Encephalitis, Arbovirus

12 month contract focused on the development of new antiviral drugs Novel candidates to be produced using Kimer Med's broad-spectrum antiviral platform 95% of viral diseases lack an approved antiviral treatment Download high resolution images here: NELSON, New Zealand, March 7, 2024 /PRNewswire/ -- Kimer Med, a New Zealand-based biotech start-up, today announced it has signed a contract valued at up to USD$750,000 (NZD$1.3 million) with Battelle, the world's largest independent, nonprofit research and development organisation. The 12 month contract is funded by the United States government through the Defense Threat Reduction Agency (DTRA), and will fall into Battelle's Accelerated Therapeutics for Combating Acute Viral Epidemics programme. The contract is focused on the discovery and development of new antiviral drug candidates for the treatment of alphaviruses. Spread mostly by infected ticks and mosquitoes, alphaviruses cause significant human and animal disease. Infections that result in encephalitis - inflammation and swelling of the brain - are often fatal and can cause ongoing neurological problems. There is currently no effective antiviral treatment for alphavirus infection. "Approved antiviral drugs are currently available for only 11 out of more than 200 viruses that cause widespread sickness, suffering and death in humans," said Kimer Med's CEO, Rick Kiessig. "Our mission is to change that. We're developing a family of broad-spectrum antivirals capable of treating many of these infections." "This contract is an important milestone for Kimer Med, as it provides another opportunity to prove the capability of our platform for rapid, broad-spectrum antiviral development," said Kiessig. Since the company's launch in 2020, Kimer Med has developed antivirals that have shown in vitro efficacy against 11 different viruses, including the priority viruses Dengue (all four serotypes) and Zika. Their technology holds significant promise to deliver vital broad-spectrum antiviral treatments with a range of applications, including: Infectious diseases: Half the world's population is at risk from mosquito-borne viral infections for which there are no antiviral treatments available. Pandemic protection: Vaccines will not be ready and waiting when the next pandemic occurs, but broad-spectrum antivirals can be stockpiled for early protection. Military use: Broad-spectrum medical countermeasures to protect military personnel against a range of existing and emerging viral threats. Healthcare and First Responders: Vital protection for frontline health workers and other first responders in the event of viral outbreaks, especially when the pathogen is unknown. "With broad-spectrum antivirals, we have within our grasp the potential to revolutionise the treatment and prevention of viral infections in the way that penicillin did for bacterial infections. We're looking forward to working with such a highly-regarded and well-resourced organisation as Battelle to advance antiviral drug candidates that will be able to treat these alphaviruses, and hopefully a range of other viruses as well," said Kiessig. About Battelle Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit . About Kimer Med Founded by Rick Kiessig and Phil Oliver in 2020, Kimer Med is a biotech start-up, based in Nelson, New Zealand. Backed by a multi-million dollar seed funding round, the company has designed a platform for the rapid development of novel, broad-spectrum antivirals. Kimer Med launched a Series A capital raise in September 2023 to progress development of their lead antiviral candidate through to Phase 1 clinical trials. For more information, visit . SOURCE Kimer Med

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ® Recommendation for use in travelers and laboratory workers follows U.S. Food and Drug Administration (FDA) approval in November 20231IXCHIQ® is the first and only vaccine approved to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the chikungunya virus Saint-Herblain (France), February 29, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged >65 years and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV. Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya poses a significant risk to individuals journeying to or residing in regions where the chikungunya virus and its mosquito vectors thrive. IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties. We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population. We will continue collaborating with regulatory authorities worldwide to increase the accessibility of IXCHIQ® across regions.” The ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR) to advise healthcare providers on appropriate use of the vaccine. About ChikungunyaChikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite2. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 20323. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries4. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas5 and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat. To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA15536. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 20197, which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program. Regulatory review by the Brazilian authority ANVISA is ongoing. About IXCHIQ®In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies. Please click here for full Prescribing Information for IXCHIQ®. About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 7099laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D.VP Global Investor RelationsM +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the approval and use of products and product candidates. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva2 Staples, J.E. Hills, S.L. Powers, A.M. "Chikungunya." In CDC Yellow Book 2020: Health Information for International Travel, by Centers for Disease Control and Prevention. New York: Oxford University Press, 20203 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 20204 https://www.who.int/news-room/fact-sheets/detail/chikungunya5 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.6 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries7 CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine Attachment 2024_02_28_IXCHIK_ACIP_Recommendation_PR_EN_Final

Biological E. Limited (BE) to Manufacture Up to 50 Million Doses of QDENGA Per Year, Accelerating Takeda’s Ability to Deliver 100 Million Doses Per Year by 2030 At the Latest Addresses the Specific Need to Offer Multi-Dose Vials for National Immunization Programs to Help Protect the Most Vulnerable Populations Dengue Incidence Continues to Increase and Poses a Growing Threat to Public Health Worldwide CAMBRIDGE, Mass. & HYDERABAD, India--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments in endemic countries by 2030 at the latest to support National Immunization Programs. MDVs offer economic and logistical advantages for National Immunization Programs by minimizing packaging and storage expenses, while also reducing medical and environmental waste. BE will ramp up to a manufacturing capacity of up to 50 million doses a year, accelerating Takeda’s efforts to manufacture 100 million doses a year within the decade. The partnership will build upon existing manufacturing capacity for the vaccine at Takeda’s facility in Singen, Germany and Takeda’s long-term partnership with IDT Biologika GmbH. This press release features multimedia. View the full release here: “Takeda's long-term goal for our dengue program has been to make QDENGA broadly available to those at risk who may benefit from immunization. Within the last year, we've successfully launched in private markets, are now launching in some public programs, and working with partners to support a broader public health impact," said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda. "We are proud to announce a strategic manufacturing partnership with Biological E. Limited, which has deep expertise in vaccine manufacturing and longstanding support of public health programs around the world. Together, we will help combat dengue on a global scale by significantly increasing manufacturing capacity for multi-dose vials of QDENGA to drive sustainable access to the vaccine in more endemic countries." Dengue fever is among the most common mosquito-borne viral diseases worldwide, with global incidence rates increasing 30-fold over the last 50 years due to urbanization, travel and climate change.1,2 Dengue is currently endemic in more than 100 countries and causes an estimated 390 million infections each year.3 The Americas, South-East Asia and Western Pacific regions are the most seriously affected, with Asia alone representing ~70% of the global burden of disease.3 “We are proud to collaborate with Takeda in the production of their groundbreaking Dengue Tetravalent Vaccine, QDENGA, in multi-dose vials,” affirmed Ms. Mahima Datla, managing director at Biological E. Limited. “Takeda’s commitment to patient-focused, value-based research and development aligns extremely well with our dedication to advancing healthcare. We are fortunate to have created an institute that attracts such strong global partners for complex vaccines and underscores our shared mission of shaping a healthier future for all. With Takeda’s esteemed history and global presence, we are honored to advance our vision of delivering highly innovative medicines and transformative care worldwide.” QDENGA is currently available for children and adults in the private market in countries in Europe, Indonesia and Thailand, and in private and some public programs in Argentina and Brazil. TAK-003 is not approved for use in India. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . About Biological E. Limited Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved Generic Injectables in its portfolio. Recently, BE has received Emergency Use Listing (EUL) from the WHO for CORBEVAX®, the COVID-19 vaccine. In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market. For further details, please visit and follow us on Facebook, LinkedIn and Twitter. About QDENGA® ▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) QDENGA® (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to help protect against any of these serotypes. In the European Union (EU) Member States, QDENGA is indicated for the prevention of dengue disease in individuals from four years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen. The indications for use of QDENGA may vary in different countries/regions. The use of QDENGA should be in accordance with local recommendations. Important Safety Information Please consult the Summary of Product Characteristics (SmPC) before prescribing. Guidance for use: QDENGA should be administered by subcutaneous injection preferably in the upper arm in the region of deltoid. QDENGA must not be injected intravascularly, intradermally or intramuscularly. Vaccination should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in a deferral of vaccination. Vaccination should be preceded by a review of the individual’s medical history (especially with regards to previous vaccination and possible hypersensitivity reactions which occurred after vaccination). Appropriate medical treatment and supervision must always be readily available in the event of a rare anaphylactic reaction following administration of the vaccine. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. A protective immune response with QDENGA may not be elicited in all vaccinees against all serotypes of dengue virus and may decline over time. It is currently unknown whether a lack of protection could result in an increased severity of dengue. It is recommended to continue personal protection measures against mosquito bites after vaccination. Individuals should seek medical care if they develop dengue symptoms or dengue warning signs. Contraindications: Hypersensitivity to the active substances or excipients listed, or to previous QDENGA dose. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. Pregnant and breast-feeding women. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 of the SmPC for how to report adverse reactions. Adverse Reactions: Most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common: (≥1/10 of subjects): upper respiratory tract infectiona, decreased appetitec, irritabilityc, headache, somnolencec, myalgia, injection site pain, injection site erythema, malaise, asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitisb, arthralgia, injection site swelling, injection site bruisinge, injection site prurituse, influenza like illness. aIncludes upper respiratory tract infection and viral upper respiratory tract infection. bIncludes pharyngotonsillitis and tonsillitis. cCollected in children below 6 years of age in clinical studies. dIncludes rash, viral rash, rash maculopapular, and rash pruritic. eReported in adults in clinical studies. Refer to the SmPC for details on full side effect pro interactions. For full prescribing information, please see the Summary of Product Characteristics (SmPC) for QDENGA®▼. Please consult with your local regulatory agency for any approved labeling in your country. The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development. About Dengue Dengue is a mosquito-borne viral disease that spreads rapidly around the world and was one of the WHO’s top 10 threats to global health in 2019.3,4 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes.3 It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.5 The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.6 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.3,7 Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. ______________________________ 1 Ebi KL, Nealon J. Dengue in a changing climate. Environmental Research. 2016;151:115-123. doi:10.1016/j.envres.2016.07.026. 2 Messina, J.P., Brady, O.J., Golding, N. et al. The current and future global distribution and population at risk of dengue. Nat Microbiol 4, 1508–1515 (2019). . 3 World Health Organization. Dengue and Severe Dengue. World Health Organization. . Published March 17, 2023. 4 World Health Organization (WHO). Ten threats to global health in 2019. Retrieved July 2023. 5 CDC. About Dengue: What You Need to Know. Published April 13, 2023. 6 Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16. 7 Reich, et al. Interactions between serotypes of dengue highlight epidemiological impact of cross-immunity. J R Soc Interface 10: 20130414. . View source version on businesswire.com: Contacts Takeda Media Contacts: Japanese Media Maiko Miura maiko.miura@takeda.com U.S. and International Media Charlotte McCormack charlotte.mccormack@takeda.com Biological E. Limited Media Contact: K. Vijay Amruth Raj Vijay.Kammari@biologicale.com +91 83740 77433 Source: Takeda Pharmaceutical Company Limited View this news release online at: