Gloucester Pharmaceuticals Completes $29 Million Financing
- ODAC Meeting Scheduled for September 2, 2009 -
CAMBRIDGE, MA - August 25, 2009 - Gloucester Pharmaceuticals today announced that it has raised $29 million in a Series D financing. The proceeds will be used to support the ongoing development of romidepsin, a novel histone deacetylase (HDAC) inhibitor for the treatment of T-cell lymphomas and other hematologic malignancies. The financing was led by new investor Novo A/S and included current investors Apple Tree Partners, ProQuest Investments, Prospect Venture Partners and Rho Ventures. Concurrent with the financing, Thomas Dyrberg, M.D., Senior Partner at Novo Ventures, will join the Board of Directors for Gloucester Pharmaceuticals.
Gloucester has filed a New Drug Application (NDA) for romidepsin in cutaneous T-cell lymphoma (CTCL) that is under review with the U.S. Food and Drug Administration (FDA). An Oncology Division Advisory Committee (ODAC) meeting is scheduled for September 2, 2009 to review romidepsin and a Prescription Drug User Fee Act (PDUFA) date is scheduled for November 12, 2009.
"We are extremely pleased to welcome Dr. Dyrberg to our Board of Directors and are grateful for the continued strong financial support of our current investors," said Alan Colowick, M.D., Chief Executive Officer of Gloucester Pharmaceuticals. "We look forward to being able to deliver on the clinical promise of romidepsin as a therapeutic option for the treatment of T-cell lymphomas."
Thomas Dyrberg, M.D., Senior Partner at Novo Ventures commented, "We are pleased to be able to join Gloucester at such an exciting time in its history. The Company has accomplished a great deal and we look forward to being a part of the progress that we believe will result in bringing this important new product to patients with T-cell lymphomas and potentially other hematologic malignancies."
Romidepsin's cyclic peptide structure is novel among members of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDAC inhibition has been shown to increase acetylation of histones and other proteins. The downstream effects of HDAC inhibition include growth inhibition, apoptosis, inhibition of angiogenesis and differentiation. Nonclinical studies suggest that romidepsin is a pan-HDAC inhibitor and is a potent inhibitor of Class I, Class II and Class IV HDACs. Romidepsin has shown activity across a range of hematologic malignancies. The most common adverse effects in clinical trials of romidepsin include fatigue, gastrointestinal disturbances and generally mild to moderate hematologic toxicity.
About Gloucester Pharmaceuticals
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, romidepsin, a novel histone deacetylase (HDAC) inhibitor, is in late-stage development for T-cell lymphomas and has shown activity across a range of hematologic malignancies. A New Drug Application for romidepsin in CTCL is under review with the FDA with an ODAC meeting scheduled for September 2, 2009 and a PDUFA date of November 12, 2009 has been set. The Company is currently enrolling patients in a registration trial for peripheral T-cell lymphoma (PTCL) and is evaluating romidepsin in multiple additional indications including multiple myeloma. For more information, please visit www.gloucesterpharma.com