While browsing the pharmaceutical news from the very first days of this new year, I had a “mosaic experience.” This is my name for the mental self-assembly process that connects seemingly disparate pieces of information to form a general impression. Here are four pieces, all from the first week of 2011:
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The United States FDA approved fewer new chemical entities and biologics in 2010 than in the two previous years, giving the thumbs up to only 21 medicines (see here), which was down from 25 in 2009 and 24 in 2008, and only marginally better than the industry’s recent low of 18 new drugs in 2007. Several high-profile candidates failed to get FDA approval during 2010.
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In his inaugural speech as Merck & Co.’s new CEO, Kenneth Frazier told investors that the company would make “tough” R&D spending decisions, would kill less-promising drugs more quickly, and would pay more attention to commercial prospects when making decisions on late- stage development (see here). To give its decision makers a vested interest in preventing potential looser candidate compounds from advancing in the development process, the company has tied researchers’ compensation to the three-year return on invested capital.
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In a deal that was largely ignored because it involved what amounts to out-of-the-pocket cash for Pfizer, the pharma giant paid Akorn-Strides (a joint venture between Akorn Inc. from Illinois and Strides Arcolab Ltd. from Bangalore, India) $63m for 16 approved and 6 filed U.S. generic drug applications (see here). This continues a line of deals Pfizer made with Strides Arcolab in 2010 to commercialize off-patent sterile injectable and oral products, including generic cancer drugs, in the U.S. through its Established Products Business Unit.
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The Indian Drug Manufacturer’s Association ( IDMA) and the China Pharmaceutical Industry Association (CPIA) signed a memorandum of understanding to enhance pharmaceutical trade between the two countries and to provide access to Indian companies in the Chinese market. In comments to the press, Indian executives said that this opens the door for negotiations that might substantially lower Indian pharma import barriers to China.
This is how what my aging neuronal network synthesizes these pieces, against the background of what I heard before:
Pharmaceutical innovation, as measured by drug approvals based on new chemical entities, is broken and shows no signs of even being on the road to recovery. The “biotech revolution,” foretold since the 1980s, never happened on a commercial level, and biosimilars are starting to erode the margins for its few established products. Re-using known entities already rules the small molecule business – the largest part of pharma by far. Continental Asia is very good at that, and they are creating larger internal markets for their generics.
Now, o pharma scientist, knowing all that you still want to discover an NCE, advance it into clinical trials perhaps? Think again, your salary might shrink if your brainchild does not become a cash cow.
Unless completely new drug discovery paradigms emerge (and eventually they will), it might be wise to invest innovative potential in what has higher and more predictable chances of relatively quick commercial success, and much less safety risk. Take another look at what is already our there. Repurpose known compounds for new medical uses — that includes drugs as well as candidates that have failed before. A vibrant professional group discusses this on LinkedIn (see here). Reformulate drugs to better meet patient and/or physician demands, and even to establish new indications. That’s pharmaceutical innovation too, but of a kind that fits the current environment much better.