- Closing conditions waived – Amended & Restated Partnership Agreement is now closed
- Acerus-Aytu jointly led commercial effort behind NATESTO® in the United States is now initiated
TORONTO–(BUSINESS WIRE)–Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that the revised commercial partnership agreement with Aytu Bioscience (“Aytu”) to accelerate the growth of NATESTO® in the United States is now closed and fully effective as of December 1, 2019. Both parties have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of USD 10 million on or before the end of January 2020, enabling Acerus to launch a U.S.-based specialty sales force, which will promote NATESTO® to urologists and endocrinologists. Aytu will continue to book all NATESTO® revenue in the United States and they will promote NATESTO® to all other specialties including internal medicine and family practice.
To accelerate the launch of Acerus’ U.S. commercial team, Aytu has agreed to transfer 5 current sales personnel to Acerus as of December 2, 2019. These staff will operate as Acerus employees but they will remain on Aytu’s payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Aytu will deduct the costs of these sales personnel from quarterly payments otherwise owed to Acerus under the revised agreement, with a final accounting to be done once per year. Throughout 2020, Acerus will be building out a complete US-based specialty care sales force and other commercial functions, significantly increasing the number of employees working directly on NATESTO® in the United States.
This co-promotion is expected to significantly increase sales force coverage of targeted U.S. prescribers, putting a higher promotional focus on urologists and endocrinologists, while enabling Aytu to focus its promotional efforts in primary care and other specialties.
“Acerus is extremely pleased to see our revised partnership with Aytu moving to execution mode as we strongly believe that the performance of NATESTO® in the U.S. will benefit from an enhanced commercial focus on urology and endocrinology,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “We are happy to welcome the former Aytu staff to the Acerus team. With this revised partnership, Acerus is effectively pivoting its focus of effort to the U.S. NATESTO® opportunity. As such, we have implemented a resource reallocation program within our Canadian office that has led to a greater than 50% reduction in headcount so that we can align our SG&A spend appropriately.”
On July 29, 2019 the companies agreed to expand their commercial partnership and amend and restate the original 2016 NATESTO® exclusive U.S. license agreement. 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.
About NATESTO® (Testosterone) Nasal Gel
NATESTO® is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a ‘no-touch’ dispenser with a metered dose pump. A copy of the NATESTO® Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO® ®/default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO® .com.
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of men’s health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO® in the United States, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 4, 2019 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
1 Mulligan T, Frick MF, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762–769
President and Chief Executive Officer