Contraceptive success amps up Evofem

Snippets

Armed with a hit in the pivotal Ampower trial, Evofem Biosciences can take its contraceptive gel, Amphora, back to the FDA, and this time it will have reasonable expectation of its approval. 86% of Ampower’s 1,400 participants did not become pregnant within the seven-month trial period, a high enough efficacy rate to meet the predetermined primary endpoint. This rate is for typical – ie imperfect – use, Evofem said; when the study participants used the gel as directed, the efficacy rate was 98.7%. The equivalent rates for the oral contraceptive pill are 91% and 99.7%, but Amphora’s USP is that it is non-hormonal – it is a combination of L-lactic acid, citric acid and potassium bitartrate, designed to keep the vaginal environment acidic and therefore inhospitable to sperm. Evofem hopes that the product might find a market among women unwilling to take systemic hormones. The company plans to resubmit the NDA for Amphora in the second quarter of next year and, if approved, could launch the drug in January 2020. Analysts from Cantor Fitzgerald put the project's 2024 sales at $196m. Evofem’s shares closed up 16% yesterday, valuing the company at almost $100m.

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