Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)

24 September 2024 If approved, the fully liquid presentation will offer healthcare providers an option that does not require reconstitution of Menveo (MenACWY vaccine) before use Marketing authorisation in EU expected by November 2024 Over 6 million doses of GSK’s MenACWY vaccine have been distributed to European countries since 2017 to help protect against invasive meningococcal disease1 GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial groups A, C, W, and Y. If approved, this single-vial presentation will be licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use. Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: “As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunisation against bacterial meningitis, support vaccine uptake and help protect as many people as possible from this devastating disease. We will continue our efforts to help prevent this disease in at-risk populations in the European Union.” GSK’s submission to the EMA is based on two positive Phase IIb trials (2017-003692-61; 2017-003456-23).2,3 The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation. Today’s positive opinion marks one of the final steps prior to the potential extension of the marketing authorisation by the European Commission (EC). The EC’s final decision is expected by November 2024. IMD is an unpredictable but serious illness that can cause life-threatening complications.4 Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours.4 One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems.4 Although anyone can get IMD, babies, young children and those who are in their late teens and early adulthood are amongst the groups at higher risk.4 The original presentation of Menveo that requires reconstitution and which was approved by the EMA in 2010 is unaffected by this recommendation.5 About Menveo GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, with more than 82 million doses distributed worldwide since 2010.6,7 Over 6 million doses have been distributed to European countries since 2017.1 It offers evidence of immunogenicity with a well-characterised safety profile.8,9 In the European Union (EU), this vaccine has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in children from 2 years of age, adolescents and adults.10 EMA Prescribing Information for Menveo can be accessed at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like

Pictured: GSK's headquarters building in West London/iStock/Tati Campelo GSK announced in its first-quarter 2024 results Wednesday that it will raise the company’s full-year guidance on the heels of another positive sales quarter thanks to strong vaccine sales. The British pharma raked in £7.4 billion (nearly $9.2 billion) in total sales, marking a 10% increase from the first quarter of last year. GSK’s vaccine sector brought in £2.2 billion ($2.7 billion) in total sales in Q1, a 22% rise from the same period in 2023. GSK is now expecting 2024’s sales to grow at the upper end of its 5% to 7% forecast range. Its core operating profit growth for the year is expected to be in the 9% to 11%, up from 7% to 10%, and annual adjusted earnings per share of 8% to 10% which was previously set at 6% to 9%. Sales in Q1 of the company’s shingles vaccine Shingrix were £945 million ($1.1 billion), an 18% increase from the same quarter last year. GSK said that sales of Shingrix increased due to strong demand following public funding expansion in European and international markets. The vaccine also had new immunization programs in Australia, Europe, and the U.K. Markets outside the U.S. represented over 50% of global sales, as the vaccine is now available in 39 countries. Respiratory syncytial virus (RSV) vaccine Arexvy generated £182 million ($227.3 million) in sales, with £154 million ($192.3 million) coming from the U.S. while noting a demand decrease that was in line with “anticipated seasonality patterns.” The vaccine was also on the uptake in other markets, such as Canada, Saudi Arabia, and Brazil. Since its launch last year, Arexvy has dominated the U.S. RSV vaccine market and outperforming sales of Pfizer’s shot Abrysvo. Arexvy was accepted for priority review by the FDA in February 2024 to extend its indication to adults 50 to59 years of age at increased risk for RSV, a potential market that includes approximately 15 million Americans. A decision by the agency is expected in early June. GSK’s meningitis vaccines, Menveo and Bexsero, brought in £299 million ($373 million) in Q1 due to a higher international demand for Menveo while Bexsero saw increased demand in Australia and launched in Vietnam. The specialty medicines sector for GSK grew 17%, pulling in £2.5 billion ($3.1 billion) in sales. The company’s HIV medicines were also a primary earner, posting £1.6 billion ($1.9 billion) in profit, a 14% bump from Q1 last year. “Together with other R&D achievements, mean we have strengthened prospects for growth in all of our key therapeutic areas this quarter: infectious diseases, HIV, respiratory/immunology and oncology,” GSK CEO Emma Walmsley said in a statement. “We expect this strong momentum to continue, and look forward to delivering another year of meaningful growth in sales and earnings in 2024.” The pharma is also involved in several legal battles, including litigation related to the heartburn medication Zantac and its alleged cancer link. According to GSK, it encountered “significant legal charges” in Q1 related to its defense in the Zantac litigation. In February 2024, the company reached a confidential settlement in one case but multiple trial dates have been set in other courts. GSK said that it cannot “meaningfully assess” what liability it may have. GSK is also suing Pfizer and BioNTech, alleging that the two companies have infringed on patents related to the mRNA technology in their COVID-19 vaccine Comirnaty. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.