Aeterna Zentaris Inc.,  a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, announced a strategic co-promotion services agreement with ASCEND Therapeutics US, LLC, (ASCEND), a specialty pharmaceutical company solely focused on women's healthcare.

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 US territories, ASCEND's EstroGel a non-patch transdermal US Food & Drug Administration (FDA) approved and commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific US territories, Macrilen, 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 Macrilen. Aeterna Zentaris is expected to book all future sales of Macrilen, 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 Macrilen 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."

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 Macrilen, is currently under review by the FDA with a PDUFA date of November 5, 2014. Macrilen 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).