Mithra and Libbs partner to commercialise Estelle oral contraceptive in Brazil

Belgium-based Mithra has signed a binding Head of Terms agreement with biopharmaceutical company Libbs for an exclusive licence to commercialise its new combined oral contraceptive (COC) product, Estelle, in Brazil.

Both companies are dedicated to women's health.

Mithra's Estelle is a new oral contraceptive product candidate that comprises 15mg of Estetrol (E4), its unique native estrogen and 3mg of Drospirenone (DRSP).

Under the deal, Mithra is eligible to receive an upfront milestone payment of €20m, half of which will be non-refundable, with the other half depending on certain development and regulatory outcomes.

In addition, it will receive guaranteed annual recurring revenues depending on minimum annual quantities (MAQ) and binding forecasts, and 40% royalties on net sales above these levels.

Mithra CEO François Fornieri said: "Libbs' confidence in the potential of Estelle to offer a convenient and safer combined oral contraceptive to Brazilian women is reflected in the strong deal terms, and we are very much looking forward to working with them."

The Estetrol-based COC product candidate is currently undergoing pivotal, open-label, single-arm Phase III trials, E4 Freedom, in the US, Canada, Europe and Russia.

Top-line results from the trials in the US and Canada are expected in the third quarter of next year, while study results from Europe and Russia are expected in the first quarter of 2019.

The two companies will work in collaboration on the regulatory submissions and other steps required for approval and launch of the product in Brazil.

In July last year, the company received approval from the US Food and Drug Administration (FDA) for the Phase III clinical trials of Estelle.