The Pipeline Report 2013: Late-Stage Standouts

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The Pipeline Report 2013: Late-Stage Standouts
The Pipeline Report 2013: Late-Stage Standouts

Cardiovascular

PRODUCTS GENERATING BUZZ
Anacetrapib Merck
Indication: Atherosclerosis (Phase III)
What the clinical trials found: Depending on dose, LDL-c fell by 16%-40% vs. placebo, and HDL-c rose by 44%-139%, depending on dose, in Phase IIb. There were no treatment-related serious adverse events.
inThought Approvability Index and Comment: 55%. Cardiologists remain excited about HDL-raising strategies. Anacetrapib is a molecular cousin of Pfizer's torcetrapib, ostensibly without the safety problems, and has a more profound impact on HDL-c and LDL-c than Roche's failed CETP inhibitor dalcetrapib. Estimated approval: Jan. 2017 (Source: Symphony Health Solutions)
Revenue forecast: $350 million in annual revenue in 2018, says Leerink Swann's Seamus Fernandez.
What the analysts are saying: CETP inhibitors represent a novel mechanism of action, but the jury is still out. Pfizer's torcetrapib increased risk of mortality and cardiovascular events. The dal-OUTCOMES trial was stopped because Roche's dalcetrapib was not reducing CV adverse events. Dalcetrapib increased HDL by 30% (and did not alter LDL). Anacetrapib, and Eli Lilly's evacetrapib, increase HDL by at least 100% and reduce LDL by 35%-45%. Physicians say that any new CETP inhibitor must also demonstrate significant plaque stabilization/regression and significant decreases in atherothrombotic disease to be seriously considered. —Portia Gordon, VP, research & consulting, GfK HealthCare

Eliquis (apixaban) Bristol-Myers Squibb/Pfizer
Indication: DVT/stroke prevention in non-valvular Afib (Prereg.)
What the clinical trials found: In Phase III, 21% reduction vs. warfarin in stroke or systemic embolism; 11% reduction in mortality; 31% reduction in major bleeding. Its overall mortality and safety are more impressive than BI's Pradaxa or J&J/Bayer's Xarelto.
inThought Approvability Index and Comment: 98%. Eliquis is a very similar drug to Pradaxa and Xarelto. Because of their very complicated development programs, there will be niches for all three of these drugs, but the clinical niche for Eliquis will be the largest. Twice delayed, a new PDUFA date is set for March. Estimated approval: March 2013 (Source: Symphony Health Solutions)
inThought revenue forecast: $5.1 billion in peak sales in 2021.
What the analysts are saying: Physicians still hold hope for this oral factor Xa inhibitor, whose NDA was resubmitted in September. Clinicians are impressed with trials establishing Eliquis superiority vs. warfarin and aspirin in preventing/reducing stroke or systemic embolism. Being third to market, Eliquis' superior safety profile will help to erode competitors' share, however, data must demonstrate superiority in stroke, bleeding and mortality in AF, and Eliquis must be competitively priced to attract payers. —Portia Gordon, VP, research & consulting, GfK HealthCare

Relaxin (serelaxin) Novartis
Indication: Acute heart failure (Phase III)
What the clinical trials found: Phase III data were mixed, showing the drug improves symptoms of shortness of breath (albeit mildly) and is safe.
inThought Approvability Index: 75%. Estimated approval: Jan. 2014 (Source: Symphony Health Solutions)
What the analysts are saying: Given the dearth of effective therapies available for heart failure patients, we think this drug is likely approvable on the current dataset…[and] could potentially cross the $1 billion/year threshold with effective marketing. —Tim Anderson, MD, senior analyst, Bernstein Research

OTHER KEY PRODUCTS IN THE PIPELINE

Lomitapide Aegerion
Hypercholesterolemia (Prereg.)

AMG 145 Amgen
Hypercholesterolemia (Ph.III)

Cangrelor AstraZeneca
Coronary artery disease (Ph.III)

Desmoteplase Bayer
Stroke (Ph.III)

BMY 13105/Bucindolol Bristol-Myers Squibb
Heart failure (Prereg.)

Edoxaban Daiichi Sankyo
VTE (Ph.III)

Avatrombopag Eisai
Idiopathic thrombocytopenic purpura (Ph.III)

Evacetrapib/LY 2484595 Eli Lilly
Atherosclerosis (Ph.III)

Ularitide EXR Therapeutics
Acute heart failure (Ph.III)

Nebivolol/valsartan Forest
Acute heart failure (Ph.III)

Stedicor Forest
Ventricular arrhythmias (Ph.III)

Kynamro (mipomersen) Genzyme/Isis
Hypercholesterolemia (Prereg.)

Darapladib GSK
Atherosclerosis (Ph.III)

Defibrotide Medison/Sigma-Tau
Veno-occlusive disorders (Ph.III)

Vorapaxar Merck
ACS (Ph.III)

MK-0653c Merck
Atorvastatin/ezetimibe
Hypercholesterolemia (Prereg.)


Tredaptive (MK-0524A) Merck
Niacin controlled release/laropiprant
Atherosclerosis (Ph. III)


LCZ696 Novartis
Heart failure (Ph.III)

Tafamidis meglumine Pfizer
Cardiomyopathies (Ph.III)

Betrixaban Portola
Thromboembolism (Ph. III)

Aspirin/omeprazole 325/40 Pozen
Cardio disorders (Ph.III)

Aleglitazar/RG1439 Roche
Cardio disorders/type 2 diab. (Ph.III)

Vapreotide BMY 41606 Salix
Esophageal varices (Prereg.)

Otamixaban Sanofi
ACS (Ph.II)

SAR236553/REGN727 Sanofi/Regeneron
Hypercholesterolemia (Ph.II)

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