Emergent BioSolutions, Inc.

GAITHERSBURG, Md., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) will host a conference call on Wednesday, November 6, 2024, at 5:00 pm eastern time to discuss the financial results for the third quarter of 2024, recent business developments, and financial outlook for full year 2024. Webcast & Conference Call InformationParticipants can access the conference call live via webcast. To join via telephone, please use the following dial-in details: U.S. / New York: +1-646-968-2525U.S. & Canada (Toll Free): +1-888-596-4144Conference ID: 5259189 A replay of the call can be accessed from the Investors page of Emergent’s website. About Emergent BioSolutionsAt Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com

Bavarian Nordic’s mpox vaccine Jynneos generated a similar immune response in adolescents as it did in adults, offering encouraging results that suggest the shot would be similarly effective. The new data were reported Wednesday by NIH, which ran the Phase 2 study. The vaccine, first approved to prevent smallpox, secured FDA emergency use authorization for mpox in August 2022. Health agencies around the globe have only greenlit the shot in adults, but the World Health Organization says it may be used off-label in areas with high need. The study is testing two doses of the vaccine in children ages 12 to 17 and comparing the data to adults 18 to 50. The new data assessed antibody levels two weeks after the second dose and monitored safety for 180 days after the second dose. The NIH found that the overall frequency of side effects was similar between the two groups and that while children reported higher rates of dizziness, the figures were comparable to other vaccines administered to adolescents. The company already snagged European approval last month based on non-inferiority data. The company said then that it was the first time the vaccine had won an adolescent approval. Another trial testing the vaccine in kids ages 2 to 12 is set to start soon. A record of the trial in a federal database says it has yet to begin recruiting, though Bavarian Nordic previously said it expected to start in October. The estimated study start time is Wednesday, according to the trial record. Jynneos is one of just a handful of vaccine options that have been relied upon to stem the latest swell of cases in Africa. Emergent BioSolutions has donated tens of thousands of doses of its vaccine to nations where cases were on the rise. That shot, ACAM2000, is not approved for mpox, but is used against smallpox, part of the same virus family. The first doses of Jynneos began to arrive in the Democratic Republic of the Congo in early September after the WHO declared a public health emergency of international concern. The biotech said then that more than 250,000 doses had been shipped and another 500,000 had been pledged by other countries. It expects to be able to provide up to two million doses by the end of the year.

Narcan nasal spray was made available over-the-counter by the FDA in March last year. Image credit: Shutterstock/ AnAdventureADa. Emergent BioSolutions has pledged to donate 20,000 doses of Narcan nasal spray (naloxone) to communities affected by opioid overdoses. Emergent said it is “working with businesses” to consider the availability of Narcan to sites including workplaces, facilities, and hospitality venues, amongst others, where accidental opioid emergencies could occur, as per an 8 October press release. The drive comes alongside the White House Challenge to Save Lives from Overdose, a nationwide initiative introduced by the Biden-Harris administration to increase training and access to opioid overdose reversal medications like Narcan. Emergent joined the Challenge in March this year as one of the main manufacturers of medication that treats opioid overdoses. An Emergent spokesperson confirmed to Pharmaceutical Technology that the donation is separate from the White House Challenge and builds upon the company’s existing donation programme. Narcan’s accessibility significantly increased last year when the US Food and Drug Administration (FDA ) approved the nasal spray for over-the-counter (OTC) use in March. At the time, it became the first opioid reversal medication available without the need for a prescription. Narcan generated $110m in revenue for Emergent in Q4 2023, up 22% from the year prior. See Also: FDA declines to approve Zealand Pharma’s hypoglycaemia therapy in infants Ipsen’s Elafibranor gains MHRA approval for PBC treatment Narcan works as an opioid receptor antagonist – it binds to opioid receptors and blocks the effects of opiates. The medication is recommended for use immediately after a suspected or known overdose of an opioid has occurred. Emergent has handed out more than 2,700 opioid emergency kits containing one carton of Narcan nasal spray and educational resources across several college campuses and public venues. As part of its inclusion in the White House’s Challenge, the biopharma has installed more than 40 opioid emergency wall units near first aid stations and automatic external defibrillators in its offices and facilities, along with providing 1,300 cartons of the medication to its employees this year. There are more than 80,000 deaths in America related to opioid overdose each year. However, for the first time, data points to the first meaningful decline in opioid overdose deaths – putting a stop to a death rate that had increased by more than 250% from 1999 to 2019. The Centers for Disease Control and Prevention (CDC), which reported the data , did not provide reasons for the downturn, but the decrease in deaths coincided with the availability of Narcan, along with other approved opioid overdose treatments. Emergent’s CEO Joe Papa said: “It is promising to see the recent decline in opioid overdose deaths for the first time in years.” Papa added the company remains “committed to playing [its] part in bringing down the number of opioid-related deaths by continuing to expand access efforts through the OTC availability of Narcan”. The news comes at a time when many of the lawsuits against drug manufacturers of prescription opioids are being settled . These include companies and pharmacy chains that have been accused of deceptive marketing practices, downplaying addiction risks and oversupplying prescription drugs. One of the largest opioid settlements to date included Johnson & Johnson , AmerisourceBergen , Cardinal Health and McKesson – together agreeing to pay $26bn to seven states in 2021. Pharmaceutical companies are also beginning to shift away from opioid-based pain medications, with several companies developing non-opioid candidates to manage pain including Vertex Pharmaceuticals and Lexicon Pharmaceuticals . Emergent meanwhile has been helping fight a different public health concern in the infectious disease space. The company won FDA approval to use its smallpox vaccine for the prevention of mpox in August, making it one of only two vaccine manufacturers against the disease, alongside Bavarian Nordic .