The first milestone was the resubmission of the Amphora New Drug Application to the U.S. Food and Drug Administration for the prevention of pregnancy that was announced November 26, 2019.
| INCLINE VILLAGE, Nev., Dec. 3, 2019 /PRNewswire/ -- PDL BioPharma Inc. (“PDL” or the “Company”) (NASDAQ: PDLI) congratulates Evofem Biosciences, Inc. (“Evofem”) (NASDAQ: EVFM) on its recent achievement of two major regulatory and clinical milestones with its lead product candidate Amphora® (L-lactic acid, citric acid and potassium bitartrate), an investigational multipurpose vaginal pH regulator (MVP-R™) for hormone-free birth control and prevention of chlamydia and gonorrhea. “We are delighted with Evofem’s progress and want to congratulate CEO Saundra Pelletier and her team for achieving these two recent important corporate milestones,” said Dominique Monnet, president and CEO of PDL. Resubmission of Amphora New Drug Application The first milestone was the resubmission of the Amphora New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for the prevention of pregnancy that was announced November 26, 2019. 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 December 2, 2019. 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 Centers for Disease Control and Prevention, domestic cases of STIs reached an all-time high in 2018 with nearly 2.4 million cases being reported.1 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. About Evofem Biosciences, Inc. Amphora® is a registered trademark and Multipurpose Vaginal pH Regulator (MVP-R™) is a trademark of Evofem Biosciences, Inc. About PDL BioPharma, Inc. NOTE: PDL, PDL BioPharma, the PDL logo and associated logos and the PDL BioPharma logo are trademarks or registered trademarks of, and are proprietary to, PDL BioPharma, Inc. which reserves all rights therein. 1 Sexually Transmitted Disease Surveillance Report, Centers for Disease Control and Prevention (CDC), October 8, 2019.
SOURCE PDL BioPharma, Inc. | ||
Company Codes: NASDAQ-NMS:PDLI, NASDAQ-NMS:EVFM |
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