Evofem Biosciences to Reduce Cost of Goods by 45% Through New Partnership with Bora Pharmaceutical Services for Commercial Manufacturing of Phexxi®
SAN DIEGO, May 10, 2022 /PRNewswire/ — Evofem Biosciences, Inc., (Nasdaq: EVFM) today announced that it has selected Bora Pharmaceuticals Services Inc. (Bora Canada as a new contract manufacturing organization (CMO) of Evofem. Bora will eventually make Phexxi® (lactic acid, citric acid and potassium bitartrate) for markets around the world.
“Through this agreement, Evofem expects to achieve a 45% reduction in the cost of goods associated with the manufacturing, packaging and testing of Phexxi as part of the company’s overall efforts to reduce expenses and continue to improve gross margin,” said Saundra Pelletier, Managing Director, Evofem. “We conducted a comprehensive assessment of CMOs worldwide to determine the best manufacturing solution for Evofem and Phexxi. Bora has proven expertise in the GMP manufacturing of drugs, enabling them to provide a safe, consistent and reliable supply of Phexxi to patients looking for a hormonal innovation.”
The application for Phexxi, the hormone-free on-demand contraceptive, which was approved by the FDA in May 2020, continues to grow in the United States Evofem recently announced its third consecutive quarter of revenue growth. Evofem has launched technical transfer activities and Bora is expected to start manufacturing Phexxi in the fourth quarter of 2022.
Initially, Bora will manufacture Phexxi for countries currently considering formal regulatory approval of Phexxi for pregnancy prevention, including Mexico and Nigeria.
“Bora is thrilled to join our new partners at Evofem as we provide women with the first and only on-demand hormone-free contraception,” said Bobby ShengCEO, Bora Pharmaceutical. “We are already accelerating and undertaking due diligence to deliver the quality, reliability and efficiency that Bora is known for.”
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 complete 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 experience 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 complete product information at www.phexxi.com.
Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for US residents only.
About Evofem Biosciences
Evofem Biosciences, Inc., (Nasdaq: EVFM) develops and markets innovative products to address the unmet sexual and reproductive health needs of women, including hormone-free, female-controlled contraception and protection against chlamydia and gonorrhea. The company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a prescription vaginal contraceptive gel without hormones. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each sexual intercourse. The first data is expected in the second half of 2022 from phase 3 of registration 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.
Bora Pharmaceuticals is a leading international CDMO specializing in a wide range of complex dosage forms, including solid, liquid and semi-solid oral capabilities for Rx and OTC products. Bora owns and operates several 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.
This press release contains “forward-looking statements”, within the meaning of the safe harbor for forward-looking statements provided for 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 relating to the time of recording Phase 3 EVOGUARD trial and outcome of foreign regulators’ review of submissions for approval of Phexxi in these countries. A variety of factors could cause actual results to differ materially from those discussed or implied by the forward-looking statements, including market and other conditions, and you are cautioned not to place undue reliance on such 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 by the forward-looking statements, or that could adversely affect the value of Evofem The assets and activities of Biosciences are disclosed in the company’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 10, 2022 All forward-looking statements are expressly qualified in their entirety by these factors. The Company undertakes no obligation to update forward-looking statements, except as required by law.
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SOURCEEvofem Biosciences, Inc.