CHMP Adopts Positive Opinion for Teva's NOMAC-E2
NOMAC-E2 is an investigational contraceptive pill combining 1.5 mg of 17-beta-estradiol with 2.5 mg of nomegestrol acetate in a 24/4 monophasic regimen, said Teva.
Unlike currently available contraceptive pills, NOMAC-E2 is a monophasic regimen containing an estrogen which is structurally identical to the major estrogen produced by the ovaries of healthy non pregnant women, combined with a selective progesterone analogue (nomegestrol acetate).
According to Teva, the CHMP issued its positive opinion following a review of data derived from clinical trials evaluating NOMAC-E2. If approved for marketing by the European Commission, NOMAC-E2 will be marketed by Teva/Theramex in select European markets.
NOMAC-E2 stands for nomegestrol acetate/17 beta estradiol combination.
Teva develops, produces and markets generic drugs in all treatment categories. The company has a pharmaceutical business, whose principal products include Copaxone and Azilect.
Tevaâ€™s active pharmaceutical ingredient (API) business provides vertical integration to Tevaâ€™s own pharmaceutical production.
Gerard van Odijk, president and CEO of Teva Europe, said: â€œWe are pleased with CHMPâ€™s recommendation to approve NOMAC-E2. NOMAC-E2, which became part of our innovative pipeline following the acquisition of Theramex, has the potential to expand women's choices in contraception by providing a unique oral contraceptive offering with natural estrogen in a modern regimen.
â€œIf approved, NOMAC-E2 will provide an important addition to Tevaâ€™s womenâ€™s health product portfolio and will advance our efforts to expand our women's health franchise globally.â€
Can the company successfully market the new pill?
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