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.
Evofem Biosciences,
Inc. is a clinical-stage biopharmaceutical company committed to
developing and commercializing innovative products to address unmet
needs in women's sexual and reproductive health. Evofem Biosciences
aims to advance the lives of women by developing novel solutions,
such as woman-controlled contraception and potential protection
from certain sexually transmitted infections. The company is
leveraging its proprietary Multipurpose Vaginal pH Regulator
(MVP-R™) platform to develop Amphora® (L-lactic
acid, citric acid and potassium bitartrate) for hormone-free birth
control and prevention of chlamydia. For more information, please
visit www.evofem.com.
Amphora® is a registered trademark and
Multipurpose Vaginal pH Regulator (MVP-R™) is a trademark of Evofem
Biosciences, Inc.
About PDL BioPharma, Inc.
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.
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.
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SOURCE PDL BioPharma, Inc.