Saturday, December 20, 2014

On Same Day As Merck's Tender Offer Formally Launched, Cubist Gets Zerbaxa® FDA Nod

The FDA squeaked in under the wire (once again!), on its own PDUFA rule deadlines, and approved this new Cubist antibacterial afterhours, late last evening (expiry date was to be tomorrow). It will undoubtedly be a big seller in the complicated urinary tract infection space, and will help Merck defend the overall price it has agreed to pay -- for Cubist.

Here's a bit of the Forbes item on the news:

. . . .Zerbaxa was specifically approved for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) that also includes infections of the kidney (pyelonephritis). For cIAI, Zerbaxa is intended to be combined with metronidazole, an antibiotic and antiprotozoal drug with particular activity against anaerobes. . . .

We will watch this -- and I may offer a few comments on the price events, and other escape clauses baked into the tender offer and merger documents, come Monday. At the airport. . .

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