Polypoidal choroidal vasculopathy

The partnership between Sanofi and SK bioscience dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.\n Sanofi is handing SK bioscience 50 million euros ($52 million) as the longtime partners take their next-gen pneumococcal conjugate vaccine program into phase 3.The move follows a phase 2 win last year for the candidate, a 21-valent pneumococcal conjugate vaccine previously called GBP410 and now renamed PCV21, which demonstrated comparable immunogenicity to a control vaccine.By including 21 serotypes, the partners aim to offer broader coverage than the current approved pneumococcal conjugate vaccines for children. Sanofi announced Monday morning that it has now launched the shot into a phase 3 study, making it the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a late-stage study in infants and toddlers.Sanofi and SK will co-fund the research and development costs, with Sanofi also paying SK the 50 million euro upfront fee. An undisclosed amount of development and commercial milestone payments could follow. Should PCV21 make it to market, Sanofi will commercialize the vaccine worldwide, except for in SK’s home turf of South Korea.“Given the vast unmet public health needs in [invasive pneumococcal disease], we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV,” Thomas Triomphe, Sanofi\'s head of vaccines, said in the Dec. 23 release.“Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease,” Triomphe added. The partnership between Sanofi and SK dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.There are currently two FDA-approved pneumococcal vaccines for children—Merck & Co.’s 15-valent Vaxneuvance and Pfizer’s 20-valent Prevnar 20.Sanofi isn’t the only Big Pharma hoping to expand the range of serotypes available in pneumococcal vaccines. GSK had been working on a 24-valent candidate acquired via its $2.1 billion acquisition of Affinivax but revealed in October that it had axed the asset. In June, Merck’s 21-valent Capvaxive became the first pneumococcal vaccine specifically designed for adults to receive FDA approval.Then, in September, Vaxcyte unveiled what analysts called “stunning” phase 1/2 data in adults for its 31-valent candidate that, if replicated in a large pivotal study, could pose a serious threat to Prevnar 20. A separate phase 2 trial of Vaxcyte’s shot in infants has recently launched.

PARIS, France I December 23, 2024 . Sanofi and SK bioscience have entered into a new chapter of their collaboration in pneumococcal vaccines with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations, reaffirming their commitment to fighting pneumococcal disease. Despite decades of public health vaccination programs, invasive pneumococcal disease (IPD) continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes. This expansion builds on the companies’ existing collaboration to develop and commercialize a PCV21 pediatric vaccine, for which the phase 3 clinical program commenced last week. This vaccine candidate is the first-ever PCV containing more than 20 serotypes to enter a phase 3 clinical study in infants and toddlers. Thomas Triomphe Executive Vice President, Vaccines, Sanofi “Given the vast unmet public health needs in IPD, we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.” Jaeyong Ahn CEO and President of SK bioscience “We’re thrilled about the expansion of our collaboration with Sanofi, which serves as the core of our strategy to develop new solutions to combat pneumococcal disease. The ongoing expansion of our state-of-the-art manufacturing base, cofinanced by Sanofi, will support launch of PCV21 and future next generation vaccines.” The PCV21 phase 3 program is based on positive phase 2 results communicated last year and will include more than 7,700 infants, toddlers, young children and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America. Under the terms of their expanded agreement, both companies will co-fund research and development costs . Sanofi will pay EUR 50M upfront to SK bioscience, followed by development and commercial milestone payments. Once registered, Sanofi will commercialize the vaccines worldwide except for South Korea, where SK bioscience will have commercial exclusivity. SK bioscience will receive royalty payments on product sales outside South Korea. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY SOURCE: Sanofi

SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Credit: SK bioscience. SK bioscience and Sanofi have expanded their agreement to jointly develop pneumococcal conjugate vaccines (PCVs) targeting both paediatric and adult populations. This partnership extension leverages their ongoing efforts with GBP410, a paediatric vaccine candidate entering Phase III trials. Under the new agreement, Sanofi will make an upfront payment of €50m ($52.1m) to SK bioscience, with additional potential milestones. Research and development expenses will be shared equally, whereas Sanofi will cover all commercialisation expenses. SK bioscience retains exclusive rights in Korea, with Sanofi handling other markets and paying royalties on international sales. Sanofi Vaccines executive vice-president Thomas Triomphe said: “Given the vast unmet public health needs in IPD, we’re delighted to extend this collaboration and continue our pursuit of innovative work in PCV. Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease.” The extended partnership includes the development of PCVs for adult use, aiming to provide comprehensive protection against pneumococcal infections. The initiation of the Phase III clinical programme for GBP410 marks it as the first candidate with over 20 serotypes in this trial phase for infants and toddlers. Phase III studies globally will assess the therapy’s safety and immunogenicity in more than 7,700 subjects who are aged six weeks to 17 years. The trials will involve up to four doses, based on the enrolment age. SK bioscience CEO Jaeyong Ahn said: “Our decision to develop next-generation PCVs and simultaneously initiate phase III clinical programme for GBP410 reflects the GBP410’s high potential for success, a promising market outlook, and our strong mutual trust. “As Korea’s leading company in the vaccine and bio-industry, we are committed to successfully bringing vaccines with blockbuster potential to market that will secure vaccine sovereignty, contribute to global health, and lead the global market.” In preparation for GBP410’s commercialisation, SK bioscience began expanding its ‘L House’ manufacturing facility at Andong, Gyeongsangbuk-do, South Korea in March, with Sanofi’s joint investment. The ground-breaking ceremony for L House took place in March 2024.