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Tough times for pharma

Posted 24/02/2011 by KatieJ

News of the planned closure of Pfizer’s research lab in Sandwich, UK. has led to much speculation about the state of the pharma industry in general. Expiring patents, dwindling pipelines and the relentless pursuit of ever more stringent regulatory and safety standards has prompted many industry onlookers to wonder whether such high R&D costs can continue to justify the returns. So the news that the success rate of bringing new drugs to market is only about half what it was only a few years ago should perhaps come as little surprise.

According to a new Biotechnology Industry Organization (BIO) and BioMedTracker (BMT) study, the overall success rate for drugs moving through clinical trials to achieve US Food and Drug Administration (FDA) approval from late 2003 to the end of 2010 is one in 10, down from one in five or six reported in previous reports from earlier years.

Interestingly, however, the report does lead to questions about where exactly pharma companies are putting their R&D spend. ‘Strikingly, oncology drugs have the toughest time making their way through the clinic, despite cancer being the most closely studied area in drug development,’ BMT senior biotechnology analyst Michael Hay is quoted as saying. Only 4.7% of cancer drugs made it from Phase 1 to be approved, the lowest success rate for all therapeutic categories considered, according to news agency Reuters, with cardiovascular drugs coming second lowest at 5.7% - not helped by growing requirement for proof of efficacy.

So where to put the research spend for a safer return on investment? Drugs for infectious diseases such as HIV and hepatitis fared best, with a 12% success rate starting from Phase 1, followed by endocrine drugs including diabetes therapies at 10.4% and autoimmune diseases such as rheumatoid arthritis at 9.4%, Reuters reports.

Better yet, the study reports that biologics – protein drugs made by biotech methods – has a 15% chance of going from Phase 1 to FDA approval, against a 7% success rate for conventional small molecule drugs.

Before pharma company execs jump onto the biotech bandwagon, though, comes the news item directly below this on the daily BIO SmartBrief bulletin that the ‘Obama budget targets brand name medicines’ – with a proposal to reduce the number of years drugmakers could exclusively market brandname biologic drugs to seven years, down from 12 in the recent US health law. He is also reported to be bent on ending controversial ‘pay-for-delay’ deals involving payoffs to delay the introduction of rival generic drugs.

Times are tough for pharmaceutical firms, and there are no signs that this situation will ease anytime soon.

Cath O’Driscoll, Deputy editor

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