Commercial Launch of Novel HDAC Inhibitor, ISTODAX®
(romidepsin), for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Targeted for Early 2010
ISTODAX Registration Special Protocol Assessment (SPA) Trial for
Peripheral T-Cell Lymphoma (PTCL) - Accrual Expected to be
Completed Early Next Year
Acquisition Expected to be Neutral to Non-GAAP Diluted Earnings in
2010 and Accretive in 2011
SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 7, 2009--
Celgene Corporation (NASDAQ:CELG) and Gloucester Pharmaceuticals
Inc., a privately held pharmaceutical company, announced a definitive
merger agreement under which Celgene Corporation will acquire Gloucester
Pharmaceuticals. Celgene says the acquisition will continue to advance
its leadership position in the development of disease-altering therapies
through innovative approaches for patients with rare and debilitating
blood cancers. Gloucester Pharmaceuticals develops new therapies that
address the unmet medical needs in the treatment of cancer, including cutaneous
T-cell lymphoma (CTCL), peripheral
T-cell lymphoma (PTCL) and other hematological malignancies.
ISTODAX® (romidepsin) was approved in November 2009, by the
U.S. Food and Drug Administration (FDA) for the treatment of CTCL in
patients who have received at least one prior systemic therapy.
Additionally, ISTODAX has received both orphan drug designation for the
treatment of non-Hodgkin’s T-cell lymphomas, which includes CTCL and
PTCL, and Fast Track status in PTCL from the Food and Drug
Administration (FDA). The European Agency for the Evaluation of
Medicinal Products (EMEA) has granted orphan status designation for
ISTODAX for the treatment of both CTCL and PTCL. Accrual of the ISTODAX
registration SPA Trial for peripheral T-cell lymphoma (PTCL) is expected
to be completed early next year.
“We are thrilled with this transaction because Celgene’s global
leadership in the development and commercialization of innovative
treatments for hematologic diseases makes them ideally suited to bring
the clinical benefits of ISTODAX to patients with CTCL,” said Alan
Colowick, M.D., Chief Executive Officer of Gloucester Pharmaceuticals.
CTCL is a type of non-Hodgkin’s lymphoma (NHL) caused by a mutation of
T-cells; most types of NHL are of T-cell origin. The malignant T-cells
involve the skin, causing plaques, patches, erythroderma and/or tumors
and can involve other organs, including the blood, lymph nodes and
viscera. According to the Cutaneous Lymphoma Foundation, this rare
orphan disease has a greater frequency among men than women; the disease
is more common after the age of 50.
“This acquisition reflects our ongoing commitment to improving the lives
of patients worldwide through innovative medicines discovered and
developed both in-house and through external opportunities,” said Sol J.
Barer, Ph.D., Chairman and Chief Executive Officer of Celgene
Corporation. “We also would like to recognize the dedication, effort and
leadership that Alan and his team have demonstrated in the process of
developing and delivering ISTODAX® to patients living with
CTCL.”
About Terms of the Agreement
The transaction has been approved by the Board of Directors of both
companies and is subject to customary closing conditions, including the
expiration or termination of the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of
the merger agreement, Celgene will acquire Gloucester Pharmaceuticals
for $340 million in cash plus $300 million in future U.S. and
international regulatory milestone payments. The acquisition of
Gloucester will be accounted for as a purchase transaction that Celgene
expects to be completed in the first quarter of 2010 and to be neutral
to non-GAAP diluted earnings for 2010 and accretive in 2011. J.P. Morgan
Securities Inc. acted as the exclusive financial advisor to Gloucester
Pharmaceuticals.
About ISTODAX
ISTODAX® (romidepsin) is a member of a new class of cancer
drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyze the
removal of acetyl groups from acetylated lysine residues in histones,
resulting in the modulation of gene expression. HDACs also deacetylate
non-histone proteins, such as transcription factors. HDAC inhibitors can
be divided into four main classes: cyclic tetrapeptides (I), short-chain
fatty acids (II), hydroxamic acids (III), and benzamides (IV). The
cyclic peptide structure of ISTODAX is novel among the cyclic
tetrapeptides. In vitro, ISTODAX causes the accumulation of
acetylated histones, and induces cell cycle arrest and apoptosis of some
cancer cell lines. For full prescribing information, visit www.ISTODAX.com.
About Gloucester Pharmaceuticals
Founded in 2003, Gloucester Pharmaceuticals, Inc. is a privately held
biopharmaceutical company that acquires clinical-stage oncology drug
candidates with the goal of advancing them through regulatory approval
and commercialization. Gloucester's first drug, ISTODAX®
(romidepsin), a novel histone
deacetylase (HDAC) inhibitor, was approved in November 2009, by the
U.S. Food and Drug Administration for the treatment of cutaneous T-cell
lymphoma (CTCL) in patients who have received at least one prior
systemic therapy. The Company is also conducting a registration trial in
peripheral T-cell lymphoma (PTCL) with an anticipated supplemental NDA
filing in 2010 for this indication. Additional studies in both
hematologic and solid tumors are currently ongoing. ISTODAX is approved
for the treatment of CTCL in the U.S. and is not approved for the
treatment of PTCL or other indications. Gloucester’s investors include
Prospect Venture Partners, Rho Ventures, ProQuest Investments, Apple
Tree Partners and Novo A/S. For more information, please visit the
Company’s website at www.gloucesterpharma.com.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through gene and
protein regulation. For more information, please visit the Company’s
website at www.celgene.com.
This release contains forward-looking statements which are subject to
known and unknown risks, delays, uncertainties and other factors not
under Celgene’s control, which may cause actual results, performance or
achievements of Celgene to be materially different from the results,
performance or other expectations expressed or implied by these
forward-looking statements. These factors include results of current or
pending research and development activities, actions by the FDA and
other regulatory authorities, and other factors described in Celgene’s
filings with the Securities and Exchange Commission such as its 10-K,
10-Q and 8-K reports.
Source: Celgene Corporation
Celgene Corporation
David W. Gryska, 908-673-9059
Senior Vice
President and Chief Financial Officer
or
Brian P. Gill,
908-673-9530
Vice President, Corporate Communications
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