Amgen’s Repatha CVOT Results Are Potential Game-Changer for Lipid-Lowering Treatment

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).

Get the Report: http://www.biopharminsight.com/cardiology-report-january-2017

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:

http://www.biopharminsight.com/cardiology-report-january-2017

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About BioPharm Insight

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.

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