Analyst Sees FDA Approval For Provenge Drug By Dendreon (DNDN); Upgrades Stock To Buy Rating
April 12, 2010 - The Wall Street Transcript has just published Biotechnology & Pharmaceuticals Report offering a timely review of the Banking sector. This Special Report contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. Please find an excerpt below.
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Dr. Jonathan Aschoff, Ph.D., is a Senior Equity Analyst at Brean Murray, Carret & Co., LLC. Prior to joining the firm in 2003, he held positions as a Senior Biotechnology Analyst at Friedman, Billings, Ramsey & Co., Inc., and at what is now RBC. He also served as an Analyst at Sturza Institutional Research. Prior to Wall Street, Dr. Aschoff was a Research Technician at New England Medical Center. He earned a Ph.D. in molecular biology and microbiology, as well as a B.S. in biology from Tufts University.
TWST: Let's start with Medivation (MDVN). Why did you have a "sell" rating on it when most analysts had it as a "buy"-rated stock?
Dr. Aschoff: I had absolutely no belief that the heterogeneous European, American and South American patient population in Medivation's Phase III trial that just failed could ever replicate the homogeneous group of Russian patients that were largely recruited at only three of 11 sites in the Russian trial - that was the original Alzheimer's trial for Dimebon. Everything about the company was difficult to trust and partner Pfizer (PFE) has made many bad investments, so that deal had no chance of scaring me away.
TWST: What about Dendreon? You had a "sell" rating for five years and now you have a "buy" rating. What happened?
Dr. Aschoff: They put up solid data early in 2009. I think the thing to learn from Dendreon (DNDN) is when a stock is essentially at an all-time low going into a pivotal event, you might want to back off from being so aggressive with a "sell" rating. You might have wanted to consider that hardly anyone favored it then, so how much lower could it go? I was able to see the data presented in Chicago last year, and then my last concern of stroke imbalance, which was an imbalance in the first two Phase III trials, was assuaged when there was no imbalance in the IMPACT trial.
The trial arms were perfectly balanced, 6-3 for a 2-1 randomized trial. So I had no safety concerns, and that's when I went from the "hold" rating that I went to about a week before to a "buy" rating at about $20 per share, and it has been almost a double from there. I don't see anything getting in the way of FDA approval for Provenge. Approval would be a material risk reduction that would justify the stock to be well into the $40s because now you have removed FDA risk and Dendreon now just has to commercialize it, which they have enough money to do smoothly, and to train the employees properly.
TWST: How important to you is company management?
Dr. Aschoff: The earlier the assets, the less I care. But it matters more when it comes to commercializing something, and then I care more. Early on it is only about what the drug does, and that's in the hands of the patients and the people at the clinical trial sites. Management then gets more involved as you get into writing up the application efficiently and considering if management is likely to give a good retort to anything that might be argued against them at an FDA panel. Are they now likely to get a partner on good terms? Can they actually sell this treatment alone or with a partner? That's really what brings more to bear on management. The pivotal data, relatively speaking, is more out of their hands.
TWST: Must small biotechs always have a partnership somewhere down the road?
Dr. Aschoff: No, they don't have to. Good data will beget that if it makes sense to have a partner, and so they don't have to. I mean, I like Ardea (RDEA), Dendreon, Alexion (ALXN) and United Therapeutics (UTHR) a lot, and they don't have large pharmaceutical partners.
TWST: Why do you like Ardea?
Dr. Aschoff: Because by the time this interview is published, I think you are going to get a very positive Phase IIb monotherapy result. The bears think Ardea's drug is unsafe; they think it works, but that it's unsafe. I think it works, I agree with them on that, and I think it's safe. I don't think you are going to have kidney complications - that's the whole argument. I cover a lot of battle ground stocks and RDEA is one of them. Their monotherapy Phase IIb data should look good and so should their combination therapy data in April. And so we have imminent catalysts, which is why I launched coverage in December. I expect positive Phase IIb data to beget acquisition of the company.
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