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How Gloucester Achieved the Impossible Even Before Inking the Celgene Deal

Gloucester Pharma FDA featEven before inking a $640 million acquisition by Celgene (CELG) earlier this week, Gloucester Pharmaceuticals had done something pretty amazing: the little biotech gained FDA approval of its lymphoma drug Istodax (romidepsin) without tapping the public markets or a partner.

According to BioWorld Insight, Gloucester is the first company to achieve such a feat in at least five years:

Aside from Gloucester, the only privately held drug makers to score approvals for unpartnered drugs were specialty pharmaceutical companies like Sirion Therapeutics Inc. or Zogenix Inc. -- and they don't exactly offer an apples-to-apples comparison. In the world of totally novel, true-biotech drug development, it seems that access to either public funding or a partner's deep pockets is mandatory to get a drug all the way through clinical and regulatory development.
So how did Gloucester do it?

CEO Alan Colowick told BioWorld a few secrets:

  • Focus on an orphan market like cutaneous T-cell lymphoma where approval can be based on single-arm Phase II studies
  • Stay lean; outsource whenever possible
  • Be a one-trick-pony: put all your resources into the lead program
  • Recruit a strong base of venture investors (and you can tell them Gloucester's investors put about $100 million in and got $640 million out about five years later)
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