Health Canada accepts Mithra’s marketing authorization application for Tibelia

Mithra announces that Health Canada has accepted the Marketing Authorization Application for its complex therapeutic Tibelia, the company’s tibolone-based product for use in Hormone Therapy (HT).

There are currently no tibolone-based products on the market in Canada for the relief of postmenopausal symptoms and prevention of osteoporosis in post-menopausal women. If approved, Tibelia would therefore be launched as a new treatment option for these indications in Canada. With the acceptance of the MAA by Health Canada, Mithra is on track to receive potential Tibelia approval as of Q4 2018. In June 2017, Mithra announced an exclusive License and Supply Agreement for Tibelia with an undisclosed Canadian partner.

The Canadian menopausal health market is currently valued at approximately EUR 80 million[1], with further growth potential as new products are introduced, offering a promising opportunity for Tibelia.

François Fornieri, CEO of Mithra, commented: “We are very pleased to see Tibelia, which could offer women new options to safely address menopausal symptoms, continue to advance globally. Today’s news reconfirms that we are on track for a marketing authorization decision in Canada as of late 2018, and we look forward to launching Tibelia® on the Canadian market with our distribution partner. With Tibelia on the market in three countries already, and launches in Sweden and Finland planned this year, we expect that Canada will be an important contributor to the growing revenues of this product.”