THE PIPELINE REPORT 2016 (IV): Cardiology

Bococizumab (RN316) Pfizer 



Indication: CV disorders/hypercholesterolemia/hyperlipidemia (Ph.III) 
What the clinical trials found: Patients with hyperlipidaemia who were on concurrent statin therapy saw significantly reduced LDL-C at week 12 compared with placebo in a Phase II study. The greatest reductions were observed in patients treated with dose regimens of 150mg twice monthly (-52.4 mg/dL) or 300mg once monthly (-44.9 mg/dL). AEs were similar across placebo and treatment groups. Credit Suisse Success Probability: 52%. Expected launch: 2018 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $747 M in annual global sales by 2020 What the analysts are saying: Bococizumab will have to fight a battle with established products that have provided real-world experience to physicians. Some believe that bococizumab may be able to achieve “best in class” status within the PCSK9 class through its technological partnership with Halozyme. The company's delivery platform promises to improve the efficacy of individual subcutaneous injections and could reduce the required dose, giving bococizumab an edge over alirocumab and evolocumab, which are also administered subcutaneously. Pfizer, the juggernaut that once ruled the cholesterol management arena with Lipitor, has experience with entering disease areas late. Coupled with a legacy in cardiology, bococizumab shouldn't be counted out. —Alex Bastian, VP, GfK Health 

Anacetrapib Merck

Indication: Atherosclerosis/hypercholesterolemia/hyperlipoproteinemia (Ph.III) 
What the clinical trials found: Anacetrapib decreased LDL-C (from 81 to 45 vs. 82 to 77 mg/dl for placebo; p < 0.001) and increased HDL-C (from 40 to 101 vs. 40 to 46 mg/dl for placebo; p < 0.001) at 24 weeks in patients with CHD or CHD risk-equivalent disease (DEFINE Ph.III) with a good cardio safety profile. 
Credit Suisse Success Probability and inThought Comment: 60%.The CETP class already has two (well, actually three) strikes, so this is definitely a high-risk/high-reward program. If it works, it'll be HUGE. If it doesn't work, you'll get kicked out of any pharma exec office for even uttering the letters “CETP” for the next 50 years. Expected launch: 2017 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $2.09 billion in annual global sales by 2020 
What the analysts are saying: CETP inhibition has failed three late-stage tests with Eli Lilly throwing in the towel this past year on their investigational agent—following earlier exits from Roche and Pfizer. The failures, however, have added urgency to Merck's development program to look closely at their own outcomes studies. This includes a futility analysis at the end of the 2016 that could provide a quick answer: Move on or move out. Any drug that can address the clinical needs for better HDL cholesterol and improved outcomes could be a mega blockbuster. Of course if it fails, it will be seen as another R&D flop to add to the pile of other CETP inhibitors. —Alex Bastian, VP, GfK Health 

Finerenone Bayer

Indication: Congestive heart failure/diabetic nephropathies (Ph.III) What the clinical trials found: Finerenone was equivalent to eplerenone in reducing a marker of heart failure (NT-PproBNP) and at the optimal dose of 10mg/20mg, there was a 44% reduction in cardiovascular events and mortality. The agent also exhibited signs of a better side-effect profile in the Phase IIb ARTS-HF. 
Credit Suisse Success Probability: 25%. Expected launch: 2020 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $117 million in annual global sales by 2020 
What the physicians are saying: Many doctors are discouraged from using MRAs, including eplerenone and spironolactone, because of the need for monitoring, and it's estimated that only a third of patients who could benefit from these agents actually receive them. Gerasimos Filippatos, MD, from Athens University Hospital Attikon, Greece, said finerenone has greater selectivity for the mineralocorticoid receptor than spironolactone and greater affinity for the receptor than eplerenone. He noted the agent distributes equally to the heart and the kidney, in contrast to eplerenone, which has been shown to distribute primarily to the kidney. In theory, finerenone should demonstrate potency and safety advantages. —Alex Bastian, VP, GfK Health 

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THE PIPELINE REPORT 2016 (III): Autoinmmune