Vivus, Inc. announced that it has been notified by Auxilium Pharmaceuticals, Inc., a subsidiary of Endo International, plc., of Auxilium's intention to return the US and Canadian commercial rights for Stendra (Avanafil) to Vivus.

Auxilium has provided its contractually obligated six-month notice of termination which, absent an agreement between Auxilium and Vivus for an earlier date, will result in the termination of the license and supply agreement on June 30, 2016.

"We are excited to reacquire the US and Canadian commercial rights for Stendra. We appreciate Endo's efforts to build the Stendra brand and understand their decision to focus their resources on Belbuca," said Seth Fischer, Vivus chief executive officer. "With Stendra's 15 minute onset-of-action, efficacy, ability to be taken with food and alcohol, and safety profile, we remain confident in Stendra's long-term prospects. We are in the process of evaluating ways for maximizing the value of Stendra and expect to make an announcement by the end of the first quarter of 2016 with our decision. As part of this process, we are working closely with Auxilium to ensure a smooth transition of Stendra back to Vivus."

Stendra (avanafil) is approved in the US by the FDA for the treatment of erectile dysfunction. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to Stendra in the US and Canada. In January 2015, Auxilium was purchased by Endo International, plc., or Endo.

Stendra is available through retail and mail order pharmacies. Auxilium currently offers programs that help patients with out-of-pocket costs.

Spedra, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. Vivus has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote Spedra for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

Vivus has granted an exclusive license to Sanofi to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.

Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). Vivus owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. Vivus is in discussions with other parties for the commercialization rights to its remaining territories.

Vivus is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea and sexual health.