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Reportlinker Adds R&D Trends: Osteoporosis - Strong pipeline bodes well for future treatment
Date:4/26/2011

tegy will evolve from just focusing on increasing bone mineral density to improving the bone quality and strength. The major change in the treatment of osteoporosis will be the launch of new efficacious and safe anabolic treatments, allowing physicians to use these treatments earlier in the algorithm and in a wider category of patients. In particular companies are targeting the Wnt pathway, bone morphogenetic proteins, and insulin-like growth factor. What are the key trends in the osteoporosis pipeline? What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market? How will new osteoporosis treatments evolve in the next 20 years? What are the requirements of European and US regulatory bodies to ensure approval of a novel candidate?

Executive Summary

Strategic scoping and focus

Datamonitor key findings

Related reports

OVERVIEW

Catalyst

Summary

CLINICAL PIPELINE OVERVIEW

Osteoporosis pipeline

The osteoporosis pipeline remains robust

Companies are focusing on developing anabolics as competition in the antiresorptive market increases

Mechanism of action

Late-stage development compounds recently discontinued

TARGET PRODUCT PROFILE

Comparator therapies

Fosamax (alendronate; Merck & Co)

Target product profile versus current level of attainment

CLINICAL TRIAL DESIGN IN OSTEOPOROSIS

Preclinical trials

Two different animal species tests are required by both the FDA and EMA

Preclinical trial design should reflect the clinical indication

Clinical trials

The FDA and EMA have different patient inclusion requirements for osteoporosis trials

Clinical endpoints

Future developments in clinical trial design

Trial endpoints unlikely to change

INNOVATIVE EARLY-STAGE APPROACHES

New targets for osteoporosis treatments

Targets
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SOURCE Reportlinker
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