Acerus Announces Significant Improvement in NATESTO® Insurance Coverage in the United States

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Jun 03, 2020 07:00 am

Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF), a specialty pharmaceutical company focused on the commercialization of novel prescription products in Men’s Health, today announced that, as of July 1, 2020, Express Scripts, Inc., one of the leading pharmacy benefit managers (PBMs) in the United States, has elected to make NATESTO® (testosterone nasal gel) a preferred brand on its National Preferred Drug List.

"This formulary placement by Express Scripts is a significant milestone in Acerus’ commercial efforts in the United States,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “Within 10 weeks of the implementation of Acerus’ market access efforts, NATESTO® has been added as Preferred on the Express Scripts National Preferred formulary. We believe this improved coverage will enhance patient access and increase physician’s prescribing of NATESTO® for the more than 13 million U.S. men diagnosed with hypogonadism."

Express Scripts serves more than 3,000 clients covering 70 million lives, including approximately 9 million lives managed by Cigna HealthCare. Drugs listed on formulary as preferred brands have been evaluated by the pharmacy benefit manager from a therapeutic and value perspective. Preferred brand drugs may be available to patients at a lower co-pay or co-insurance than non-preferred brand drugs.


NATESTO® is the only FDA-approved, topically applied therapy for low testosterone that does not have a black box warning related to transference of testosterone to children or women. A recently published clinical study in the Journal of Urology has demonstrated that NATESTO® can restore serum testosterone levels while maintaining gonadotropin hormones within the normal range, while also maintaining sperm concentration, motility, and total motile sperm count.

NATESTO® is available by prescription only and patients should speak with their doctor about whether NATESTO® is right for them.

NATESTO® is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of use: Safety and efficacy of NATESTO® in males less than 18 years old have not been established.

Please refer to the NATESTO® Instructions for Use for all the important warnings and precautions before using or prescribing this product.

About Acerus

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 the United States and Canada, and through a global network of licensed distributors in other territories.

Acerus’ shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit and follow us on Twitter and LinkedIn.

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 impact of the increased insurance coverage on the commercial potential of NATESTO® in the U.S., and could differ materially from what is currently expected as set out above. In particular, these assumptions include but are not limited to, the following: the COVID-19 pandemic will not affect our business plan and that of our suppliers, the COVID-19 pandemic will not last many months and health care professionals will be available to hear about our products and to continue education programs related to them. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 3, 2020 which is available at 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.

Edward Gudaitis
President and Chief Executive Officer
[email protected]
(905) 817-8194

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