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FDA Acting Faster in Areas of Unmet Medical Need: An Expert Analyst Discusses the Current Regulatory Environment with The Wall Street Transcript

67 WALL STREET, New York - April 26, 2013 - 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 and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Health Care - Biotechnology and Pharmaceuticals - Executive Officer Interviews - Biotechnology and Pharmaceutical Investing - Orphan Drug and Biologics Manufacturing - Biotechnology and Pharmaceutical Companies Valuation

Companies include: Gilead Sciences Inc. (GILD), Biogen Idec Inc. (BIIB), Celgene Corporation (CELG), Amgen Inc. (AMGN), Illumina Inc. (ILMN), Life Technologies Corporation (LIFE), Ariad Pharmaceuticals Inc. (ARIA), Bristol-Myers Squibb Co. (BMY), Abbott Laboratories (ABT), Alexion Pharmaceuticals, Inc. (ALXN), YM BioSciences Inc. (YMI), Achillion Pharmaceuticals, Inc (ACHN) and many more.

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

TWST: How would you describe the regulatory environment for pharmaceuticals right now? And what are the biggest potential regulatory risks that you are monitoring at the moment?

Mr. Ferreiro: There is always regulatory risk. There are a couple of problems right now. One, I think there is some feeling that sequestration, which will result in cut to the FDA budget, will lengthen time lines for approvals, and no one wants to see that. So just general lengthening in cycle times if their budgets are smaller; it's not a good thing for the industry in general. And that's obviously a risk because investors don't like delays.

Secondly, I think investors worry about the FDA because it's so concerned about safety, and you start to see things creep into labels like for Ariad (ARIA) that has a black box pointing on its new CML drug Iclusig that no one was really expecting, and the reason the black box pointing is because the way its pivotal trial was designed, which was in a refractory setting, so there was no control.

So I think it's just general concern from the FDA over safety and including basically a laundry list of potential safety precautions on labels is always a risk, because that could impact marketing and could create reasons for docs to avoid prescribing a drug at first, until they become comfortable with the safety precautions on the label. And so I'd say those are probably the biggest concerns.

But on the flip side, I think you can see why the FDA is cautious, looking to the HCV space because you are seeing a lot of explosive development in HCV right now, and you are seeing lot of the new drugs tried in combination in clinical trial one and other. And last year we had a major safety event: Bristol-Myers (BMY), who was running a Phase II program, had...

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.