Aeterna Zentaris Inc. (NASDAQ:AEZS) and Megapharm Ltd entered an exclusive distribution and quality agreement for commercialization of Aeterna Zentalis’ oral ghrelin agonist, macimorelin. Megapharm will commercialize the drug in Israel and Palestine to treat child-onset growth hormone (CGHD) and adult growth hormone deficiency (AGHD).
Megapharm to market macimorelin in Isreal
According to the agreement, the Israel biopharmaceutical company will obtain registration for the marketing of macimorelin in the Palestinian Authority and Israel. On the other hand, Aeterna Zentaris will focus on manufacturing, supply, regulatory support, maintenance of IP as well as quality assurance control. The company expect macimorelin’s regulatory process to be finalized in the second half of this year.
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Macimorelin is an oral ghrelin agonist available in active small molecules used in stimulating the pituitary gland to secrete growth hormone. The US FDA granted Aeterna commercial approval for the drug in December 2017 for use in AGDH patients. Also, the FDA has granted Orphan Drug Designation for macimorelin in AGHD diagnosis. In Europe, the drug received marketing approval for AGHD patients in January 2019. EMA’s Pediatric Committee approved Aeterna’s macimorelin in March 2017, a mandatory filing for commercialization application in Europe for new medicinal products.
Aeterna delighted to being macimorelin to Israel and the Palestine Authority
Aeterna CEO, Dr. Klaus Paulini, stated that the marketing agreement was a huge milestone for the company’s current business development strategy of expanding macimorelin’s distribution network. The CEO added that they were delighted to partner with a leading company like Megapharm and were looking forward to working with them as commercialization partners for macimorelin for CGHD and AGHD diagnosis.
Commenting on the agreement, Megapharm CEO, Miron Drucker stated that macimorelin has shown significant potential in the evaluation of deficiencies of growth hormone in children and adults. The levels of stimulated growth hormone are evaluated in blood samples after ingesting macimorelin for GHD assessment. The CEO lauded the initiative to establish an agreement with Aeterna, making the macimorelin available in Israel and the Palestinian Authority.