12:00 AM
Sep 07, 2009
 |  BioCentury  |  Strategy

A small, private affair

In 2004, Gloucester Pharmaceuticals Inc. took a bet on a small molecule HDAC inhibitor that Fujisawa Co. Ltd. was divesting. That bet looks to have paid off, as FDA's the Oncologic Drugs Advisory Committee last week recommended approval of Istodax romidepsin to treat cutaneous T cell lymphoma.

ODAC voted 10-0 with one abstention that Istodax romidepsin has a favorable risk/benefit profile in patients with cutaneous T cell lymphoma (CTCL), based on impressive duration of response data from two single-arm Phase II trials (see Cover Story).

If FDA follows the panel's recommendation, Gloucester would join the ranks of only a handful of private companies that have managed to get compounds through to approval without a larger biotech or pharma partner (see "A Rare Breed").

Gloucester acquired worldwide rights to Istodax prior to Fujisawa's merger with Yamanouchi Pharmaceutical Co. Ltd. to form Astellas Pharma Inc.

According to CEO Alan Colowick, Gloucester was founded...

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