FDA Acceptance of Smaller Clinical Trials Offers Upside to Biotech Stocks: Exclusive Interview with David Nierengarten, Ph.D., an Analyst at Wedbush Securities Covering the Biotechnology and Biopharmaceuticals Sector

Wall Street Transcript

67 WALL STREET, New York - May 1, 2014 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Health Care - Biotechnology and Pharmaceuticals - Orphan Drug and Biologics Manufacturing - Oncology Drug Development - Orphan Drugs - FDA Approval Process - Biotechnology and Pharmaceutical Companies Valuation - Genetic and Cell Therapies

Companies include: Celadon Group Inc. (CLDN), Novartis AG (NVS), Celgene Corporation (CELG), NPS Pharmaceuticals, Inc. (NPSP), Amgen Inc. (AMGN), Dendreon Corp. (DNDN), Infinity Pharmaceuticals, Inc. (INFI) and many others.

In the following excerpt from the Biotechnology and Pharmaceuticals Report, an expert analyst discusses the outlook for the sector for investors:

TWST: What's the FDA environment like, especially in the oncology space? It seems like things have loosened up a little bit, especially in that area.

Dr. Nierengarten: I'm not necessarily convinced that the FDA is more lenient. What I do see is a greater willingness within the agency to accept newer clinical trial designs. It's being more receptive to the idea that for targeted agents, we don't need to run a traditional, 1,000-patient study. We can look at surrogate endpoints, run smaller clinical trials and things like that. They still are rigorous in evaluating those newer designs, but they are different and they're newer, and it's nice to see the FDA being accepting of that.

TWST: What does the pipeline look like within your universe, now and as you look ahead?

Dr. Nierengarten: It's pretty exciting, I think. There are a lot of therapies that are going through clinical trials that make a lot of sense. Of course they are not all going to work, but I think we're seeing a very interesting phase in drug development these days, especially, again, with the more targeted agents. I'm pretty encouraged about the pipeline as it looks today, which means I'm encouraged how it's going to look a few years from now.

I continue to keep my eye on genetic and cell therapies. Gene therapy seems to have been resurrected...

For more of this interview and many others visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs, portfolio managers and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

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