Organon’s XACIATO™ (clindamycin phosphate) Vaginal Gel 2% Available Nationwide to Treat Bacterial Vaginosis (BV) in Females Aged 12 and Older

Despite being the most common vaginal condition,¹ BV symptoms are often mistaken for a yeast infection²

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV). BV results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome (environment) and can lead to symptoms of odor and discharge.³ BV has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.^4,5

In addition to the physical symptoms,³ BV can also impact a woman’s emotional wellbeing.² In fact, a 2017 survey among 304 women diagnosed with BV² found that 79% avoided intimacy with their partner² and 68% felt self-conscious because of their condition.² Most women with symptoms of BV require treatment.⁶ Women with recurrent BV have reported frustration with recurrence after initial treatment,⁷ with 58% of them experiencing recurrent infection within 12 months.⁷

XACIATO, pronounced zah-she-AH-toe, is a colorless single-dose vaginal gel that can be applied at any time of day and is formulated with the goal of limiting leakage and increasing vaginal retention time (time spent in place).⁴ As demonstrated by an in vitro study using clindamycin HCl, the gel increases viscosity (thickness and stickiness) at body temperature and gradually releases clindamycin, over time.^4,8

“As a company focused on women's health, we make it a priority to listen to women and their providers, so that we understand their needs and put forward innovative solutions,” said Juan Camilo Arjona Ferreira, M.D., Head of Research & Development and Chief Medical Officer at Organon. “What drew us to XACIATO is that it was formulated with specific needs in mind and studied in a patient population that was representative of women with BV.”¹

XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.

“BV is the most common form of vaginitis,^1,9 disrupting the lives of approximately 21 million women.^1,5 For these women, it’s important to consider her individual treatment needs, such as route of administration, cost, adverse events, dosing and duration of treatment,”^7,10 said Erica Montes, M.D., Board-Certified Obstetrician and Gynecologist and a Fellow of the American College of OB/GYN. “The availability of XACIATO is important as it’s one dose for women experiencing BV and it can be taken at any time of day.”

In 2022, Organon and Daré Biosciences completed an agreement whereby Organon will license global rights to XACIATO.

Information about XACIATO, and the eVoucher instant savings coupon for eligible patients, can be found at XACIATO.com.

About BV

BV is the most common vaginal condition in women of reproductive age in the United States, affecting approximately 21 million women.^1,5 The condition results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor or discharge.³ BV may self-resolve in up to 30% of women, but most symptomatic women require treatment.^6,11 If left untreated, BV may lead to serious complications.^2,11 BV has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.^4,5

About XACIATO

XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5g of vaginal gel containing 100mg of clindamycin.

Selected Safety Information

XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.

Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.

XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment.

The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.

XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug.

There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Please see the Prescribing Information, Patient Information, and Instructions for Use.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Forward-Looking Statements

Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding product development and commercialization plans for XACIATO. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on our current plans and expectations and are subject to a number of significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from the forward-looking statements.

Risks and uncertainties that may affect our future results include, but are not limited to, an inability to fully execute on the nationwide commercialization plans for XACIATO; our product development and commercialization plans within the United States or internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception and fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the Securities and Exchange Commission ("SEC"), including the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

¹ Bacterial vaginosis statistics. Centers for Disease Control and Prevention. Last reviewed February 10, 2020. Accessed October 19, 2023. https://www.cdc.gov/std/bv/stats.htm

² Understanding women’s experiences with bacterial vaginosis. American Sexual Health Association. Accessed October 19, 2023. https://www.ashasexualhealth.org/understanding-womens-experiences-with-bacterial-vaginosis/

³ Bacterial vaginosis - CDC basic fact sheet. Centers for Disease Control and Prevention. January 5, 2022. Accessed October 19, 2023. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm

⁴ Mauck C, Hillier SL, Gendreau J, et al. Single-dose bioadhesive clindamycin 2% gel for bacterial vaginosis. Obstet Gynecol. 2022;00:1–11. DOI: 10.1097/AOG.0000000000004805.

⁵ Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-9.

⁶ Bacterial vaginosis. Centers for Disease Control and Prevention. July 19, 2021. Accessed October 19, 2023. https://www.cdc.gov/std/treatment-guidelines/bv.htm

⁷ Muzny CA, Kardas P. A Narrative Review of Current Challenges in the Diagnosis and Management of Bacterial Vaginosis. Sex Transm Dis. 2020 Jul;47(7):441-446. doi: 10.1097/OLQ.0000000000001178. PMID: 32235174; PMCID: PMC7294746.

⁸ Mondal P, Hemant AH, Johnston TP. Evaluation of TRI-726 as a drug delivery matrix. Drug Dev Ind Pharm. 2011;37(8):995-1001. doi:10.3109/03639045.2011.555913

⁹ Paladine HL, Desai UA. Vaginitis: diagnosis and treatment. Am Fam Physician. 2018;97(5):321-329.

¹⁰ Chavoustie SE, Eder SE, Koltun WD, et al. Experts explore the state of bacterial vaginosis and the unmet needs facing women and providers. Int J Gynaecol Obstet. 2017;137(2):107-109.doi: 10.1002/ijgo.12114.

¹¹ Kairys N, Garg M. Bacterial vaginosis. NCBI Bookshelf. Updated July 4, 2023. Accessed October 5, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459216/

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Source: Organon & Co.