Rho Venture Capital: 2004 News

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Gloucester Pharmaceuticals Receives Fast Track Designation for FK228 in Cutaneous T-Cell Lymphoma

CAMBRIDGE, MA
October 12, 2004

Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for FK228 (depsipeptide) as monotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have relapsed
following, or become refractory to, one other systemic therapy. FK228, Gloucester's lead product, is currently being evaluated in CTCL and a range of other hematologic and solid tumor indications in Phase 2 clinical trials sponsored by Gloucester, as well as the National Cancer Institute (NCI), under a Cooperative Research and Development Agreement (CRADA).

In granting the Fast Track Designation for FK228, the FDA stated the following:

Development of new therapies in CTCL is needed;

For patients with progressive or symptomatic CTCL requiring treatment, there is no consensus on standard systemic therapy;

Existing single agent and combination therapies give reasonable response rates but the responses are short lived; and

The potential of FK228 to address an unmet medical need for the systemic therapy of CTCL has been demonstrated in a series of Phase 1 and Phase 2 clinical trials where objective and durable clinical responses have been observed.

"We are pleased that the FDA has granted Fast Track designation for FK228 and has recognized the serious unmet medical need of patients with CTCL and the potential of FK228 to meet that need" stated William McCulloch, M.B., FRCP, Chief Medical Officer of Gloucester. "If the objective and durable clinical responses that we have seen to date in clinical studies of FK228 continue to be observed in ongoing clinical studies, we believe that FK228 could become a significant new treatment option for patients and physicians."

"Receiving Fast Track designation for FK228 is a key element of our product development strategy and will assist us in moving more efficiently through the regulatory process in cooperation with the FDA" commented Joseph S. "Jay" Mohr, President and Chief Executive Officer of Gloucester Pharmaceuticals. "We believe that FK228 is the first HDAC to receive Fast Track designation of the treatment of CTCL."

About Fast Track Designation
The Fast Track program is designed to facilitate and expedite the development and review of new products that demonstrate the potential to address an unmet medical need for serious or life-threatening conditions. A Fast Track designation refers to a formal process for interacting with the FDA during drug development. Specific benefits include the opportunity for more frequent interactions and meetings with the FDA, in order to seek their input into development plans, as well as the option of submitting sections of a New Drug Application (NDA) on a rolling basis, rather than simultaneously. Fast Track designation may further lead to a priority review of an NDA within a 6 month timeframe.

About FK228
FK228 (depsipeptide) is one of a new class of anti-cancer agents, known as histone deacetylase (HDAC) inhibitors, and is the only bicyclic peptide in this group. FK228 is currently in Phase 2 clinical trials for the treatment of cutaneous T-cell lymphoma (CTCL), as well as renal cell carcinoma, hormone refractory prostate cancer and a number of other solid tumor and hematological indications in co-operation with the NCI. In numerous preclinical studies performed by Fujisawa, the NCI and others, the inhibition of histone deacetylation caused cell cycle arrest, differentiation and apoptotic cell death in cancer cells of various types. Phase 2 data reported at the annual 2004 meeting of the American Society of Clinical Oncology (ASCO) showed an overall response rate of fifty percent (50%) in patients with cutaneous T-cell lymphoma. Gloucester acquired rights to FK228 from Fujisawa Pharmaceutical Co, Ltd. in April 2004 under an exclusive, worldwide license agreement.

About CTCL
CTCL is a group of diseases, including Mycosis Fungoides and Sézary syndrome, all constituting types of non-Hodgkin's lymphoma in which certain cells of the lymph system (T-cells) become cancerous and affect the skin. The disorder is characterized by abnormal accumulation of malignant T-cells in the skin, which result in the development of itchy rashes, plaques and tumors. Occasionally malignant cells can be found circulating in the bloodstream and visceral (internal organ) involvement can occur. There are about 40,000 CTCL patients world wide (20,000 U.S.), with another 3,000 (1,500 U.S.) new cases reported each year.

About Gloucester Pharmaceuticals, Inc.
Gloucester Pharmaceuticals, Inc. is a privately held, venture-backed company that develops and commercializes innovative products for the treatment of cancer. The company employs an in-licensing strategy to build a diversified product portfolio to address the significant unmet medical need in the management of cancer. Gloucester's lead product is FK228, a novel HDAC inhibitor in Phase 2 studies, which the company acquired from Fujisawa Pharmaceutical Co, Ltd. in April 2004.
Gloucester is headquartered in Cambridge, Massachusetts. For more information visit our newly enhanced website at www.gloucesterpharma.com.

This press release contains forward-looking statements concerning Gloucester that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements.
There are a number of important factors that could cause Gloucester's actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in pre-clinical and early clinical studies such as the results referred to in this release will be indicative of results obtained in future clinical trials; whether FK228 will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and for which indications, if any; and whether the patent and patent applications owned or licensed by Gloucester will protect the Company's technology and prevent others from infringing it. Gloucester disclaims any intention or obligation to update any forward-looking statements.