QUÉBEC CITY, Aug. 5, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced a strategic co-promotion services agreement with ASCEND Therapeutics® US, LLC, ("ASCEND"). Under the terms of the agreement, expected to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific U.S. territories, ASCEND's EstroGel® a non-patch transdermal U.S. Food & Drug Administration ("FDA") approved and commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific U.S. territories, MacrilenTM, Aeterna Zentaris' product for use in the evaluation of adult growth-hormone deficiency ("AGHD"), for which a New Drug Application ("NDA") is currently under review by the FDA, with a Prescription Drug User Fee Act ("PDUFA") date of November 5, 2014. In consideration for these co-promotion services, each party will be entitled to receive, from the other party, commissions on net sales of each other's product.
As part of its commercial strategy, Aeterna Zentaris anticipates using approximately 20 sales representatives to cover its assigned U.S. specific territories, while ASCEND will use its existing sales force of over 35 sales representatives to cover its territories. Overall, more than 50 sales representatives are expected to promote both EstroGel® and MacrilenTM. Aeterna Zentaris is expected to book all future sales of MacrilenTM, while ASCEND will book all sales of EstroGel®.
David Dodd, Chairman, CEO at Aeterna Zentaris stated, "This co-promotion agreement is an important step in our strategy of transitioning into a commercially operating specialty biopharmaceutical company; the co‑promotion of ASCEND's EstroGel® will jump start our commercial activities, while the FDA continues its active NDA review for the approval of MacrilenTM in the evaluation of AGHD. We very much look forward to working with ASCEND, as it will enable us to use our new commercial structure not only for the co‑promotion of EstroGel®, but also for the potential launch of MacrilenTM, as well as for other commercial products that we plan to acquire, in-license or co-promote in the future."
Jay Bua, President & CEO at ASCEND Therapeutics stated, "We look forward to collaborating with Aeterna Zentaris on this co-promotion agreement. It will immediately extend our share of voice of the EstroGel® franchise as well as open opportunities to future co-promotional activities."
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The Company has completed a Phase 3 trial for use in evaluating AGHD, and a NDA in this indication for macimorelin, under the trade name MacrilenTM, is currently under review by the FDA with a PDUFA date of November 5, 2014. MacrilenTM has been granted orphan drug designation by the FDA for use in AGHD. Furthermore, macimorelin is in a Phase 2 trial as a treatment for cancer-induced cachexia. Aeterna Zentaris owns the worldwide rights to this novel patented compound.
EstroGel® 0.06% (estradiol gel) is an FDA-approved, estrogen therapy (ET) gel and the only non-patch transdermal ET that provides relief for two major problems due to menopause: moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar/vaginal atrophy. EstroGel® is marketed in over 70 countries and is the most prescribed estrogen product in Europe, as well as the most prescribed transdermal estrogen product in Canada. Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). For full prescribing information and boxed warning, please see www.estrogel.com.
About ASCEND Therapeutics
ASCEND Therapeutics® US, LLC, is a specialty pharmaceutical company solely focused on women's healthcare. Built on more than 100 years of success by its parent company Besins Healthcare S.A., ASCEND continues to embody excellence by concentrating on high standards in commercial and product development. ASCEND sustains its commitment to making a difference in women's healthcare through knowledge, innovation and quality products in all aspects of outreach. For more information, visit www.ascendtherapeutics.com.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology. The Company's pipeline encompasses compounds at various stages of development. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the specific outcome of our recently announced global resources optimization program and the financial impact on the Company resulting therefrom, and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
SOURCE: Aeterna Zentaris Inc.
For further information: Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406, [email protected]