3/23/03
The biotech rally last week was the best we?ve seen in recent months. This corresponded with the general upbeat trend in all the US equity markets. Today?s note will focus on Versicor (VERS), a small biotech company developing a franchise in infectious disease. Last week the company released results of a Phase III trial with anidulafungin. This drug belongs to a new class of antifungals called echinocandins. They work by an entirely different mechanism than other two currently available classes (triazoles and amphotericins) of anti-fungal agents. The echinocandins have the advantage of being cidal while not having the serious toxicities of the amphotericins. The real advantage of the echinocandins is that they can more easily treat resistant organisms. The only approved member of this class is Cancidas (caspofungin from Merck) and it is being used widely. Anidulafungin and micafungin from Versicor and Fujisawa respectively are in the pipeline as potential competitors. Fujisawa filed on micafungin with the FDA in April of ?02 and received an FDA letter on January 29th ?03 asking for more data. This may put both of these drugs on similar time-lines. The other new antifungal on the market is voriconazole (Vfend) from Pfizer but again this is a different class of drug but definitely an improvement over previous members of its class and is approved to treat life-threatening infections.
What I like about Versicor is that anidulafungin is an approvable drug in light of the just released Phase III results. The company hopes to file with the FDA by end April using this Phase III data supplemented with Phase II data from an invasive candidiasis trial and interim data from a Phase III aspergillosis study. They also have a near-term pipeline candidate in dalbavancin, a long acting drug with a similar spectrum of activity as vancomycin. This could be very useful in getting patients home quickly and make outpatient care simpler. VERS? stock went down a few points after announcing results of the Phase III anidulafungin trial. The trial met the primary endpoint of non-inferiority to the comparator, fluconazole. However at a repeat endoscopy a few weeks after therapy more patients in the anidulafungin arm recurred. The drug did have a very good safety profile. On a quick analysis most investors came to the conclusion that giving anidulafungin intravenously was no better than the current oral therapy and patients recurred more frequently so therefore this was no great shakes. What?s missing in this analysis is that the company has really no intention of trying to treat esophageal candidiasis. We already have a very successful and simple oral therapy. However, this indication is probably the easiest route through the FDA-- that is unless the FDA raises the bar. It is like Celgene getting Thalidomide approved for leprosy?did anyone think this was really going to be a major use? The real goal is to get anidulafungin approved quickly and then have it used in invasive candidiasis and candida septicemia (many candida infections of these kinds are caused by organisms resistant to fluconazole) as well as invasive aspergillosis. Phase III trials are underway for these other more serious candida infections. For these indications anidulafungin should be a superior drug to the common triazoles, however there will be competition from others in its class. In summary I think investors did not appreciate Versicor?s strategy for anidulafungin. With one late phase drug about to be filed with the FDA, another in Phase III trials and a deep pipeline this company could certainly be an attractive takeover candidate for a large pharma looking to solidify an infectious disease franchise. I like Versicor at the current price of $10.47?in fact I think it?s a bargain. VERS? financial statistics include a market cap of $272 million, 26 million shares mostly in a public float, and cash and equivalents of $62 million with no long-term debt to speak of.