Cardiology Report January 2017

31 January 2017

In this report we highlight some of the major recent developments, important catalysts and current trends occurring in the cardiology drug development field including Amgen’s announcement at the start of February that it met its primary and key secondary composite endpoints. Amgen’s news has significant implications for the entire PCSK9-inhibitor class and experts BPI spoke to said that anything lower than a 35% MACE reduction may mean that the cost outweighs the treatment benefit.

BPI’s Cardiology Report also highlights articles covering experts’ dubious expectations for Merck’s (MRK) hypercholesterolemia drug anacetrapib’s Phase III CV trial following termination of three drugs of the same CETP inhibitor class. Pfizer’s (PFE) torcetrapib, Roche’s (ROG.VX) dalcetrapib and Eli Lilly’s (LLY) evacetrapib all suffered high-profile clinical trial failures over the past decade.

Additionally, the report offers insights on several ongoing therapies under development to prevent heart failure (HF), including Novartis’ (NOVN.VX) Entresto (sacubitril/valsartan) and Mesoblast’s (MSB.AX) MPC-150-IM. The perforation risk of MPC-150-IM’s transendocardial delivery could possibly limit its administration to specialized cardiology cell injection centers or warrant cardiologist training, but the significant positive outcomes of the earlier Phase II trial have analysts optimistic, forecasting peak sales of the HF therapy to be $5.2 billion if successful.

Analyses provided in BPI’s Cardiology Report includes:

• Uncertain expert expectations about Novartis’ RLX030 (Serelaxin), despite analysts’ confidence based on previously positive dyspnoea and CV mortality outcomes. Analysts predict peak sales of Serelaxin could reach $1 billion.

• Cardiorentis’ ularitide has expert split over its Phase III success prospects in acute decompensated HF. Some noted previously highly significant efficacy signals at the same dose in an earlier study, while others questioned how closely past and current endpoints correlate.

• Overall expert optimism for Capricor Therapeutics’ (NASDAQ:CAPR) CAP-1002’s Phase I/II trial in myocardial infarction (MI) and ischemic left ventricular (LV) dysfunction, despite an earlier trial’s certain failed endpoints. Analysts predict peak sales of CAP-1002 could reach $1 billion.

• Experts’ pessimistic projections for Cerenis Therapeutics’ (EPA:CEREN) CER-001’s Phase II trial in atherosclerosis regression, after a previous study demonstrated insignificant atheroma outcomes. Despite experts’ low expectations, if successful analysts are predicting peak sales of $3.4 billion.

Companies mentioned in this report: Amgen, Alnylam, Capricor, Cardiorentis, Cerenis, The Medicines Company, Merck, Mesoblast, Novartis, Sanofi, Regeneron and more.

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