Tristan Cesar Mañalac’s Post

📢 More News in Pharma GSK has signed a licensing agreement worth up to €1.4bn with CureVac to develop mRNA vaccines for flu, Covid-19, and avian flu. The deal includes an initial €400mn payment and potential milestone payments of €1.05bn, plus royalties. This agreement will allow GSK to develop combination vaccines for flu and Covid-19, positioning them against competitors like Moderna, Pfizer, and BioNTech SE. CureVac, who are facing commercialisation challenges and a significant drop in shares, will benefit from this cash injection and shift focus to early-stage oncology vaccines, cutting 30% of its workforce to save €25mn annually (𝐢𝐟 𝐲𝐨𝐮 𝐚𝐫𝐞 𝐞𝐟𝐟𝐞𝐜𝐭𝐞𝐝 𝐛𝐲 𝐭𝐡𝐢𝐬 𝐆𝐄𝐓 𝐈𝐍 𝐓𝐎𝐔𝐂𝐇 𝐖𝐈𝐓𝐇 𝐌𝐄). GSK will fully control vaccine development, enhancing its capabilities against evolving flu and Covid-19 variants. GSK's Chief Scientific Officer, Tony Wood, expressed enthusiasm for the partnership's potential to set new standards in mRNA vaccines. CureVac CEO, Alexander Zehnder, MD, MBA, emphasised the strategic shift to ensure long-term success despite the difficult decision to reduce staff. #Pharma #mRNA #vaccines #biotech #innovation #healthcare #virology #covid

> Press Release 19 June: WACKER & CordenPharma are pleased to announce their joint consortium has officially entered the pandemic readiness state as of 1 June 2024. Following a successful expansion and qualification phase, the companies are now in stand-by phase for at least five years. In the event of a new pandemic, WACKER and CordenPharma have taken the necessary steps to produce 80 million vaccine doses a year within an extremely short time, with most of the production steps taking place in Germany, and every production step occurring within the European Union. As part of the consortium, CordenPharma is ready to manufacture custom and standard lipids in our Frankfurt (DE) and Chenôve (FR) sites, as well as provide aseptic fill & finish and packaging of the chosen mRNA-based vaccine at our Caponago (IT) facility. In its site in Halle (Germany), WACKER will produce plasmid DNA (pDNA), which is an essential starting material for the manufacture of mRNA. Dr. Michael Quirmbach, CEO of CordenPharma Group, commented: “Obtaining the official confirmation of pandemic readiness by the German government is a major milestone for CordenPharma. I am extremely proud of our teams across the CordenPharma sites involved in establishing and delivering our pandemic readiness plan on schedule. We are now ready, together with our partner WACKER, to manufacture end-to-end mRNA-based vaccines for the German government and other customers.” “We have expanded our Halle site into a Competence Center for mRNA production,” said WACKER CEO Dr. Christian Hartel. “WACKER has invested over 100 million Euros in this expansion and created over 100 highly qualified jobs. Our expertise in making mRNA and LNPs will contribute to the fight against future pandemics. Together with CordenPharma, we are proud to serve the German government in its pandemic preparedness plans.” Read the full press release here: https://lnkd.in/d6vBdaPK #CordenPharma #wacker #pandemic #mrna #pdna #lipids #injectables #fillfinish #pharmaceuticals #vaccine #germany

The patent dispute over the breakthrough mRNA technology The development and approval of effective COVID-19 vaccines represented a significant advance during the ongoing pandemic (Szabo et al., 2022). Numerous vaccine candidates are based on the lipid nanoparticle-encapsulated nucleoside-modified mRNA (mRNA-LNP) platform. However, Moderna/US NIAID (mRNA-1273) and Pfizer/BioNTech (BNT162b2 or Comirnaty®) were the first mRNA-LNP vaccines to enter clinical trials and receive emergency authorization and regulatory approvals (Pfizer-LOA-051021, 2021; Moderna-LOA-08312022, 2022). For More info: https://lnkd.in/gWjGRj7R

Breaking News: Zuellig Pharma and Substipharm Biologics Join Forces to Expand Imojev Vaccine Access in Asia 🌐💉 In a groundbreaking collaboration, Zuellig Pharma and Substipharm Biologics have forged a strategic alliance to broaden access to the Imojev vaccine across Asia. This partnership marks a significant step in enhancing vaccine distribution and availability, especially in regions where it is critically needed. Imojev, renowned for its efficacy against Japanese Encephalitis, will now see an extended reach, thanks to the combined efforts of these industry leaders. The collaboration aims to address healthcare gaps, ensuring that more communities in Asia can benefit from the protection offered by the Imojev vaccine. This alliance underscores the shared commitment of Zuellig Pharma and Substipharm Biologics to advancing public health in the region. As the news unfolds, it's evident that this collaboration has the potential to make a lasting impact on vaccine accessibility and contribute significantly to disease prevention in Asia. #BiopharmaNews #VaccineAccess #HealthcareCollaboration

Thoughts on this? >> GSK surrenders HSV vaccine hopes after phase 2 fail, ceding race to Moderna, BioNTech >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #pharmaceutical #competitivemarketing #biotech

And a last post from me about ISBS Baltimore:   I was really eager to see the last session on "Estimands in Vaccines" organised by Martin Posch.   I had the privilege to chair it and it haven't been disappointed: - There was first some great learnings from the main COVID19 Vaccines trials which read-out during the pandemic presented by my former colleagues for the EU network Florian Klinglmueller and Benjamin Hofner and summarized here [1]. They brought some clarity about the definition of interim, confirmatory and primary analyses and even coined the term "decisive analysis”, referring to the data analysis used for benefit/risk assessment. - Regulators also started a much-needed discussion on the estimands used in immunogenicity and efficacy trials, which was topped up by the excellent presentations from Hege Michiels and Michael Fay. Take-home message for me is that more often than not, a per-protocol analysis excluding the ramp-up period and focusing on compliant participants seems satisfactory on both sides of the regulatory divide. Even though it is not really clear what estimand is being estimated in this case, there seems to be agreement that under some strong assumptions such an analysis would be a decent proxy for a principal stratum analysis (see also [2]). These are really useful learnings – equally I feel some guidance is needed to agree on the language used for these strategies. Funnily enough we seem to agree on what to do but not how to name it. I have seen elsewhere a similar strategy called “hypothetical” – which I think is misleading. There is also some form of consensus that in an efficacy trial, participants contribution to the person-year counts should be censored after the occurrence of the intercurrent event. Moderna called this in its COVID19 trial a “treatment policy” strategy, which I also think is misleading. Finally, I thought the paper from Hofner et al was really excellent. Regulators have a vantage point on drug development that few of us can have and I feel sharing learnings after sufficient hindsight should be done more often. Every move of the needle counts and helps the next program. This reminded me of the work we had done a couple of years ago with master protocols [3] ! [1] Hofner, Benjamin, et al. "Vaccine development during a pandemic: General lessons for clinical trial design." Statistics in Biopharmaceutical Research (2023): 1-13. [2] Fu, Rong, et al. "Application of estimand framework in ICH E9 (R1) to vaccine trials." Journal of Biopharmaceutical Statistics 33.4 (2023): 502-513. [3] Collignon, Olivier, et al. "Current statistical considerations and regulatory perspectives on the planning of confirmatory basket, umbrella, and platform trials." Clinical Pharmacology & Therapeutics 107.5 (2020): 1059-1067.

One solution to the “status quo” and “failure of imagination” for mRNA vaccine production in South Africa: Build South Africa’s industrial base for vaccines manufacturing! Imagine a future when South Africa reduced uncertainty surrounding vaccine availability by becoming a leading producer and exporter of the ingredients and key starting materials needed for mRNA vaccines. It’s possible.

GSK's recent halt of its HSV therapeutic vaccine development is a wake-up call for the pharmaceutical industry. The Phase I/II trial failure underscores not just the inherent challenges posed by viruses like herpes, which can hide in our bodies and reactivate unpredictably, but also the urgency for innovative solutions. With millions affected globally and current treatments offering limited relief, the race isn’t over. Companies like Moderna and BioNTech are now primed to fill the void with mRNA technology—a promising approach that has already changed the landscape for vaccines in the wake of COVID-19. The pressing need for effective therapeutic and prophylactic options against HSV has never been clearer. As we navigate the complexities of vaccine development, let’s keep our hopes alive for breakthroughs that could transform the lives of millions. The future of HSV solutions lies in the innovation and competition that GSK's exit has ignited.

𝐆𝐒𝐊 𝐚𝐧𝐝 𝐂𝐮𝐫𝐞𝐕𝐚𝐜 𝐒𝐭𝐫𝐢𝐤𝐞 €𝟏.𝟒𝐛𝐧 𝐃𝐞𝐚𝐥 𝐟𝐨𝐫 𝐦𝐑𝐍𝐀 𝐕𝐚𝐜𝐜𝐢𝐧𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 GSK has closed a substantial licensing deal with the German biotech company CureVac. This deal, potentially valued at up to €1.4 billion, aims to advance the development of vaccines targeting flu, Covid-19, and avian flu. Under the terms of this agreement, GSK will pay an upfront fee of €400 million to CureVac for full control over the vaccine development process. Additional milestone payments could total €1.05 billion, dependent on the success in development and sales, alongside subsequent royalties. This strategic partnership strengthens GSK's position in the competitive field of mRNA vaccines, enabling them to develop combination vaccines for flu and Covid-19. These vaccines would be adaptable to combat new and emerging seasonal variants, positioning them as direct competitors to established mRNA vaccines from Moderna, Pfizer, and BioNTech. For CureVac, this deal provides a crucial financial boost. The company has encountered significant challenges in commercializing its products and has recently announced plans to reduce its workforce by nearly one-third, aiming to decrease staffing costs by €25 million. This workforce reduction is part of a broader strategy to manage costs while refocusing on the development of early-stage oncology vaccines. CureVac's journey in the vaccine industry has been fraught with hurdles. Although it was one of the pioneers in developing Covid-19 vaccines, it could not keep pace with its competitors in bringing a vaccine to market. In 2021, CureVac entered into an initial €150 million deal with GSK to develop vaccines adaptable to Covid-19 variants, but this collaboration has yet to yield a clinically approved product. With the new agreement, GSK assumes complete responsibility for advancing the vaccine development, including tackling the growing threat of avian flu, which has seen an increase in cases and several human infections worldwide. The revamped focus and downsizing at CureVac are aligned with the firm's shift towards innovative technologies and the development of oncology vaccines, where it still trails behind its German counterpart, BioNTech. Alexander Zehnder, CureVac's CEO, emphasized that the substantial financial backing and the opportunity to streamline operations are critical for the company's long-term success, despite the difficult decision to reduce the workforce. This strategic pivot includes one-off severance and restructuring costs estimated at €15 million. Source: FT, 5.7.24 #biopharma #insights #vaccines

#News: Sanofi announced a deal worth up to $1.4 billion with Novavax on Friday for its #COVID19vaccine, giving the Maryland-based biotech a much-needed boost to its struggling business. The French pharma is dropping $500 million upfront for #Novavax’s #COVID19 #vaccine, with the goals of co-commercializing its current formulation as well as developing a combination vaccine for #COVID and #flu. An additional $700 million is up for grabs in milestone payments. Along with another potential $200 million in milestones for additional vaccines made with Novavax’s Matrix #adjuvanttechnology, deal totals $1.4 billion—more than double the #biotech’s current market cap of $627 million. Read more from BioSpace 👇🏽 https://lnkd.in/dHCXrgcb