Infective vaginitis

Organon, a global women’s healthcare company, initiated XACIATO™ commercial activities in the fourth quarter of 2023 XOMA further expands its late-stage portfolio with synthetic royalty and milestone interests in two additional women’s health assets: Ovaprene®, an investigational potential first-in-category Phase 3 hormone-free monthly intravaginal contraceptive, and Sildenafil Cream, 3.6%, a potential first-in-category Phase 3-ready candidate for female sexual arousal disorder Bayer HealthCare holds the exclusive rights to U.S. commercialization of Ovaprene® XOMA provided $22 million upfront as non-dilutive royalty capital solution to Daré Bioscience EMERYVILLE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA) announced today it has acquired an economic interest in three women’s health assets - XACIATO™ (clindamycin phosphate) vaginal gel 2%, Ovaprene®, and Sildenafil Cream, 3.6% - from Daré Bioscience, Inc., for an upfront payment of $22 million. XACIATO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. In 2022, Daré entered into a license agreement with Organon, which initiated XACIATO™ commercial marketing activities in the fourth quarter of 2023. “XACIATO™, an important therapy, becomes the fifth commercial asset in XOMA’s royalty portfolio, and our royalty monetization transaction with Daré also adds two first-in-category Phase 3 royalty assets that have the potential to create additional value for our shareholders. Each of the three assets represents a meaningful advance in the women’s health category that has typically been under-represented and has significant growth potential,” stated Brad Sitko, Chief Investment Officer at XOMA. “XOMA structured an attractive, non-dilutive royalty capital solution that provides Daré with additional financial resources to advance its pipeline through key catalysts and aligns with its stockholders, enabling them to participate in the future value created by XACIATO™, Ovaprene®, and Sildenafil Cream.” Under the terms of the agreement, XOMA will receive the remaining royalties related to XACIATO™ not already included in Daré’s December 2023 royalty-backed financing agreement, which equates to low to high single-digit royalties on net sales. XOMA also is entitled to potential milestone payments based on the commercial success of XACIATO. Additionally, XOMA has acquired an interest in a potential milestone and a low single-digit synthetic royalty on Ovaprene®, as well as a low single-digit synthetic royalty on Sildenafil Cream, 3.6%. Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré. AdvisorsGibson, Dunn & Crutcher LLP served as XOMA’s legal advisor, while Daré was advised by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. TD Cowen, a division of TD Securities, acted as exclusive financial advisor to Daré. About XACIATO™ (clindamycin phosphate) vaginal gel 2%XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older, which is under a global license agreement with Organon. For more information, including important safety information, please visit www.xaciato.com. About Ovaprene®Ovaprene® is a novel investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to use monthly option and prevent pregnancy by releasing a locally acting, non-hormonal agent, which impedes sperm motility, and physically blocks sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones. U.S. commercial rights to Ovaprene® are under a license agreement with Bayer. About Sildenafil Cream, 3.6%Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow the Company on LinkedIn. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to XACIATO™, Ovaprene®, and Sildenafil Cream, 3.6%. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, and our third-party licensees will not be able to market them. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® (faricimab), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet), are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor ContactXOMA Media ContactJuliane SnowdenKathy VincentXOMA CorporationKV Consulting & Management+1 646-438-9754+1 310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com

Medicines360 and DKT WomanCare are joining forces to increase availability and use of AVIBELA, an affordable, effective, long-acting hormonal IUD developed by Medicines360, across Africa, South and Southeast Asia, Central America, and the Caribbean.SAN FRANCISCO and PARIS, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Medicines360, a global nonprofit pharmaceutical organization specializing in women’s health, and DKT WomanCare, a global marketing and distribution organization focused on increasing the availability and use of high-quality contraceptive and reproductive health products, have entered into a partnership to expand access to AVIBELA, an affordable, quality-assured, long-acting hormonal IUD that is more than 99% effective at preventing pregnancy.1 This important collaboration will help more women learn about, access, and use this highly effective, modern form of contraception. The 52 mg levonorgestrel-releasing intrauterine system (“hormonal IUD”) has been largely inaccessible in lower- and middle-income countries (LMICs) due to factors limiting availability and affordability. An estimated 218 million women in LMICs have an unmet need for modern contraception, resulting in approximately 111 million unintended pregnancies (nearly 1 in 2) each year. 2 With this strategic partnership, more women around the world will have the ability to choose from a broader mix of safe, effective, and affordable contraceptive methods, including AVIBELA. "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360. “With their proven track record of building markets for new high-quality contraceptives, DKT WomanCare will help us provide more women across the world with the contraceptive options they want and deserve. Together, we will make meaningful improvements in access to build a brighter future for women.” Leveraging their global marketing expertise and reach, DKT WomanCare will increase awareness of AVIBELA, build markets, and ensure broader access across the public and private sectors in Africa, South and Southeast Asia, Central America, and the Caribbean. DKT WomanCare will draw on the experience of its parent company, DKT International, to leverage the organization’s extensive network of national and regional offices alongside DKT WomanCare’s established partnerships with ministries of health, global procurement agencies, social marketing organizations, and commercial distributors. Lauren Archer, DKT WomanCare’s Managing Director, celebrated the partnership. “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception. We look forward to working with Medicines360 to achieve these goals.” “This partnership is a wonderful opportunity to educate users and practitioners about the benefits of hormonal IUDs, expanding long-term contraceptive options to women everywhere with quality products like AVIBELA,” said Chris Purdy, President of DKT International. As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies. Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market. AVIBELA is a trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean. For more information about AVIBELA, please visit www.avibela.com. AVIBELA™ Important Safety Information Who is not appropriate for AVIBELAContraindications to use of AVIBELA include: pregnancy; use for post-coital contraception (emergency contraception); acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy; infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor (benign or malignant); conditions associated with increased susceptibility to pelvic infections; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine system (IUS) placement; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; a previously inserted IUS that has not been removed; a history of hypersensitivity reaction to any component of AVIBELA (reactions may include rash, urticaria, and angioedema). Clinical considerations for use of AVIBELAUse AVIBELA with caution after careful assessment in patients with coagulopathy or who are taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removal of the IUS if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of AVIBELA insertion, while the remainder were diagnosed more than six months after insertion. PID is often associated with sexually transmitted infection (STI), and AVIBELA does not protect against STIs. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Pregnancy related risks with AVIBELAIn the case of pregnancy with AVIBELA in place, advise the woman of the increased risks for pregnancy complications, including miscarriage, premature delivery, infection and sepsis. Ectopic pregnancy should be excluded, and removal of the system should be considered. Removal of AVIBELA or probing of the uterus may result in spontaneous abortion. When a woman becomes pregnant with AVIBELA in place, the relative likelihood of ectopic pregnancy is increased. Ectopic pregnancy may require surgery and may result in loss of fertility. Women with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy. Be aware of other serious complications and most common adverse reactionsSome serious complications with IUSs like AVIBELA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of AVIBELA is essential in order to minimize serious infections such as GAS. Perforation (total or partial, including penetration/embedment of AVIBELA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation is suspected, the IUS should be removed as soon as possible. Delayed detection or removal of AVIBELA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. Partial or complete expulsion of AVIBELA may occur, resulting in the loss of contraceptive protection. Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts. In a large clinical trial of 1,751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include procedural bleeding, vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne. About Medicines360Located in San Francisco, California, Medicines360 is a nonprofit global women’s health pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org. About DKT WomanCare Together, non-profits DKT WomanCare and DKT International are among the largest providers of reproductive health products, services, and technology in the world. Operating in more than 100 countries, they leverage principles of social entrepreneurialism and focus on ensuring wide access and availability of products, building up the capacity of health providers, and empowering consumers. For more information, see www.dktinternational.org and www.dktwomancare.org. Contacts:Heidi GlasserDirector of Marketing and Communications, Medicines360hglasser@medicines360.org Lauren ArcherManaging Director, DKT WomanCarelauren@dktwomancare.org References: Avibela (levonorgestrel-releasing intrauterine system) 52 mg [Summary of Product Characteristics and Prescribing Information]. Impact RH360; 2022.Sully EA et al., Adding It Up: Investing in Sexual and Reproductive Health 2019, New York: Guttmacher Institute, 2020, https://www.guttmacher.org/fact-sheet/investing-sexual-and-reproductive-health-low-and-middle-income-countries

San Diego-drugmaker Dare Bioscience describes itself as the rare biotechnology company focused exclusively on womens health, a category it says the broader industry has too often overlooked.But that identity can create hurdles, according to company CEO Sabrina Johnson. At times, she said, investors have been hesitant to fund research presented as womens health, citing their unfamiliarity with the space. How do we frame the conversation so that its clear, at the bottom line, that this is healthcare, said Johnson, who has run Dare since 2017.Drug research and development for conditions only or disproportionately affecting women has long been neglected, resulting in less venture funding for new startups and, for diseases like endometriosis, few treatment options. Reproductive medicine, meanwhile, is in the spotlight in the U.S. following the Supreme Courts reversal of Roe v. Wades protection for abortion and litigation challenging the Food and Drug Administrations approval of the abortion pill mifepristone.Challenges have brought attention, though. Notably, the Biden administration last November launched a womens health initiative that aims to catalyze greater funding and accelerate research. Private investors have already been funneling more money into womens health companies, although the past years downturn in biotech appears to have cooled activity in 2023.There is growing recognition of how under-invested womens health has been historically and therefore the opportunity for innovation and significant returns, said Erika Seth Davies, CEO of Rhia Ventures, a venture firm focusing on maternal and reproductive health equity.Barriers to investmentThe term womens health covers a broad spectrum. Typically it refers to conditions and diseases that are specific to female anatomy or are more prevalent in women than men. Often this is interpreted as meaning reproductive health, involving pregnancy, fertility and menopause.But it can also include gynecological disorders like endometriosis or uterine fibroids, as well as vaginal infections and urinary tract infections. Cancers of the breast, cervix and uterus are generally specific to women, while conditions like migraines and osteoporosis affect women more often than men.On the one hand, there's great opportunity in calling it women's health, said Johnson, referring to how the term can focus attention on who the diseases affect. But on the other hand, fundamentally these are healthcare conditions.While oncology receives significant attention and funding, other conditions under the umbrella of womens health dont, which can impact the kinds of treatments that become available. Lack of funds is often a major reason biotech companies halt research of a drug candidate, or prioritize other programs. And larger companies have chosen to pursue other areas: Bayer, previously a major player in the womens health sector, said last year it would shift focus from womens health to immunology, rare diseases and neurology.Across the ecosystem comprising academic and industry R&D, limited investment in womens health research and development stagnates the required innovation needed to support women with these conditions and others across every stage of a womans life, said Marcel van Duin, chief scientific officer at womens health company Organon.A lack of clinical trial data can also slow progress. Female participants have been underrepresented in early-phase clinical testing, and it wasnt until 2015 before the National Institutes of Health established sex as a biological variable for designing NIH-funded studies. Insufficient information on sex-specific outcomes can make it harder to determine how a potential treatments effect may vary.We have a lack of understanding of female diseases, and then a lack of understanding of diseases that may affect women differently or disproportionately, said Raysa Bousleiman, vice president of healthcare at Silicon Valley Bank, an investment firm now owned by First Citizens Bank. And just because of that lack of data, it becomes more of an uphill battle for these life science companies that are trying to develop solutions.Bousleiman believes terminology plays a role. A lot of [womens health] has some stigma, she said. What I've seen talking to a lot of founders in the women's health space, in biopharma and other sectors is that a lot of men don't even know there's an issue. So you don't want to invest in something you don't know.The numbers certainly bear that out. In 2019 across the U.S. and Europe, $122 billion was invested across 3,225 biopharma deals, according to SVB. Only $1.3 billion, across 60 deals, was invested in womens health biopharma companies.A 2021 analysisof NIH-backed research, meanwhile, found diseases that primarily affect men received more funding than those affecting women.Mifepristones spotlightSince last year, the FDA has been in court over its 2000 approval of the abortion pill mifepristone, which is widely used in the U.S. to terminate pregnancy. The conservative group Alliance for Hippocratic Medicine filed a lawsuit against the FDA and the Department of Health and Human Services last March claiming the agency unlawfully applied its accelerated approval process to the drug. A district court judge in Texas later ruled to suspend the pills approval, drawing appeals from the Biden administration and mifepristones manufacturer.The initial decision sparked concern from the broader biotech sector as some saw the case undermining the FDAs authority and potentially setting a precedent for any group to sue the FDA over controversial drug approvals. Biopharma leaders have spoken against the suit, which presents new risks for investors and companies working in reproductive health.The effect [of the mifepristone case] on biomedical research and development will be far bigger than womens health, said Davies. No corner of the health care industry will be untouched by such a destructive act to politicize a system and processes that are supposed to be grounded in data and evidence.The case has now made its way to the Supreme Court, which is expected to weigh in this spring on whether the pills availability should be limited. (In 2016, the FDA expanded the pills use from seven weeks gestation up to 10 weeks. A few years later in 2021, the agency allowed prescriptions to be delivered by mail.)While the challenge to mifepristone is particularly high profile, its not the first time an FDA decision in reproductive medicine has been challenged. The agencys recommendation to allow over-the-counter use of the Plan B emergency contraception pill was overridden by Barack Obamas Secretary of Health and Human Services in 2011. The FDA later approved OTC access after further litigation.The spotlight of the mifepristone case can cut two ways. While it presents the prospect of new legal risks for reproductive medicine, it also shows the need for safe and effective pharmaceutical solutions, said Bousleiman.More recently, the FDA took a similar step with the birth control pill sold as Opill, which last year the regulator approved as the first oral contraceptive available for OTC use.Success stories like this are important, especially when it comes to moving the needle on womens health investment and encouraging others to pursue a new wave of innovations that will benefit women, Duin said.A growing market?Among the most active areas of investment in womens health is whats termed femtech. These technology-centered companies operate within the healthcare sector, but focus on women-specific needs like fertility and pregnancy. Demand for such services soared after the Supreme Court overturned Roe v. Wade in 2022 and continued to fuel the sector last year.Femtechs growth could have knock-on effects for drug R&D. A lot of these digital health companies are calling out the fact that women's health has been so neglected, Bousleiman said. So it might [also] be bringing investor attention back to the R&D side, because not all women's health issues can be solved with an app or by seeing a provider.R&D investment does seem on the upswing. Across womens health, venture capital funding over the first nine months of 2023 was up by 8%, compared to the same period in 2022. Bousleiman says that, compared to the overall slowdown seen in life sciences last year, the womens health sector experienced something more akin to a speed bump.Investors are also seeing opportunities in womens health companies that arent focused on reproduction. In the third quarter of 2023, these companies saw a single-quarter record of $435 million invested, according to SVBs report. Although the amount pales in comparison to the funding typical of biotech more broadly, the data suggest a positive trend.Success begets success and dollars will follow that, Johnson said.Buy-in from investors can pay back more than some might think. While only about 1% of R&D is invested in female-specific conditions outside of oncology, Johnson says this still led to a large number of drugs that generate more than $500 million in annual revenue.In the U.S., women make many of the healthcare buying and usage decisions, according to the consultancy Oliver Wyman. Additionally, working women in the U.S. spend about $15 billion more than men on out-of-pocket healthcare costs per year, per a report from Deloitte. The additional spending is partly due to pregnancy-related costs, but also because women are more likely to seek out treatments than men and are more likely to be misdiagnosed.A health care system that doesnt work for all people is literally detrimental to U.S. economic growth and prosperity, said Davies. Investors, of course, are concerned with their returns on investment, and also must pay close attention to the health of the larger economic environment.Looking aheadAcross all sectors, venture investment in womens health has more than quadrupled since 2018, per SVB, compared to a 28% increase in healthcare investment broadly. Acquisitions have picked up as well, with 15 companies acquired over the past two years, more than in the four prior years combined.Still, the downturn in the life sciences market has affected the field, with less money invested and fewer exits, such as IPOs or acquisitions, in 2023 than in 2022. Since the life sciences is a capital-intensive field, partnerships with larger companies can help bridge the gap. Organon and Dare partnered in 2022 to bring Dares gel for bacterial vaginosis to market, for example.Womens health companies, like all of biotech, also need to appeal to generalist investors who can provide more funding as companies advance. During a recent webinar, Bousleiman pointed to hopeful signs on that front. We've seen some really impressive activity by these types of firms this year, and believe it'll lead to more investor interest in the space.The Biden administrations new womens health initiative could further help. Launched Nov. 13, the program requires relevant agencies to deliver recommendations on how to advance research in womens health within 45 days. Perhaps relatedly, one week later the FDA announced plans to hold, with the Duke-Margolis Center for Health Policy, a workshop on developing drugs to prevent preterm birth.Organon CEO Kevin Ali has said his company is ready to contribute to the administrations initiative.Well undoubtedly see the impact of this push coupled with further investment in womens health innovation involving academic scientific research, patient organizations, philanthropic leaders, VCs and industry R&D stakeholders on the overall womens health market, added Organons Duin.Executives and investors are optimistic further investment in womens health could be forthcoming. It's about time and I think all the right pieces are in place, said Johnson. '