The Pipeline Report 2014: Class Seekers

Share this article:
The Pipeline Report 2014: Class Seekers
The Pipeline Report 2014: Class Seekers

Cardiology

PRODUCTS GENERATING BUZZ

Alirocumab/SAR236553 Sanofi/Regeneron
Indication: Hypercholesterolemia, hyperlipoproteinemia (Ph. III)
What the clinical trials found: A 47% reduction in LDL-C in a Phase III monotherapy study; 73% reduction when added to Lipitor in a Phase II trial. The percentage who reported treatment-emergent AEs was 78.4% ezetimibe, 69.2% alirocumab (ODYSSEY MONO).
inThought Approvability Index and Comment: 67%. This monoclonal antibody targets proprotein convertase subtilisin/kexin type 9 (PCSK9), for LDL-C reduction. This won't compete with statins, but a large number of people are statin-intolerant or refractory, so these drugs will help them. Estimated launch: 2016 (Source: Credit Suisse)
Credit Suisse revenue forecast: $865 million in global sales by 2020
What physicians are saying: [At press time, new AHA/ACC treatment guidelines emphasized the benefit of statins while noting a lack of evidence that non-statin treatments reduce CV events. -Ed.] A few cardiologists warn that cholesterol lowering, consistent at two weeks, begins to wane by four. Cleveland Clinic's Steven Nissen noted that a four-week dosing schedule may be more attractive than biweekly, “but the frequency is not a make-or-break consideration.” —Alex Bastian, VP, GfK Bridgehead

Anacetrapib Merck
Indication: Atherosclerosis (Pre-reg.)
What the clinical trials found: Clearance time was estimated to be up to two years, data from Phase I and II studies of shorter duration indicate. A 138% increase in HDL-C and a 40% reduction in LDL-C (DEFINE) was seen.
inThought Approvability Index and Comment: 20%. This is pretty much the last man standing in the cholesterol ester transfer protein (CETP) inhibition category—the HDL-raising target that was so exciting a few years ago. In theory, the science is still sound. Many think other failures were class effects, and that this one is doomed, but there's no hard evidence of that. And if Phase III turns out to be OK, where others weren't, this will be a big success. Estimated launch: 2017 (Source: Symphony Health Solutions)
Credit Suisse revenue forecast: $2.4 billion in global sales by 2020
What the physicians are saying: Cardiologists said its tendency to stick around is a concern, but shouldn't prevent acceptance or approval. But Yale's Harlan Krumholz told Forbes, “A drug would have to be known to be incredibly safe before you would be willing to have it hang around in your body for years.” —Alex Bastian, VP, GfK Bridgehead

Evolocumab/AMG-145 Amgen
Indication: Hypercholesterolemia, hyperlipoproteinemia (Ph. III)
What the clinical trials found: Reductions in LDL-C of up to 59% in pooled data from four 12-week Phase II studies involving populations with high cholesterol. AEs were seen more frequently with AMG-145 vs. placebo (57% vs. 49%), but it's considered safe and tolerable.
inThought Approvability Index and Comment: 25%. The second of two highly attractive development-stage compounds targeting PCSK9, AMG-145 is slightly behind the Sanofi/Regeneron product. Estimated launch: 2016 (Source: Credit Suisse)
Credit Suisse revenue forecast: $1 billion in global sales by 2020
What physicians are saying: “A 20% lowering of LDL cholesterol is clinically meaningful,” said Nissen, who is conducting clinical trials of AMG-145 for which he gets research support. Brigham and Women's Hospital's Robert Giugliano added, “Statins...even at high doses do not always achieve the targeted level of LDL (bad) cholesterol in our high-risk patients. The LAPLACE-TIMI 57 study is very relevant in that the addition of AMG-145 to background therapy with statins resulted in significant reductions in LDL-C at all the doses tested.” —Alex Bastian, VP, GfK Bridgehead

OTHER KEY PRODUCTS IN THE PIPELINE

Anivamersen-pegnivacogin Archemix
ACS (Ph. III)

Epanova AZ
Hypertriglyceridemia (Pre-reg.)

Avatrombopag Baxter
ITP (Ph. III)

Candesartan/nifedipine Bayer
Hypertension (Ph. III)

Metreleptin BMS
Lipodystrophy (Pre-reg.)

Gencaro (bucindolol) BMS
Heart failure (Pre-reg.)

Droxidopa Chelsea
Orthostatic hypotension (Pre-reg.)

Edoxaban Daiichi Sankyo
Venous thromboembolism (Ph. III)

Eritoran Eisai
Septic shock (Ph. III)

Evacetrapib Eli Lilly
Cardio disorders (Ph. III)

LY3015014 Eli Lilly
Hypercholesterolemia (Ph. III)

Tafamidis FoldRx
Cardiomyopathies (Ph. III)

Rinolazine Gilead
CAD (Ph. III)

Darapladib GSK
Atherosclerosis (Ph. III)

Eltrombopag GSK
ITP (Ph. III)

Desmoteplase Lundbeck
Stroke (Ph. III)

Vorapaxar/MK-5348 Merck
Thrombosis (Pre-reg.)

Ezetimibe/simvastatin MK-0653A Merck
ACS (Ph. III)

Relaxin (serelaxin) Novartis
Heart failure (Pre-reg.)

AHU 377/valasartan Novartis
Heart failure/hypertens. (Ph. III)

RN-316/PF04950615 Pfizer
Hypercholesterolemia (Ph. III)

Betrixaban Portola
Thromboembolism (Ph. III)

Terutroban Servier
Thromboembolism (Ph. III)

Defibrotide SOBI
Veno-occlusive dis. (Ph. III)

Perindopril XOMA
Hypertension (Ph. III)

Page 2 of 7
Share this article:

Email Newsletters

More in Features

Read the complete April 2014 Digital Edition

Read the complete April 2014 Digital Edition

Click the above link to access the complete Digital Edition of the April 2014 issue of MM&M, with all text, charts and pictures.

Antidote: Are e-cigarettes safe?

Antidote: Are e-cigarettes safe?

The pros and cons of e-cigarettes

Combating concept churn

Combating concept churn

There's no cure. But the good news is that prophylaxis is possible.