NEW YORK--(BUSINESS WIRE)--In its latest Cardiology Report, BioPharm Insight (BPI) reported that Amgen’s Repatha Phase III FOURIER trial will be deemed successful by experts if it shows a 35% reduction in major cardiovascular events (MACE).
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The report from BPI, the most comprehensive life science news and analytical solution, highlights recent editorial coverage of cardiology therapies in development that have potentially market-moving clinical events expected in the next few months. It also provides analysis of sales forecasts and licensing deals.
“Amgen’s announcement at the start of February that it met its primary and key secondary composite endpoints was a hugely anticipated event for a drug predicted to have peak sales in excess of $7 billion,” said Peter Murphy, BPI senior editorial analyst. Amgen management has reiterated the cardiovascular outcomes trial (CVOT) trial is powered to show a 15% risk reduction but did not provide further details on FOURIER outcomes, which the market widely expects could be a game-changer for the lipid-lowering treatment space. While equity analysts think a 20% reduction has been hit, experts BPI spoke to said that anything lower than a 35% MACE reduction may mean that the cost outweighs the treatment benefit.
“Although Amgen’s news has significant implications for the entire PCSK9-inhibitor class, experts expect to see similar results between Repatha and its competitor Praluent,” said BPI reporter Alexandra Thompson. Amgen’s (NASDAQ:AMGN) Repatha and Praluent, from Sanofi (EPA:SAN) and Regeneron Pharmaceuticals (NASDAQ:REGN), were approved within one month of each other in 2015 and are currently the only two anti-PCSK9s on the market.
BPI reports, though, that so far physicians and payers alike are not satisfied that PCSK9 inhibitors successfully lower LDL-c (bad cholesterol) levels. The market is looking for evidence that the reduction in LDL also drives a reduction in the likelihood of patients suffering potentially catastrophic cardiovascular events. Praluent’s Phase III CVOT is due in late 2017, and Alnylam Therapeutics (NASDAQ:ALNY)/The Medicines Company’s (NASDAQ:MDCO)/inclisiran is due to start its own Phase III trials soon.
BPI’s Cardiology Report also highlights articles covering experts’ dubious expectations for Merck’s (NYSE:MRK) hypercholesterolemia drug anacetrapib’s Phase III CV trial following termination of three drugs of the same CETP inhibitor class. Pfizer’s (NYSE:PFE) torcetrapib, Roche’s (VTX:ROG) dalcetrapib and Eli Lilly’s (NYSE: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’ (VTX:NOVN) Entresto (sacubitril/valsartan) and Mesoblast’s (ASX:MSB) 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.
Other 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.
Learn more about expected market catalyst events in Cardiology Indications with BioPharm Insight’s full report:
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BioPharm Insight is the most comprehensive life science market intelligence and analytics solution, featuring a team of investigative journalists writing exclusive news and thousands of healthcare data points, aggregated into one centralized source. In addition to the proprietary articles, BioPharm Insight is currently tracking 250,000 management and R&D contacts, 7,500 biopharma companies with full pipeline data, 120,000 investigational and approved drug profiles, 28,000 M&A and licensing deals, 10,000 extended sales forecasts and epidemiology profiles for hundreds of indications.