UB-621

DUBLIN, Aug. 8, 2022 /PRNewswire/ -- The "Genital Herpes Treatment Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global genital herpes treatment market is expected to grow at a CAGR of 3.76% during 2022-2028 The global genital herpes treatment market is segmented based on drug type, distribution channel, virus type, route of administration, and geography. The Acyclovir segment reported a significant share of around 50.44% among all drug types. The Acyclovir is the leading segment due to availability in all three major routes of administration. The key player in the genital herpes treatment GSK has the branded drug Zovirax. Acyclovir is the oldest drug in the antiviral category and has many generic versions of Zovirax available on the market. The Retail pharmacies segment reported a significant share of around 49.79% among all distribution channels. The retail pharmacy segment is showing the highest share due to the availability of branded and generic versions of all antiviral drugs in retail pharmacies. People who have genital herpes is most referred to go to nearby retail pharmacy outlet for anti-genital herpes treatment because of the stigma related to sexually transmitted diseases. The HSV-2 segment reported a major share of around 84.10% among all virus types. HSV-2 is the leading virus type segment as HSV-2 is the leading cause of genital herpes. According to WHO data published in 2022, an estimated 491 million (13%) aged 15-49 years were suffering from infections worldwide in 2016. More women than men are infected with HSV-2. Among all routes of administration, the oral segment reported a major share of around 64.03%. Mostly all the anti-genital herpes drugs are available in an oral formulation. Chronic suppressive doses of oral antivirals, including Acyclovir (Zovirax), valacyclovir (Valtrex), and famciclovir, have significantly reduced the incidence of clinical recurrence and the rate of asymptomatic excretion. Oral administration of Acyclovir effectively suppresses recurrent genital herpes. Daily administration of Acyclovir reduces the recurrence rate by up to 80%, and 25-30% of patients have no further recurrence while taking the drug. North America is the major revenue contributor to the global genital herpes treatment market, with a share of more than 40%. In North America, the US is the key revenue contributor mainly due to an increase in the demand for genital herpes drugs reflecting the growing awareness of various antiviral drugs and their benefits against different STIs, including genital herpes. Europe is the second-largest regional market and is witnessing steady growth owing to increasing acceptance of both branded and OTC antiviral drugs for treating genital herpes. However, APAC is likely to see faster growth than all other regions. Around 1 in every ten people in APAC are infected with HSV-2, which majorly causes genital herpes. The APAC region is witnessing high demand for off-label, generic, and OTC drugs for treating genital herpes. The region has many regional and local vendors offering generic and OTC antiviral drugs, which are majorly used for treating genital herpes. Promising Investigational Therapies for Treating Genital Herpes Researchers have been working on the development of herpes vaccines for decades. Several clinical trials have been conducted to test therapeutic (to reduce recurrence and viral shedding in people already infected with HSV) and prophylactic (to prevent infection) drug candidates. mRNA-1608 a Moderna's HSV vaccine candidate is a vaccine candidate against HSV-2 infection. Moderna believes that an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, the Company intends to bring a strong antibody reaction with neutralizing and effector functionality shared with cell-mediated immunity. HSV 2 Vaccines, RVx-201, NE HSV-2 Vaccine, HDIT 101, Pritelivir, UB-621, and other critical Genital Herpes pipeline medicines are in various stages of clinical trials for the treatment of Genital Herpes. Sanofi, Rational Vaccines, BlueWillow Biologics, Heidelberg ImmunoTherapeutics, AiCuris, and United Biopharma are some of the most well-known pharmaceutical companies active in the field. X-Vax Technology announced in May 2021 that it is preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its experimental herpes simplex virus 1 and 2 vaccines (HSV-1 and -2). The FDA granted AiCuris Breakthrough Therapy Designation for Pritelivir to treat HSV infections in immunocompromised patients in June 2020. Increasing Demand for Genital Herpes Treatment by Homosexuals Homosexual acceptance increased by double digits between 2002 and 2019. This includes a 21-point increase in South Africa since 2002 and a 19-point increase in South Korea over the same period. India has also seen a rise of 22 points since 2014. MSM groups are at increased risk of HIV and other STIs due to sexual networks, the number of concurrent partners, and behavioral or biological factors such as condom-less sex, anal sex, drug use, etc. MSM are vulnerable demographics to spreading STIs. While anyone having sex can get an STD, the sexually active LGBT population, including gay, bisexual, and MSM, are at greater risk. In addition to getting higher rates of HSV, more than half of all new HIV infections happen among MSM. Many aspects contribute to the higher rates of STIs among MSM. Growing Burden of Sexually Transmitted Diseases As the latest data from WHO, an expected 3.7 billion individuals younger than 50, or 67% of the populace, in 2016 had HSV-1 contamination (oral or genital). The assessed predominance of the contamination was most elevated in Africa (88%) and least in the Americas (45%). Genital herpes caused by HSV-2 is a global problem. According to WHO data published in 2022, an estimated 491 million (13%) aged 15-49 years suffered from infections worldwide in 2016. More women than men are infected with HSV-2. In 2016, an estimated 313 million women and 178 million men lived with the infection. This is because male-to-female sexually transmitted HSV is more efficient than female-to-male sexual transmission. Genital herpes is a worldwide issue, and an expected 491 million (around 13%) individuals between 15 and 49 years suffer from this STD. In 2016, around 313 million women and 178 million men had genital herpes. This is because sexual transmission of HSV is more proficient from men to ladies than from ladies to men. The pervasiveness of HSV-2 disease was assessed to be most noteworthy in Africa (44% in ladies and 25% in men), trailed by the Americas (24% in ladies and 12% in men). Key Vendors GlaxoSmithKline Glenmark pharmaceuticals Viatris Novartis Teva Pharmaceuticals Bausch Health Companies Other Prominent Vendors Reddy's Laboratories Cipla Pfizer Eli Lilly & Company Avet Pharmaceuticals Aurobindo Pharma Centurion Remedies Abbott Macleods Pharmaceuticals FDC Hetero Zydus Group Torrent Pharma Finecure Pharmaceuticals ADLEY FORMULATIONS Medico Remedies Zeelab Pharmacy Key Topics Covered: 1 Research Methodology 2 Research Objectives 3 Research Process 4 Scope & Coverage 4.1 Market Definition 4.2 Base Year 4.3 Scope of the Study 5 Report Assumptions & Caveats 5.1 Key Caveats 5.2 Currency Conversion 5.3 Market Derivation 6 Market at a Glance 7 Introduction 7.1 Overview 7.1.1 STI Control Health Policy Agenda 7.1.2 Global Prevalence of HSV Infections 7.1.3 Risk of HIV and Genital Herpes Among the LGBTQ+ Community 8 Market Opportunities & Trends 8.1 R&D of Genital Herpes Vaccine Candidates 8.2 Rise in Genital Herpes Cases in LGBTQ+ Community 8.3 Market Growth Potential in Low-Middle-Income Countries 8.4 Increased Online Purchase of Genital Herpes Therapeutics 9 Market Growth Enablers 9.1 Increased Burden of STDs 9.2 Awareness of STIs 9.3 Demand for Topical Genital Herpes Treatment Drugs 10 Market Restraints 10.1 Social Stigma Associated With STDs 10.2 Side Effects & Adverse Reactions to Genital Herpes Medications 10.2.1 Risks Associated With Valacyclovir 10.3 Limitations of Genital Herpes Treatment Medications 11 Market Landscape 11.1 Market Overview 11.2 Market Size & Forecast 11.3 Five Forces Analysis 12 Drug Type 12.1 Market Snapshot & Growth Engine 12.2 Market Overview 12.3 Acyclovir 12.4 Valacyclovir 12.5 Famciclovir 12.6 Other Drugs 13 Distribution Channel 13.1 Market Snapshot & Growth Engine 13.2 Market Overview 13.3 Retail Pharmacies 13.4 Hospital Pharmacies 13.5 Online Pharmacies 14 Virus Type 14.1 Market Snapshot & Growth Engine 14.2 Market Overview 14.3 HSV-2 14.4 HSV-1 15 Route of Administration 15.1 Market Snapshot & Growth Engine 15.2 Market Overview 15.3 Oral 15.4 Topical 15.5 Injection 16 Geography 16.1 Market Snapshot & Growth Engine 16.2 Geographic Overview For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Taipei, Taiwan – July 13th, 2021 –United BioPharma (UBP) announced today that its subsidiary company in Shanghai (China) has received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for a larger Phase 2 clinical trial with UB-621, an anti-HSV (Herpes Simplex Virus) monoclonal antibody, to evaluate its safety and efficacy in adults with recurrent Genital Herpes (RGH). Earlier in an open label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous (SC) injection of UB-621 at doses ranging from 0.1mg/kg to 5mg/kg. In particular, UB-621 was found to have a remarkably long half-life of approximately 25.3 days. The first phase 2 IND for a randomized, single-blinded, placebo-controlled study with single dose of UB-621 was approved by NMPA in late 2020. The current phase 2 study is further optimized with a larger number of trial subjects treated with repeat doses of UB-621, and with clinical-relevant endpoints that will support the subsequent phase 3 trial should the results of this new study meet the preset safety and efficacy targets. Genital Herpes (GH) disease is a life-long HSV-2 infection of the genitalia and urogenital tract. It is one of the most common sexually transmitted infections and is a leading cause of genital ulcers around the world. Patients with genital herpes often suffer from recurring episodes of symptom outbreaks, which usually involve painful ulcerations. Genital Herpes has been viewed as a significant global public health problem, as it can also intensify and exacerbate the transmission of human immunodeficiency virus 1 (HIV-1). Currently, there are no effective vaccines against HSV and most of current medications for genital herpes are generic nucleoside acyclovir analogues. Although there are several approved antiviral agents for treatment of GH outbreaks and for suppressive therapy, these antivirals are not always effective and could result in the development of drug resistance. Therefore, new interventions for effective prophylactic and therapeutic purposes are still in need. It has been reported that more than 50% of recurrent GH patients under daily long-term suppressive therapy with small molecule drugs experience at least one recurrent episode every year. Although resistant HSV infection is not common (0.1~0.6%) in immunocompetent patients, the prevalence increases to 3.5~10% in immunocompromised patients. Drug-resistant HSV infections may be treated with foscarnet, but this drug is known to its narrow therapeutic window and nephrotoxicity. UB-621 is a novel, fully human monoclonal antibody that interferes with HSV infection by binding specifically to HSV envelope glycoprotein D (gD). It can neutralize both wild type HSV lab strains and multi-drug-resistant clinical isolates. Our pre-clinical and early clinical data show that UB-621 has the potential to suppress recurrence of genital herpes. About UB-621 UB-621, a fully human IgG1 monoclonal antibody, functions to block viral entry through binding to the surface envelope glycoprotein D (gD) of HSV, type I and type II. UB-621 has been demonstrated to exhibit a high-affinity binding (Kd, 3.6 × 10-11 M) to gD protein and a high potency against both HSV-1 and HIV-2 infections. UB-621 also shows capability to inhibit cell-to cell spread of HSV-1 and HSV-2. Results in virus plaque reduction assays demonstrated that UB-621 is not only more potent than acyclovir (ACV) in inhibiting clinical HSV isolates of American and Asian origins, but also exerts marked neutralization activity towards ACV-resistant HSV strains from various sources. HSV disease animal model studies show that UB-621 exhibits both prophylactic and therapeutic activities, and can reduce severity of genital HSV-2 infection. In HSV-1 infected mice model, UB-621 can prevent virus transmission from eye infection site to neuron and to brain region. A subcutaneous (SC) liquid formulation of UB-621 has been demonstrated safe and well tolerated in healthy volunteers in a Phase I study. UB-621 exhibits a long half-life of approximate 25 days, which may allow a monthly or quarterly dosing scheme to treat HSV infection. UB-621 is entering a Phase II clinical study with patients suffering from recurrent genital herpes. About Recurrent Genital Herpes Genital herpes is a common sexually transmitted disease (STD) caused by herpes simplex virus type 1 or 2, but most are infected by herpes simplex virus type 2. There are approximately 500 million genital herpes patients around the world, 38% of them may have 6 or more recurrences per year and 20% of them may have more than 10 recurrences during the first year. When symptoms occur, small blisters are usually produced around the genitals or anus, and then the blisters break into superficial ulcers that become painful. Superficial ulcers would heal within about two to four weeks without leaving scars. However, symptoms of genital herpes may recur after weeks or months. About United BioPharma United BioPharma (UBP) is a clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to research, development and manufacturing of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou, China, and liaison offices in the U.S. The company has a global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the patients. For more detailed information, please visit the website at: http://www.unitedbiopharma.com United BioPharma Forward-Looking Statements The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements. News Contact: Dr. Mei June Liao, Executive Vice President, Product Development +886-3-5979288 # 6700 meijune.liao@unitedbiopharma.com