Full Press Release Details
Bioscience Announces Closing of Global License Agreement with Organon to Commercialize XACIATO (clindamycin phosphate vaginal
gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis
will receive a $10 million upfront payment from Organon
estimated 21 million American women experience bacterial vaginosis
DIEGO, June 30, 2022 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,
today announced that the exclusive license agreement entered into on March 31, 2022 with Organon (NYSE: OGN), a global women's
healthcare company, has become fully effective. Under the agreement, Organon licensed global rights to XACIATO (clindamycin phosphate
vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis in females 12 years of age and older. XACIATO received
both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis.
connection with the closing, Dar will receive a $10 million upfront payment from Organon. Dar is eligible to receive
potential milestone payments of up to $182.5 million and tiered double-digit royalties based on net sales. XACIATO is expected to be
available commercially in the U.S. in Q4 2022.
vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S."
said Sabrina Martucci Johnson, President and CEO of Dar . "The Dar team identified bacterial vaginosis as an area
in need of new treatment options. We are thrilled to be collaborating with Organon, one of the premier companies in women's health,
as we believe Organon's commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition."
Bioscience is a biopharmaceutical company committed to advancing innovative products for women's health. The company's mission
is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and
well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual
first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel, 2%), is a lincosamide antibacterial indicated for the
treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon.
XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Dar 's portfolio also
includes potential first-in-category candidates in clinical development: Ovaprene , a novel, hormone-free monthly contraceptive whose
U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat
female sexual arousal disorder utilizing the active ingredient in Viagra ; and DARE-HRT1, a combination bio-identical estradiol and
progesterone intravaginal ring for hormone therapy following menopause. To learn more about XACIATO , Dar 's full
portfolio of women's health product candidates, and Dar 's mission to deliver differentiated therapies for women,
please visit www.darebioscience.com.
may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors
section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Dar
will use these channels to distribute material information about the company, and may also use social media to communicate important
information about the company, its finances, product and product candidates, clinical trials and other matters. The information Dar
posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages
investors, the media, and others interested in the company to review the information Dar posts in the Investors section of its
website and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the
company may use to communicate information will be posted in the Investors section of Dar 's website.
cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.
Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will,"
"estimate," "continue," "anticipate," "design," "intend," "expect,"
"could," "plan," "potential," "predict," "seek," "should," "would,"
"contemplate," "project," "target," "objective," "endeavor" or the negative
version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements
relating to Dar 's expectations about its agreement with Organon, including commercial distribution and sale of XACIATO,
receipt of payments from Organon, and expected timing of commercial availability of XACIATO in the United States. Forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause Dar 's actual results, performance or achievements
to be materially different from those expressed or implied by the forward-looking statements in this press release, including, without
limitation: the risks that none of the milestones under the agreement with Organon may be achieved and none of potential milestone payments
become payable; the potential for royalty payments to be subject to reductions and offsets; dependence on Organon to commercialize licensed
products and on other third parties for commercial supplies of licensed products and components and Dar 's lack of control
over the efforts and resources expended by those third parties; general industry conditions and competition; general economic factors,
including inflation, rising interest rates and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic; 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; Dar 's ability to
accurately predict its future financial condition, operating results and performance; Dar 's or its licensee's ability
to accurately predict future market conditions; third-party 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 patents owned or licensed by Dar and other protections for innovative products; and the exposure of Dar ,
its commercial counterparties and other third parties on which it relies to litigation, including patent litigation, and/or regulatory
actions. Dar 's forward-looking statements are based upon its current expectations and involve assumptions that may never
materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary
statements. For a detailed description of Dar 's risks and uncertainties, you are encouraged to review its documents filed
with the SEC including Dar 's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the date on which they were made. Dar undertakes no obligation
to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as
on behalf of Dar Bioscience, Inc.:
on behalf of Dar Bioscience, Inc.:
Dar Bioscience, Inc.