Healthcare Industry News: EnVivo Pharmaceuticals
News Release - August 21, 2007
Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkin's LymphomaBOULDER, Colo. and MONTREAL, Aug. 21 (HSMN NewsFeed) -- 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® for hematological malignancies and with Gemzar® 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.
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 http://www.pharmion.com.
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® and Gemzar®. 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.
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