BOULDER, Colo. and MONTREAL, Feb. 14 /PRNewswire-FirstCall/ -- Pharmion Corporation and MethylGene Inc. 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(R) for solid tumors, two Phase I/II combination trials with Vidaza(R) for hematological malignancies and with Gemzar(R) 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.
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.
MethylGene Inc. 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(R), Gemzar(R) and Taxotere(R). 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 http://www.methylgene.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements relating to MGCD0103, 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 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 September 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.
CONTACT: Breanna Burkart, Director, Investor Relations and Corporate
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MethylGene Inc.; or Donald F. Corcoran, President & CEO of MethylGene Inc.,
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Web site: http://www.pharmion.com/