Healthcare Industry News: Aloxi
News Release - October 11, 2007
AkaRx and MGI PHARMA Announce Closing of Development and License Agreement
PARAMUS, N.J.--(HSMN NewsFeed)--AkaRx, Inc., a Paramus, New Jersey biopharmaceutical company, and MGI PHARMA, INC. (NASDAQ: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 being developed for the treatment of thrombocytopenia, 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 of thyroid hormone targeting thyroid cancer. AKR-201 is in pre-clinical development and has received an orphan drug designation from the United States Food and Drug Administration.
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 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® (palonosetron hydrochloride) Injection, Dacogen® (decitabine) for Injection, and Gliadel® 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 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.
Source: MGI PHARMA
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