Overcoming Phase II Attrition Problem

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The most important challenge facing the pharmaceutical industry in 2009 is the need to improve R&D productivity. Since the mid-1990s, the total number of novel drugs, including new chemical entities (NCEs) and biologic license applications (BLAs) approved per year, has generally declined.

At the same time, the cost of bringing a drug to market has risen precipitously. In 2001, the cost to discover and develop a drug that successfully reached the market was approximately $800 million; it had risen to approximately $900 million by 2004. Some R&D executives have predicted that the cost to develop a marketed drug will reach $2 billion by 2010.

Declines in the number of approved drugs in a given year are mainly the result of high rates of attrition of pipeline agents during the preceding 10–12 years.

via genengnews.com

This is all true, but the number of drugs failing spectacularly this year in Phase III after promising Phase II results seems to have gone up. With quite a few blockbuster cancer drugs going off patent this year and next, it does not auger well for the near future, unless some smart companies take advantage of the hiatus.

Posted via web from sally church’s posterous

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    I am the author of the GEN article. As we discuss in the article (and in the larger report on which it is based), both Phase II and Phase III attrition are too high. Some of the same factors that appear to be responsible for Phase II attrition (and some of the same potential solutions) carry over into Phase III as well.
    Allan Haberman
    http://www.biopharmconsortium.com
    http://biopharmconsortium.blogspot.com

  • http://profile.typepad.com/maverickny MaverickNY

    Hi Allan,
    Thank you for your comment, it certainly is a big industry problem that needs to be addressed, but probably not an easy one to fix quickly.
    Indeed, in cancer, as more information is found out about the science and biology of the disease, so we see drugs targeting smaller and smaller subsets within each tumour type. My guess is that there will be a lot more falling by the wayside before we see improvements in the long run.
    Companies also need to get smarter with their R&D. For example, the FDA ODAC only last week rejected two promising new agents for the treatment of elderly AML because they did not have a comparative arm to enable assessment to be made as to whether the drugs actually had an effect or not.
    One thing’s for sure, things are going to get quite interesting over the next few years in R&D alone, never mind any major legislative impacts!

  • http://www.biopharmconsortium.com Allan Haberman

    Sally,
    Faulty trial design (as in the example you gave) is a big issue with all therapeutic areas. And in some cases, especially with certain Alzheimer’s drugs, companies have taken drugs that had iffy results in Phase II into Phase III, where they bombed as should have been expected.
    In oncology, one big issue is that many cancers are not so much an issue of targets, but of pathways and networks. (We discuss this in our larger report.) Dealing with this issue will require systems-based molecular diagnostics, (which are now being implemented in leading cancer centers), plus multiple targeted (or multi-targeted) drugs.