38 days until the end-need sr. leadership input

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anonymous

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Counting down to the final date. Not happy. Why doesn't Amgen just settle? So many jobs will be lost. This is a great company, and I really don't want to leave Regeneron. If there is anyone from upper management on this thread, can you please give us anything tangible as to options for hope that we will retain a job, even if the judges rule against us? Any chance that we will be retained for a period of time beyond WARN? Any chance of an acquisition, or a speedy trek through the FDA on another product (beyond Sari and Dupi, since they are already all hired)?
 


















Keep dreaming. Len and his medical affairs and legal department really fucked this one up. The bigger question for people that were hired for Praluent had no information that we were launching at risk. Sanofi had no clue also. Sanofi reps just got moved into the role where Regeneron hired. Currently getting my own legal advice as I wouldn't of taken the job if we were at risk for patent infringement. What a cluster.
 






  • Praluent won't likely get a stay during the appeal so product likely pulled in Q1
  • Even after 18 month appeal, Praluent injunction likely to be upheld
  • Amgen never settles IP cases and only 20% of cases like this ever go to royalties.

http://www.investors.com/news/techn...eneron-sanofi-in-amgen-patent-battle-leerink/

Biotech Amgen (AMGN) will likely triumph in a patent battle with Regeneron Pharmaceuticals (REGN) and Sanofi (SNY), requiring the duo to pull LDL-buster Praluent from the shelves — an unprecedented first, Leerink analyst Geoffrey Porges said Friday.

Regeneron and Sanofi have asked a federal circuit judge to grant a stay of the injunction beyond 45 days. That would allow them to market Praluent during the appeal, which typically runs up 16 months, Porges wrote in a research report Friday.

But the odds don't look good. Specialists believe "regardless of the ultimate merits of Regeneron and Sanofi's case, they will face an unprecedented (and probably first) branded pharmaceutical product withdrawal in the middle of this quarter," he wrote.

The most important catalyst will be whether the Federal Circuit extends the stay, Porges says. Of 158 permanent injunctions (PIs) granted in federal or district court since a 2006 case involving Ebay, only 37 parties (23%) were granted a stay.

In Regeneron and Sanofi's case, though, it would be the first time a branded drug would be pulled from shelves as a result of patent litigation. They have made the argument that public interest would not be served by pulling Praluent, which offers a lower dosage than Amgen's Repatha.

Examining medical-device cases, the district court has stayed a PI in five cases. But at the federal level, the PI was affirmed and not extended, resulting in the removal of those products from the market. Those precedents appear to be "stacked" against Regeneron and Sanofi, Porges said.

To Regeneron and Sanofi's public interest argument, Porges noted that public interest is actually better served in siding with the patent holder, thus encouraging the risky investment required in bringing an innovative product to market.

Porges also looks at several outcomes. It's possible that the case could be remanded to the district court. The federal circuit could also require Amgen, Regeneron and Sanofi to seek settlement assistance via the Circuit Mediation Office. But that process only happens in 10%-20% of cases.

Amgen, the No. 1 biotech firm by market cap, is unlikely to settle, he wrote. The company "notoriously takes the stance to never settle IP disputes and vigorously defends the company's IP, as evidenced by the blockage of market entry for Roche's Epogen competitor Mircera until the infringed patent expired."
 






anonymous said:
Keep dreaming. Len and his medical affairs and legal department really fucked this one up. The bigger question for people that were hired for Praluent had no information that we were launching at risk. Sanofi had no clue also. Sanofi reps just got moved into the role where Regeneron hired. Currently getting my own legal advice as I wouldn't of taken the job if we were at risk for patent infringement. What a cluster.
Click to expand...
 


















anonymous said:
Counting down to the final date. Not happy. Why doesn't Amgen just settle? So many jobs will be lost. This is a great company, and I really don't want to leave Regeneron. If there is anyone from upper management on this thread, can you please give us anything tangible as to options for hope that we will retain a job, even if the judges rule against us? Any chance that we will be retained for a period of time beyond WARN? Any chance of an acquisition, or a speedy trek through the FDA on another product (beyond Sari and Dupi, since they are already all hired)?
Click to expand...

You named some possible options for REGN. How many of them look good? Dupi/Sari will be in same boat since REGN bypassed too many check/balances.

Why do you ask our SR Leadership anything? They're the idiots who drove REGN into this situation. If they knew, we wouldn't be here.

Just update your resume and leave like the rest of us.
 






I came over for the Praluent launch. It is NOT going to be OK. I have to agree with anon @5:22 a.m. on the article post.
Here's what I know/believe. PI = Permanent Injunction, by the way:
  1. Amgen wants us gone, NEVER had the idea of royalties.They won the LAST major patent challenge & injunction case.
  2. LenS made it pretty clear @JP Morgan conference that Royalties = Guilt = No Way in Hell. http://www.fiercepharma.com/pharma/...gan-everything-you-need-to-know-all-one-place and read "Updated Story" article. Trust me, our CEO sees "all or nothing" with AMGN.
  3. Praluent has [cough] under-performed, and won't turn a profit anytime soon. Still too many mouths to feed after SNFI layoffs. Even if we overturn the PI- we already have thin 2017 budgets. Even a "modest" royalty would impact head count, territory size, ability to compete.
  4. Managed care will bail. Most Praluent business comes from parity plans, meaning equal opportunity for R or P. Let's face it, the AMGN RAS can do lots more than a REGN FAS to pull through a patient. We already lost a Praluent exclusive plan this year (Tricare); UHC is the only other major commercial player where P>R - for now.
  5. Success means getting PI overturned, which (per article) happens 23% of the time. The appeal doesn't matter to sales; if you can't sell Praluent, and can't for maybe years, you don't need a sales force! And if our lawyers see we can't overturn the PI, REGN leadership will cut us loose - PDQ.
  6. Won't go into detail, REGN already has contingency plans with the expectation that PI will remain. Plans might go into effect prior to 45 day suspense.
  7. Timing is all wrong for PCSK9s! We can't say removing P hurts patients, we only have firm data on a biomarker (LDL-C). In 2017, R will have plaque regression + true outcomes data. P's outcomes - maybe Q1-2018? PBMs still believe $4 generic statins (w/outcomes data) should be maxed out first, and they know patients don't take them. We pushed next step after statins; MC plans added Zetia and we spent a year trying to peel that away. Even branded copay for Zetia + generic Lipitor is way less than Med D co-insurance. We might have a better argument in 5 years.
  8. Next commercial launch for REGN (RSV) is at best 1.5-2 yrs away. Maybe dupi when it expands its label, but we don't have 6-9 months.
DO NOT buy into the hype that DR, BT, and other sales leaders tell you - it ain't "Business As Usual." Same time they are telling us it's no big deal, and it's going to be fine, they are talking to headhunters as well. Actions speak a lot louder than empty catch phrases.

If we get a miracle (PI gets overturned) great. But it will be a miracle. And nothing the Alliance has done to this point has worked. If someone can point out anything, please post back. I want someone to make me feel better about this, and the picture has just gotten more and more grim the more I learn.
And if the miracle happens, that gets us back to the issue we've had since launch: The Sanofi-Regeneron business relationship has serious flaws.

C'mon, someone throw a ray of sunshine my way... seriously...
 






I came over for the Praluent launch. It is NOT going to be OK. I have to agree with anon @5:22 a.m. on the article post.
Here's what I know/believe. PI = Permanent Injunction, by the way:

  1. Amgen wants us gone, NEVER had the idea of royalties.They won the LAST major patent challenge & injunction case.
  2. LenS made it pretty clear @JP Morgan conference that Royalties = Guilt = No Way in Hell. http://www.fiercepharma.com/pharma/...gan-everything-you-need-to-know-all-one-place and read "Updated Story" article. Trust me, our CEO sees "all or nothing" with AMGN.
  3. Praluent has [cough] under-performed, and won't turn a profit anytime soon. Still too many mouths to feed after SNFI layoffs. Even if we overturn the PI- we already have thin 2017 budgets. Even a "modest" royalty would impact head count, territory size, ability to compete.
  4. Managed care will bail. Most Praluent business comes from parity plans, meaning equal opportunity for R or P. Let's face it, the AMGN RAS can do lots more than a REGN FAS to pull through a patient. We already lost a Praluent exclusive plan this year (Tricare); UHC is the only other major commercial player where P>R - for now.
  5. Success means getting PI overturned, which (per article) happens 23% of the time. The appeal doesn't matter to sales; if you can't sell Praluent, and can't for maybe years, you don't need a sales force! And if our lawyers see we can't overturn the PI, REGN leadership will cut us loose - PDQ.
  6. Won't go into detail, REGN already has contingency plans with the expectation that PI will remain. Plans might go into effect prior to 45 day suspense.
  7. Timing is all wrong for PCSK9s! We can't say removing P hurts patients, we only have firm data on a biomarker (LDL-C). In 2017, R will have plaque regression + true outcomes data. P's outcomes - maybe Q1-2018? PBMs still believe $4 generic statins (w/outcomes data) should be maxed out first, and they know patients don't take them. We pushed next step after statins; MC plans added Zetia and we spent a year trying to peel that away. Even branded copay for Zetia + generic Lipitor is way less than Med D co-insurance. We might have a better argument in 5 years.
  8. Next commercial launch for REGN (RSV) is at best 1.5-2 yrs away. Maybe dupi when it expands its label, but we don't have 6-9 months.
DO NOT buy into the hype that DR, BT, and other sales leaders tell you - it ain't "Business As Usual." Same time they are telling us it's no big deal, and it's going to be fine, they are talking to headhunters as well. Actions speak a lot louder than empty catch phrases.

If we get a miracle (PI gets overturned) great. But it will be a miracle. And nothing the Alliance has done to this point has worked. If someone can point out anything, please post back. I want someone to make me feel better about this, and the picture has just gotten more and more grim the more I learn.
And if the miracle happens, that gets us back to the issue we've had since launch: The Sanofi-Regeneron business relationship has serious flaws.

C'mon, someone throw a ray of sunshine my way... seriously...
 












anonymous said:
I came over for the Praluent launch. It is NOT going to be OK. I have to agree with anon @5:22 a.m. on the article post.
Here's what I know/believe. PI = Permanent Injunction, by the way:

  1. Amgen wants us gone, NEVER had the idea of royalties.They won the LAST major patent challenge & injunction case.
  2. LenS made it pretty clear @JP Morgan conference that Royalties = Guilt = No Way in Hell. http://www.fiercepharma.com/pharma/...gan-everything-you-need-to-know-all-one-place and read "Updated Story" article. Trust me, our CEO sees "all or nothing" with AMGN.
  3. Praluent has [cough] under-performed, and won't turn a profit anytime soon. Still too many mouths to feed after SNFI layoffs. Even if we overturn the PI- we already have thin 2017 budgets. Even a "modest" royalty would impact head count, territory size, ability to compete.
  4. Managed care will bail. Most Praluent business comes from parity plans, meaning equal opportunity for R or P. Let's face it, the AMGN RAS can do lots more than a REGN FAS to pull through a patient. We already lost a Praluent exclusive plan this year (Tricare); UHC is the only other major commercial player where P>R - for now.
  5. Success means getting PI overturned, which (per article) happens 23% of the time. The appeal doesn't matter to sales; if you can't sell Praluent, and can't for maybe years, you don't need a sales force! And if our lawyers see we can't overturn the PI, REGN leadership will cut us loose - PDQ.
  6. Won't go into detail, REGN already has contingency plans with the expectation that PI will remain. Plans might go into effect prior to 45 day suspense.
  7. Timing is all wrong for PCSK9s! We can't say removing P hurts patients, we only have firm data on a biomarker (LDL-C). In 2017, R will have plaque regression + true outcomes data. P's outcomes - maybe Q1-2018? PBMs still believe $4 generic statins (w/outcomes data) should be maxed out first, and they know patients don't take them. We pushed next step after statins; MC plans added Zetia and we spent a year trying to peel that away. Even branded copay for Zetia + generic Lipitor is way less than Med D co-insurance. We might have a better argument in 5 years.
  8. Next commercial launch for REGN (RSV) is at best 1.5-2 yrs away. Maybe dupi when it expands its label, but we don't have 6-9 months.
DO NOT buy into the hype that DR, BT, and other sales leaders tell you - it ain't "Business As Usual." Same time they are telling us it's no big deal, and it's going to be fine, they are talking to headhunters as well. Actions speak a lot louder than empty catch phrases.

If we get a miracle (PI gets overturned) great. But it will be a miracle. And nothing the Alliance has done to this point has worked. If someone can point out anything, please post back. I want someone to make me feel better about this, and the picture has just gotten more and more grim the more I learn.
And if the miracle happens, that gets us back to the issue we've had since launch: The Sanofi-Regeneron business relationship has serious flaws.

C'mon, someone throw a ray of sunshine my way... seriously...
Click to expand...
 






anonymous said:
I came over for the Praluent launch. It is NOT going to be OK. I have to agree with anon @5:22 a.m. on the article post.
Here's what I know/believe. PI = Permanent Injunction, by the way:

  1. Amgen wants us gone, NEVER had the idea of royalties.They won the LAST major patent challenge & injunction case.
  2. LenS made it pretty clear @JP Morgan conference that Royalties = Guilt = No Way in Hell. http://www.fiercepharma.com/pharma/...gan-everything-you-need-to-know-all-one-place and read "Updated Story" article. Trust me, our CEO sees "all or nothing" with AMGN.
  3. Praluent has [cough] under-performed, and won't turn a profit anytime soon. Still too many mouths to feed after SNFI layoffs. Even if we overturn the PI- we already have thin 2017 budgets. Even a "modest" royalty would impact head count, territory size, ability to compete.
  4. Managed care will bail. Most Praluent business comes from parity plans, meaning equal opportunity for R or P. Let's face it, the AMGN RAS can do lots more than a REGN FAS to pull through a patient. We already lost a Praluent exclusive plan this year (Tricare); UHC is the only other major commercial player where P>R - for now.
  5. Success means getting PI overturned, which (per article) happens 23% of the time. The appeal doesn't matter to sales; if you can't sell Praluent, and can't for maybe years, you don't need a sales force! And if our lawyers see we can't overturn the PI, REGN leadership will cut us loose - PDQ.
  6. Won't go into detail, REGN already has contingency plans with the expectation that PI will remain. Plans might go into effect prior to 45 day suspense.
  7. Timing is all wrong for PCSK9s! We can't say removing P hurts patients, we only have firm data on a biomarker (LDL-C). In 2017, R will have plaque regression + true outcomes data. P's outcomes - maybe Q1-2018? PBMs still believe $4 generic statins (w/outcomes data) should be maxed out first, and they know patients don't take them. We pushed next step after statins; MC plans added Zetia and we spent a year trying to peel that away. Even branded copay for Zetia + generic Lipitor is way less than Med D co-insurance. We might have a better argument in 5 years.
  8. Next commercial launch for REGN (RSV) is at best 1.5-2 yrs away. Maybe dupi when it expands its label, but we don't have 6-9 months.
DO NOT buy into the hype that DR, BT, and other sales leaders tell you - it ain't "Business As Usual." Same time they are telling us it's no big deal, and it's going to be fine, they are talking to headhunters as well. Actions speak a lot louder than empty catch phrases.

If we get a miracle (PI gets overturned) great. But it will be a miracle. And nothing the Alliance has done to this point has worked. If someone can point out anything, please post back. I want someone to make me feel better about this, and the picture has just gotten more and more grim the more I learn.
And if the miracle happens, that gets us back to the issue we've had since launch: The Sanofi-Regeneron business relationship has serious flaws.

C'mon, someone throw a ray of sunshine my way... seriously...
Click to expand...



I think most agree with this post. If you know more about the contingency plans .6) please share, I've asked many and never get a straight answer
 






I think most agree Praluent is toast. If the previous poster knows anything about contingency plans please share, I've asked management several times with no real answer
 






anonymous said:
I think most agree Praluent is toast. If the previous poster knows anything about contingency plans please share, I've asked management several times with no real answer
Click to expand...

The communication from management is business as usual and focus on core business. Not sure what that really means due to the fact that we're in the biotechnology business and failed to secure patents. Sounds like Retardaron is just retarding-on!
 


















anonymous said:
Counting down to the final date. Not happy. Why doesn't Amgen just settle? So many jobs will be lost. This is a great company, and I really don't want to leave Regeneron. If there is anyone from upper management on this thread, can you please give us anything tangible as to options for hope that we will retain a job, even if the judges rule against us? Any chance that we will be retained for a period of time beyond WARN? Any chance of an acquisition, or a speedy trek through the FDA on another product (beyond Sari and Dupi, since they are already all hired)?
Click to expand...

Why the fuck would Amgen settle? They have a history of not settling. They can have 100% control of the market. You think they would settle so Regeneron reps can keep their job? This isn't a charity business and they aren't run by Mister Rogers Neighborhood.

Better look for a new job and get ready for unemployment.
 






This is an epic fuckup by Regeneron that will be studied for years in any classroom dealing with any-trust- patents, Harvard Business Review. Nice legacy Len!! How does it feel to lose 80 million in one day?? Or to know a slew of reps will be out of a job.
 






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