- Aeterna Zentaris (AEZS) has announced that Novo Nordisk Healthcare AG has exercised its right to terminate the amended development and commercialization licence agreement
- The agreement was previously entered into between Aeterna’s wholly-owned subsidiary and Novo for Macrilen (macimorelin)
- Following Novo’s 270-day notice period, Aeterna will regain full U.S. and Canadian rights to the product
- Aeterna Zentaris Inc. is a specialty biopharmaceutical company
- Aeterna Zentaris Inc. was down 3.469 per cent, trading at $6.40 as at 11:25 AM ET
Aeterna Zentaris (AEZS) announced that Novo Nordisk Healthcare AG has exercised its right to terminate the amended development and commercialization licence agreement.
The agreement was previously entered into between Aeterna’s wholly-owned subsidiary and Novo for Macrilen (macimorelin).
Macrilen (macimorelin) is the first and only U.S. FDA and European Commission-approved oral test for adult growth hormone deficiency (AGHD) diagnosis.
Following Novo’s 270-day notice period, Aeterna will regain full U.S. and Canadian rights to the product.
The terms of the commercial licence empower Novo Nordisk to return the regulatory approvals and intellectual property and provide certain other assistance to aid in an orderly transition of Macrilen’s (macimorelin) rights to Aeterna.
Until the end of those 270 days, commercial licence requires Novo Nordisk to continue selling and promoting Macrilen (macimorelin) in the U.S., and Novo Nordisk’s financial support of the pivotal safety and efficacy DETECT trial remains unchanged until the end of that notice period.
“We have always strongly believed in the value of macimorelin and remain fully committed to our plans to continue commercialization in the U.S. and Canada as well as continuing the pediatric development in our ongoing DETECT-trial,” stated Dr. Klaus Paulini, Chief Executive Officer of Aeterna.
“Additionally, we believe that macimorelin’s value has the potential to substantially increase as we plan for success with its potential expanded use in CGHD,” he added.
Macimorelin has been marketed in the U.S. by Novo Nordisk under the trade name Macrilen.
Under the commercial licence, Novo Nordisk was granted an exclusive licence for the development, manufacturing, registration and commercialization of Macrilen (macimorelin) in the U.S. and Canada.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need.
Aeterna Zentaris Inc. was down 3.469 per cent, trading at $6.40 as at 11:25 AM ET.
