Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkin's Lymphoma
21 Agosto 2007 - 1:00PM
PR Newswire (US)
BOULDER, Colo. and MONTREAL, Aug. 21 /PRNewswire-FirstCall/ --
Pharmion Corporation (NASDAQ:PHRM), along with its collaborator
MethylGene Inc. (TSX: MYG), today announced that the U.S. Food and
Drug Administration (FDA) has designated the Companies' histone
deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the
treatment of Hodgkin's lymphoma in the United States. Criteria for
designation require that the product be intended for treatment of a
condition affecting fewer than 200,000 people in the United States,
and the application must include a rationale for the use of the
drug in the rare disease or condition. Preliminary data from a
MGCD0103 Phase II monotherapy clinical trial in relapsed and
refractory Hodgkin's lymphoma were presented at the American
Society of Clinical Oncology 2007 Annual Meeting in June and were
included in the application for Orphan Drug Designation. The data
demonstrated an objective complete response (CR) plus partial
response (PR) rate of 40 percent and a disease control rate (CR +
PR + stable disease for > 6 cycles) of 45 percent in a
population of 20 evaluable patients that had relapsed disease or
were refractory (unresponsive) to all previous treatments,
including, in most cases, bone marrow transplantation. Fatigue and
gastrointestinal side effects were the most common adverse events
and dose modification was effective in many of these patients.
Orphan Drug Designation allows special incentives for sponsors
planning to test a product for use in a rare disease or condition.
These incentives include, tax credits, research and development
grant funding, and reduced filing fees during development or at the
time of application for marketing approval. Once approved, the
product may qualify for seven years of marketing exclusivity in the
United States. MGCD0103 is an orally-administered,
isotype-selective HDAC inhibitor. The compound is currently in two
Phase I/II clinical trials, in combination with Vidaza(R) for
hematological malignancies and with Gemzar(R) in solid tumors, and
in four Phase II monotherapy clinical trials in hematological
malignancies. About Hodgkin's Lymphoma Hodgkin's lymphoma (HL) is a
cancer of the lymphatic system that begins in the lymph nodes and
progresses to other organs, including the lungs, liver, bone and
bone marrow. It is characterized by the presence of Reed-Sternberg
cells. Currently, there is no known cause of the disease, but
epigenetic alterations, including histone acetylation, have been
identified. In addition, the Epstein-Barr virus, HIV and familial
history are known risk factors. The disease is slightly more
prevalent in men than women, and the median age of diagnosis is 38.
About Pharmion Pharmion is a leading global oncology company
focused on acquiring, developing and commercializing innovative
products for the treatment of hematology and oncology patients in
the U.S., Europe and additional international markets. Pharmion has
a number of products on the market including the world's first
approved epigenetic drug, Vidaza(R), a DNA demethylating agent. For
additional information about Pharmion, please visit the company's
website at http://www.pharmion.com/. About MethylGene MethylGene
Inc. (TSX: MYG) is a publicly-traded biopharmaceutical company
focused on the discovery, development and commercialization of
novel therapeutics for cancer. The Company's lead product,
MGCD0103, is an oral isotype-selective HDAC inhibitor presently in
multiple clinical trials for solid tumors and hematological
malignancies, including Phase II monotherapy and Phase I/II
combination trials with Vidaza(R) and Gemzar(R). MGCD265 is an oral
kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor
tyrosine kinases. In addition, MethylGene has several preclinical
programs: MGCD290 an HDAC inhibitor in combination with azoles for
fungal infections; an HDAC program for Huntington's disease; a
sirtuins program for cancer; and a beta-lactamase program to
overcome antibiotic resistance. MethylGene's development and
commercialization partners include Pharmion Corporation, Taiho
Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website
at http://www.methylgene.com/. Safe Harbor Statement under the
Private Securities Litigation Reform Act of 1995: This release
contains forward-looking statements, which express the current
beliefs and expectations of management. Such statements are based
on current expectations and involve a number of known and unknown
risks and uncertainties that could cause Pharmion's future results,
performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include, but are not limited to, the
potential failure of product candidates, including MGCD0103, to
demonstrate safety and efficacy in clinical and non-clinical
testing; the ability to complete regulatory submissions and gain
regulatory approvals in a timely manner; the ability to initiate
and complete trials at the referenced times; the impact of
competition from other products under development by Pharmion's
competitors; the uncertainty of the regulatory environment and
changes in the health policies of various countries; acceptance and
demand for new pharmaceutical products and new therapies;
uncertainties regarding market acceptance of products newly
launched, currently being sold or in development; failure of
third-party manufacturers to produce the product volumes required
on a timely basis and fluctuations in currency exchange rates.
Additional risks and uncertainties relating to Pharmion and its
business can be found in the "Risk Factors" section of Pharmion's
Quarterly Report on Form 10-Q for the quarterly period ended June
30, 2007, its Annual Report on Form 10-K for the year ended
December 31, 2006 and in our other filings with the U.S. Securities
and Exchange Commission. Forward-looking statements speak only as
of the date on which they are made, and Pharmion undertakes no
obligation to update publicly or revise any forward-looking
statement, whether as a result of new information, future
developments or otherwise. DATASOURCE: Pharmion Corporation
CONTACT: Breanna Burkart, Director, Investor Relations and
Corporate Communications, +1-720-564-9144, , or Anna Sussman,
Director, Investor Relations and Corporate Communications,
+1-720-564-9143, , both of Pharmion Corporation; or Rhonda Chiger
of Rx Communications Group, LLC, +1-917-322-2569, , for MethylGene
Inc.; or Donald F. Corcoran, President & CEO of MethylGene
Inc., +1-514-337-3333, ext. 373 Web site: http://www.pharmion.com/
http://www.methylgene.com/
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