Research and Markets: An Essential Report on Why Drugs Fail

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/d99c8a/why_do_drugs_fail) has announced the addition of the "Why Do Drugs Fail?" report to their offering.

This report analyses recent drug failure events and examines potential areas of remedy for regulators and companies.

- Greedy companies being economical with the truth?

- Overzealous regulators pursuing political agendas?

- Poorly designed or inconclusive clinical trials?

Whatever your view, the failure of a drug late in its development or, worse still, post-launch hurts. It hurts the developer commercially, it hurts the credibility of the regulator, it hurts those patients who are able to benefit from it and it undermines confidence in the industry as a whole.

Statistics may indicate that the rate of drug approval failure hasn't increased, but there has been a succession of failures and withdrawals, some of them very high profile, which have knocked profits, investment and confidence.

What can be learnt from these events and what action can the industry and regulators take to improve their performance in this critical area?

The rate of drug failure – be it at the approval stage or post launch – may have increased only slightly, but that rate has to be seen in the context of a long term decline in new products being brought to the market. Over the last 10 years, the regulatory demand and commercial imperatives facing the industry have been growing. Safety has become a key issue, allied to the need not only to prove efficacy, but efficacy which is superior to currently available products.

Desirable trends?

Some will argue that these trends are both desirable and necessary for the provision of safe medicines in a cost constrained world. Others argue that unless reformed, the current regulatory path will effectively eliminate the widespread development of new drugs and deny effective medicines to the mass of the treatable patient population who can take them safely.

The impact on the industry's profitability and ability to invest in new research and development is being felt. With a number of significant products losing patent protection over the coming period, there are clear holes appearing in many companies' portfolios.

This report analyses recent drug failure events and examines potential areas of remedy for regulators and companies.

This 75-page, highly-detailed report goes beyond the public statements of the organisations involved to question real motivations and identify the external pressures affecting decisions and outcomes.

In-Depth Case Studies Provide Real World Insight!

- COX-2 inhibitors (Pain)

- Avandia (Diabetes)

- Lotronex and Zelnorm (Irritable Bowel Syndrome)

- Tysabri (Multiple Sclerosis)

- Iressa (Cancer).

Key Topics Covered:

-State of the industry and market dynamics

-Black box warnings and withdrawals

-Consequences of drug withdrawals and black box warnings since 2004

-Drug non-approvals

-Late-stage clinical failure and pipeline re-evaluation

-Discussion

-Acknowledgement

Products Mentioned:

- COX-2 inhibitors (Pain)

- Avandia (Diabetes)

- Lotronex and Zelnorm (Irritable Bowel Syndrome)

- Tysabri (Multiple Sclerosis)

- Iressa (Cancer)

For more information visit http://www.researchandmarkets.com/research/d99c8a/why_do_drugs_fail.

Source: Espicom Business Intelligence Ltd