LONDON, September 30 /PRNewswire/ -- Pfizer is poised to be the company to benefit most from Merck & Co’s withdrawal of its COX-2 inhibitor, Vioxx (rofecoxib), according to data from Pharmaprojects, the world’s leading database tracking pharmaceutical R&D. Pharmaprojects also notes that Merck’s relatively small late stage pipeline indicates that it could struggle to fill the hole left by the US$2.5 billion product.
Vioxx, Merck & Co’s market-leading blockbuster COX-2 inhibitor was withdrawn today, ending mounting speculation about its cardiovascular toxicity. Merck reported results of long-term studies of Vioxx which showed a higher than acceptable risk of cardiovascular toxicity appearing after 18 months of treatment. Pharmaprojects previously reported data from Merck-sponsored trials, presented at the 8th World Congress on Clinical Pharmacology & Therapeutics, Brisbane, Australia, in August 2004, which showed COX-2 inhibitors posed potential cardiovascular risk in individuals predisposed to thrombosis. COX-2 is currently the most common human target for drug development reported by Pharmaprojects.
Table 1: Coxibs currently on the market --------------------------------------------------- --------------------------------------------------- Generic Name Originator Any Indication --------------------------------------------------- etoricoxib Merck & Co Arthritis, osteo Arthritis, rheumatoid Pain, musculoskeletal Pain, post-operative Dysmenorrhoea celecoxib Pfizer Arthritis, rheumatoid Arthritis, osteo Pain, musculoskeletal valdecoxib Pfizer Arthritis, rheumatoid Arthritis, osteo Pain, musculoskeletal Dysmenorrhoea parecoxib sodium Pfizer Pain, post-operative --------------------------------------------------- ---------------------------------------------------
Vioxx was launched for the treatment of osteo- and rheumatoid arthritis, and pain, including post-operative pain, migraine, and dysmenorrhoea. Merck is likely to attempt to transfer many Vioxx users to Arcoxia (etoricoxib), its other coxib, which is marketed for most of the indications covered by Vioxx. There is no available alternative for migraine sufferers yet, though Pfizer’s valdecoxib is currently awaiting approval for this indication. As Table 1 shows, Pfizer has the remaining 3 coxibs currently on the market, so is likely to seek to benefit from Merck’s discomfort.
Figure 1 (http://www.prnewswire.co.uk/) shows that there are a number of COX-2 inhibitors still under active development which are also poised to profit from the withdrawal. Notably, Novartis’ Prexige (lumiracoxib) has recently been approved by in the EU, for the treatment of pain, dysmenorrhoea, and osteo- and rheumatoid arthritis. However, this drug has had a problematic development, having previously been rejected by the US FDA, which has requested additional data. Drugs in Phase III trials include Almirall-Prodesfarma’s LAS-34475, a COX-2 specific inhibitor for arthritis and pain, which has shown positive results in early clinical trials. Although this is an active area of development, it looks as if the market is unlikely to soon be flooded with replacement products.
Figure 2 (http://www.prnewswire.co.uk/) illustrates the extent to which Vioxx’s withdrawal could cause Merck problems. It has no new active substances in development above Phase III, so is unlikely to be able to launch anything completely new for more than a year. Although Merck’s near term pipeline prospects are less than glowing, it has a healthy early-stage pipeline which could prove fruitful in the future.
However speculation is likely to mount as to whether the shortfall may make Merck, a company that has previously ‘gone it alone’, a candidate for merger or takeover.
About Pharmaprojects
Pharmaprojects, the leading database tracking pharmaceutical development from early preclinical study through to launch or discontinuation, has 24 years’ experience as an information provider to the healthcare industry. Pharmaprojects uses a fully searchable application that allows you to pinpoint the specific information you are looking for, whether it be comprehensive drug profiles, a competitor’s pipeline or licensing opportunities. Available weekly on the Web and monthly via CD-ROM format; Pharmaprojects is also accessible weekly via online hosts PJB Publications, Dialog and DataStar, Ovid Technologies and STN International.
For editorial information: For product information: Ian Lloyd, Managing Editor Hayley McKechnie, Marketing Manager Telephone: +44-(0)20-7017-6886 Telephone: +44-(0)20-7017-6860 Email:ian.lloyd@pjbpubs.com Email: hayley.mckechnie@pjbpubs.com Website: http://www.pharmaprojects.com/
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CONTACT: For editorial information: Ian Lloyd, Managing Editor,Telephone: +44-(0)20-7017-6886, Email:ian.lloyd@pjbpubs.com;For product information: Hayley McKechnie, Marketing Manager,Telephone: +44-(0)20-7017-6860, Email:hayley.mckechnie@pjbpubs.com