SAN
DIEGO, May 10, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (Nasdaq: EVFM) today
announced it has selected Bora Pharmaceuticals Services Inc.
(Bora) Canada as Evofem's new
contract manufacturing organization (CMO). Bora will eventually
manufacture Phexxi® (lactic acid, citric acid, and
potassium bitartrate) for markets worldwide.
"With this arrangement, Evofem expects to realize a 45 percent
reduction in the cost of goods related to the manufacturing,
packaging, and testing of Phexxi as part of the company's overall
efforts to reduce spend and continue to improve gross margin," said
Saundra Pelletier, Chief Executive
Officer, Evofem. "We conducted a comprehensive evaluation of CMOs
worldwide for the best manufacturing fit for Evofem and Phexxi.
Bora has proven expertise in GMP manufacturing of drug products,
allowing them to supply a safe, steady, and reliable supply of
Phexxi for patients seeking a non-hormonal innovation."
Demand for Phexxi, the hormone-free, on-demand contraceptive,
which was FDA-approved in May 2020,
continues to grow in the U.S. Evofem recently reported its third
consecutive quarter of revenue growth. Evofem has initiated
technical transfer activities, and Bora is expected to begin
manufacturing Phexxi in the fourth quarter of 2022.
Initially, Bora will manufacture Phexxi for nations currently
considering formal regulatory approval of Phexxi for the prevention
of pregnancy, including Mexico and
Nigeria.
"Bora is thrilled to join our new partners at Evofem as we
provide women the first and only hormone-free, on-demand
contraception," said Bobby Sheng,
CEO, Bora Pharmaceuticals. "We are
already ramping up and undertaking the due diligence to deliver the
quality, reliability, and efficiency Bora is known for."
About Phexxi
Phexxi is an on-demand method of birth control used to prevent
pregnancy. Phexxi is not effective when used after sex.
For more information about Phexxi, talk to your healthcare
provider and see full Product Information
at www.phexxi.com.
Important Safety Information
- Rare cases (0.36%) of bladder and kidney infections have been
reported. If you have a history of urinary tract problems that keep
coming back, you should not use Phexxi.
- Contact your healthcare provider if you are experiencing
genitourinary side effects such as vaginal burning, itching,
discharge, genital discomfort (including in male partners), yeast
infection, urinary tract infection, or bacterial vaginosis.
- Phexxi does not protect against sexually transmitted
infections, including HIV.
For more information about Phexxi, talk to your healthcare
provider and see full Product Information
at www.phexxi.com.
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.
Intended for United States residents
only.
About Evofem Biosciences
Evofem Biosciences, Inc., (Nasdaq: EVFM) is 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 chlamydia and
gonorrhea. The Company's first FDA-approved
product, Phexxi® (lactic acid, citric acid,
and potassium bitartrate), is a hormone-free, on-demand
prescription contraceptive vaginal gel. It comes in a box of 12
pre-filled applicators and is applied 0-60 minutes before each act
of sex. Top-line data is expected in the second half of 2022 from
the registrational Phase 3 EVOGUARD trial evaluating Phexxi
for the prevention of chlamydia and gonorrhea in women, two
potential new indications. Learn more
at phexxi.com and evofem.com.
About Bora
Bora Pharmaceuticals is a premier international CDMO
specializing in a wide range of complex dosage forms including oral
solid, liquid, and semi-solid capabilities for both Rx and OTC
products. Bora owns and operates multiple cGMP manufacturing
facilities in Asia and
North America offering services
for clinical and commercial manufacturing, packaging, and
analytical testing.
Phexxi® is a registered trademark of Evofem
Biosciences, Inc.
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 the timing of the
registrational Phase 3 EVOGUARD
trial and the outcome of review of foreign regulatory
agencies of submissions for approval of Phexxi in
those countries. Various factors could cause actual results to
differ materially from those discussed or implied in the
forward-looking statements, including market and other conditions,
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, are
disclosed in the Company's SEC filings, including its Annual Report
on Form 10-K for the year ended December 31, 2021, filed with
the SEC on March 10, 2022. All forward-looking statements are
expressly qualified in their entirety by such factors. The Company
does not undertake any duty to update any forward-looking statement
except as required by law.
Evofem Biosciences Contacts:
Media Contact
Jack Hirschfield
Evofem Biosciences, Inc.
jhirschfield@evofem.com
(512) 674-5163
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
Bora Contact:
info@bora-corp.com
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SOURCE Evofem Biosciences, Inc.