Full Press Release Details
Bioscience Announces New Development Program, DARE-PDM1, as a Potential First-in-Category Treatment for Primary Dysmenorrhea
Utilizes Proprietary Hydrogel Technology for Vaginal Delivery of Diclofenac, a Nonsteroidal Anti-Inflammatory; Phase 1 Study Targeted
Dar Portfolio Accomplishments Include:
Additional Portfolio Programs (DARE-GML and grant-funded DARE-LBT);
Agreement with Organon to Commercialize XACIATOTM;
IDE Approval for Pivotal Contraceptive Efficacy Study;
Phase 1/2 Data for both DARE-HRT1 and DARE-VVA1
Anticipated Milestones Include:
First Commercial Sale;
Cream, 3.6% for Female Sexual Arousal Disorder Phase 2b Topline Data;
Pivotal Study Recruitment; DARE-PDM1 Phase 1 Study
DIEGO, December 12, 2022 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,
today announced a new development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient
diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way. Dar 's new investigational product, DARE-PDM1,
will deliver diclofenac vaginally via the Company's proprietary hydrogel technology. A Phase 1 study of DARE-PDM1 is targeted for
2023. Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential
to be a first-in-category product. Following clinical development, Dar intends to leverage the existing safety and efficacy data
for diclofenac to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-PDM1
2022 has been an incredibly successful year for our portfolio in terms of:
expanding our portfolio with additional differentiated product candidates that we believe further our leadership as an accelerator of
innovative products in women's health;
securing a global commercialization collaboration for our first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2%,
a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older, which is the second
commercial collaboration agreement for our portfolio (the first was entered into with Bayer in 2020 for Ovaprene); and
demonstrating clinical success (such as with DARE-HRT1 and DARE-VVA1) and advancing regulatory and clinical development to enable important
2023 milestones (such as the Sildenafil Cream Phase 2b topline data targeted for 2Q-2023 and Ovaprene pivotal study recruitment initiation
targeted for mid-2023)," said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
a company, we are committed to addressing unmet needs in women's health. We believe that we have assembled a robust portfolio in
women's health and that all of our programs have the opportunity to be either first-line or first-in-category, or both,"
Johnson added. "It is our belief that prioritizing women's health is not only good for the many women lacking effective or
convenient therapeutic choices, but also for a broad set of stakeholders, because contraception, fertility, and vaginal and sexual health,
our areas of focus, are compelling markets impacting millions of women and we have seen that innovation in these areas has led to commercially
successful brands. Specifically, we find these market research statistics compelling: Only approximately 1% of healthcare research is
invested in female-specific conditions beyond oncology, and women's health conditions outside of oncology comprise less than 2%
of the current healthcare pipeline. Yet, women's health products outside of oncology make up 27% of the total number of blockbuster
products (products that each have over $500 million in annual sales) and contribute 35% of the total sales dollars generated by blockbuster
products. This is why we believe investment in women's health will be efficient and disproportionately impactful in terms of translating
dollars invested in R&D to ultimate revenue generated, and therefore, not only good for the 50% of the population to whom these products
are targeted, but also a good business model."
Primary Dysmenorrhea and DARE-PDM1
dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy, typically described as cramping pain in the lower
abdomen before or during the menstrual period. Primary dysmenorrhea usually begins during adolescence and is a leading cause of recurrent
short-term school absence in adolescent girls and a common problem in women of reproductive age. Recent market research suggests that
the global market for dysmenorrhea treatment is estimated to be valued at USD $11 billion and that the size of this market is expected
to increase to USD $25 billion by the year 2028. According to the American College of Obstetricians and Gynecologists' Committee
on Adolescent Health Care, dysmenorrhea is the most common menstrual symptom among adolescent girls and young women, and most adolescents
experiencing dysmenorrhea have primary dysmenorrhea. Prevalence rates of dysmenorrhea vary but range from 50% to 90%. A prospective study
of college students found that 72% of monitored periods were painful, most commonly during the first day of menses, and 60% of the women
studied reported at least one episode of severe pain.
the same hydrogel technology found in XACIATO, and consistent with our portfolio of differentiated and novel product candidates, we are
developing DARE-PDM1 to address a critical unmet medical need in women's health," said Dr. Annie Thurman, Medical Director
of Dar Bioscience. "The most common interventions for primary dysmenorrhea include oral NSAIDs and hormonal contraceptives
which often can produce undesirable side effects. By incorporating diclofenac into our proprietary hydrogel for vaginal administration,
we believe we can provide a treatment option that addresses the pain-related symptoms of the condition while minimizing side effects
commonly seen with use of oral NSAIDs," continued Dr. Thurman.
Updates Previously Announced in 2022:
(clindamycin phosphate) vaginal gel, 2%, FDA-approved for treatment of bacterial vaginosis in females 12 years of age and older
vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S. The condition
results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and
June, Dar announced that the exclusive license agreement entered into in March 2022 with Organon (NYSE: OGN), a global
women's healthcare company, became fully effective. Under the agreement, Organon licensed global rights to XACIATO. Under the license
agreement Dar received a $10 million cash payment from Organon after the license became effective. Dar is eligible to
receive potential milestone payments of up to $182.5 million as well as tiered double-digit royalties based on net sales. Launch preparation
activities are ongoing and the first commercial sale of XACIATO is anticipated in the first half of 2023 in the U.S.
- investigational hormone-free monthly intravaginal contraceptive
October, Dar announced that the FDA approved an Investigational Device Exemption (IDE) application allowing Dar
to proceed with a single arm, open-label pivotal contraceptive efficacy study of Ovaprene. The multi-center, single arm, non-comparative,
pivotal Phase 3 study will evaluate Ovaprene's effectiveness as a contraceptive device along with its safety and usability. If
successful, Dar expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. The Ovaprene
investigator meeting for the pivotal study took place in December and initiation of recruitment for the study is targeted for mid-2023.
January 2020, Dar and Bayer announced an exclusive licensing agreement for U.S. commercial rights to Ovaprene. Under the
agreement, Dar received an upfront payment and access to Bayer's extensive clinical, regulatory, manufacturing and commercial
expertise while retaining control over Ovaprene's development and regulatory approval process. Bayer received the right to obtain
exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dar .
If Bayer, in its sole discretion, makes payment to Dar of $20 million, which Dar intends to apply to reimbursement of
clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Dar will also be
entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double digit tiered royalties on
Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option
for women seeking a hormone-free, self-administered and monthly birth control method.
Cream, 3.6% - investigational treatment for female sexual arousal disorder
a joint communication released in November of this year, Dar and its development partner, Strategic Science and Technologies,
LLC, reported that subject screening for the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% had completed,
allowing for a topline data announcement target of 2Q-2023. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled
study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
Approximately 160 to 170 subjects in total are expected to complete the study for inclusion in the topline data assessment targeted for
Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category
option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and,
of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is
the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of ED
in men. Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from
experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their
condition. For context on the potential market opportunity for an FDA-approved treatment for FSAD, the prevalence of complete ED in men
is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.
clinical development is successful, Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option.
& DARE-VVA1 Phase 1/2 data
April, Dar announced the initiation of a Phase 1/2 clinical study of DARE-HRT1, a novel, investigational intravaginal
ring (IVR) designed to deliver bio-identical 17 -estradiol and bio-identical progesterone continuously over a 28-day period as part
of a hormone therapy (HT) regimen following menopause. HT is used to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated
with menopause. Positive efficacy results from this study were announced in October, including statistically significant results
for improvement in both the vasomotor and vaginal symptoms of menopause. Dar anticipates that the topline pharmacokinetics (PK)