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What: Shares of biotechnology company ViroPharma (Nasdaq: VPHM) soared as much as 16% today after the company received supplemental approval to Cinryze's Biologics License Applications from the Food and Drug Administration for industrial scale manufacturing changes.
So what: The ruling today is important because it allows ViroPharma to adequately ramp up Cinryze production, with the relabeling process of previously produced vials only expected to take six weeks.
Now what: Today's FDA ruling is also important because ViroPharma has been in a world of hurt since the FDA ruled against it in allowing generic competition to enter the market to compete against its previous blockbuster, Vancocin. Since that ruling, both Akorn (Nasdaq: AKRX) and Watson Pharmaceuticals (NYSE: WPI) have entered the market with generic versions of the drug. Therefore, Cinryze is ViroPharma's new horse in the race, and today's actions allow it to greatly increase production and potentially profits. I'm still not sold on ViroPharma given the huge windfall it took with Vancocin's loss, but this is definitely a step in the right direction.
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