Much like Amgen last year, Regeneron/Sanofi know what the Praluent data is. It will be positive and hit their endpoints, but like Amgen's data the MAGNITUDE OF EFFECT is less than what is going to move the needle for access. It's like passing a test with a 60% or low D. If the data was better, they would have released topline results teasers about how great the data is. That's what Novartis did with Entresto. The Praluent team is now trying to find the best way to spin this data. Hopefully, they aren't as arrogant as Sean Harper in claiming that payers are being irresponsible for not believing his bullshit.
What this means is that both drugs will be duds and niche products. The dreams of a $5-6B dollar market will be tempered down to a <$3B market for both drugs with a slow trajectory to peak sales. The data will be similar so that means no drug we be convincingly superior. If Praluent had better data, Amgen could ride a class effect if Praluent was allow on market.
With $32 in cash from overseas, it will only be a matter of time for major M&A. With all the office of the future consolidation, it looks like TO ready for sale.
http://www.ajmc.com/focus-of-the-we...-for-sanofis-praluent-to-lead-off-acc-meeting
ODYSSEY Outcomes Results for Sanofi's Praluent to Lead Off ACC Meeting
Mary Caffrey
The annual meeting of the American College of Cardiology (ACC), which runs March 10-12, 2018, in Orlando, Florida, will open with cardiovascular outcomes results for the PCSK9 inhibitor alirocumab (Praluent). The meeting also features updates on anti-inflammatory drugs, the use of SGLT2 inhibitors in heart failure, and how cardiology is shifting to new healthcare delivery models.
The next round of competition between 2 powerful drugs to lower cholesterol will come March 10, 2018, when the annual American College of Cardiology (ACC) Scientific Session opens in Orlando, Florida. That’s when results from the ODYSSEY Outcomes trial will show whether Sanofi-Regeneron’s alirocumab (Praluent) has a superior cardiovascular (CV) benefit to Amgen’s evolocumab (Repatha).
ODYSSEY Outcomes took longer, but there’s speculation that the wait will be worth it, if the data show the powerful class of injectable therapy, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, also produce significant CV benefits alongside their ability to reduce low-density lipoprotein (LDL) cholesterol by up to 60%. Both are approved to be used with maximally tolerated statins in patients with atherosclerotic CV disease and familial hypercholesterolemia (FH), a genetic condition.
The trial results from ODYSSEY Outcomes will “define the role of PCSK9 inhibition in cardiovascular medicine,” said Deepak L. Bhatt, MD, MPH, FACC, associate editor of ACC.org, in the article, “Trends for 2018: What’s Ahead in Our Journey in Cardiovascular Medicine?” which appears today on acc.org.
The ODYSSEY Outcomes results will come nearly a year after the last ACC meeting, where results from FOURIER showed Repatha had a modest CV benefit—a 15% reduction in a composite primary endpoint, with no reduction in CV death. Despite a 27% reduction in heart attacks and a 21% reduction in strokes over 2 years, analysts weren’t wowed and neither were payers.
Over the past year, physicians have told The American Journal of Managed Care® they continue to face prior authorization hurdles when prescribing PSCK9 inhibitors, and a study published this month by Penn Medicine found the barriers are so high they raise questions whether patients with clear need—such as those with FH—are being unfairly denied access.
With ODYSSEY Outcomes due in a late-breaking session to kick off this year’s ACC meeting, Bhatt said, “Physicians are hoping there’ll be a greater degree of benefit in the ODYSSEY trial than was seen in the FOURIER trial.”
ODYSSEY is a smaller trial, with 18,000 patients compared with FOURIER’s 27,000, but it has a longer follow-up period, and a different composite endpoint, which could lead to different results. ODYSSEY Outcomes’ composite includes heart attacks, strokes, death from CV causes, and hospitalization for angina. FOURIER added coronary revascularization to the composite outcome.
“We are in a new era for the treatment of cholesterol,” said ACC.org editor-in-chief Kim A. Eagle, MD, MACC. As others have, Eagle cited the clinical results for PCKS9 inhibitors are being weighed against the costs—the drugs cost more than $14,000 a year. Several analyses have been published that say the drugs are not cost-effective at that price, including some that question the value for payers of Amgen’s offer of a money-back guarantee if patients have a heart attack while taking the drug.
What this means is that both drugs will be duds and niche products. The dreams of a $5-6B dollar market will be tempered down to a <$3B market for both drugs with a slow trajectory to peak sales. The data will be similar so that means no drug we be convincingly superior. If Praluent had better data, Amgen could ride a class effect if Praluent was allow on market.
With $32 in cash from overseas, it will only be a matter of time for major M&A. With all the office of the future consolidation, it looks like TO ready for sale.
http://www.ajmc.com/focus-of-the-we...-for-sanofis-praluent-to-lead-off-acc-meeting
ODYSSEY Outcomes Results for Sanofi's Praluent to Lead Off ACC Meeting
Mary Caffrey
The annual meeting of the American College of Cardiology (ACC), which runs March 10-12, 2018, in Orlando, Florida, will open with cardiovascular outcomes results for the PCSK9 inhibitor alirocumab (Praluent). The meeting also features updates on anti-inflammatory drugs, the use of SGLT2 inhibitors in heart failure, and how cardiology is shifting to new healthcare delivery models.
The next round of competition between 2 powerful drugs to lower cholesterol will come March 10, 2018, when the annual American College of Cardiology (ACC) Scientific Session opens in Orlando, Florida. That’s when results from the ODYSSEY Outcomes trial will show whether Sanofi-Regeneron’s alirocumab (Praluent) has a superior cardiovascular (CV) benefit to Amgen’s evolocumab (Repatha).
ODYSSEY Outcomes took longer, but there’s speculation that the wait will be worth it, if the data show the powerful class of injectable therapy, the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, also produce significant CV benefits alongside their ability to reduce low-density lipoprotein (LDL) cholesterol by up to 60%. Both are approved to be used with maximally tolerated statins in patients with atherosclerotic CV disease and familial hypercholesterolemia (FH), a genetic condition.
The trial results from ODYSSEY Outcomes will “define the role of PCSK9 inhibition in cardiovascular medicine,” said Deepak L. Bhatt, MD, MPH, FACC, associate editor of ACC.org, in the article, “Trends for 2018: What’s Ahead in Our Journey in Cardiovascular Medicine?” which appears today on acc.org.
The ODYSSEY Outcomes results will come nearly a year after the last ACC meeting, where results from FOURIER showed Repatha had a modest CV benefit—a 15% reduction in a composite primary endpoint, with no reduction in CV death. Despite a 27% reduction in heart attacks and a 21% reduction in strokes over 2 years, analysts weren’t wowed and neither were payers.
Over the past year, physicians have told The American Journal of Managed Care® they continue to face prior authorization hurdles when prescribing PSCK9 inhibitors, and a study published this month by Penn Medicine found the barriers are so high they raise questions whether patients with clear need—such as those with FH—are being unfairly denied access.
With ODYSSEY Outcomes due in a late-breaking session to kick off this year’s ACC meeting, Bhatt said, “Physicians are hoping there’ll be a greater degree of benefit in the ODYSSEY trial than was seen in the FOURIER trial.”
ODYSSEY is a smaller trial, with 18,000 patients compared with FOURIER’s 27,000, but it has a longer follow-up period, and a different composite endpoint, which could lead to different results. ODYSSEY Outcomes’ composite includes heart attacks, strokes, death from CV causes, and hospitalization for angina. FOURIER added coronary revascularization to the composite outcome.
“We are in a new era for the treatment of cholesterol,” said ACC.org editor-in-chief Kim A. Eagle, MD, MACC. As others have, Eagle cited the clinical results for PCKS9 inhibitors are being weighed against the costs—the drugs cost more than $14,000 a year. Several analyses have been published that say the drugs are not cost-effective at that price, including some that question the value for payers of Amgen’s offer of a money-back guarantee if patients have a heart attack while taking the drug.