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)