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Another day, another 18-0 positive recommendation from a Food and Drug Administration advisory panel. Vertex Pharmaceuticals (Nasdaq: VRTX ) followed in Merck's (NYSE: MRK ) footsteps yesterday gaining a unanimous recommendation to approve its hepatitis C treatment telaprevir.
If it sounds more like a coronation than an advisory panel, that's because they basically were. Getting past the panel of outside experts is easy for drugs with stellar efficacy and reasonable side effect profiles. For drugs with questionable efficacy like Cell Therapeutics's (Nasdaq: CTIC ) pixantrone or potential side effects like obesity drugs from Arena Pharmaceuticals (Nasdaq: ARNA ) and VIVUS (Nasdaq: VVUS ) , the meetings can be considerably harder.
The current standards of care -- Roche's Pegasys or Merck's Pegintron -- cure less than half the patients treated with them, and they cause flu-like symptoms that make them challenging to take for the 48-week course required for the most common strain of hepatitis C.
Telaprevir has the advantage of not only nearly doubling the cure rate, but in patients that respond to the drug quickly, it allows patients to cut the time on Pegasys or Pegintron in half.
As I've said before, I love Vertex's science. It's pretty clear why the Rule Breakers team recommended the stock in 2005 and 2007. But the stock has run up quite a bit since then, and I question the lofty valuation. There are an awful lot of sales already priced into its $11 billion market cap. The upside seems limited when everyone already assumes it'll be a blockbuster; Vertex is trading flat today, despite the good news.
Sales of telaprevir in the billions don't seem out of the question given the number of patients that are waiting to be cured of their hepatitis C. But what happens when the next big thing that works even better comes along? Future coronations could have telaprevir being sent to live among the commoners.
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