Elan and EntreMed Execute License Agreement for NanoCrystal® Technology
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Elan Corporation, plc and EntreMed, Inc. have announced that they have entered into a License Agreement in which EntreMed has been granted rights to utilize Elan's NanoCrystal Technology to develop the oncology product candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol).
Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain clinical, manufacturing, and regulatory milestones. Additionally, Elan will receive royalty payments based on sales of Panzem® NCD.
Under the License Agreement and corresponding Services Agreement, Elan will manufacture EntreMed's Panzem® NCD, a NanoCrystal Technology formulation with improved bioavailability and absorption.
Other marketed pharmaceutical products in the United States utilizing Elan's NanoCrystal Technology include TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals), and Rapamune® (marketed by Wyeth).
In 2004, the parties signed a Clinical Supply Agreement covering the supply of Panzem® NCD for Phase 1 trials.
These Agreements extend the Panzem® NCD supply arrangement to Phase 2 and later trials. Panzem® NCD is currently in Phase 1b clinical studies in patients with advanced cancer.
EntreMed expects to announce the commencement of multiple Phase 2 trials in early 2006.
Paul V. Breen, Executive Vice President, Elan Drug Technologies, said, "We are pleased to extend our relationship with EntreMed."
"We hope that these agreements will lead to the launch of a new product with unique benefits to cancer patients."
EntreMed President and Chief Executive Officer, James S. Burns commented, "These agreements continue our relationship with Elan for further development and manufacturing of Panzem® NCD, our lead clinical drug candidate."
"Interim results from our Phase 1b studies demonstrated that daily dosing with the Elan formulation maintains blood levels of 2ME2 within the desired therapeutic range, allowing us to move forward with Phase 2 clinical trials."
Mr. Burns further commented, "Expanding the Elan relationship is a logical next step for EntreMed that provides us with access to process improvements and continuity of supply for further scale-up and clinical development."
"We look forward to working closely with Elan to meet our development goals and move Panzem® NCD towards commercialization."