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Apparently there was nothing to worry about with Savient Pharmaceuticals' (Nasdaq: SVNT ) second attempt to get gout treatment Krystexxa approved by the Food and Drug Administration. The company announced yesterday that the agency had given the drug a thumbs-up.
Effectiveness and safety for the gout drug weren't much of a concern after an advisory panel recommended approving the drug by a margin of 14 to 1. But the FDA sent the drugmaker back to the drawing board last year to fix some manufacturing issues.
That type of problem is always a bit concerning, simply because investors don't get the same look at the manufacturing of a drug as they do into effectiveness and safety. It turns out Savient had everything under control.
On the conference call this morning, management reiterated its plan to find a buyer for the company. Without anything else in the pipeline and essentially no other drugs -- Savient sells Oxandrin, but it has faced generic competition since 2006 --Savient makes for a very clean takeout target.
Gout is a type of arthritis, so the obvious potential buyers include the companies selling blockbuster anti-inflammatory drugs: Abbott Labs (NYSE: ABT ) , Johnson & Johnson (NYSE: JNJ ) , Merck (NYSE: MRK ) , Pfizer (NYSE: PFE ) , and Amgen (Nasdaq: AMGN ) .
Savient has been up as much as 35% so far today on the news, which values the company at about $1.35 billion. Guessing how much a pharmaceutical or large biotech company might be willing to pay for the drug is a little difficult. Analysts' estimates for the peak sales for Krystexxa are all over the place. Even if you could guess them accurately, you still have to factor in the purchaser's expected return over the life of the drug. An FDA-approved drug has a fairly low risk profile, but you still have to factor in potential patent challenges that could result in early generic competition, as well as newer brand-name drugs that might work better than Krystexxa.
Investors who haven't jumped on board yet might be best off passing on Savient and chocking it up to a lesson that sometimes manufacturing woes can be rectified. A company like this one that fellow Fool Tom Jacobs found might offer less risk if you're looking to buy a company before it's sold.