SAN DIEGO, Dec. 11, 2020 /PRNewswire/ -- Evofem Biosciences,
Inc., (NASDAQ: EVFM) today announced that two U.S. patents
which cover Phexxi® (lactic acid, citric acid and potassium
bitartrate) and its labeled indication are now listed in
the U.S. Food and Drug Administration (FDA) publication
Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the Orange
Book.
Phexxi is the first and only FDA-approved, non-hormonal
contraceptive vaginal gel that is designed to be used immediately
before or up to an hour before intercourse. It was approved in
May 2020 and is now available in the
U.S. by prescription. Phexxi works to maintain vaginal pH, which
reduces sperm mobility, lowering the chance of sperm reaching the
egg.
"The Orange Book listing of these two patents covering Phexxi's
composition of matter and its method of use in prevention of
pregnancy is an important step in the ongoing development of our
patent portfolio, which currently covers Phexxi into 2033," said
Evofem Biosciences CEO Saundra
Pelletier. "We plan to further expand our intellectual
property estate as we continue to develop and iterate our vaginal
pH modulator platform for additional unmet medical needs, including
the prevention of chlamydia and gonorrhea in women and other
potential indications."
The newly listed method of use patent, number 10,568,855 (the
'855 patent), covers contraception using the L-Lactic Acid Phexxi
formulation. The '855 patent was issued by the U.S. Patent and
Trademark Office (USPTO) on February 25, 2020 and is
expected to expire in March 2033.
The newly listed patent number 6,706,276 (the '276 patent) is a
composition of matter patent covering Phexxi®. Evofem has an
exclusive license to this patent, which is held by Rush University. The '276 patent was issued by the
USPTO on March 16, 2004, and is expected to expire in
March 2026 based on the five-year
patent term extension application that was timely filed by the
patent owner.
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage
biopharmaceutical company committed to developing and
commercializing innovative products to address unmet needs in
women's sexual and reproductive health, including hormone-free,
woman-controlled contraception and protection from certain sexually
transmitted infections (STIs). The Company's first commercial
product, Phexxi® (lactic acid, citric acid and potassium
bitartrate), is the first and only hormone-free, prescription
vaginal gel approved in the United States for the
prevention of pregnancy. The Company is evaluating EVO100 in
a Phase 3 clinical trial, 'EVOGUARD,' for the prevention
of urogenital Chlamydia trachomatis and Neisseria
gonorrhoeae infection in women. For more information,
please visit www.evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences,
Inc.
About PHEXXI®
Phexxi® (lactic acid, citric acid, and potassium
bitartrate) is a prescription vaginal gel used to prevent pregnancy
in females who choose to use an on-demand method of birth control.
Phexxi® is only effective when used
immediately before (or up to one hour before) each
act of vaginal sex. Phexxi® is not effective when used after
vaginal sex.
IMPORTANT SAFETY INFORMATION
WHAT ARE THE POSSIBLE SIDE EFFECTS OF PHEXXI® (lactic
acid, citric acid, and potassium bitartrate) vaginal gel 1.8%, 1%,
0.4%?
If you have had a history of repeated urinary tract infections
or other urinary tract problems, avoid Phexxi®.
The most common side effects were vaginal
burning, vaginal itching, vaginal yeast infection, urinary tract
infection, vaginal area discomfort, bacterial vaginosis, and
vaginal discharge. Women also reported genital discomfort, pain
while urinating, and vaginal pain. Some male partners reported
genital discomfort.
What else should I know about using Phexxi®?
Phexxi® does not protect against any sexually transmitted
diseases, including HIV. Avoid using Phexxi® with a vaginal
ring.
Contact your healthcare provider if you are experiencing severe
genital irritation or discomfort or urinary tract symptoms. Avoid
Phexxi® if you or your sexual partner is allergic to lactic
acid, citric acid, potassium bitartrate, or any of the ingredients
in Phexxi®. Stop using Phexxi® if you develop an allergic
reaction.
Please see full Prescribing Information for
Phexxi®, including Patient Information.
Please report side effects by contacting Evofem Biosciences
toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Forward Looking Statements
This press release includes "forward-looking statements," within
the meaning of the safe harbor for forward-looking statements
provided by Section 21E of the Securities Exchange Act of 1934, as
amended; and the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements related to anticipated
duration of the newly listed patents and the anticipated five-year
term extension for U.S. patent number 6,706,276. Various
factors could cause actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Important factors that could cause actual
results to differ materially from those discussed or implied in the
forward-looking statements, or that could impair the value of
Evofem Biosciences' assets and business, including without
limitation obtaining the patent term extension for the '276 patent,
are disclosed in Evofem's SEC filings, including its Annual Report
on Form 10-K for the year ended December 31, 2019 filed
with the SEC on March 12, 2020, its Current Report on Form 8-K
filed with the SEC on June 2, 2020, and its Quarterly Report
on Form 10-Q for the quarter ended September 30,
2020 filed with the SEC on November 9, 2020. All
forward-looking statements are expressly qualified in their
entirety by such factors. Evofem does not undertake any duty to
update any forward-looking statement except as required by law.
Investor Relations Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490-3248
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SOURCE Evofem Biosciences, Inc.