AFREZZA: WAS SANOFI SANDBAGGING AFREZZA?

[compound26]

AFREZZA: WAS SANOFI SANDBAGGING AFREZZA?

Note: please see the link below for the version with links to the original sources.

www.afrezzajustbreathe.com/afrezza-was-sanofi-sandbagging-afrezza/

But Marcus, the Laguna Hills endocrinologist, said Sanofi’s educational and marketing efforts fell short, especially in teaching doctors how to do the FDA-mandated lung tests.

Those are tests endocrinologists don’t typically perform. Marcus said Sanofi offered a class, but no hands-on training with either lung-testing equipment or with the Afrezza inhalers themselves.

“Sanofi didn’t have a wise plan for introducing this product,” he said.

What’s more, Marcus said many of the patients he prescribed Afrezza to ended up dropping it because it wasn’t covered by their insurance. [As reported by LA Times].

“A world-changing drug deserves better marketing. I’ve done more to market Afrezza myself than Sanofi ever did,” a TuDiabetes user wrote. [As reported by LA Times].

“There is no doubt that Sanofi has been a poor partner. One wonders if there was ever any commitment to the product at all,” wrote another TuDiabetes user. [As reported by LA Times].

Sanofi is looking to reinvigorate growth in its diabetes franchise through its marketed products Lantus and Toujeo, and Patton said this left the French Pharma Giant “conflicted” when it came to Afrezza. “Inhaled insulin can directly compete with Lantus and Toujeo in Type 2 patients, and with all of the prandial insulins in both Type 1 and 2 they were conflicted. No way Sanofi was going to go against its golden goose franchise.” [As reported by mobile.in-pharmatechnologist.com]

I also want to say. Please do not pull the plug on this insulin yet. I still have hope it will survive. Sanofi did not market this drug correctly. The PROVIDERS and INSURANCE COMPANIES needed to be educated first, then the roll out to the patients. From what I am hearing Sanofi did not educate the endos. Everyone is afraid of the lung spirometry test which is NO BIG DEAL. Endos need to have the lung spirometry equipment in office (Dr. Goddard in New York City does it in office before prescribing Afrezza). But the insurance companies are refusing to pay. One big HINT for Mannkind and/or Sanofi. When rolling out a new drug, in today’s insurance market, PRICE IT COMPETITIVELY. Comment on Tudiabetes.org.

Sanofi did not promote this drug; in fact, I will quote one shareholder “Sanofi walked Afrezza into bankruptcy.” Or tried to. Comment on Tudiabetes.org.

Both my primary care and endo were happy to prescribe it… It’s not like the majority of doctors weren’t willing to prescribe it once they had been educated by the drug reps on the product— the problem is, the sanofi reps seemingly made no effort to do that— or when they did they totally failed to illustrate it’s amazing benefits—- and the vast majority of the diabetes population doesn’t know it exists…. Comment on Tudiabetes.org.

I have had ZERO severe hypos since starting it in February of last year. Your post is on point as it relates to the target marketing and launch of the drug and I won’t comment on whether or not I believe the drug is more appropriate for T2’s. Sanofi was the wrong partner, period. Comment on Tudiabetes.org.

Fair enough and this is why Sanofi has done an awful job on the marketing and distribution front. According to many they haven’t even heard about Afrezza and in most cases neither has their doctors or endos. There has to be a start somewhere and the early adopters are that start. Comment on Tudiabetes.org.

Good— sanofi never had its interests in mind and made exactly zero attempt to commercialize it’s game changing drug. Comment on Tudiabetes.org.

We can speculate all day as to Sanofi’s motives.. My understanding is that the last couple years, sales of Lantus, their biggest market-winner, have been dropping, despite an increase in the number of PWD overall, so they wanted another very different diabetes drug to try and offset that. Those plans may have been internally derailed by the development and approval for Toujeo and now the new T2D combo insulin+GLP-1 drug they’ve applied for approval (Lixilan), while at the same time Lantus will have new competition from Lily’s biosimilar insulin. So Afrezza didn’t get the attention it needed… Comment on Tudiabetes.org.

Interestingly, up here in rural Alaska, there was a swarm of sanofi reps touting afrezza for a week or two and then nothing…. I did see exactly one magazine advertisement while sitting in the waiting room at the dentist office—- A world changing drug deserves better marketing. I’ve done more to market afrezza myself than sanofi ever did. Comment on Tudiabetes.org.

I think ultimately they need a robust marketing and negotiation program with insurers to ensure both widespread awareness of how well it works and affordable prices in combination with good insurance coverage to be successful… Both things that sanofi failed miserably at— or seemingly didn’t even try to do… Comment on Tudiabetes.org.

Many providers clearly haven’t received solid education on the product. I guess we can pin that on Sanofi, or perhaps disinterest. Comment on Tudiabetes.org.

While we agree that the marketing of Afrezza by Sanofi was essentially nil (this comment by Sanofi’s rep was laughable, “Sanofi spokeswoman Susan Brooks said the company didn’t scrimp on promoting Afrezza.”) I think an often not talked about or considered barrier to entry is the fact that diabetics tend to be stubborn to change when things are going well. Kind of the “if it ain’t broke, don’t fix it” attitude. Comment on Tudiabetes.org.

I believe Sanofi had no intention of promoting Afrezza. Sanofi basically sat on the drug until they were able to market their new injectable…. the name of it escapes me at the moment. Remember how excited everyone was when Merck bought SmartInsulin from Dr. Zion. It was ready for large animal studies. Merck shelved it. Why? They had no insulin of any kind to sell. But they did have Januvia. And certainly were not interested in a cure while they could milk the huge Type 2 market. They are working on SmartInsulin now (under another name) but only because there is another company working on a Smart Insulin of their own. It’s all about the money. And they have made their $50 thou a year off my daughter for the past ten years. Sanofi is being sued by another company for failing to keep up their part of the bargain re marketing and promotion. Slow roll out? It was a NO Roll out. Comment on Tudiabetes.org.

Sanofi has destroyed the Afrezza launch and Mannkind is running out of money. They should be sued. Comment on Tudiabetes.org.

I’m voting with my feet when it comes to sanofi— I am switching from lantus to tresiba. Sanofi will never again profit from my illness in one hand while attempting to screw the world out of afrezza with the other. Comment on Tudiabetes.org.

I will boycott Sanofi as soon as we can. If Afrezza goes out of business, we will use the new Novo fast acting when it comes to market. She is using Tresiba. We will never use Toujeho. Comment on Tudiabetes.org.

[dudley]

I've been chewing on this like a dog with a bone.  There was clear and compelling evidence as far back as last April that SOMETHING was happening to the early adopters on Afrezza.  Pretty hard to deny screen shots from CGM's and lab printouts showing HbA1c readings.  Even the most raw Marketing 101 student had to see that this was marketing gold - a legitimate Golden Goose egg-laying development.  With a clear claim to superiority as well as ease of use being self-evident (just watch the video of prepping the injection site vs. Eric doing his Afrezza dose in 5 seconds in the crowded stands of a ball game !) , a marketing campaign that could literally conquer the prandial insulin space could have been unleashed.  Yes, a clinical trial would have been required but that could have been worked in with the clamp study easily enough and had it all done by the fall.  Yet somehow one of the biggest and supposedly most competent drug marketers in the world missed this truly gold-screaming, in-your-face opportunity completely.  All they could come up with was a goofy looking old fart in a hideous hat as "DTC" ?

They fumbled the ball so badly it almost HAD to be planned.  If this ever goes to trial I would say MNKD has an excellent chance of prevailing due to gross negligence and failure to apply reasonable standards of effort in commercializing the product.  Maybe it will give them some leverage in negotiations, maybe not.  I have never seen a worse bungling job in my life and a relatively sharp attorney could make the claim easily enough in court it seems.

[dreamboatcruise]

dudley... hard to judge the strength of MNKD's case without knowing what they agreed to in the JAC and what they objected to. If they never forced SNY to use their override power, then it would seem the case is considerably weaker unless MNKD could somehow show that their agreement was only given because of some fraud or deception on SNY's part.

If the case is weak, SNY may still offer some token in order to get a release, but it wouldn't be the huge numbers some are tossing around... IMO.

Let's hope MNKD was on the record as objecting to the SNY slow roll.

[mnholdem]

And so it seems that Sanofi is still conflicted. If they go to court (again) Sanofi's image as a great partner takes another hit and perhaps a judge sees to it that their wallet takes a hit as well. However, if Sanofi settles with MannKind Corporation for hundreds of $millions in exchange for non-disclosure, they provide the cash infusion that will enable MannKind to re-launch Afrezza, which they do NOT want.

Conflicted.

[joeypotsandpans]

Right now is not the time to spending resources (both financial and human) on this. If you think about it the more successful they can make Afrezza either on their own or with another partner would only validate the fact that SNY was inept, apathetic, and not fully committed to seeing it become successful which in turn would elevate the potential damages from the time lost of their failed so called launch/efforts. We need to pursue/address that issue from a better position of strength down the road, not when we need to allocate the aforementioned resources to gaining traction going forward. Having said all that, if they ponied up a DECENT kiss goodbye fee, it would be prudent to at least consider it. Otherwise, prove they mishandled it by showing just how successful it should have been even before any label improvement. If you do that, they would be hard pressed to defend their ineptness and lack of fiduciary responsibility according to the agreement.

[compound26]

Let's compare the terms of the Toujeo Savings Card with those of the Afrezza Savings Card:

Toujeo Savings Card

www.toujeo.com/savings-card

Savings Card carries maximum savings of $500 off per pack for the duration of the program.

Afrezza Savings Card

www.afrezza.com/save-on-afrezza

Maximum benefit is $150 off per prescription depending on your out-of-pocket costs for the duration of the program.

Wow, how did Sanofi envision Afrezza to be competitive with these kind of pricing strategy?


www.afrezzajustbreathe.com/afrezza-was-sanofi-sandbagging-afrezza/#more-1251

[dudley]

Jan 21, 2016 13:37:24 GMT -5 compound26 said:

Let's compare the terms of the Toujeo Savings Card with those of the Afrezza Savings Card:

Toujeo Savings Card

www.toujeo.com/savings-card

Savings Card carries maximum savings of $500 off per pack for the duration of the program.

Afrezza Savings Card

www.afrezza.com/save-on-afrezza

Maximum benefit is $150 off per prescription depending on your out-of-pocket costs for the duration of the program.

Wow, how did Sanofi envision Afrezza to be competitive with these kind of pricing strategy?


www.afrezzajustbreathe.com/afrezza-was-sanofi-sandbagging-afrezza/#more-1251

Not just pricing.  They completely failed to really differentiate Afrezza as anything other than inhaled, and spend an inordinate amount of time dwelling on the black box and other warnings - more like they are trying to scare you away rather than get you to try it.  No mention of the science (monomer molecules - just like a healthy pancreas produces vs. the engineered hexamer all other insulins use).  No mention of the countless studies and patient hours with no lung issues.  No mention of the completely benign aspect of the carrier particles and the virtually instantaneous absorption of the insulin into the bloodstream - nothing lingers.  No mention that - guess what - insulin is ALWAYS in your lungs because it is ALWAYS in the bloodstream. This is true for any insulin, normal pancreas or injection.  Anything that is in the bloodstream is by default in the lungs due to the massive capillary network that runs through the lungs. 

Any real effort to promote Afrezza simply has to outline these things - the science, the safety, the PK profile and above all else a compelling visual of an Afrezza huff vs. an injection.  Not to repeat myself but a side-by-side video comparison of taking an Afrezza dose vs. an injection is one of the most powerful marketing tools anywhere on the planet.

Sanofi failed miserably on all counts - a high school marketing project could have done a better job of presenting Afrezza, all while staying within FDA guidelines.

One can only hope Mannkind 2.0 sees this as clearly as we do and rectifies all these horrendous marketing shortcomings.

[compound26]

Did Sanofi satisfy its obligation of using Commercially Reasonable Efforts to market, promote and Commercialize Afrezza?

Under Section 5.1(c) of the partnership agreement:

Sanofi shall use Commercially Reasonable Efforts to market, promote and Commercialize Product in the Field in countries in the Territory where regulatory approval has been received, it being understood that the application of Commercially Reasonable Efforts may result in Sanofi deciding not to market, promote or Commercialize Product in any particular country or countries.

Under Section 1.25 of the partnership agreement:

“Commercially Reasonable Efforts” shall mean:

    (a)     With respect to efforts of Sanofi as measured on a country by country basis: that measure of efforts and resources consistent with Sanofi’s and its Affiliates’ own efforts and resources applied to its and their own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential, taking into account all relevant factors including issues of safety and efficacy, product profile, difficulty in developing or manufacturing the applicable Product or sourcing raw materials necessary therefor, competitiveness of alternative third party products in the marketplace, regulatory approvals (including pricing approvals), pricing and reimbursement, the patent or other proprietary position of the applicable Product, the regulatory requirements involved and the potential profitability of the applicable Product for Sanofi and its Affiliates as compared to the expected profitability of other products of its then current or in development product portfolios; and

    (b)     With respect to efforts of the Licensors: the use of reasonable efforts and resources, in good faith, consistent with the efforts and resources that a pharmaceutical or biotechnology company of similar size and situation to the Licensors, in the exercise of prudent legal, medical, scientific and business judgment, would commonly apply to its own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential to the applicable Product.

[lakers]

Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits.

Read more: mnkd.proboards.com/thread/4834/ajmc-sny-mnkd-breakup-insight?page=2#ixzz3z35G6Lbq

Pfizer, Nektar Reach Exubera Settlement

November 13, 2007

Pfizer and Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product. Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities. Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems." - See more at: www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlement#sthash.pfSObdSy.dpuf

A fair settlement needs to include $30M EMA MAA, $20M Japan MAA, $25M for qualifying Sanofi's insulin, $200M on-going Pediatric trial, 5-yr/8K PWD lung trial, $30M supply chain transition, $50M breach of min insulin purchase with AMPH, possibly $250M first sale milestone.

So, the settlement range is ~ $355M-$605M. This is still pocket change considering that Pfizer sank $2B into Exubera plus $135M settlement.

U.S. legal judgement is based on precedence. At min, $355M would extend runway by 2.5 - 3 years.

[goyocafe]

Feb 2, 2016 16:39:06 GMT -5 lakers said:

Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits.

Read more: mnkd.proboards.com/thread/4834/ajmc-sny-mnkd-breakup-insight?page=2#ixzz3z35G6Lbq

Pfizer, Nektar Reach Exubera Settlement

November 13, 2007

Pfizer and Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product. Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities. Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems." - See more at: www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlement#sthash.pfSObdSy.dpuf

A fair settlement needs to include $30M EMA MAA, $20M Japan MAA, $25M for qualifying Sanofi's insulin, $200M on-going Pediatric trial, 5-yr/8K PWD lung trial, $30M supply chain transition, $50M breach of min insulin purchase with AMPH, possibly $250M first sale milestone.

So, the settlement range is ~ $355M-$605M. This is still pocket change considering that Pfizer sank $2B into Exubera plus $135M settlement.

That would be nice! Yes? Spoken in the French voice of the little frog in "Princess and the Frog". It's all Disney from here on out if it gets better, and a friggin' nightmare if it goes South.
 

[therealisaching]

Feb 2, 2016 16:39:06 GMT -5 lakers said:

Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits.

Read more: mnkd.proboards.com/thread/4834/ajmc-sny-mnkd-breakup-insight?page=2#ixzz3z35G6Lbq

Pfizer, Nektar Reach Exubera Settlement

November 13, 2007

Pfizer and Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product. Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities. Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems." - See more at: www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlement#sthash.pfSObdSy.dpuf

A fair settlement needs to include $30M EMA MAA, $20M Japan MAA, $25M for qualifying Sanofi's insulin, $200M on-going Pediatric trial, 5-yr/8K PWD lung trial, $30M supply chain transition, $50M breach of min insulin purchase with AMPH, possibly $250M first sale milestone.

So, the settlement range is ~ $355M-$605M. This is still pocket change considering that Pfizer sank $2B into Exubera plus $135M settlement.

U.S. legal judgement is based on precedence.

The settlement range is zero - to whatever number MNKD can demonstrate they are damaged.  Time isnt on our side.  RLS didnt provide upfront payments.  Without another deal being inked soon there isnt a source of cash to get the company to year end.

Unfortunately, this leaves Matt with little leverage on this front. 

[mindovermatter]

Feb 2, 2016 16:39:06 GMT -5 lakers said:

Who said Sanofi is free from liability w/ Mnkd. Read Biodel, Genzyme lawsuits.

Read more: mnkd.proboards.com/thread/4834/ajmc-sny-mnkd-breakup-insight?page=2#ixzz3z35G6Lbq

Pfizer, Nektar Reach Exubera Settlement

November 13, 2007

Pfizer and Nektar Therapeutics have reached an agreement settling their contractual issues regarding Exubera and Nektar's new inhaled insulin product, which is currently in Phase I. Nektar will receive a one-time payment of $135 million from Pfizer to end all obligations under existing agreements relating to Exubera and the new product. Also, if Nektar finds a new partner, Pfizer will transfer its remaining rights and all economic benefits for Exubera and the new product. This would include the transfer of the Exubera NDA and INDs and all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities. Jeffrey B. Kindler, chairman and chief executive officer of Pfizer and Howard W. Robin, president and chief executive officer of Nektar issued a joint statement about the settlement, "This agreement demonstrates the industry leadership of Pfizer and the company's desire to work with world-class biotechnology partners like Nektar. The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and its next generation inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems." - See more at: www.contractpharma.com/contents/view_breaking-news/2007-11-13/pfizer-nektar-reach-exubera-settlement#sthash.pfSObdSy.dpuf

A fair settlement needs to include $30M EMA MAA, $20M Japan MAA, $25M for qualifying Sanofi's insulin, $200M on-going Pediatric trial, 5-yr/8K PWD lung trial, $30M supply chain transition, $50M breach of min insulin purchase with AMPH, possibly $250M first sale milestone.

So, the settlement range is ~ $355M-$605M. This is still pocket change considering that Pfizer sank $2B into Exubera plus $135M settlement.

U.S. legal judgement is based on precedence. At min, $355M would extend runway by 2.5 - 3 years.

While it would be great to see Mannkind be able to extract something from Sanofi, the Nektar arrangement with PFizer is specific to them and, imo, isn't a very good model to use in regards to Mannkind. The contract with Sanofi is different than the contract Nektar had with Pfizer. I have stated we should soon find out what Sanofi will do as I am sure Sanofi wants to wrap this up sooner rather than later. Sanofi has a lot of bigger problems to deal with at this time.

[longinvstr]

Jan 14, 2016 19:19:40 GMT -5 mnholdem said:

And so it seems that Sanofi is still conflicted. If they go to court (again) Sanofi's image as a great partner takes another hit and perhaps a judge sees to it that their wallet takes a hit as well. However, if Sanofi settles with MannKind Corporation for hundreds of $millions in exchange for non-disclosure, they provide the cash infusion that will enable MannKind to re-launch Afrezza, which they do NOT want.

Conflicted.

Conflict-ion all around

The best leverage (for either lawsuit or ND settlement) MNKD can wield is in having Afrezza become a (new) instant success.  That'll take money.  It takes money to make drugs successful and file lawsuits.  Both also require large investments of HR capital.  There's no doubt, we don't have enough of either to fight both fronts.  IMHO, there is only time/money enough for one path, Afrezza proof of concept in the market.  We may have a good case but it must wait.  What is the statute of limitations for breach of contract?

[nadathing]

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.

[compound26]

Feb 2, 2016 18:00:24 GMT -5 nadathing said:

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. 

Had Sanofi made the "commercially reasonable efforts", the TRx should be (at least) a couple of times higher than the current level.