Posted by: shoji | October 5, 2007

Drug innovation or me-too?

Nature Biotechnology published an abridged transcript of a Bioentrepreneur round-table discussion (“What pharma wants”; doi:10.1038/bioe.2007.2). The last part of the transcript captures  the biotech/pharma industry’s dilemma:

  1. Create innovative drugs that may fail or
  2. Make improvements to existing classes of drugs and push them into the market.

In the first case, a company may pursue entirely novel targets and/or treatment modalities that are not currently in use. Innovation always sounds good in media bites, but it does not always result in business success. (It may not result in clinical success, either.)

The reason is that most prospective drugs fail– and sometimes entire approaches fail. One example is “gene therapy”. We’ve all heard the potential for gene therapy to cure disease, but it is still unrealized despite the mass sums invested in research and development. Another example is ribozymes for gene silencing– and the list goes on and on.

The failure of an innovative drug has grave consequences in the marketplace. Read up on Pfizer’s torcetrapib failure in Phase III clinical trials. This drug would have been the first-in-class CETP inhibitor (to raise “good” cholesterol).

By contrast, there is a market for me-too drugs. And it doesn’t mean that the me-too drug isn’t innovative or has no advantage compared to the first-in-class drug. One example of this is the “statin” class of cholesterol lowering drugs. The exemplar statin is Lipitor (generic name atorvastatin) the largest-selling drug in the world (worldwide sales of US$12.9B in 2006). which the FDA approved in 1997. However, the first-in-class lovastatin (brandname Mevacor) was FDA approved in 1987.

Importantly, Lipitor proved itself to be “better” at lowering cholesterol than other statin drugs in clinical trials and was priced aggressively at launch. Another factor in Lipitor’s market success was that physicians and the public at large were educated about high cholesterol and the advantages to lowering cholesterol in the period prior to Lipitor’s launch. That is, the market need for a drug like Lipitor took time to develop, and this was developed by the earlier statins.

Ultimately, as seen in the transcript excerpt below, whether a biotech/pharmaceutical company chooses the path of innovation or “me-too” will depend in part on the regulatory environment, the market for goods, and the financial market. The question is how to ensure the path to innovation is not overlooked.

Klaus Wilgenbus (SVP, Boehringer Ingelheim):

“In the end, therapeutic advances and not me-too’s will drive future pharmaceutical markets..”

Sanjay Kakkar (CEO, Trigen):

“I’m not sure I actually agree with that. I think that society has shown quite clearly that it’s not prepared to accept the risk associated with innovation… I think actually you do see companies succeeding with me-too products. [cites the statin market]… So I’m not so sure that innovation is rewarded. I think we see that the risk associated with innovation, even once products get to market, are being treated very cautiously in our society right now.”

Ray Hill (Executive Director, Head of Licensing and External Research, Merck UK):

“I think we’ve got into a discussion that to some extent is the dilemma of the pharmaceutical industry right now. What should you work on?”

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Responses

  1. […] I blogged earlier about statins (cholesterol-lowering miracle drugs) in a post about innovation vs. me-too […]


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