– 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 childhood-onset growth hormone deficiency expected to be initiated in Q1 2021
CHARLESTON, S.C., Nov. 16, 2020 (GLOBE NEWSWIRE) —Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the “Company”), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that, through a wholly-owned subsdiary, it has entered into an amendment (the “Amendment”) of its existing License Agreement with Novo Nordisk Biopharm Limited (“NNBL”) related to the development and commercialization of macimorelin.
Under the terms of the original License Agreement, Novo Nordisk was granted the exclusive right to commercialize macimorelin in the United States (“U.S.”) and Canada. Novo Nordisk is currently marketing macimorelin in the U.S. under the tradename Macrilen™ for the diagnosis of adult growth hormone deficiency (“AGHD”). Aeterna, in collaboration with Novo Nordisk, is currently developing the expanded use of macimorelin for the diagnosis of childhood-onset growth hormone deficiency (“CGHD”), an area of significant unmet need. Aeterna has entered into the start-up phase for the clinical safety and efficacy study, Study P02, evaluating macimorelin for the diagnosis of CGHD, which is expected to be initiated in Q1 of 2021.
Under the Amendment, Aeterna continues to retain all rights to macimorelin outside of the U.S. and Canada but, in demonstration of Novo Nordisk’s continued commitment to macimorelin, Novo Nordisk has agreed to make an immediate upfront payment to Aeterna of €5 million, which accelerates and replaces the U.S.$5 million later stage regulatory approval milestone that Novo Nordisk would have been required to pay only upon successful achievement of regulatory approval of macimorelin in the U.S. for the diagnosis of CGHD. Under the Amendment, all other future potential commercialization milestone payments remain unchanged. In addition, under the Amendment, Novo Nordisk and Aeterna have agreed that solely Aeterna will conduct the pivotal Study P02 in partnership with a contract research organization. Given the full transfer of development activities to Aeterna, Novo Nordisk is then adjusting the percentage of Study P02 clinical trial costs that Novo Nordisk is required to reimburse to Aeterna from 70% to 100% of costs up to €9 million, and includes reimbursement of Aeterna’s budgeted internal labor costs. Any additional external jointly approved Study P02 trial costs incurred over €9 million will be shared equally between Novo Nordisk and Aeterna. To reflect Novo Nordisk’s additional and earlier investment in macimorelin, the royalty payment Aeterna receives on sales in the U.S. and Canada will be reduced from 15% to 8.5% for annual net sales up to U.S.$40 million and returns to 15% or more for annual net sales of macimorelin over U.S.$40 million.
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.
Aeterna Zentaris is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.
The Company is actively pursuing business development opportunities for the commercialization of macimorelin in Europe and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.
This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to anticipated benefits of the Amendment, potential payments to the Company under the Amendment, the Company obtaining approval of macimorelin for CGHD and the resulting potential to significantly increase the available patient population for macimorelin, the Company’s ability to secure marketing partners for macimorelin for GHD in Europe and elsewhere, the commencement of the CGHD Study P02, the ability of the Company to identify and develop therapeutic uses for macimorelin in new indications and the ability of the Company to expand its pipeline of products, and may include, but are not limited to statements preceded by, followed by, or that include the words “will,” “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption “Key Information – Risk Factors” filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen™ (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen™ (macimorelin), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
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