TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced that the agreement with Endo Ventures Bermuda Limited (an affiliate of Endo International plc) relating to the commercialization of NATESTO™ in the United States and Mexico will be terminated, effective June 30, 2016.
Under the terms of the agreement with Acerus, Endo will continue to sell and distribute NATESTO™ in the U.S. until the effective date of termination.
“While we are disappointed with Endo’s previously announced strategic business decision to realign their U.S. branded resources from urology retail to their pain franchise, we are fully committed to the continued success of NATESTO™ in the U.S.,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Our immediate focus is on finding a new NATESTO™ partner in the U.S., the largest market for testosterone replacement therapy. We are encouraged by the positive physician and patient feedback received on the product to date, and believe there will be strong interest from other companies to step in and continue to drive the launch of NATESTO™.”
Acerus will host a conference call to update investors on the status of its business and 2016 priorities on Thursday, January 7, 2016 at 8:30 a.m. Eastern Time. Following the discussion, Acerus management will address inquiries from investment analysts.
To access the call live, please dial 416-340-2216 or 1-866-225-2055. Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays.
A replay of the conference call will be available until 11:59 p.m. Eastern Time on Tuesday, January 12, 2016 by dialing 905-694-9451 or 1-800-408-3053, using access code: 2285177#.
About NATESTO™ (Testosterone) Nasal Gel
NATESTO™ is the first and only testosterone nasal gel to be approved and launched in the United States for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. For further information on NATESTO™ in the United States (including the product label and prescribing information), please see the FDA website at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, or visit: www.NATESTO.com.
Acerus has filed a New Drug Submission with Health Canada for NATESTO™, and the product is currently under review.
Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.
Acerus markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing an Acerus licensed nasal gel technology, is the first and only testosterone nasal gel available in the United States for replacement therapy in adult males diagnosed with hypogonadism. It is also currently filed for approval in Canada. TEFINA™, a ‘use as required’ nasal testosterone gel, is an Acerus drug development candidate aimed at addressing significant unmet need for women with female sexual dysfunction.
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 ability of Acerus to secure a new commercial partner for NATESTO™, 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, 2015 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.