SNY mothership and the weapon is deployed. I'm still contacting my colleagues inside GSK and NOVO as I really no nobody inside SNY. But this is obvious albeit legally covered as most judges are oblivious and subject to corruption.
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Post by esstan2001 on Feb 2, 2016 18:46:21 GMT -5
I agree with Matt. SNY tried a traditional approach and failed. They didn't sandbag it, meaning intentionally trying to bury it. I think the new CEO concluded it was more work than they were anticipating, a long haul and they needed to redirect their efforts to existing drugs that were 100% in their portfolio. IMO that may have been the case in the beginning, but at some point, likely in Q3/4 I believe they made the soft decision to bail, and contractually the earliest they could exit was Jan this year. Recall that during the SNY investor days were was absolutely no mention of Afrezza in any of their plans...I for one (and many here I am sure) had a pit in the stomach at that point, but I think we also were willing to delude ourselves into thinking that we were still not into the launch phase, just the groundwork of doc education and clearing the decks with insurance coverage. Oh boy DBC, I could use some of that Scotch about now, and I'm still in the office working!!! Wow. George Costanza's boss- www.nydailynews.com/entertainment/seinfeld-actor-daniel-von-bargen-dies-64-article-1.2137413He attempted suicide a few years ago due to the effects of diabetes... the shennanigans that have helped get mannkind into this state are a criminal shame and really need to stop- I hope diabetics really learn about Afrezza and advocate strongly for it, and soon.
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Post by matt on Feb 2, 2016 18:57:38 GMT -5
Sanofi was spending at least $14 million a month on this launch. Sure, they could have spent more than that, but was part of the reason they didn't spend a function of MNKD not having a deep balance sheet. If it had all been on Sanofi's dime it would be one thing, but did Hakan limit the spending due to MNKD's balance sheet constraints? Nobody asks that question, but they probably should. Given that spending that did happen, in addition to the upfront payments Sanofi did make, makes it a little difficult to argue this was a sand bag job.
As for the regulatory filing, I am sure Sanofi had conversations with the respective rapporteurs. We will never know the essence of those conversations, but given the FDA restrictions the rapporteurs may well have suggested additional clinical testing before they could recommend submission of a marketing authorization.
In the end, there are just too many unknowns and unknowables to reach a fair opinion either for Sanofi or MNKD. It is what it is, which is a failed launch.
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Post by rckhntr on Feb 2, 2016 19:08:02 GMT -5
"In the end, there are just too many unknowns and unknowables to reach a fair opinion either for Sanofi or MNKD. It is what it is, which is a failed launch."
Agree wholeheartedly. We just don't know 95% of what went on, and as you suggest, probably never will. All this speculation about settlements and lawsuits is wasted energy. As the old saying goes......"money talks", and SNY has much more than MNKD.
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Post by dreamboatcruise on Feb 2, 2016 19:20:03 GMT -5
IMO that may have been the case in the beginning, but at some point, likely in Q3/4 I believe they made the soft decision to bail, and contractually the earliest they could exit was Jan this year. Recall that during the SNY investor days were was absolutely no mention of Afrezza in any of their plans...I for one (and many here I am sure) had a pit in the stomach at that point, but I think we also were willing to delude ourselves into thinking that we were still not into the launch phase, just the groundwork of doc education and clearing the decks with insurance coverage. I had that same strange stomach feeling momentarily, but a couple of sips of some Kool Aid and it seemed to pass... it's always so soothing, chamomile tea has nothing on it.
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Post by lakers on Feb 2, 2016 21:31:22 GMT -5
Both Sanofi and Mnkd knew in early Aug 2014 that a 6-month Phase 4 Superiority Study enabling label improvement would be the key to place Afrezza higher in PBM formulary w/o PA, ST. Sanofi chose to ignore the obvious - check my posts in other threads re: Hakan interview Oct 2014 and SD early adopter meeting Dec 2015. Mnkd had a slide in a CC w/ Superiority/label improvement study planned. If this is not sandbagging then what is. This is easily proven in court.
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Post by cjc04 on Feb 2, 2016 22:06:58 GMT -5
What exactly was SNY spending all the money on? A bunch of Salaries for people who did nothing? I remember reading about all these wonderful positions being created in SNY's higher archly for Afrezza. They accomplished NOTHING!!!! I literally had a SNY rep (who sells Tojeau) laugh at me last week and ask how MNKD stock price was doing.
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Post by myocat on Feb 2, 2016 22:22:56 GMT -5
The amount they had spent was peanut. The purpose was to drive MNKD and Afrezza out to reduce competition with their diabetic drugs.
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Post by kball on Feb 2, 2016 22:27:05 GMT -5
What exactly was SNY spending all the money on? A bunch of Salaries for people who did nothing? I remember reading about all these wonderful positions being created in SNY's higher archly for Afrezza. They accomplished NOTHING!!!! I literally had a SNY rep (who sells Tojeau) laugh at me last week and ask how MNKD stock price was doing. Makes me sick to read this.
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Post by uvula on Feb 2, 2016 22:41:02 GMT -5
If SNY was operating in good faith wouldn't they offer to relinquish control right away instead of making us wait until April. I think mnkd cannot sell to foreign countries until after april because Sny is still in charge . ( I could be wrong about this.)
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Post by mnkdorbust on Feb 2, 2016 22:55:23 GMT -5
What exactly was SNY spending all the money on? A bunch of Salaries for people who did nothing? I remember reading about all these wonderful positions being created in SNY's higher archly for Afrezza. They accomplished NOTHING!!!! I literally had a SNY rep (who sells Tojeau) laugh at me last week and ask how MNKD stock price was doing. Makes me sick to read this. Pisses me off more than anything. I'd moonlight as a "sales rep" on my own time for MannKind because I believe in the product as well as to give SNY and any SNY sales rep that has that attitude a big F you.
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Post by 4allthemarbles on Feb 2, 2016 23:12:29 GMT -5
I doubt we can do anything real until April (regarding sales, pricing, etc.). They won't give it back early because they want to drip MNKD dry. But, we will find out more tomorrow. I am sure there will be some type of news (it may not be material or huge, but something). That said, Matt had a good post above, but I just can't see this as a successful/ slow or any other type of launch that was meant to be successful. But if MNKD feels there is recourse, they will go after them as soon as they get Afrezza back.
That SFY rep laughing at a poster and then talking about stock price- get one of those guys in a deposition.
There could be a lot more behind the scenes we won't know about, but it sure feels like sandbagging.
I will wait until documents are filed (or a parting payoff) before relying on anything to come of the SFY sandbag theory. For now, I will look forward.
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