AkaRx and MGI PHARMA Announce Closing of Development and License Agreement
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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.