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EMEA Accepts For Review Vidaza(R) Marketing Authorization Application For Higher-Risk Myelodysplastic Syndromes
Pharmion Corporation
(Nasdaq: PHRM) announced that the European Medicines Agency (EMEA)
has accepted for review the Company's Marketing Authorization Application
(MAA) for Vidaza(R) (azacitidine for injection) in patients with
higher-risk myelodysplastic syndromes (MDS) and announced its intent to
review the application under the Accelerated Assessment Procedure. Pharmion
submitted the Vidaza MAA to the EMEA earlier this month.
The Accelerated Assessment Procedure is granted for medicinal products
that are expected to be of major public health interest, particularly from
the point of view of therapeutic innovation. Accelerated Assessment reduces
the time limit for the Committee for Medicinal Products for Human Use
(CHMP) to give an opinion from 210 days to 150 days. At any time during the
marketing authorization application evaluation, the CHMP may decide to
continue the assessment under standard centralized procedure timelines.
The application is based upon clinical data which include the results
from the Company's Phase 3 multi-center, international, randomized study of
Vidaza(R) (azacitidine for injection) in the treatment of patients with
higher-risk MDS. The primary objective of this Phase 3 trial was to
demonstrate superiority in overall survival of Vidaza versus conventional
care regimens, and these data were presented at the American Society of
Hematology annual meeting in December 2007.
Vidaza has been designated as an Orphan Medicinal Product in the EU for
the treatment of MDS, which, if approved, entitles the drug to ten years of
market exclusivity for the approved indication. Vidaza has also been
designated as an Orphan Medicinal Product in the EU for the treatment of
acute myeloid leukemia (AML).
About Vidaza
In May 2004, Vidaza became the first drug approved by the FDA for the
treatment of patients with Myelodysplastic Syndromes (MDS). The FDA
approved Vidaza, the first in a new class of drugs called demethylation
agents, for treatment of all five MDS subtypes, which include both low-risk
and high-risk patients. These subtypes include: refractory anemia (RA) or
refractory anemia with ringed sideroblasts (RARS) if accompanied by
neutropenia or thrombocytopenia or requiring transfusions; refractory
anemia with excess blasts (RAEB), refractory anemia with excess blasts in
transformation (RAEB- T), and chronic myelomonocytic leukemia (CMMoL).
Vidaza is believed to exert its antineoplastic effects by causing
hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic
cells in the bone marrow. The concentration of Vidaza required for maximum
inhibition of DNA methylation in vitro does not cause major suppression of
DNA synthesis. Hypomethylation may restore normal function to genes that
are critical for differentiation and proliferation. The cytotoxic effects
of Vidaza cause the death of rapidly dividing cells, including cancer cells
that are no longer responsive to normal growth control mechanisms. Non-
proliferating cells are relatively insensitive to Vidaza. Vidaza was
approved for IV administration in January 2007.
About Epigenetics
Vidaza is the first of a new class of anti-cancer compounds known as
epigenetic therapies. Epigenetics refers to changes in the regulation of
gene expression, and DNA methylation and histone deacetylation are two of
the more studied epigenetic regulators of gene expression. Epigenetic
changes can silence gene expression and, unlike DNA mutations, may be
reversed by targeting the mechanisms involved. The silencing of key cell
cycle control genes and tumor suppressor genes through these two mechanisms
of epigenetic regulation has been demonstrated in vitro and in vivo in
hematological malignancies and in solid tumors. These key growth control
genes can be re- expressed in cancer cells when DNA hypermethylation is
reversed by Vidaza. The epigenetic approach to cancer therapy is that
rather than using molecules that kill both normal and tumor cells, the
silenced genes are reactivated through targeted epigenetic therapy,
re-establishing the cancer cell's natural mechanisms to control abnormal
growth.
About MDS
Myelodysplastic syndromes, or MDS, are a group of diseases in which the
bone marrow does not function normally, resulting in the production of
malformed or immature blood cells. The majority of patients with
higher-risk MDS eventually experience bone marrow failure. Up to 50 percent
of MDS patients succumb to complications, such as infection or bleeding,
before progressing to acute myeloid leukemia (AML). MDS patients have a
median survival of four months to five years depending on risk
stratification. Higher-risk patients have a median survival of five to 14
months. Alleviation of disease-related complications, including transfusion
requirements and hematologic improvement are key treatment goals in
lower-risk MDS. Altering the natural history of disease is one of the most
important treatment goals in higher-risk MDS.
Important Safety Information
Vidaza is contraindicated in patients with a known hypersensitivity to
Vidaza or mannitol and in patients with advanced malignant hepatic tumors.
In clinical studies, the most commonly occurring adverse reactions by
SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%),
vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%),
fatigue (35.9%), injection site erythema (35.0%), constipation (33.6%),
neutropenia (32.3%) and ecchymosis (30.5%). Other adverse reactions
included dizziness (18.6%), chest pain (16.4%), febrile neutropenia
(16.4%), myalgia (15.9%), injection site reaction (13.6%), aggravated
fatigue (12.7%) and malaise (10.9%). The most common adverse reactions by
IV route also included petechiae (45.8%), rigors (35.4%), weakness (35.4%)
and hypokalemia (31.3%).
Because treatment with Vidaza is associated with neutropenia and
thrombocytopenia, complete blood counts should be performed as needed to
monitor response and toxicity, but at a minimum, prior to each dosing
cycle.
Because Vidaza is potentially hepatotoxic in patients with severe pre-
existing hepatic impairment, caution is needed in patients with liver
disease. In addition, Vidaza and its metabolites are substantially excreted
by the kidneys and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, it may be useful to monitor renal
function.
Vidaza may cause fetal harm. While receiving treatment with Vidaza,
women of childbearing potential should avoid becoming pregnant, and men
should avoid fathering a child. In addition, women treated with Vidaza
should not nurse.
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.
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. In particular, Pharmion can not assure you that its MAA for
Vidaza will be reviewed on an accelerated assessment schedule or that
Vidaza will ultimately receive a marketing authorization in the EU.
Important factors that could cause or contribute to such differences
include the regulatory status and timing of regulatory approvals for
Vidaza; the impact of competition from other products sold by Pharmion's
competitors in the EU; the regulatory environment and changes in the health
policies and structure of various countries; acceptance and demand for new
pharmaceutical products and new therapies, uncertainties regarding
Pharmion's ability to enforce market exclusivities in member states of the
EU; failure of third-party manufacturers to produce the product volumes
required on a timely basis, fluctuations in currency exchange rates, and
other factors that are discussed in Pharmion's 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.
Pharmion Corporation
http://www.pharmion.com
View drug information on Vidaza.
EMEA acceptã pentru examinare Vidaza (R) cererea de autorizaþie de comercializare mai mare de risc, sindroame mielodisplazice - EMEA Accepts For Review Vidaza(R) Marketing Authorization Application For Higher-Risk Myelodysplastic Syndromes - articole medicale engleza - startsanatate