PDL BioPharma Congratulates Evofem Biosciences on Achieving Major Regulatory and Clinical Milestones with its Lead Product Candidate Amphora®
"We are delighted with Evofem's progress and want to congratulate CEO
Resubmission of Amphora New Drug Application
The first milestone was the resubmission of the Amphora New Drug Application ("NDA") to the
Positive Top-Line Results from AMPREVENCE Phase 2b Trial
The second milestone was the reporting of positive topline results from the AMPREVENCE Phase 2b trial evaluating Amphora for the prevention of chlamydia (primary endpoint) and gonorrhea (secondary endpoint) that was announced
The AMPREVENCE study met both its primary and secondary endpoints, with a 50% relative risk reduction in chlamydia infection and a 78% relative risk reduction in gonorrhea infection compared to placebo. Both results were statistically significant. Chlamydia and gonorrhea are the two most commonly reported sexually transmitted infections (STI) in the United States. According to the
Consistent with previous trial results, Amphora was generally safe and well tolerated in this study population.
PDL holds a 29% equity stake in Evofem. For additional information about these milestones, please visit https://evofem.investorroom.com/news-releases.
Amphora® is a registered trademark and Multipurpose Vaginal pH Regulator (MVP-R™) is a trademark of
PDL's mission is to improve the lives of patients and create value for our shareholders and our people by applying our capital and expertise for the successful development and commercialization of innovative therapeutics by our partner companies. For more information please visit www.pdl.com.
1 Sexually Transmitted Disease Surveillance Report,
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