Date: 2012-06-18
Type of information: Product acquisition
Compound: Ceplene® (histamine dihydrochloride)
Company: Epicept (USA) Meda (Sweden)
Therapeutic area: Cancer - Oncology
Type agreement: product acquisition
Action mechanism:
Disease: acute myeloid leukemia
Details: EpiCept Corporation has sold all of its rights to Ceplene® in the territories previously licensed to Meda AB, and a portion of its remaining Ceplene® inventory, to Meda for approximately $2.6 million in cash and the assumption of EpiCept's ongoing responsibilities related to the manufacture and maintenance of the marketing authorization of Ceplene® in the European Union. The drug has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.
The cash received from this transaction together with the savings from future expenses, after making a partial prepayment on EpiCept\'s existing term loan with MidCap Financial LLC of approximately $0.8 million , will enable EpiCept to operate into the fourth quarter 2012 without further financing.
Under the terms of the transaction, Meda has as of the closing date assumed responsibility for the manufacturing of Ceplene® in the territories previously licensed to Meda and will absorb all of the remaining expenses relating to the post-approval clinical study of Ceplene® that is required by the European Medicines Agency (EMA). EpiCept has also agreed to relinquish all future milestone payments and royalty on future sales of Ceplene® by Meda. In conjunction with the closing of this transaction EpiCept will close its EpiCept GmbH facility in Munich, Germany .
EpiCept maintains full ownership of Ceplene® in those countries not previously licensed to Meda, including all of North and South America . The Company\'s agreement with Megapharm Ltd. for the sales of Ceplene® in Israel is not a part of the transaction.
The sale of licensed Ceplene® rights to Meda provides additional liquidity to the Company\'s operations and may enhance EpiCept\'s ability to finalize a transaction with potential acquirers or with investors or licensors of AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Financial terms:
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