AkaRx and MGI PHARMA Announce Closing of Development and License Agreement.PARAMUS, N.J. -- AkaRx, Inc., a Paramus, New Jersey Paramus (IPA: /pəˈræməs/) is a borough in Bergen County, New Jersey, United States. As of the United States 2000 Census, the borough population was 25,737. biopharmaceutical company, and MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA, INC. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that their previously announced Development and License Agreement has become effective. The Agreement provides MGI PHARMA with the exclusive rights to develop AKR-501, a novel, small molecule thrombopoietin mimetic mimetic /mi·met·ic/ (mi-met´ik) pertaining to or exhibiting imitation or simulation, as of one disease for another. mi·met·ic adj. 1. Of or exhibiting mimicry. 2. being developed for the treatment of thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , and an option to acquire AkaRx at MGI PHARMA's sole discretion at any time up to January 8, 2010. AKR-501 is an orally-available, full agonist that targets the c-Mpl receptor on platelet producing cells to stimulate platelet production. In accordance with the terms of the transaction, MGI PHARMA has made payments of $45 million, in the aggregate, to AkaRx and its shareholders to acquire certain license rights and the right to acquire all of AkaRx's capital stock from AkaRx shareholders at any time prior to January 8, 2010. Under the terms of the Development and License agreement, MGI PHARMA has assumed responsibility for certain development activities during the option period. If MGI PHARMA elects to exercise its option to acquire all of AkaRx's capital stock, additional payments of approximately $255 million would be made at that time. As part of the agreements, MGI PHARMA also obtained rights to AKR-201, a metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. of thyroid hormone Thyroid hormone Any of the chemical messengers produced by the thyroid gland, including thyrocalcitonin, a polypeptide, and thyroxine and triiodothyronine, which are iodinated thyronines. See Hormone, Thyrocalcitonin, Thyroid gland, Thyroxine targeting thyroid cancer Thyroid Cancer Definition Thyroid cancer is a disease in which the cells of the thyroid gland become abnormal, grow uncontrollably, and form a mass of cells called a tumor. . AKR-201 is in pre-clinical development and has received an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . About AKR-501 AKR-501 is a novel, orally-available, small molecule thrombopoietin mimetic being developed for the treatment of thrombocytopenia. AKR-501 is a full agonist that targets the c-Mpl receptor on megakaryocytes to stimulate platelet production. AKR-501 does not compete with thrombopoietin, the natural c-Mpl ligand, for binding to the receptor. Rather, AKR-501 works additively with thrombopoietin to enhance platelet production. Furthermore, pharmacokinetic studies demonstrate the absence of a food effect for AKR-501, suggesting the drug can be dosed without regard to meals. In phase 1 single and multi-dose studies evaluating the safety of AKR-501 in healthy volunteers, significant increases in platelet count Platelet Count Definition A platelet count is a diagnostic test that determines the number of platelets in the patient's blood. Platelets, which are also called thrombocytes, are small disk-shaped blood cells produced in the bone marrow and involved in relative to baseline values were observed. Adverse events were mild and similar to those that were seen in subjects treated with placebo. About AkaRx AkaRx, Inc. is a biopharmaceutical company headquartered in Paramus, New Jersey, and dedicated to the development of novel therapeutic treatments that address unmet medical needs and provide significant benefits over currently available therapies. AkaRx, Inc. was formed as a spin out of the Yamanouchi Pharmaceutical Co., Ltd and Fujisawa Healthcare, Inc. merger of 2005. About MGI PHARMA MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi[R] (palonosetron hydrochloride) Injection, Dacogen[R] (decitabine) for Injection, and Gliadel[R] Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com. This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA to continue to increase sales of its marketed products, the ability of MGI PHARMA to achieve its objectives for 2007, the successful completion of clinical trials for the Company's other product candidates, and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements. |
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