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     311  0 Kommentare Aeterna Zentaris Amends License Agreement with Novo Nordisk for Commercialization and Development of Macimorelin - Seite 2

    Under the Amendment, both companies will continue to closely coordinate the activities related to the development and commercialization of macimorelin in the U.S. and Canada through a joint steering committee, with each party having decision rights in certain areas. Novo Nordisk will also receive co-ownership of the U.S. and Canadian patents and trademarks owned by Aeterna on macimorelin but will be required to transfer co-ownership in those patents back to Aeterna on the occurrence of certain termination events.

    In addition, upon regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD, if Novo Nordisk determines not to commercialize macimorelin in Canada, then Aeterna has the option to exclusively license rights to macimorelin in Canada (but not in U.S.) to a third party. The Amendment also confirms that Aeterna has the right to use the results from Study P02, if successful, to support Aeterna seeking regulatory approval and ongoing efforts to seek partnering opportunities for macimorelin in Europe and other regions outside of the two countries licensed to Novo Nordisk, the U.S. and Canada.

    “We are pleased with our continued partnership with Novo Nordisk and the work we are doing to advance the expanded use of macimorelin for the diagnosis of CGHD after successfully completing the dose range finding Study P01,” commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris. “The Amendment of the License Agreement with Novo Nordisk puts a significant emphasis on the importance of our pediatric co-development of macimorelin and Novo Nordisk’s commitment to the continued commercialization and expansion of macimorelin. The Amendment lowers not only our financial obligation for conducting Study P02, but also provides us with the benefit of an upfront non-dilutive payment of €5 million.”

    The Amendment will be filed on SEDAR at www.sedar.com. The foregoing description of the terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment.

    About Aeterna Zentaris Inc.

    Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Company’s lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen through a License Agreement with Novo Nordisk where Aeterna Zentaris receives royalties on sales. Aeterna Zentaris owns all rights to macimorelin outside of the U.S. and Canada.

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    Aeterna Zentaris Amends License Agreement with Novo Nordisk for Commercialization and Development of Macimorelin - Seite 2 - Company to receive upfront payment of €5 million replacing a later stage regulatory approval milestone of U.S.$5 million  - Novo Nordisk committing to fund €9 million of the budgeted AEZS-130-P02 (“Study P02”) clinical trial costs for …