Research and Markets: PCSK9 Inhibitors - A New Class of LDL-cholesterol Lowering Agents

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/qwqxrh/pcsk9_inhibitors) has announced the addition of the "PCSK9 inhibitors - A new class of LDL-cholesterol lowering agents" report to their offering.

Several agents that inhibit PSCK9 are in development for the treatment of hypercholesterolemia. PSCK9 destroys LDL-cholesterol receptors on cell surfaces. By blocking destruction of that LDL-receptor, PSCK9 inhibitors facilitate removal of LDL-cholesterol from the blood. Regeneron and Amgen both have agents in this class respectively, REGN727 and AMG 145, that are in advanced stages of clinical development.

Accordingly, this report looks at the underlying science. It also evaluates the two clinical programs for evidence of efficacy and safety found in the data, and also from the perspective of regulatory approval and the labels that the programs may or may not support. Related, it also assesses the market niches into which they best fit and the competitive profiles of the two.

Key Topics Covered:

Introduction

Lipid metabolism-an overview

Regeneron and Sanofi's REGN727 (SAR236553, Alirocumab)

Amgen's AMG 145

Clinical and Regulatory Discussion

Market Analysis

  • Market overview
  • Competitive issues
  • Pipeline competition

Summary Opinion

Appendix 1. ATP III National Cholesterol Education Program treatment Guidelines-Adapted

Appendix 2. Treatment emergent adverse events during a 12 week study of REGN727 therapy in Heterozygous familial hypercholesterolemia patients

Appendix 3. Zetia NDA trials

Appendix 4. Summary of mipomersen trials

Companies Mentioned:

  • Alnylam/The Medicines Company
  • Amgen
  • Bristol-Meyers Squibb
  • Eli Lilly
  • Genentech/Roche
  • Merck
  • Novartis
  • Pfizer
  • Regeneron/Sanofi

For more information visit http://www.researchandmarkets.com/research/qwqxrh/pcsk9_inhibitors

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Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals

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Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals