Healthcare Industry News: Vidaza
News Release - February 14, 2008
MethylGene and Pharmion Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous LeukemiaMONTREAL, QUEBEC and BOULDER, COLORADO--(Healthcare Sales & Marketing Network)--Feb 14, 2008 -- MethylGene Inc. (Toronto:MYG.TO ) and Pharmion Corporation (NasdaqGS:PHRM ) 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 acute myelogenous leukemia (AML) 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.
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 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 one Phase I combination clinical trial with Taxotere® for solid tumors, two Phase I/II combination trials with Vidaza® for hematological malignancies and with Gemzar® for pancreatic cancer, and five Phase II clinical trials in hematological malignancies.
MGCD0103 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an Orphan Medicinal Product by the EMEA for the treatment of Hodgkin lymphoma and acute myelogenous leukemia.
About Acute Myelogenous Leukemia (AML)
Acute myelogenous leukemia (AML) is a cancer of the blood and bone marrow that is characterized by the rapid proliferation (growth) of abnormal white blood cells. These cells are unable to perform their regular functions and eventually crowd out healthy red and white blood cells. Leukemia cells can also spread to other parts of the body. People afflicted with AML are susceptible to increased risk of infections, anemia and bleeding.
AML is the one of the most common forms of leukemia and occurs most often in older adults - the average age being 65. The American Cancer Society estimates that 13,410 new cases and 8,990 deaths occurred in the United States in 2007.
Although several risk factors for AML have been identified, the specific cause of AML remains unclear. AML is a potentially curable disease; but only a minority of patients are cured with current therapies. Current treatments for AML include chemotherapy, blood transfusions and stem cell transplants.
MethylGene Inc. (Toronto:MYG.TO ) 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 and Phase II combination trials with Vidaza®, Gemzar® and Taxotere®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene's preclinical programs include: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections and a sirtuins program for cancer. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at www.methylgene.com.
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®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the impact of unilateral decisions and/or strategies of our collaborators; the results of clinical trials; the ability to demonstrate pharmacokinetic / bioequivalency; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD0103, MGCD265 or MGCD290. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, which you are urged to read, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2006, under the heading 'risk factors', the final prospectus filed on February 23, 2007, and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.
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