Aeterna Zentaris’ Marketing Authorization Application for Macrilen™ (macimorelin) for Evaluation of Adult Growth Hormone Deficiency Accepted by European Medicines Agency

Posted by Karen Goldfarb

November 28, 2017 at 10:14 AM

Aeterna Zentaris Inc. (AEZS-NASDAQ) announced the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) to evaluate adult growth hormone deficiency (AGHD) has been accepted by the European Medicines Agency (EMA) for regulatory review. Aeterna seeks to become the future for AGHD management and for Macrilen to emerge as the drug that endocrinologists and their staff use as the preferred test for their patients.

Macrilen™ is the first innovation in adult GHD testing in over 50 years. Aeterna believes that the drug could eliminate the testing burden of the current standard, which requires physician-supervised administration and up to double digital patient blood draws over several hours. Macrilen™, an orally available ghrelin agonist, stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of Macrilen™ for the assessment of growth hormone deficiency (GHD).

AGHD affects roughly 75,000 adults across the U.S., Canada, and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland, and is typically characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life, as well presents a higher risk for cardiovascular issues.

On March 7, 2017, the Pediatric Committee of the EMA agreed to the Company’s Pediatric Investigation Plan (PIP) for Macrilen™, a prerequisite for filing an MAA for any new medicinal product in Europe. The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen™ in AGHD. The start of the EMA review procedure for the MAA has now been confirmed by EMA as November 23, 2017. 

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Topics: AEZS, Macrilen

NDA for Aeterna Zentaris' (AEZS) Macrilen™ Granted December 30, 2017 PDUFA Date

Posted by Karen Goldfarb

July 19, 2017 at 11:23 AM

Aeterna Zentaris Inc. (AEZS-NASDAQ) announced that it has been notified by the U.S. Food and Drug Administration (FDA), that the Company’s New Drug Application (NDA) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017. 

The Company remains confident that the FDA will approve its NDA and, accordingly, is moving forward with preparations to launch the product in the first quarter of 2018. In other news, the Company also announced that Mr. Kenneth Newport is no longer a member of the Board of Directors effective as of July 12, 2017.

Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. The product candidate has been granted orphan drug designation by the FDA for diagnosis of AGHD. Aeterna owns the worldwide rights to this patented compound and has significant patent protection remaining. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. Aeterna proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.

AGHD affects roughly 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks. 

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Topics: AEZS, Macrilen

May 2017 Update Released on Aeterna Zentaris (AEZS)

Posted by Karen Goldfarb

May 15, 2017 at 2:59 PM

Crystal Research Associates has released an 11-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial and regulatory filing milestones, and financial position. 

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Topics: AEZS

April 2017 Update Released on Aeterna Zentaris (AEZS)

Posted by Karen Goldfarb

April 5, 2017 at 1:33 PM

Crystal Research Associates has released an 11-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial and regulatory filing milestones, and financial position. 

 

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Topics: AEZS

February 2017 Update Released on Aeterna Zentaris (AEZS)

Posted by Karen Goldfarb

February 27, 2017 at 2:56 PM


Crystal Research Associates has released a 10-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial and regulatory filing milestones, and financial position. 

Download Update

 

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Topics: AEZS

September 2016 Update Released on Aeterna Zentaris (AEZS)

Posted by Laura Swartz

September 26, 2016 at 9:13 PM

Crystal Research Associates has released a 16-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial and regulatory filing milestones, and financial position. 

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Topics: AEZS

First Quarter 2016 Update on Aeterna Zentaris

Posted by Laura Swartz

May 10, 2016 at 11:43 AM

AeternaZentaris_transparent.pngSpecialty biopharmaceutical company Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX) held a conference call and webcast this morning to discuss its first quarter 2016 financial and operating results. A link to a replay of the full webcast is available here.

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Topics: AEZS

NEW RESEARCH: Quarterly Update Released on Aeterna Zentaris (AEZS)

Posted by Laura Swartz

April 7, 2016 at 1:55 PM

Crystal Research Associates has released a 16-page Quarterly Update on specialty biopharmaceutical company, Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). The Update specifically details Aeterna's recent news and developments, recent and anticipated clinical trial milestones, and financial position. 

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Topics: AEZS

Positive Phase 2 Data in Prostate Cancer from Biopharma Company Aeterna Zentaris

Posted by Laura Swartz

September 28, 2015 at 12:59 PM

Aeterna Zentaris Inc. (AEZS) (TSX: AEZ) today announced that its lead oncology compound, zoptarelin doxorubicin (formerly AEZS‑108), met the primary endpoint of the investigator-driven and sponsored Phase 2 clinical trial in Castration- and Taxane-Resistant Prostate Cancer (CRPC) and demonstrated good tolerability. The primary endpoint was Clinical Benefit (CB) defined as remaining progression-free by RECIST and Prostate Specific Antigen (PSA) after treatment for 12+ weeks.

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Topics: AEZS

NEW RESEARCH: 12-page Quarterly Update on Aeterna Zentaris (AEZS-NASDAQ)

Posted by Laura Swartz

July 27, 2015 at 11:28 AM

We published a 12-page Quarterly Update on specialty biopharmaceutical company Aeterna Zentaris, Inc. this morning. The report updates readers on Aeterna's news, milestones, and clinical and commercial development status since the publication of our base report, the Executive Informational Overview from April 2015.

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Topics: AEZS

New Slide Deck Available on Specialty Biopharma Company, Aeterna Zentaris Inc.

Posted by Laura Swartz

June 11, 2015 at 9:25 AM

Crystal Research Associates has released a slide presentation on Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX) to summarize major facets of Aeterna's product development and key milestones, as presented in greater detail in the 52-page Executive Informational Overview available for download here

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Topics: AEZS

Aeterna Zentaris Finalizes Key Promotional Agreement with Merck’s EMD Serono, Inc.

Posted by Laura Swartz

May 7, 2015 at 1:14 PM

Specialty biopharmaceutical company Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX) announced this morning that it has entered into a promotional services agreement with EMD Serono, Inc., the U.S. and Canadian biopharmaceutical businesses of Merck KGaA (MRK-NYSE). Under the agreement, Aeterna can begin promoting Saizen® [somatropin (rDNA origin) for injection] to designated medical professionals in specified territories in the U.S. Aeterna will work within the realm of field promotion of Saizen® by driving awareness of the product among medical professionals, and expects to be compensated on the basis of new, eligible patient starts on Saizen® above an agreed-upon baseline. This is the second promotional services agreement for Aeterna in recent months, as the company accelerates its transition into a commercially operating specialty biopharma by leveraging its sales force.

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Topics: AEZS

NEW RESEARCH: 52-page Report Available on Aeterna Zentaris Inc. (AEZS-NASDAQ)

Posted by Laura Swartz

April 21, 2015 at 4:11 PM

Crystal Research Associates has issued a comprehensive, 52-page Executive Informational Overview (EIO) on Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). 

Company Snapshot

Aeterna Zentaris (“Aeterna” or “the Company”) is transitioning into a specialty biopharmaceutical company in oncology, endocrinology, and women’s health. With a focus on establishing revenues and profitability while optimizing resources to reduce its burn rate, the Company co-promotes a non-patch estrogen replacement therapy, EstroGel®, in specific U.S. markets with partner, Ascend Therapeutics (“Ascend”). As well, Aeterna holds a pipeline of candidates in varying stages of development and is working to acquire, in-license, or co-promote other commercial compounds.

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Topics: AEZS

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