Dr. Klaus Paulini reports
AETERNA ZENTARIS PROVIDES UPDATE ON MACRILEN(TM) (MACIMORELIN), REITERATES ADVANCEMENT OF PEDIATRIC DETECT TRIAL
Aeterna Zentaris Inc. has noted that sales of Macrilen (macimorelin) will be temporarily discontinued in the United States commercial market for the diagnosis of adult growth hormone deficiency (AGHD), effective May 23, 2023, and until anticipated relaunch with an alternative commercialization partner. This temporary action follows the Aug. 29, 2022, announced decision by Aeterna's former North American commercialization partner Novo Nordisk Healthcare AG to end its licence agreement for this product in North America.
The company is actively seeking alternative development and commercialization partners for Macrilen (macimorelin) in the U.S. and other territories currently not partnered. The decision to temporarily discontinue sales of Macrilen in the United States does not have any impact on the sales and commercialization efforts in the United Kingdom and European economic area. On March 16, 2023, Aeterna announced that Pharmanovia, a global life cycle management health care company, had acquired the exclusive rights and licence to commercialize Ghryvelin (macimorelin's brand name in the U.K. and European economic area (EEA)) in the territory for the diagnosis of adult growth hormone deficiency (AGHD) and, if approved, for childhood-onset growth hormone deficiency (CGHD) from the company's previous EEA and U.K. partner, Consilient Health.
"We remain confident in macimorelin's value and effectiveness for the diagnosis of AGHD," said Dr. Klaus Paulini, chief executive officer of Aeterna. "We believe that our partnership with Pharmanovia and the patent issued by the USPTO [U.S. Patent and Trademark Office] (see more information below) are additional indications of macimorelin's medical and commercial potential. We remain focused on a commercialization path for North America that will capture not only this value, but the further opportunities we believe exist in the ongoing Detect trial, as we continue in discussions with possible commercialization partners in North America. At the same time, we continue to move forward with our commercialization partners for the EEA, the U.K. and other territories already partnered."
USPTO issues notice of allowance for Aeterna U.S. patent application for
The company also announced today that the USPTO has issued a notice of allowance for Aeterna's U.S. patent application No. 17/375,709 titled, "Use of
in assessing growth hormone deficiency in children." The company anticipates the issue of the formal registration of this U.S. patent application in the coming months.
AEZS-130-P02 (the Detect trial), Aeterna's pivotal phase 3 safety and efficacy study evaluating macimorelin for the diagnosis of CGHD, remains continuing. Most clinical sites in the U.S. as well as European countries are open for patient recruitment. "We believe the potential opportunities for expanded commercial success will increase as we move closer to completing our Detect trial and potential approval for the diagnosis of CGHD," Dr. Paulini continued.
Dr. Paulini concluded: "We are pleased to have received further commercial validation of the potential of the use of macimorelin for the diagnosis of CGHD with the notice of allowance received for our U.S. patent. We remain optimistic about the progress made in our Detect trial and are laser focused on our efforts to successfully execute on our plans, in order to meet the anticipated completion of enrolment at the end of this year. At the same time, we remain committed to exploring all strategic options for our macimorelin asset in North America and territories not currently partnered."
Macimorelin is marketed under the brand name Ghryvelin (macimorelin) in the U.K. and European economic area, and Macrilen in the United States for the diagnosis of adult growth hormone deficiency (AGHD). In addition, Aeterna Zentaris is currently conducting a pivotal phase 3 safety and efficacy study, AEZS-130-P02 (also referred to as the Detect trial), evaluating macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD).
Macimorelin (Macrilen, Ghryvelin), a ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of macimorelin for the assessment of AGHD. Approval of macimorelin was granted by the FDA (United States Food and Drug Administration) in 2017 and by the EMEA in 2019, based on phase 3 data showing that oral macimorelin provides accuracy comparable with that of standard insulin tolerance testing (ITT), but has a more favourable safety profile compared to ITT. Oral macimorelin also reduces false positive test results, helping to avoid unnecessary treatment of patients.
Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The company's lead product, macimorelin (Macrilen, Ghryvelin), is the first and only U.S. FDA- and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The company is 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.
Aeterna Zentaris is dedicated to the development of therapeutic assets and has recently taken steps to establish a growing preclinical pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease).
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