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CATALYST: Roche is finding it difficult to manufacture its novel antiretroviral drug T-20.

Roche's new HIV drug, T-20, should launch next year. However, it already seems that producing sufficient quantities of T-20 will be a challenge - particularly before the full-scale production facility for the drug comes online. Roche will need to manage customer expectations carefully in the early stages of T-20's launch, or risk losing confidence.

Swiss pharma company Roche is already trying to manage patient and advocacy group expectations regarding the availability of T-20, or Fuzeon as it has now been named, following concerns that demand for the drug will massively outweigh supply capabilities.

While the drug is conceivably a treatment option for tens of thousands of patients with resistance problems, Roche envisages being able to provide it to only 3,000 patients by March 2003. The problem is that T-20's complex structure makes manufacturing the drug a highly intricate process.

To overcome the manufacturing shortfalls, Roche and partner Trimeris have set out to bring a new production facility online in Colorado. But in the meantime, Roche will have to rely upon careful allocation of the drug from a relatively small pilot plant.

Activist groups, physicians, and patients have been scrutinizing T-20's development because of the substantial advance it theoretically offers. As the first of a new class of antiretrovirals, it is eagerly awaited, especially as the marketing of clinical trial results has been particularly well received.

Given that demand is highly likely to exceed supply, if Roche is to maintain customer confidence it must demonstrate that it has taken as many precautionary steps as possible to minimize the effects of the shortage. Assuming that the company can manage expectations successfully, the capacity problems may well have the effect of increasing, rather than decreasing demand for the drug. 

Related reports: Datamonitor, "The HIV Pipeline - A Complete Overview" (BFHC0456)

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The HIV Pipeline - A Complete Overview
Introduction

Analysis of the late and early stage HIV pipeline, including antiretrovirals, vaccines and immunotherapies, and identifying licensing opportunities across geographical markets and differentiated therapeutic sectors.

Scope

Class by class analysis of the 101 pipeline candidates currently in development for the treatment of HIV

Drug classes include NNRTIs, NRTIs, Protease Inhibitors, Entry Inhibitors, Immunotherapeutics and Biologics

Interpretation of clinical and commercial aspects of the 31 candidates in phase II and III trials

Comparative overview of the characteristics of the HIV pipeline by class composition, and company type

Strategic insight into the future shape of the market, and key considerations for players at all levels from discovery to marketing specialists

Report Highlights

HIV management is due to undergo a major shift with the imminent introduction of new classes of therapeutic products. While the majority of pipeline candidates appear to be intended for complementary use with conventional therapeutics, some may have the potential to force older products out of the market.

Differentiation, forced by a plateau in advance in meeting unmet need, will attract new players from distinct sectors to compete in the HIV market, forcing conventional market leaders to reappraise both their position in the market, and approach to its future domination.

Whilst some new market entrants may be able to drive their own market penetration, the majority will require the market presence of more established players to achieve market entry. Tactical collaboration will prove central to market growth.

Reasons to Purchase

Features, benefits, strengths and weaknesses of all major products set to enter the HIV market and a reference to all developmental compounds

Assess the impact of novel class entry on current HIV therapeutics, and the flexibility of existing classes to counter this potential revolution

Appraise the strategies employed by market leaders to counter the imminent arrival of numerous new market entrants

Identify the tactics new market entrants will employ to maximize impact on a market currently dominated by a small number of strong competitors

Identify potential candidates for licensing through an independent analysis of the positioning of pipeline candidates and their developers.

Report Code: BFHC0456 Report Format: PDF Publication Date: 30th July 2002
View Table of Contents

Price:   $1,500.00 / £960.00

To order - click here

 

 

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