19 Apr 2016
Acerus Pharmaceuticals Corporation, a Canadian pharmaceutical company, announced that it has entered into a license and supply agreement with Medinova AG, a Swiss pharmaceutical company, granting Acerus the exclusive rights to commercialise Gynoflor in Canada.
Gynoflor is an ultra-low dose estrogen (estriol) and lactobacillus combination vaginal tablet used for the treatment of atrophic vaginitis due to estrogen deficiency during menopause, for the restoration of vaginal flora following the use of anti-infectives and for the treatment of certain vaginal infections. Currently, there are no approved products in Canada containing estriol, or the unique combination of estrogen and lactobacillus.
Gynoflor is approved in 39 countries across Europe, Asia-Pacific, the Middle East, Africa and South America. It was first approved in Germany in 1982 and it is estimated that up to 28 million women worldwide have been treated with the product to date. In addition, a total of 4,655 women have been studied as part of its extensive clinical trial program.
“This transaction strengthens our current women’s health portfolio and supports our strategic objective of expanding our presence in this therapeutic space,” said Tom Rossi, president and chief executive officer of Acerus. “Gynoflor is a novel product which, if approved, has the potential to contribute significant revenues to our Canadian business. We look forward to bringing this highly differentiated product to market as expeditiously as possible.”
Under the terms of the licensing agreement, Medinova AG will supply finished product to Acerus at a fixed price. Acerus plans to submit a New Drug Submission to Health Canada and will consult with the agency in order to ensure that all requirements are met prior to filing.