Publication date: 11/12/2017
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce finalization and signature of the contract with Libbs, the Women’s Health leader in Brazil, for an exclusive license to Estelle® in Brazil. This follows the binding Heads of Terms announced in September 2017. Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently in Phase III trials in the US and Canada as well as in Europe and Russia, with top line results expected in Q3 2018 and Q1 2019, respectively.
Under the terms of the contract, Mithra is eligible to receive a EUR 20 million upfront milestone payment, with EUR 14 million to be received upon signature of the contract and EUR 6 million in early 2018. Half of the upfront milestone payment is non-refundable, with the remainder dependent on certain development and regulatory outcomes.
In addition to the commercial agreement announced in September, the two companies have signed a manufacturing agreement enabling Libbs to produce Estelle® for the Brazilian market at its production facility in Sao Paulo (Brazil). Under the terms of the commercial and manufacturing agreement, Mithra will receive guaranteed annual recurring revenues based on minimum annual quantities (MAQ) and binding forecasts, and for sales exceeding these forecasts, a royalty rate of 40% on net sales will be applicable. The Estelle® manufacturing agreement may be expanded to include other territories in the future, offering Mithra a competitively priced future manufacturing source when the Mithra CDMO2 reaches full capacity.
Moreover, the contract includes a supply agreement for DRSP, giving Mithra an important alternative supply source for this key API. Libbs also plans to evaluate the possibility of supplying E4.
François Fornieri, CEO of Mithra, commented:
“We are very pleased with the finalized contract, as we are confident that Libbs, as the undisputed leader in Women’s Health in Brazil, is the best possible partner for the commercialization of Estelle® in this important territory. The contract could generate several hundred million euros of revenues for Mithra over the duration of the agreement. Moreover, the mutually benefical expanded collaboration should allow for the competitively priced production of Estelle® as well as a global back-up supply of our other key APIs.”
Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg Estetrol (E4), its unique native estrogen, and 3 mg DRSP. Currently, pivotal Phase III Estelle® trials (E4 Freedom) are ongoing in the US and Canada as well as in Europe and Russia, with top line results expected in Q3 2018 and Q1 2019, respectively.
The E4 Freedom studies are open-label single arm trials to assess the safety and efficacy of Estelle® in over 1,550 participants in Europe/Russia and approximately 2,000 participants in the US/Canada, over a period of 13 cycles. Patient enrolment is completed in both studies.
Libbs is a privately owned biopharmaceutical company headquartered in Sao Paulo, Brazil. Libbs has a key focus on Women’s Health, where it is the market leader for the Brazilian market, with a market share of approximately 25% in number of units. In 2015, net turnover of Libbs reached 1.33 billion R$/EUR 350 million (+9% y-o-y)3, with Women’s Health currently representing over 30% of total revenue at the company. Libbs has approximately 2400 employees.