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Post by lakers on Jan 15, 2016 3:11:19 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1452838541330-a9b49c59-c071-43f4-b785-96135f29b4ea&tls=la%2Cd%2C9%2C3 |
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Post by lakers on Jan 15, 2016 3:16:43 GMT -5
I've tried posting the last part of the SNY Letter ref San Diego meeting at least 5 times, however it won't post. Don't know why. In short it asks the participants to fill out a questionnaire based on their experience with Afrezza and to send it in 2-3 days prior to the meeting. Not much more. It seems to me SNY expressed strong interest in how well Afrezza works in conjunction with a CGM. Now that they are out, perhaps some of the other BP's also realize this. Andres Boss sent the letter to participants. Boss is former Mnkd CMO, now Sanofi Sr. Dir, Afrezza lead. [It's clear Mnkd repeatedly pushed Sanofi to conduct superiority trial earlier only to be overruled. Just as The Afrezza US lead finally relented, the mother ship bailed. JAC meeting minutes are routinely kept. They will help Mnkd case in court. Sanofi still holds the trump card that if they lose and the award trebled due to their intentional hold back for conflict of interest, they will have no choice but acquire Mnkd to avoid paying big bucks, then recoup by the $1.6B RnD tax credit carryover. I believe if they own 100% Afrezza and TS, they will make it successful. That's what Al wants as his legacy. In this ironic scenario, Sanofi will have acquired Mnkd for cheap. Mnkd may win the battle, but they win the war. So do PWDs. Then there will be Second Launch as promised after all albeit a few years later. Al couldn't care less as long as Afrezza survives to help PWDs. That's what he cares about. The followings prove that both Mnkd and Sanofi knew that the superiority trial was the key to unlock Afrezza potential. Perhaps, Olivier sandbagged Afrezza as his overture was spurned by Al. Sanofi only presses pedal to metal when they own Afrezza 100%. Hindsight, Al should have sold Mnkd to Sanofi outright. Chris was a believer. Mnkd was a hot date in 2014 asking for a lot of dough for marriage.] 10/27/14, Hakan said in an interview: SCVBJ: What lessons were learned along the way about how to bring a new drug to market? In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products. We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients. The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales. When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments. Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy. Read more: mnkd.proboards.com/thread/4532/change-conduct-clinical-trials-future#ixzz3xIhciU7C |
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Post by suebeeee1 on Jan 15, 2016 3:27:17 GMT -5
Interesting. Thank you for sharing this. Several questions come to mind. The first is: did Afrezza perform as well as within the San Diego "formal setting" as the early adopters had seen at home and reported? What was Sanofi really hoping to accomplish? Did they establish a protocol that they are willing to release?
Or was it just a huge failure.
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Post by LosingMyBullishness on Jan 15, 2016 5:28:44 GMT -5
Great post. Very comprehensible. So that's why Al is out of it. Either Matt can get it right without bringing SNY to court or they sue SNY and SNY buys MNKD with pocket money. They they would create a profitable niche for the needlephobic. My idea about Al's mission was that he wanted to change diabetes for the whole community and believed that Afrezza can deliver quality of life to the masses.
SNY understood that Afrezza will not only canibalize existing SNY products but might also reduce the overall turnover in the diabetes market. SNY does not know this exactly and that was another reason to do a slow launch.
Imaging they target only the needlephobic and then it turns out that all of them have a much better and longer life. That's when things get out of control. such big player do not like that. I believe this is why they charged premium from the start and were very careful.
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Post by peppy on Jan 15, 2016 7:11:35 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1452838541330-a9b49c59-c071-43f4-b785-96135f29b4ea&tls=la%2Cd%2C9%2C3This is interesting because the pediatric trials included CGM. The trial data, clinicaltrials.gov/ct2/show/record/NCT02527265?term=afrezza&recr=Open&no_unk=Y says recruiting.
: using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well.
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Post by derekewhitlock on Jan 15, 2016 7:38:02 GMT -5
Lakers,
First off, thank you for your continued sensible and fact supported posts. Your input has been greatly appreciated. I do have one question regarding the above: Now that Sanofi has terminated the MNKD agreement how could they now acquire MNKD without the approval of MNKD? Does Sanofi still hols a contractual right to acquire MNKD after providing notice of termination? Thank you,
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Post by mnholdem on Jan 15, 2016 8:21:43 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. How could it be that Sanofi's US managers were unaware that Sanofi's CEO/BoD were terminating the agreement in a few weeks? I find myself analyzing and asking, "Why, then, would Sanofi gather this data?" By picking the brains of successful early adopters of Afrezza, what if Sanofi's intent was to use their final weeks gathering intel to determine if/how CGM-based control can be used to achieve superior results with their fast-acting injected insulin Apidra (see highlighted sentence above).
Humble apologies if my skepticism rubs anyone the wrong way. It's just that I no longer trust anything that has been said or done by this French pharmaceutical giant. 
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Post by kball on Jan 15, 2016 8:50:55 GMT -5
(follow up letter)
Dear XXXXXXXXX
Thank you for your participation in the recent SD meeting.
It proved crucial in our strategy to silence the most vocal and successful early adopters, as well as gave us the necessary information to determine if PWD became aware of ideal dosing and timing with Afrezza around mealtime, and we were to pursue even the most halfhearted launch attempt with this new therapy, it would greatly and negatively impact the rest of our existing diabetes franchise which we've spent billions on and rely on for billions more in revenue.
Good luck to you.
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Post by dictatorsaurus on Jan 15, 2016 9:12:45 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. How could it be that Sanofi's US managers were unaware that Sanofi's CEO/BoD were terminating the agreement in a few weeks? I find myself analyzing and asking, "Why, then, would Sanofi gather this data?" By picking the brains of successful early adopters of Afrezza, what if Sanofi's intent was to use their final weeks gathering intel to determine if/how CGM-based control can be used to achieve superior results with their fast-acting injected insulin Apidra (see highlighted sentence above).
Humble apologies if my skepticism rubs anyone the wrong way. It's just that I no longer trust anything that has been said or done by this French pharmaceutical giant.
In such big companies the left hand doesn't know what the right hand is doing. It's business as usual until the guys at the very top pull the plug. It's very possible middle management and the Sanofi personnel working directly with Mannkind had the best of intentions. Apparently corporate had other plans. |
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Post by peppy on Jan 15, 2016 9:17:19 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. How could it be that Sanofi's US managers were unaware that Sanofi's CEO/BoD were terminating the agreement in a few weeks? I find myself analyzing and asking, "Why, then, would Sanofi gather this data?" By picking the brains of successful early adopters of Afrezza, what if Sanofi's intent was to use their final weeks gathering intel to determine if/how CGM-based control can be used to achieve superior results with their fast-acting injected insulin Apidra (see highlighted sentence above).
Humble apologies if my skepticism rubs anyone the wrong way. It's just that I no longer trust anything that has been said or done by this French pharmaceutical giant.
Matt B. was on Apidra with a CMG. Matt has documented better blood glucose control on Afrezza, with a CMG. (on tape, with a digital footprint) afrezzadownunder.com/
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Post by mindovermatter on Jan 15, 2016 9:24:22 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. How could it be that Sanofi's US managers were unaware that Sanofi's CEO/BoD were terminating the agreement in a few weeks? I find myself analyzing and asking, "Why, then, would Sanofi gather this data?" By picking the brains of successful early adopters of Afrezza, what if Sanofi's intent was to use their final weeks gathering intel to determine if/how CGM-based control can be used to achieve superior results with their fast-acting injected insulin Apidra (see highlighted sentence above).
Humble apologies if my skepticism rubs anyone the wrong way. It's just that I no longer trust anything that has been said or done by this French pharmaceutical giant.
Very simple. Sanofi is a large bureaucratic company. And like large companies, decisions made in the boardroom don't always filter out to the lower levels until the decision is publicly made. The Afrezza managers were probably left in the dark as to not interfere with their job knowing that Afrezza was going to die on the vine even though top brass knew they were going to kill it. It's why so many people hate working for large companies. |
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Post by parrerob on Jan 15, 2016 10:16:12 GMT -5
What I don't understand is why not going on another year ? If You want to take out from the market a product why You prefer to give it back immediately instead of going on with slow launch and doing nothing with insurance ? OK You can put in Your budget some 100s millions more for a lawsuite but then You are sure about Your target.
First users seems all impressed ! If the problem was their basal products they could buy Afrezza (not for sale, sure) considering also they were aware of the results from first users. SNY knows very well that in the long term what they are going to loose with their basal portfolio will generate much and much more income from concurrency basal products .....
And they could also take their hands on the TS pipeline !!!!!!
No no.... There is another side of the plate that is still not visible !
If another partnership will be done in the future, never again imo with exclusivity ! MNKD should start now and always keep his hands on the marketing side. Please Mr. Mann don't give another change to Afrezza with other BPs as MRK, NVO, LLY and friends ! |
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Post by charleyd on Jan 15, 2016 11:08:51 GMT -5
oxotnik1 • 1 hour 50 minutes ago Flag 5users liked this postsusers disliked this posts0Reply Copy of Letter SNY sent out to participants of Dec 5th San Diego Meeting (PART 1) Afrezza Patient Advisory Board Here is the letter SNY sent out to the Initial Adopters prior to the San Diego (Del Mar) meeting on Dec 5. I had been asked not to share it, but now with SNY out it makes no matter. I've removed the recipient's name per recipient's request. I've broken letter up into two parts, as it would not all fit for some reason. This is part 1. Part 2 will come next. Dear XXXXXXXXXXXXXXX Thank you for your willingness to participate in the Sanofi Patient Advisory Board for our upcoming Afrezza study. We are looking forward to a successful meeting in San Diego on December 5th. Sanofi appreciates your willingness to help us shape the future on insulin delivery and your experience is of utmost importance as we continue our work to better understand dosing needs and guidelines with prandial (mealtime) insulins. We are learning from individuals that they are using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well. We believe your experience and perspective will help us to: · Develop an in-depth understanding of the challenges and barriers as well as the successes related to mealtime insulin · Provide innovative advice and dynamic perspectives on the use of both inhaled and injectable mealtime insulin in combination with CGM · Create a blueprint for the design and instructions for the use of Afrezza and injectable mealtime insulin for the Phase 4 study that will be launched by Sanofi in the near future. finance.yahoo.com/mbview/threadview/?&bn=0243242e-59fb-3abc-8d27-962c7bf26a1d&tid=1452838541330-a9b49c59-c071-43f4-b785-96135f29b4ea&tls=la%2Cd%2C9%2C3This is interesting because the pediatric trials included CGM. The trial data, clinicaltrials.gov/ct2/show/record/NCT02527265?term=afrezza&recr=Open&no_unk=Y says recruiting.
: using Afrezza together with continuous glucose monitoring (CGM) and are achieving good blood sugar results. We are interested in investigating the use of Afrezza with CGM in a formal clinical study and need your help in the development of instructions for individuals new to Afrezza and for those on injectable mealtime insulin as well.
Why would the Pediatric Trial not serve as the de facto superiority trial that we have all been clamoring about? If the use of CGM monitoring leads to the optimization of use, that has driven many early adopters to experience dramatically lower HbA1c results, then why would this not also occur in the Pediatric Trial? Is the protocol too rigid to allow this? If not, and superior results are indeed obtained, why would this not be applicable to the total diabetic population? |
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Post by tayl5 on Jan 15, 2016 11:15:48 GMT -5
I can easily imagine a scenario where Sanofi senior management meets, decides there are too many launches occurring simultaneously and prioritizes. With low revenues and relatively flat growth curve, Afrezza is an easy target. Unless someone stands up at that meeting and forcefully defends the program (likely not a good career move), it's history. No need to look for ulterior motives and complex schemes. C-level managers are paid to make those big decisions. Everyone else just reacts.
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Post by lakers on Jan 15, 2016 12:19:57 GMT -5
If you are looking for a Smoking Gun to prove breach of Commercially Reasonable Effort and Sandbagging much like the other sandbagging lawsuit Sanofi received, you got at least one here. This bolsters the leverage to extract max settlement from Sanofi to extend the runway. I'd prefer Mnkd goes for a full multi-billion suit instead of accepting a possible settlement of the remaining $725M bonus and forgiven $65M loan. Sanofi internationally delayed or not even started critical post-Mktg studies and superiority trial among other things. Winnability also depends on precedence, behavioral pattern. Sanofi intentionally slowed a drug approval to avoid a $708M payout, Genzyme shareholder suit alleges By Nicole GrayNov. 11, 2015 DIVE BRIEF: The American Stock Transfer & Trust Company, LLC, is suing Sanofi on behalf of Genzyme rights holders. When Sanofi acquired Genzyme and its lead candidate Lemtrada (alemtuzumab) in 2011, the agreement was structured so that Genzyme shareholders would receive milestone payments—assuming Lemtrada was approved by March 31, 2014. The lawsuit alleges that Sanofi intentionally delayed approval of the multiple sclerosis (MS) drug. The suit alleges that Sanofi intentionally ignored FDA concerns about clinical trial design. When Lemtrada was approved in November 2014, it came with a black box warning and entered a relatively competitive market. At the same time, Sanofi was aggressively marketing Aubagio (teriflunomide), its once-a-day tablet for relapsing MS. Overall, Genzyme rights owners missed out on at least $708 million in milestone payments. DIVE INSIGHT: Many merger/acquisition agreements incorporate milestone payments based on achieving certain R&D or approval milestones. The agreement between Sanofi and Genzyme was typical in this fashion. Genzyme came to the table with a lead candidate and Sanofi agreed to usher it through the R&D process, with the goal of achieving certain milestones at specific dates. The almost eight-month delay between the target approval date for Lemtrada and its actual approval date, as well as Sanofi's decision to privilege Aubagio over Lemtrada (according to the lawsuit), proved costly in many ways. Lemtrada was approved as a disease-modifying therapy with a price tag of $158,000 per two-treatment regimen. The market was ready. As Lemtrada launched, other contenders were entering the market as well. Biogen introduced the oral drug Tecfidera and Novartis unveiled Gilenya. The only downside was that Lemtrada was approved as a third-line therapy. The major grievance of Genzyme rights holders is a huge lost opportunity for a possible $708 million, and perhaps as much as $3.8 billion, if the allegations are true. The case, which was just filed this week, is American Stock Transfer & Trust Company LLC v. Sanofi, U.S. District Court, Southern District of New York, No. 1:15-cv-08725. www.biopharmadive.com/news/sanofi-intentionally-slowed-a-drug-approval-to-avoid-a-708m-payout-genzym/408996/ |
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