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New Developments in Transplant Rejection Drugs

Published by: Datamonitor

Published: Oct. 21, 2002 - 37 Pages


Table of Contents


Overview

Introduction

Companies need to consider their strategies for encouraging organ donation, but should avoid heavy-handed legislative efforts to escape negative publicity. In the field of transplant drugs R&D, six promising drugs are making their way to market. Two new drugs in the Novartis transplantology portfolio have been delayed; meanwhile, promising alternatives from Fujisawa and Isotechnika/ Roche
are progressing through clinical trials.



Scope

Analysis of the issues and solutions surrounding the shortage of organ donors with epidemiological data by organ and year from the seven major markets

Key data contrasting the number of organs transplanted in each of the major markets with the number of patients on waiting lists

Analysis of six important drugs in development for transplant indications



Report Highlights

The greatest limiting factor in the transplant drugs market is the lack of donor organs. Pharmaceutical companies may consider political lobbying to encourage legislation imposing mandatory organ donation with optional “opt out”.

Novartis’ Certican and Myfortic have been delayed. Regulatory filings have yet to be made for the US market, as Novartis waits on extra clinical trial data to strengthen its submissions. Datamonitor predicts that these drugs will not now be launched in the US until 2004. Of products in development, Fujisawa’s FK778 is of greatest potential. An agent that is both immunosuppressive and active against polyomaviruses has enormous potential.



Reasons to Purchase

Trial data: Target drug development to avoid costly mistakes

Competitive analysis: Benchmark your company against the leaders

Market analysis: Plan future product positioning with confidence



DRIVERS AND TRENDS

The greatest limiting factor in the transplant drugs market is the lack of donor organs. Pharmaceutical companies may consider political lobbying to encourage legislation imposing mandatory organ donation with optional “opt out”. Several countries, including Germany, have implemented systems of “presumed consent”, making everyone a potential organ donor at death

Two Novartis drugs in development have been delayed, but other promising candidates from Fujisawa and Isotechnika/ Roche are progressing through trials



EPIDEMIOLOGY AND RELATED ISSUES

The organ transplant drug market is limited chiefly by the shortage of organs to transplant. Several countries have passed laws attempting to redress this situation.



PIPELINE ANALYSIS

Six key drugs are in development for transplant indications. The launches of Certican and Myfortic have been delayed; these products will now reach the key US market in 2004.



DATASETS

Table 1: Organ transplants and waiting lists, US, 1996-2000

Table 2: Organ transplants, Japan, 1995-2000

Table 3: Organ transplant waiting lists, Japan, 31/05/2002

Table 4: Organ transplants and waiting lists, Germany, 1998-2000

Table 5: Organ transplants and waiting lists, UK and Eire, 1996-2000

Table 6: Organ transplants and waiting lists, France, 1997-2001

Table 7: Organ transplants and waiting lists, Italy, 1997-2001

Table 8: Organ transplants and waiting lists, Spain, 1997-2001

Table 9: Late stage drugs in development for transplant indications

Abstract

Introduction: Companies need to consider their strategies for encouraging organ donation, but should avoid heavy-handed legislative efforts to escape negative publicity. In the field of transplant drugs R&D, six promising drugs are making their way to market. Two new drugs in the Novartis transplantology portfolio have been delayed; meanwhile, promising alternatives from Fujisawa and Isotechnika/ Roche are progressing through clinical trials. Scope: * Analysis of the issues and solutions surrounding the shortage of organ donors with epidemiological data by organ and year from the seven major markets * Key data contrasting the number of organs transplanted in each of the major markets with the number of patients on waiting lists * Analysis of six important drugs in development for transplant indications. Report Highlights: The greatest limiting factor in the transplant drugs market is the lack of donor organs. Pharmaceutical companies may consider political lobbying to encourage legislation imposing mandatory organ donation with optional "opt out". Novartis' Certican and Myfortic have been delayed. Regulatory filings have yet to be made for the US market, as Novartis waits on extra clinical trial data to strengthen its submissions. Datamonitor predicts that these drugs will not now be launched in the US until 2004. Of products in development, Fujisawa's FK778 is of greatest potential. An agent that is both immunosuppressive and active against polyomaviruses has enormous potential. Reasons to Purchase: * Trial data: Target drug development to avoid costly mistakes * Competitive analysis: Benchmark your company against the leaders * Market analysis: Plan future product positioning with confidence

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