Wacker Chemie AG

A US trade probe into pharmaceuticals is underway. And it’s hitting many of the key aspects of the supply chain. The investigation, announced Monday, will cover finished drug products, medical countermeasures, active pharmaceutical ingredients, “key starting materials” and derivative products. Its scope suggests the Trump administration could be planning expansive levies on the pharma sector — potentially ensnaring companies like chemical manufacturers that previously thought they might be unaffected. “It looks like it’s going to be pretty broad,” but it will depend on what categories of products are ultimately covered under the potential tariffs, Adams Lee, an international lawyer at Harris Sliwoski, told Endpoints News . Lee said that a key issue will be whether the Trump administration exempts products or materials that can’t be sourced from the US. He added that any Section 232 tariffs could be contrary to the pharmaceutical exclusions granted for the reciprocal tariffs that Trump announced earlier this month. Under the Trade Expansion Act, a Section 232 investigation will assess if an import “threatens to impair the national security” of the US. The Commerce Department will look at current and projected demand for pharmaceuticals, how much US capacity can meet domestic demand and how feasible it is to boost US production, among other things. A notable target of the probe is “medical countermeasures,” which include biologics, drugs and devices that could be used in the case of a public health emergency. Potential tariffs on such products could hit companies like Bavarian Nordic, which has been contracted multiple times by the US government to supply and stockpile its vaccines in case of a public health emergency, such as for mpox outbreaks. And the administration’s decision to review products early on in the supply chain, such as “key starting materials, and derivative products of those items,” could put companies like Lonza’s chemical spinouts Arxada, Wacker Chemie and Apollo Scientific at risk of tariffs. Key starting materials include the chemical substances used to make active pharmaceutical ingredients. Meanwhile, both generic and non-generic drug products are at risk of tariffs. Generic drugs are non-patented medicines and are much cheaper than their brand-name counterparts because they are easier to make. Putting taxes on generics will strain the already thin profit margins faced by their manufacturers, which could lead to drug shortages if companies decide to exit the market altogether. Generic medicines make up about 92% of daily drugs taken by Americans, according to a report from the API Innovation Center, and 83% of these use a foreign API. China especially has an abundance of tariffs already stacked, reaching a total of 125%, so its likely pharma-specific tariffs could also be added. The Trump administration launched a Section 232 investigation into pharma products on April 1. Typically, such investigations can take up to 270 days to complete, which would be around December. But there’s a chance tariffs could arrive sooner than that. As part of the probe, the Commerce Department is asking for public comment, data or analysis by May 7 — 21 days after its Federal Register notice is due for publication. Some comments will be confidential, but some will be made public. The comment period offers companies a chance to voice concerns about how tariffs could impact their operations or the supply chain. “Companies should avail themselves of the public comment period to explain any and all consequences from potential levies on pharma, especially unintended consequences, because it could make a difference,” Squire Patton Boggs partner Sarah Rathke told Endpoints News. Some analysts believe President Donald Trump will undertake a “dual-track” strategy by invoking the International Emergency Economic Powers Act for the pharma tariffs alongside the 232 investigation. The dual approach will likely give Trump a higher chance of taxing pharma goods quicker and for a longer period of time, according to Leerink Partner analysts, as the IEEPA doesn’t require a lengthy investigation. Alexis Kramer contributed reporting.

COPENHAGEN, Denmark, Nov. 14, 2024 /PRNewswire/ -- MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), today announced the appointment of Veronica Gambillara Fonck as its new Chair of the Board of Directors. Gerd Zettlmeissl, the previous Chair, who was instrumental in the transition of MinervaX from a preclinical-stage company to a well-funded clinical-stage company, has stepped down from his role for personal reasons but will continue to support MinervaX as a senior advisor. Veronica has been a board member of MinervaX since 2022, following an investment by Pureos Bioventures, where she has served as a Partner since 2022. She has over 18 years of experience across the pharma and biotech industry in various operational roles in vaccine development and has been instrumental in building and growing companies. Veronica was the Co-Founder and CEO of LimmaTech Biologics, a company developing vaccines to prevent life-threatening diseases caused by pathogens resistant to antimicrobial treatments, and GlycoEra AG, a biotech company developing medicines for a variety of diseases using its CustomGlycan platform. Per Fischer, Chief Executive Officer of MinervaX, said: "Veronica has been a key member of our board since October 2022 and her extensive vaccine development experience has been invaluable in the progress of our novel, prophylactic vaccine candidate against GBS. Veronica in her new role as Chair will oversee the next important phase of company development as we prepare for Phase III studies with our maternal GBS vaccine. I would like to thank Gerd for his valuable contributions to the success of MinervaX over the past four years, and we are pleased that we will continue to benefit from his vast experience in his new advisory role." Veronica Gambillara, new Chair of the Board of Directors of MinervaX, commented: "I am thrilled to be taking on this role at such a pivotal stage of development for MinervaX as we advance towards Phase III studies with our GBS vaccine in pregnant people and advance our Phase I studies in older adults. GBS remains a significant unmet medical need, and I look forward to working closely with the board and management team to achieve the full potential of our GBS vaccine to prevent these life-threatening infections." Veronica began her career focusing on clinical R&D and international regulation within the MedTech field. In 2009, she moved to GlycoVaxyn, a specialist vaccine biopharmaceutical company where she held roles in clinical, regulatory, and business development. Veronica was a core member of the GlycoVaxyn team responsible for building and contributing to the success of the company in preparation for its acquisition by GSK in 2015 for $190 million. She is also a board member at Memo Therapeutics. The new Chair appointment follows the recently announced manufacturing agreement with Wacker Biotech in September as MinervaX begins establishing commercial manufacturing for its GBS vaccine candidate. GBS is a major global cause of maternal and infant ill health with no approved vaccine available to prevent the rising early and late onset of GBS. The rising number of GBS cases reported globally each year has reached 410,000 with approximately 147,000 stillbirths and infant deaths reported each year, demonstrating the urgent need for an approved GBS vaccine. Notes to Editors: About MinervaX MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and also for vaccination of older/at risk adults. Phase II clinical data from its maternal vaccination program suggest a high efficacy, based on the preliminary Correlate of Protection data from a natural history study. MinervaX's GBS vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS, the Alpha-like protein family (AIpN). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX's GBS vaccine will confer protection against virtually 100% of all GBS isolates. Details of MinervaX's completed Phase II clinical trials in pregnant people can be found at under the identifiers NCT04596878 and NCT05154578. In addition to pregnant people, MinervaX is also pursuing Phase I development of its novel GBS vaccine in older adults, under identifier NCT05782179. SOURCE MinervaX ApS WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MinervaX has joined forces with Wacker Biotech to manufacture MinervaX's active protein ingredients of its GBS vaccine. GBS is responsible for nearly 50 percent of all life-threatening infections in newborns. At any given time, some 15-25 percent of the population, including pregnant people are spontaneously colonized with GBS, and during pregnancy, they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and in the newborn child, may result in sepsis, pneumonia, or meningitis, all of which carry a significant risk of severe morbidity, long-term disability or death. With no generally implemented and fully protective preventative treatment available for GBS, this underlines the unmet medical need of developing and provide a vaccine to prevent adverse pregnancy outcomes and life-threatening infections in infants caused by GBS. Furthermore, older adults and adults with certain co-morbidities such as diabetes or obesity are also at an increased risk of severe GBS infections and form a second population that would benefit from a prophylactic vaccine against this potentially fatal disease. MinervaX's lead vaccine candidate, is a novel protein-only vaccine, based on fusions of highly immunogenic and proactive protein domains from selected surface proteins of GBS. The company is strongly committed and dedicated to advancing its novel vaccine and has successfully completed two Phase II clinical trials of its maternal vaccine against GBS and is in preparation to commence Phase III clinical trials in this indication. Data from MinervaX's GBS vaccine is very positive, demonstrating an acceptable safety profile in pregnant people and their infants, with high immunogenicity, leading to functionally active antibodies, with the potential for broad coverage and protection, alleviating the need for excessive use of antibiotics. Wacker Biotech will manufacture the active ingredients of MinervaX's novel vaccine candidate, alongside performing the technology transfer, process validation and process characterization activities for later commercial manufacturing. Subsequently, Wacker Biotech will perform all key functions critical to ensure stable commercial supply at its site in Amsterdam, The Netherlands. Per Fischer, CEO of MinervaX, said, "GBS can be life-threatening for newborn babies and is linked to over half a million preterm births annually. Following the EUR 54 million financing last year, our team is advancing the development of our novel prophylactic vaccine against GBS for the benefit of all populations at risk, worldwide. Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies." Ronald Eulenberger, Managing Director of Wacker Biotech B.V. in Amsterdam, stated, "With our strong background in E. coli processes, process characterization, and process validation experiences, we at Wacker Biotech are perfectly suited to support MinervaX with its ongoing program for the prevention of invasive GBS disease."