Christmas Comes Early For AEZS With FDA Approval Of Macrilen

(RTTNews) - Shares of Aeterna Zentaris Inc. (AEZS) (AEZ.TO) skyrocketed in after-hours trading on Wednesday, following FDA approval of the Company's Macrilen, more than a week earlier than scheduled.

Macrilen, an orally available ghrelin agonist, is indicated for use in the diagnosis of patients with adult growth hormone deficiency.

Macrilen works by stimulating a patient's growth hormone (GH) secretion, after which a healthcare provider will determine how well the body responds by measuring the patient's GH levels over a period of time. Low GH levels, despite giving an effective stimulating agent, confirm a diagnosis of Adult Growth Hormone Deficiency (AGHD).

The historical gold standard for evaluation of AGHD has been the insulin tolerance test ("ITT"), an intravenous test requiring many blood draws over several hours. In contrast, Aeterna's Macrilen is administered orally, and is said to have many advantages, say, convenience, ease-of-use, safety, and is unlikely to have any of the contraindications associated with the insulin tolerance test.

The Company believes that in the U.S. alone, about 40,000 confirmatory tests for AGHD are conducted every year. With Macrilen having an edge over ITT, Aeterna is confident of capturing over 50% of the market within 2-3 years of commercial launch.

Macrilen is expected to be available commercially in the United States during the first quarter of 2018. Since Macrilen carries the Orphan Drug status, it will enjoy seven-year market exclusivity. Analysts have pegged Macrilen's peak sales potential at around $70 million.

Commenting on the approval, Michael Ward, Chief Executive Officer of Aeterna Zentaris said, "In the absence of an FDA-approved diagnostic test for AGHD, Macrilen fills an important gap and addresses a medical need for a convenient test that will better serve patients and health providers."

AEZS closed Wednesday's trading at $2.01, down 0.50%. In after-hours, the stock rose 61.69% to $3.24.