Sanofi comments about Afrezza from today's press release 2/9

[lakers]

What A Joke Sanofi Is Claiming They Made A Substantial Effort To Sell Afrezza In Today's Press Release
Sanofi did virtually little to promote Afrezza in the United States alone, narrowly targeting only a handful of markets to promote the drug using very limited marketing means like a couple of print ads and a very small sales force. Sanofi did not even make an effort to talk about Afrezza during their own healthcare/investor presentations, keeping it completely off their radar screen. Now in comparison Sanofi did do a substantial effort to promote Toujeo across the globe spending a lot of money on print ads, television ads and using their entire diabetes sales force to promote and sell the drug globally. Despite the huge disparity in resources and support Sanofi allocated in favor of Toujeo vs. Afrezza, Afrezza managed to still generate some sales in the U.S. thanks to the amazing effort early adopters using the drug initiated on their own to promote the great benefits they were experiencing using Afrezza across social media. Had Sanofi reversed its strategy placing all its emphasis and resources on Afrezza instead of Toujeo I believe the two drugs sales results in 2015, would be reversed with Afrezza nearing blockbuster results. Here is Sanofi comments about Afrezza from today's press release.

"Afrezza® sales were €2 million and €7 million in the fourth quarter and 2015, respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza® despite Sanofi's substantial efforts. Sanofi intends to work with MannKind to support a smooth transition and will continue to make Afrezza® available in the United States for a period of up to approximately 180 days after the date of Termination, as set forth in the License and Collaboration Agreement"
finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455021382894-ac3a8458-dded-415f-a8cc-9f290234cf68&tls=la%2Cd%2C3%2C3

As for Toujeo, I'm pleased to see the encouraging launch uptake. As you can see from the chart, the sales performance of the brand has accelerated over the recent quarters, primarily driven by rapid market access in the US and fast adoption by prescribers.
This uptake compares favorably with other brands in the same therapeutic category. Outside the US, Toujeo is also gaining momentum following its rollout in over 20 markets, including Germany, the UK, Japan, and Canada.
Overall, diabetes performed in line with our revised guidance, and we continue to expect global sales to be down minus 4% to minus 8% annually over the period of 2015 to 2018. As we enter 2016 we expect benefit from the initiatives we launched last year to further improve our operational effectiveness.
www.thestreet.com/story/13453308/3/sanofi-sny-earnings-report-q4-2015-conference-call-transcript.html

[symbil]

means they serve as the distribution channel until October?

[suebeeee1]

Let the CYA commence!

[compound26]

It appears to me Sanofi probably stopped any real efforts on promoting Afrezza at the beginning of June 2015, when the 2015 ADA meeting was in session. Or alternatively, a decision was reached by Sanofi at that time that Afrezza would be dropped from Sanofi's portfolio as soon as possible (i.e., at the beginning of 2016).

If one looks at the Symphony reports on NRx and TRx, he/she will notice that the NRx reached 311 on June 5, 2015 and has been hovering around 300 since then. This indicates that no real efforts were made by Sanofi to expand the prescribing base after June 2015.

mnkd.proboards.com/attachment/download/1788

Amy Tenderich's recap on the 2015 ADA meeting confirms that Sanofi wasn't putting any real efforts into promoting Afrezza from the beginning. 

www.healthline.com/diabetesmine/overview-ada-scientific-sessions-2015#8

"Although this big sign greeted attendees at the main entrance to the Exhibit hall, there wasn’t as much buzz about Sanofi’s Afrezza as you might expect, given that is one of the most exciting new treatment options recently FDA-approved and launched (it’s the first commercially viable non-invasive insulin, for God’s sake!)

Frankly, I was expecting Afrezza to be the drug plastered all over the convention shuttle buses this year, but nope, that seemed to be mostly Invokana again, like last year.

Afrezza was covered in a “Product Theater” on Saturday morning. This was a very, dry medical introduction of the drug, that due to regulations had to start with the long laundry list of possible risks and drawbacks. Although the session was a pretty packed house of about 180 doctors I’d guess, it certainly wasn't inspiring by any stretch of the imagination.

And it appears the only other presentation on Afrezza at this entire conference was a corporate-sponsored CME (continuing medical education) symposium held on Sunday evening. I would’ve loved to have been a fly on the wall at that one.

The "low profile" of Afrezza was corroborated by prominent endocrinologist Dr. Irl Hirsch when I bumped into him in the ADA speaker room. We shrugged our shoulders at each other over how Afrezza doesn’t seem to be getting a fair shake (see the LA Times article on same topic, and one analyst who remarks that the distraction of the ADA conference itself may be one reason that Afrezza prescriptions are coming in so slowly – how ironic!) Observers are holding their breaths to see how the upcoming consumer ad campaign affects Afrezza sales, it seems.

When I met with Sanofi execs, I was able to ask them directly, and was told there’ve been three barriers to Afrezza’s success so far:

1.    Physicians haven’t heard about inhalable insulin for several years (and lingering memories of the Exubera fiasco don’t help)

2.    The requirement for a pulmonary function test is a deterrent – doctors have to figure out where to refer patients for this, or decided to fork over the roughly $600 to get their own machine

3.    Reimbursement is a struggle, as Medicare and the other Payors already have one or more preferred rapid-acting insulin products on their formularies, so Afrezza is getting bumped to a lower tier (meaning not covered so much)

Sanofi does plan to begin a consumer advertising campaign towards the end of this year that will focus on digital and print, but no TV ads, according to Andrew Purcell, Head of the Diabetes Business Unit at Sanofi. They’re hoping to “demonstrate success” with the drug first, and also by then, the newly approved 12-unit cartridge will be available too (although personally I’d be more excited about a 2-unit option).

Meanwhile, Sanofi was making a big splash about their new long-acting insulin Toujeo, with a smoother profile and even less incidence of hypoglycemia than their market-leader Lantus. They were presenting a lot of positive data on Toujeo, which comes in a Solostar pen similar to that for Lantus, but tweaked especially for this product to carry 450 units. And the big deal is that they’re rolling out a new coaching program (Toujeo COACH), in which patients get one-on-one training and optional followup calls and emails from a nurse or CDE. Nice! Who doesn’t love a little hand-holding with a new diabetes tool? We heard the company just announced extending this COACH program to Afrezza too -- much-need, and cool! Meanwhile, they assure us they are not abandoning Lantus, for doctors and patients who remain loyal to that drug."

[dictatorsaurus]

Sneaky slithery amphibians never change. Don't expect a graceful exit. More like a scorned ex-wife throwing jabs on the way out.

The sooner this nightmare called Sanofi ends the better. Soon enough mnkd will determine it's own fate. And then there will be no excuses.

[Deleted]

MannKind needs to find US and foreign partners ASAP.

[blindhog1]

Feb 9, 2016 13:21:55 GMT -5 suebeeee1 said:

Let the CYA commence!

If Sanofi feels the need to defend themselves now....they realize what is coming and how it will play out.

Let the depositions begin.

Did I mention that today my A1C was 6.6

[Deleted]

Feb 9, 2016 13:44:59 GMT -5 blindhog1 said:

Feb 9, 2016 13:21:55 GMT -5 suebeeee1 said:

Let the CYA commence!

If Sanofi feels the need to defend themselves now....they realize what is coming and how it will play out.

Let the depositions begin.

Did I mention that today my A1C was 6.6

Nice number. Post it on Twitter in the #afrezza channel. hopefully your doc is getting patients on Afrezza for the better

[Deleted]

Is this relevant here?

www.reuters.com/article/us-regeneron-pharms-results-idUSKCN0VI16Y

Sales of cholesterol-lowering Praluent, which was approved in July, were $7 million in the fourth quarter, missing the average estimate of $23 million, according to J.P. Morgan analyst Cory Kasimov

Regeneron Pharmaceuticals Inc (REGN.O) reported lower-than-expected quarterly sales for its new cholesterol drug and reiterated expectations of a "gradual uptake" for the treatment, which has been tipped to be its next blockbuster


Will Brandicourt now say Praluent is causing cardio vascular sales decrease? 

[kdaddyfresh2000]

Feb 9, 2016 13:09:27 GMT -5 lakers said:

What A Joke Sanofi Is Claiming They Made A Substantial Effort To Sell Afrezza In Today's Press Release
Sanofi did virtually little to promote Afrezza in the United States alone, narrowly targeting only a handful of markets to promote the drug using very limited marketing means like a couple of print ads and a very small sales force. Sanofi did not even make an effort to talk about Afrezza during their own healthcare/investor presentations, keeping it completely off their radar screen. Now in comparison Sanofi did do a substantial effort to promote Toujeo across the globe spending a lot of money on print ads, television ads and using their entire diabetes sales force to promote and sell the drug globally. Despite the huge disparity in resources and support Sanofi allocated in favor of Toujeo vs. Afrezza, Afrezza managed to still generate some sales in the U.S. thanks to the amazing effort early adopters using the drug initiated on their own to promote the great benefits they were experiencing using Afrezza across social media. Had Sanofi reversed its strategy placing all its emphasis and resources on Afrezza instead of Toujeo I believe the two drugs sales results in 2015, would be reversed with Afrezza nearing blockbuster results. Here is Sanofi comments about Afrezza from today's press release.

"Afrezza® sales were €2 million and €7 million in the fourth quarter and 2015, respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza® despite Sanofi's substantial efforts. Sanofi intends to work with MannKind to support a smooth transition and will continue to make Afrezza® available in the United States for a period of up to approximately 180 days after the date of Termination, as set forth in the License and Collaboration Agreement"
finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455021382894-ac3a8458-dded-415f-a8cc-9f290234cf68&tls=la%2Cd%2C3%2C3

As for Toujeo, I'm pleased to see the encouraging launch uptake. As you can see from the chart, the sales performance of the brand has accelerated over the recent quarters, primarily driven by rapid market access in the US and fast adoption by prescribers.
This uptake compares favorably with other brands in the same therapeutic category. Outside the US, Toujeo is also gaining momentum following its rollout in over 20 markets, including Germany, the UK, Japan, and Canada.
Overall, diabetes performed in line with our revised guidance, and we continue to expect global sales to be down minus 4% to minus 8% annually over the period of 2015 to 2018. As we enter 2016 we expect benefit from the initiatives we launched last year to further improve our operational effectiveness.
www.thestreet.com/story/13453308/3/sanofi-sny-earnings-report-q4-2015-conference-call-transcript.html



Does anyone know someone at Sanofi with real credibility who can speak to the real deal with how the Sanofi salesforce tried to sell Afrezza?  


I know we are all "six degrees of Kevin Bacon related" to someone who knows someone who knows someone yada yada yada, but the rumor tenuousness of the actual ground level marketing is all I have really seen.  TIA

[kdaddyfresh2000]

Feb 9, 2016 13:09:27 GMT -5 lakers said:

What A Joke Sanofi Is Claiming They Made A Substantial Effort To Sell Afrezza In Today's Press Release
Sanofi did virtually little to promote Afrezza in the United States alone, narrowly targeting only a handful of markets to promote the drug using very limited marketing means like a couple of print ads and a very small sales force. Sanofi did not even make an effort to talk about Afrezza during their own healthcare/investor presentations, keeping it completely off their radar screen. Now in comparison Sanofi did do a substantial effort to promote Toujeo across the globe spending a lot of money on print ads, television ads and using their entire diabetes sales force to promote and sell the drug globally. Despite the huge disparity in resources and support Sanofi allocated in favor of Toujeo vs. Afrezza, Afrezza managed to still generate some sales in the U.S. thanks to the amazing effort early adopters using the drug initiated on their own to promote the great benefits they were experiencing using Afrezza across social media. Had Sanofi reversed its strategy placing all its emphasis and resources on Afrezza instead of Toujeo I believe the two drugs sales results in 2015, would be reversed with Afrezza nearing blockbuster results. Here is Sanofi comments about Afrezza from today's press release.

"Afrezza® sales were €2 million and €7 million in the fourth quarter and 2015, respectively. On January 4, 2016, Sanofi informed MannKind Corporation, that it has exercised its option to terminate its agreement. This termination will become effective on April 4, 2016. This action is in line with the terms of the contract, and the decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza® despite Sanofi's substantial efforts. Sanofi intends to work with MannKind to support a smooth transition and will continue to make Afrezza® available in the United States for a period of up to approximately 180 days after the date of Termination, as set forth in the License and Collaboration Agreement"
finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1455021382894-ac3a8458-dded-415f-a8cc-9f290234cf68&tls=la%2Cd%2C3%2C3

As for Toujeo, I'm pleased to see the encouraging launch uptake. As you can see from the chart, the sales performance of the brand has accelerated over the recent quarters, primarily driven by rapid market access in the US and fast adoption by prescribers.
This uptake compares favorably with other brands in the same therapeutic category. Outside the US, Toujeo is also gaining momentum following its rollout in over 20 markets, including Germany, the UK, Japan, and Canada.
Overall, diabetes performed in line with our revised guidance, and we continue to expect global sales to be down minus 4% to minus 8% annually over the period of 2015 to 2018. As we enter 2016 we expect benefit from the initiatives we launched last year to further improve our operational effectiveness.
www.thestreet.com/story/13453308/3/sanofi-sny-earnings-report-q4-2015-conference-call-transcript.html

Anyone have a WSJ subscription:  www.wsj.com/articles/sanofi-is-forced-to-end-latest-diabetes-effort-1455052005

[compound26]

Sanofi Is Forced to End Latest Diabetes Effort

www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284

www.wsj.com/articles/sanofi-is-forced-to-end-latest-diabetes-effort-1455052005

(Strangely that sometimes I can open the full article from the WSJ site per the link above. Sometimes I can not).

[lakers]

Excerpts follow.

But others saw more fundamental reasons to scrap the idea: Novo Nordisk said at the time that it couldn't overcome the fact that inhaled insulin wouldn't eliminate the need for injections. That is because only short-acting insulin, which is taken as a boost at mealtimes, could be administered via an inhaler. Most diabetes patients on insulin--those with Type 1 or advanced Type 2--also take a long-acting version to provide a constant minimum level, which would need to be injected.

By ending the agreement when it did, Sanofi capped its 2015 losses at roughly EUR200 million. [This wouldn't stand as CRE. Pfizer spent $2B+$135M settlement. This is great news for the expected Sanofi's large settlement extending Mnkd runway by a few years.]

But Sanofi badly underestimated the toll that safety concerns would have on Afrezza's sales.

Existing worries among doctors over links with lung cancer were compounded by the U.S. Food and Drug Administration's warning that inhaled insulin could cause breathing difficulties in people with respiratory problems. The agency also required MannKind to run a follow-on trial to determine whether Afrezza did increase patients' cancer risk.

The agency also stipulated that doctors test patients' lung health with a device known as a spirometer before prescribing the drug. As most diabetes doctors don't have a spirometer, they would need to send patients to another physician for the test.

Doctors might have been more willing to take on the risk and effort of prescribing Afrezza if MannKind had demonstrated that it is more effective than injected insulin, said Jane Chiang, senior vice president for medical affairs at the American Diabetes Association. But the company's clinical trials for Afrezza proved only that it is as effective as, not better than, the injected alternative, a status that is reflected in Afrezza's FDA label.

Further, most payers in the U.S. have Afrezza in a "tier three" reimbursement category. That generally comes with higher copays and requires physicians to explain why they prescribed Afrezza over standard injected insulin. Sanofi also priced Afrezza at a premium to its injectable counterparts.

MannKind's Mr. Pfeffer said pricing and reimbursement issues "dramatically outweigh the other factors" related to Afrezza's slow uptake.

Without a clinical trial showing that Afrezza worked better than injected insulin [Ground for breach of Commercially Reasonable Effort (CRE). Sanofi should have started Phase 4 Superiority trial in Sept 2014 before PBMs place Afrezza as Tier2 w/o PA, ST.], Sanofi's advertising campaign centered on the novelty of inhaling versus injecting. But the company overestimated the extent to which patients would switch to Afrezza due to a needle aversion, said Eamonn O'Connor, an analyst at the health-care consulting firm Decision Resources Group.

Despite these setbacks, Afrezza has gained a small but avid following among patients who say it works significantly better for them than injected insulin.

Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said.

Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind.

But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment.
Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3O

[agedhippie]

Feb 9, 2016 16:28:37 GMT -5 compound26 said:

Sanofi Is Forced to End Latest Diabetes Effort

www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284

www.wsj.com/articles/sanofi-is-forced-to-end-latest-diabetes-effort-1455052005

(Strangely that sometimes I can open the full article from the WSJ site per the link above. Sometimes I can not).

The Nasdaq link worked for me. Not a bad article, they even have a quote from mikep!

[mindovermatter]

Feb 9, 2016 17:08:00 GMT -5 lakers said:

Excerpts follow.

But others saw more fundamental reasons to scrap the idea: Novo Nordisk said at the time that it couldn't overcome the fact that inhaled insulin wouldn't eliminate the need for injections. That is because only short-acting insulin, which is taken as a boost at mealtimes, could be administered via an inhaler. Most diabetes patients on insulin--those with Type 1 or advanced Type 2--also take a long-acting version to provide a constant minimum level, which would need to be injected.

By ending the agreement when it did, Sanofi capped its 2015 losses at roughly EUR200 million. [This wouldn't stand as CRE. Pfizer spent $2B+$135M settlement. This is great news for the expected Sanofi's large settlement extending Mnkd runway by a few years.]

But Sanofi badly underestimated the toll that safety concerns would have on Afrezza's sales.

Existing worries among doctors over links with lung cancer were compounded by the U.S. Food and Drug Administration's warning that inhaled insulin could cause breathing difficulties in people with respiratory problems. The agency also required MannKind to run a follow-on trial to determine whether Afrezza did increase patients' cancer risk.

The agency also stipulated that doctors test patients' lung health with a device known as a spirometer before prescribing the drug. As most diabetes doctors don't have a spirometer, they would need to send patients to another physician for the test.

Doctors might have been more willing to take on the risk and effort of prescribing Afrezza if MannKind had demonstrated that it is more effective than injected insulin, said Jane Chiang, senior vice president for medical affairs at the American Diabetes Association. But the company's clinical trials for Afrezza proved only that it is as effective as, not better than, the injected alternative, a status that is reflected in Afrezza's FDA label.

Further, most payers in the U.S. have Afrezza in a "tier three" reimbursement category. That generally comes with higher copays and requires physicians to explain why they prescribed Afrezza over standard injected insulin. Sanofi also priced Afrezza at a premium to its injectable counterparts.

MannKind's Mr. Pfeffer said pricing and reimbursement issues "dramatically outweigh the other factors" related to Afrezza's slow uptake.

Without a clinical trial showing that Afrezza worked better than injected insulin [Ground for breach of Commercially Reasonable Effort (CRE). Sanofi should have started Phase 4 Superiority trial in Sept 2014 before PBMs place Afrezza as Tier2 w/o PA, ST.], Sanofi's advertising campaign centered on the novelty of inhaling versus injecting. But the company overestimated the extent to which patients would switch to Afrezza due to a needle aversion, said Eamonn O'Connor, an analyst at the health-care consulting firm Decision Resources Group.

Despite these setbacks, Afrezza has gained a small but avid following among patients who say it works significantly better for them than injected insulin.

Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said.

Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind.

But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment.
Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3O

It remains to be seen if MNKD will be receiving any sizable settlement check or one at all. I'd love to wake up tomorrow with news of one but this company always finds a way to disappoint.