SAR-440894

Tasos Katopodis/Getty Images Emergent said the vaccine candidate against the mosquito-borne illness showed an increase in immune response as measured by anti-chikungunya virus SNA. Tasos Katopodis/Getty Images After months of bad news regarding COVID-19 vaccine manufacturing issues, Emergent BioSolutions posted positive two-year data related to its investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. This morning, Maryland-based Emergent announced its single-dose vaccine showing strong efficacy two years after the injection. In previous announcements, Emergent said the vaccine candidate against the mosquito-borne illness showed an increase in immune response as measured by anti-chikungunya virus serum neutralizing antibodies (SNA). Emergent said SNA mean titers were 19 times higher than pre-vaccination titers following that injection in the two-year follow-up. All subjects in the single-dose regimen remained seropositive at their one-year and two-year visits. Full results from the two-year follow-up will be published later, the company added. Emergent’s CHIKV VLP vaccine candidate received Fast Track designation from the U.S. Food and Drug Administration in 2018 and PRIME designation from the European Medicines Agency in 2019. Karen L. Smith, executive vice president and chief medical officer at Emergent BioSolutions, said she is pleased with the positive data from the Phase II CHIKV VLP study. The data presented at the International Society of Travel Medicine (ISTM) annual meeting last week is expected to be evaluated in a Phase III study later this year. “Chikungunya disease is a recognized public health threat for which no vaccine or treatment exists. As a leader in travel health and as a company that has tackled infectious diseases for decades as part of our mission – to protect and enhance life – Emergent is committed to meeting this significant unmet medical need,” Smith said in a statement. The chikungunya virus is a mosquito-borne illness found in more than 100 different countries globally, including the Caribbean and parts of the Americas. Viral symptoms include fever, joint pain, headache, muscle pain, joint swelling, or rash. The musculoskeletal pain is often debilitating and can last for months or even years. Mortality rates are not high with chikungunya, but more than 1.3 billion people live in areas where it is endemic, which can place a significant burden on healthcare facilities. Emergent isn’t the only company developing a drug for the chikungunya virus. Earlier this year, Germany’s Evotec SE began clinical development for a monoclonal antibody for the treatment and potential prevention of chikungunya virus infections. In January, Evotec launched a Phase I study assessing the safety, pharmacokinetics, and immunogenicity of EVT894 compared to placebo in healthy volunteers. EVT894, which was initially developed by Sanofi and out-licensed to Evotec in 2018 , is a fully human monoclonal antibody that targets a viral protein and has shown potent neutralizing activity in in vitro and in vivo models. Chikungunya isn’t the only mosquito-borne virus that threatens large portions of the globe. Other diseases like malaria, dengue, and Zika are also significant concerns. Earlier this week, Takeda released long-term safety and efficacy results from the ongoing pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial assessing its dengue vaccine candidate TAK-003. Data showed the vaccine provided 83.6% protection against the need for hospitalization and 62% overall efficacy against the virus. The protection levels are regardless of an individual’s previous dengue exposure, the company said. Also this week, researchers from the Francis Crick Institute and the Latvian Institute of Organic Synthesis announced a potential breakthrough in malaria , a disease caused by parasites transmitted through a mosquito bite. The scientific team developed a new compound that can block part of the life cycle of the parasite. The compound is designed to prevent the parasites from breaking out of the red blood cells where it makes its home after being transmitted into a person – halting the illness before it starts. Featured Jobs on BioSpace

SUCCESSFUL START TO 2021 WITH STRONG STRATEGIC POSITION AND LONG-TERM STRATEGY: ACTION PLAN 2025 "THE DATA-DRIVEN R&D AUTOBAHN TO CURES" GOOD PROGRESS WITHIN PRODUCT DEVELOPMENT PARTNERSHIPS AND CO-OWNED PORTFOLIO CONTINUED POSITIVE FINANCIAL PERFORMANCE; NO MATERIAL IMPACT THROUGH COVID-19 PANDEMIC HAMBURG, GERMANY / ACCESSWIRE / May 11, 2021 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced the financial results and corporate updates for the first quarter 2021. HIGHLIGHTS RECORD LIKE-FOR-LIKE GROWTH OF BASE BUSINESS, STRONG BALANCE SHEET SUPPORTS ACCELERATING GROWTH Group revenues from contracts with customers increased by 11% to € 133.1 m (Q1 2020: € 119.4 m); Base business growth of 28%, adjusted for the end of the Sanofi payment (since April 2020) and unfavourable fx effects EVT Execute revenue growth of 16% (11% adjusted for material recharges) to € 136.9 m (Q1 2020: € 118.2 m), EVT Innovate revenues up 21% (20% adjusted for material recharges) to € 28.2 m (Q1 2020: € 23.3 m) Just - Evotec Biologics grew by more than 60% to € 9.7 m (Q1 2020: € 5.9 m) Like-for-like growth of adjusted Group EBITDA of 16%, despite higher R&D expenses; adjusted Group EBITDA of € 21.1 m (Q1 2020: € 30.0 m) affected by the anticipated end of the Sanofi payment (since April 2020) and unfavourable fx effects Increased expenses for unpartnered R&D of € 14.9 m (Q1 2020: € 11.4 m) according to strategy Strong balance sheet with comfortable net debt position of € 56 m (equivalent to 0.6x EBITDA) provides significant room for financing further growth; non-operating result benefits from fair value adjustment of the investment in Exscientia Ltd. POSITIVE DEVELOPMENT WITH SEVERAL NEW AND EXPANDED PARTNERSHIPS; JUST - EVOTEC BIOLOGICS FURTHER GAINING MOMENTUM Multiple new and extended partnerships and alliances (e.g. with Annexon, Chinook Therapeutics, Related Sciences, Takeda, The Mark Foundation, ...) New development collaborations and INDiGO contracts signed (e.g. Riboscience, Step Pharma, ...) New iPSC- multi-year partnership with the Medical Center Hamburg Eppendorf ("UKE") Bristol Myers Squibb extend partnership in the field of targeted protein degradation Just - Evotec Biologics continuing on its success course: progress of the first J.POD (R) facility in Redmond on schedule; construction of first European "J.POD (R) 2 EU" expected to start in H2 2021 facility in Redmond on schedule; construction of first European "J.POD 2 EU" expected to start in H2 2021 Partnership on oncology project EVT801 with Kazia Therapeutics (after period-end) New BRIDGEs ("beLAB2122" and "beLAB1407" (after period-end)) Projects entering into clinical phases (EVT894 (Chik-V); Immuno-oncology project A2a receptor antagonist (Exscientia)) CORPORATE HIGHLIGHTS Implementation of next long-term strategic framework Action Plan 2025 "The data-driven R&D Autobahn to Cures" Chairman of the Supervisory Board of Evotec to retire from office effective as of the end of the Annual General Meeting on 15 June 2021 (after period-end) GUIDANCE FOR FULL-YEAR 2021 CONFIRMED Business outlook for 2021 confirmed and mid-term targets given for the first time Group revenues expected to be in a range of € 550 - 570 m (€ 565 - 585 m at constant exchange rates) (2020: € 500.9 m) Adjusted Group EBITDA expected to be in the range of € 105 - 120 m (€ 115 - 130 m at constant exchange rates) (2020: € 106.6 m) Unpartnered research and development expenses expected to be in a range of € 50 - 60 m (2020: € 46.4 m) INTRODUCTION OF MID-TERM GOALS ALIGNED WITH ACTION PLAN 2025 Introduction of mid-term goals until 2025 at Capital Markets Day on 20 April 2021, targeting revenues growth to > € 1,000 m, adjusted EBITDA of >= € 300 m and unpartnered research and development expenses of > € 100 m Given current global insecurities surrounding the COVID-19 pandemic, a likely negative impact - though less pronounced than in 2020 - is already estimated within the guidance for revenues and adjusted EBITDA stated above. Key figures of consolidated income statement & segment information Evotec SE & subsidiaries - First quarter of 2021 1) Adjusted for negative exchange rate effects of € 6.0 m, Group revenues amount to € 139.1 m 2) Of which unpartnered R&D expenses of € 14.9 m in Q1 2021 (Q1 2020: € 11.4 m) 3) Before changes in contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result 4) Revenues from material recharges of € 5.6 m are allocated to EVT Execute as of Q1 2021 5) Revenues from material recharges of € 0.3 m are allocated to EVT Innovate as of Q1 2021 More detailed information and financial tables are available in our interim statement for the first quarter published on the Evotec website under the following link: Webcast/Conference Call The Company is going to hold a conference call to discuss the results of the first quarter 2021 as well as to provide an update on its performance in the reporting period. The conference call will be held in English. Conference call details Date: Tuesday, 11 May 2021 Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT) From Germany: +49 69 20 17 44 220 From France: +33 170 709 502 From Italy: +39 023 600 6663 From UK: +44 20 3009 2470 From USA: +1 877 423 0830 Access Code: 94660964# A simultaneous slide presentation for participants dialling in via phone is available at . Webcast details To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event. A replay of the conference call will be available for seven days and can be accessed from Germany by dialling +49 69 201744221, from UK by dialling +44 20 3364 5150 and from USA by dialling +1 (844) 307-9362. The access code is 315614523#. The on-demand version of the webcast will be available on our website: . ABOUT EVOTEC SE Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,700 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to and follow us on Twitter @Evotec. FORWARD LOOKING STATEMENTS Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based. IR Contact Evotec SE: Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com SOURCE: Evotec AG View source version on accesswire.com: