Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 338

Acerus and Aytu Bioscience to Co-promote Natesto® in the United States

Posted by fidest press agency su giovedì, 1 agosto 2019

Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that it will be taking an expanded role in the commercialization of NATESTO® in the U.S. The company has entered into an amended and restated licensing agreement with Aytu BioScience, Inc. (NASDAQ: AYTU), which will, upon closing, move the partnership from an out-license model to a co-promotion arrangement that the companies believe will leverage their collective product, marketplace and Men’s Health experience to capture a significant share of the U.S. market for NATESTO®. Under the terms of the new agreement, Aytu returns the NDA for NATESTO® in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies’ joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists (Acerus Sales Channel). Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO® to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels.To establish a high performing commercial footprint in the U.S., Acerus has engaged Syneos Health (NASDAQ: SYNH), a leading integrated biopharmaceutical solutions organization including the industry’s largest Contract Commercial Organization (CCO), to be its commercialization partner. Syneos Health has extensive experience in Men’s Health and with NATESTO®, and offers an end-to-end model that will enable Acerus to rapidly stand up a U.S. commercial team; to scale across all aspects of commercialization, including medical and regulatory affairs, managed markets, marketing and sales; and will provide greater flexibility and effectiveness in resource deployment.Low testosterone is estimated to affect approximately 39% of men over 45 years old in the U.S.; however, because the condition is underdiagnosed the overall prevalence is uncertain1. While patients have access to other treatment options, NATESTO® is unique in that it is administered in seconds via a convenient and simple nasal gel applicator, addressing the risk of testosterone transference associated with other topical products, which carry “black box” warnings on their product labels.

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