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Coxibs - Past Problems...Future Potential

Published by: LeadDiscovery

Published: Oct. 1, 2006 - 62 Pages


Table of Contents



The biology of the cyclooxygenase pathway

Inflammatory response to prostaglandins

Immunomodulatory effects of prostaglandins

Hyperalgesic effects of prostaglandins

Pyretic effects of prostaglandins

Prostaglandin-mediated mucosal protection

Cardiovascular effects of the prostaglandins

Thrombotic effects of the prostaglandins

Angiogenic activity of the prostaglandins

Airway effects of the prostaglandins

An introduction to COX inhibitors

The mechanism of action of aspirin and its therapeutic effects

Other early COX inhibitors

Complications associated with NSAIDs

GI Toxicity

Misoprotol as a strategy for reducing gastrointestinal injury with NSAIDs

PPI use a strategy for reducing gastrointestinal injury with NSAIDs

The rational for Coxib development

The identification of COX-2

Expression of COX-1 and COX-2

Improved gastrointestinal safety as the rational for Coxib development

A Role for COX-2 in cancer

A Role for COX-2 in Alzheimer’s disease

The existence of COX-3-an under-investigated molecular target for novel analgesics

Clinical data on approved and late stage Coxibs

Serendipitous selective COX-2 inhibitors

Nimesulide

Etodolac

Meloxicam

Rationally designed COX-2 inhibitors

First generation Coxibs

Rofecoxib (Vioxx; Merck)

Background data

Reduced gastrointestinal adverse effects of Vioxx

Pivotal trials

VIGOR (Vioxx Gastrointestinal Outcomes Research) study

Comment on VIGOR

APPROVe (Adenomatous Polyp Prevention on Vioxx) trial

Celecoxib (Celebrex; Pfizer)

Background data

Pivotal trials

CLASS (Celecoxib Long-Term Arthritis Safety Study) trial

SUCCESS-I

Second generation Coxibs

Valdecoxib (Bextra; Pfizer )

Background data

Dynastat (parecoxib; Pfizer)

Background data

Arcoxia (etoricoxib; Merck)

Background data

Pivotal trials

MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) study

Prexige (lumiracoxib; Novartis)

Background data

TARGET (Therapeutic Arthritis Research and Gastrointestinal Event Trial)

Differentiating the risk of COX-2 inhibitor family members

Risk of skin rash

Cardiovascular risk

Cardiovascular risk of the Coxibs - mechanistic insight

Hypertension Risk

Effect of COX-2 inhibition on atherosclerosis

Effect of COX-2 inhibitors on thrombosis

Cardiac arrhythmias

Structural rather than class related causes of differential cardiovascular effects

Clinical data supporting use of Coxibs for new indications

Cancer

Colorectal cancer

Adenoma Prevention with Celecoxib (APC) trial

Prevention of Spontaneous Adenomatous Polyps (PreSAP) trial

Adenomatous Polyp Prevention on Vioxx (APPROVe)

Optimizing colorectal chemoprevention-Extension to chemotherapy?

Cervical dysplasia

Breast cancer

Lung cancer

Alzheimer's disease

Safety recommendations following reintroduction of COX-2

Regulatory stand point

Current status of approved Coxibs, future events & pipeline agents

Merck Franchise

Vioxx

Arcoxia

Pfizer Franchise

Celebrex

Bextra

Dynastat

Novartis Franchise

Prexige

Other Coxibs in clinical stage development

Knock-on effect of Vioxx's withdrawal

Sales performance of other COX-2 inhibitors

Immediate effects of Vioxx withdrawal

Historical and current sales figures of Coxibs

Historical and current sales figures of NSAIDs

Emerging alternatives to COX-2 inhibitors

Phospholipase A2 inhibitors

Lipoxygenase inhibitors

Variations on NSAIDs

Focus on Nitronaproxen (NicOx)

DMARDs

DMOARDs

Conclusions & Recommendation on future use of Coxibs

Abstract

Spanning the field of pain, inflammation and oncology, as well as more recently for unwanted reasons, cardiovascular disease the cyclooxygenase-2 (COX-2 or Coxibs) have sat in the spot light for almost a decade now.

The first Coxib, Celebrex (celecoxib), arrived on the market in 1998 rapidly becoming a blockbuster soon to be followed by another equally successful drug from the same class, Vioxx (rofecoxib). Soon after however, cardiovascular adverse effects were found to be associated with Vioxx leading to its withdrawal and sparking the start of a turbulent period affecting not only Vioxx, but the Coxib class as a whole and more generally all NSAIDs.

LeadDiscovery’s report Coxibs - Past Problems…Future Potential was written to provide all in the drug development sector a detailed look at the events leading up to the withdrawal of Vioxx, the status of the Coxib class 2 years on and its future potential.

Far from slipping into the pharmaceutical backwater this class continues to provide blockbuster revenues for Pfizer and potential for others. This report is key to companies considering reentry into the COX-2 arena and those developing other analgesics that could canabilize the coxib market. The report is also written with the aim of guiding companies investing in chemoprevention and Alzheimer’s disease, indications that have been investigated as target for the Coxibs.

Against a backdrop of litigations brought against Merck & Co and new regulatory guidelines for the coxibs, Pfizer’s Celebrex generated $1.7 billion in revenue last year and continues to win approval for new indications, the most recent being ankylosing spondylitis. The continued potential of the Coxibs is evidenced by clear activity of this class in the prevention of certain pre-cancerous growths and uncertainty over the cardiovascular safety of NSAIDs. Most recently data has emerged offering a possible explanation behind the cardiovascular activity of the Coxibs offering the potential to rationally design new agents with improved therapeutic margins.

Coxibs - Past Problems...Future Potential is designed to help readers address questions such as:
  • What trials have been conducted and what do they mean?
  • How does the use of an NSAID plus a gastroprotective agent compare to that of a Coxib with respect to gastrointestinal safety?
  • What is the cardiovascular risk attached to the Coxibs - is the risk simply a reflection of the comparator used in pivotal trials?
  • Do the Coxibs still offer an advantage over NSAIDs
  • What is the mechanism of increased cardiovascular events, what is their time frame and how can they be minimized?
  • What is the regulatory view on the Coxib class and NSAIDs?
  • Is the development of Coxibs for the prevention/treatment of cancer or Alzheimer’s disease justifiable?
  • What is the current status of approved and pipeline Coxibs?
  • How has the Coxib market changed since 2003?
  • Should companies attempt to develop new Coxibs?
  • If so what should be the developmental goals and what should be the indications?


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