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Pharmion (NASDAQ: PHRM) (February 11, 2008)MethylGene and Pharmion Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
MethylGene Inc. (TSX: MYG) and Pharmion (NASDAQ: PHRM) announced earlier today that the European Medicines Agency (EMEA) and the European Commission (EC) designated MGCD0103, a histone deacetylase (HDAC) inhibitor, as an Orphan Medicinal Product for the treatment of acute myelogenous leukemia in the European Union (EU). Criteria for designation require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons in the EU.
Orphan Medicinal Product Designation allows special incentives for sponsors planning to test a product for use in a rare disease or condition generally characterized by a small number of patients. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Once approved, the product may qualify for 10 years of marketing exclusivity in the EU.
About MGCD0103
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) for the treatment of Hodgkin lymphoma 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.
About 18,000 new cases of AML are diagnosed in Europe each year and the trend in overall incidence of AML has generally been stable or slowly increasing. AML is a rare form of cancer accounting for approximately 30 percent of all leukemias in the adult population and approximately 0.6 percent of all cancers. AML is estimated to affect less then two in 10,000 persons in the EU. The survival rate for AML at five years for adults under 55 is approximately 23 percent and for adults over 55 is approximately 10 percent.
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.
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 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.
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 , a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at www.pharmion.com.
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Xynergy Corporation, Inc (PINKSHEETS: XYNG) (February 11, 2008) announced earlier today it intends to unveil its revolutionary Hydrogen Generator to key industry leaders, its shareholders, and to the media early this fall. The Company will announce sometime in the near future specific dates, locations and times relative to the demonstration of the prototype generator. The generator has been used to power a restaurant and has proven to power certain gas engines using water as the power source of the generator, including salt water. The company believes it will be able to mass produce their revolutionary generator cost efficiently, making it truly an alternative energy source. The company is working on prototyping several other revolutionary technologies and will be announcing the debuting of those as well. The generator will be marketed to restaurants, small offices and businesses, and residential homes initially.
This will be the first and only time anybody outside of management will have the opportunity to see this technology in operation. The Company intends on demonstrating several uses of its generator, including the powering of restaurants and other extraordinary uses. Production is underway.
Management has recently made several key announcements regarding the progress of the Company, including commencement of the filing process in order to become a fully reporting company pursuant to the Securities Exchange Act of 1934. Management has begun the registration process in order to facilitate management's intent to provide investors with greater ongoing disclosure and to move the trading of the Company's common stock from the current exchange to the Over The Counter Bulletin Board.
ABOUT XYNERGY CORPORATION
The company is engaged in the development and investment of alternative energy technology and the identification, marketing and utilization of applications for such technologies. The company has identified several business sectors that these technologies can serve, including restaurants, commercial bakeries, gas stations, and all small businesses, as well as gas engines for automobiles and boats. This technology has the potential to revolutionize the energy industry because it is believed that this technology, which uses water as a power source, is the only one in the world that can turn hydrogen into real power in a cost efficient manner, making it truly an alternative energy solution.
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Drinks Americas Holdings, Ltd. (OTCBB: DKAM)(February 11, 2008), a leading developer and marketer of premium beverages that partners with renowned icons, announced earlier today that it has made its second shipment consisting of 1,000 cases of Trump Super Premium Vodka to Russia. This shipment is part of Drinks Americas' contract with Recolte (its distribution partner in Russia) to purchase approximately $7.5 million of Trump Super Premium Vodka this year. This shipment, as well as others to Russia, are in coordination with Wanders, the Dutch distillery that produces Trump Super Premium Vodka. The 1,000-case shipment consists of various sizes of Trump Super Premium Vodka.
Recolte launched the Trump Super Premium Vodka brand at Moscow's Millionaires Fair in November 2007. The famous exhibition, held in one of Moscow's largest exhibition halls, featured the world's most prominent luxury goods and was attended by only qualified millionaires and Russia's most affluent consumers. In 2005, the vodka market in Russia was $10.2 billion and is expected to double in size by 2009.
Patrick Kenny, President and CEO stated, "We are happy that sales in Russia are underway and our partners have taken time to work through the logistical issues of starting to ship goods from our Dutch distiller to Russia. The sales revenue and profit margins from our expansion in Russia have significant implications for Drinks Americas' top and bottom line in the near term. The news of this expansion has interested other potential markets. We are looking aggressively at other export opportunities and expect to ship to partners in Asia this year."
ABOUT DRINKS AMERICAS
Drinks Americas develops, owns, markets, and nationally distributes alcoholic and non-alcoholic premium beverages associated with renowned icon celebrities. Drinks Americas' portfolio of premium alcoholic beverages includes Trump Super Premium Vodka and Willie Nelson's Old Whiskey River Bourbon. The Company's non-alcoholic brands include the distribution of Paul Newman's Own Lightly Sparkling Fruit Juice Drinks and Flavored Waters.
Other products owned and distributed by Drinks Americas include award-winning Damiana Liqueur and Aguila Tequila from Mexico, Cohete Rum Guarana from Panama, and Rheingold Beer. Damiana, Old Whiskey River, Aguila Tequila and Cohete Rum are Gold and Silver Medal award winners respectively from the International Beverage Tasting Institute and the San Francisco International Wine and Spirits Competition.
For further information, please visit our website at www.drinksamericas.com Drinks Americas was founded in 2004 by J. Patrick Kenny, a leading expert in beverage sales and marketing. Mr. Kenny developed his industry expertise in a variety of management positions at the world's leading beverage companies, including Joseph E. Seagram and Sons and The Coca-Cola Company. He has also acted as advisor to several Fortune 500 beverage marketing companies, and has participated in several beverage industry transactions.
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