EIDP, Inc.

While Merck & Co. 's infant respiratory syncytial virus (RSV) antibody clesrovimab is nearing approval, sanofi also won approval last year for its RSV prevention drug beyforts in partnership with astrazeneca. This news undoubtedly brings new hope to the global healthcare industry, especially in the field of RSV vaccines. "We would very much welcome having more participants on board because it increases the scale of the competition," Thomas Triomphe, Sanofi's executive vice president for vaccines, said of the upcoming RSV competition during an analyst call on Friday. He stressed that more players mean more innovation and better healthcare solutions, which is good for the industry as a whole and for patients. Triomphe noted that Merck still has more data on clesrovimab after announcing phase 2b/3 clinical results last week. In the meantime, Sanofi remains "very confident" in the Beyfortus numbers it has released so far, he said. He mentioned that the protection data provided by Beyfortus in six months is very encouraging, as the effect has not diminished. "After six months, we were still seeing 83 percent hospitalization efficacy," he said, adding that he believed "the duration of protection from Beyfortus was significantly more favorable compared to clesrovimab." This data suggests that Beyfortus has a significant advantage in preventing RSV infection. In Merck's infant RSV study, clesrovimab successfully reduced RSV-related hospitalizations and RSV-related lower respiratory tract infection hospitalizations by 84 percent and 91 percent, respectively, over five months compared to placebo. This result is impressive and shows the great potential of clesrovimab in preventing RSV infection. At the trial's primary endpoint, clesrovimab reduced the incidence of RSV-related medical lower respiratory tract infections by 60 percent compared to placebo. This data provides further evidence of the effectiveness of clesrovimab in preventing RSV infection. Sanofi Chief Financial Officer franois-xavier Roger noted in a conference call on Friday that the inherent uncertainty of cross-trial comparisons suggested that existing Beyfortus data showed a reduction of about 75 percent in the incidence of lower respiratory tract infections with clesrovimab compared to 60 percent with Clesrovimab. This data further reinforces Beyfortus' advantage in preventing RSV infection. And, whether or not Merck brings clesrovimab into the 2025-2026 RSV season as planned, "2025 will be a year of growth for Beyfortus," the CFO stressed. He is confident that Beyfortus' sales will grow significantly as it gradually gains market share. Since it was approved last July, Beyfortus has gradually built up its sales profile. In the third quarter of 2024, sales of this preventive antibody reached 645 million euros ($699), an increase of 382% compared to the same period in 2023. Overall, sales of the drug have reached 845 million euros since the beginning of the year, which is close to the best-selling threshold. Sanofi said at the time that Beyfortus quickly fell into a supply crunch shortly after going public last year due to "higher than expected demand." To counter this, Sanofi and its partner Astrazeneca have moved quickly to ensure there is no repeat of the supply crunch in 2024. Recently they added a new filling line and shipped antibody doses ahead of the 2024 RSV season. "There are 20 markets and we don't see any capacity constraints," Triumph said on Sanofi's conference call. "We will increase supply next year and the year after to make sure there are no supply constraints." This initiative demonstrates Sanofi's confidence in the future of Beyfortus and its commitment to meeting the needs of the global market. The comments by Sanofi executives came as the French pharmaceutical company reported a 15.7 per cent rise in third-quarter sales. This growth was mainly driven by the excellent performance of its immunology product Dupixent, which brought in sales of nearly 3.5 billion euros (about $3.8 billion), an increase of about 24 percent over the third quarter of 2023. Sanofi confirmed DuPont's full-year sales target of about 13 billion euros. Elsewhere, newly launched drugs rose 67.1 percent to 727 million euros ($787), led by hemophilia drug Altuviiio, Pompeii disease treatment Nexviazyme and Rezurock for graft-versus-host disease. The strong performance of these new drugs further strengthens Sanofi's position in the field of innovative medicines. Meanwhile, Sanofi's consumer health division, Opella, saw revenue rise 7.9 percent. This growth shows that Sanofi is also making significant progress in consumer health. Earlier this week, Sanofi confirmed it had entered exclusive talks with U.S. private equity firm Clayton, Dubilier & Rice to sell a controlling 50 percent stake in its consumer healthcare business, which is valued at around 16 billion euros. This move will further strengthen Sanofi's financial strength and provide additional financial support for its future expansion.

Johnson & Johnson (JNJ) and Eli Lilly (LLY), two pharmaceutical giants, are expected to get new data on their key drugs in the highly competitive dermatology market. Johnson & Johnson evaluated the use of its drug Tremfya in patients with moderate plaque psoriasis involving a specific site of low body surface area that has failed local treatment. In a press release, Johnson & Johnson explained that "special sites" refer to those sensitive or highly visible areas affected by psoriasis, such as the scalp, face, skin folds, and genitals. According to Johnson & Johnson, the SPECTREM study is the first large-scale trial to measure skin clearance and other outcomes in a patient group. The drugmaker found that 74.2% of patients treated with Tremfya met the primary endpoint by achieving disease clearance or minimal disease. In contrast, only 12.4 percent of patients in the placebo group achieved the same level of response. Tremfya also proved beneficial in secondary endpoints and patient-reported measures of quality of life, Johnson & Johnson said. According to the company, although psoriasis has a significant impact on patients' daily lives, the patient population is largely underserved by systemic treatment. Tremfya is positioned as a strong successor as competition for biosimilars heats up and the impact of the Inflation Reduction Act on drugmakers' immunity star Stelara looms. The biologic recently gained recognition in ulcerative colitis, competing with AbbVie's Humira successor Skyrizi. Meanwhile, Eli Lilly tested its IL-13 inhibitor Ebglyss in patients with moderate to severe atopic dermatitis who had previously been treated with Regeneron and Sanofi's immune giant Dupixent (dupilumab). The Phase 3b ADapt study found that 57 percent of patients with Eli Lilly's drug had a 75 percent or greater improvement in their eczema Area and Severity Index (EASI-75) score at week 16. The study measured the extent and severity of skin disorders. By week 24, 60 percent of patients treated with ebglyss experienced this level of improvement. Lilly said in a press release that the results were generally consistent with previous studies of the drug in patients who had not used Dupixent. By week 16, 46 percent of Ebglyss patients with an inadequate response to Dupixent met EASI-75 criteria. Mark Genovese, M.D., senior vice president of Eli Lilly's immunization division, said in a company release: "This trial supports a growing body of data suggesting that healthcare providers can be confident in using Ebglyss as a first-line biologic therapy for moderate to severe atopic dermatitis, and highlights that Ebglyss offers meaningful benefit to individuals who have already tried other biologic therapies, such as dupilumab, and may have a more difficult-to-treat disease." Ebyglyss received its first FDA approval for atopic dermatitis last month, following European approval in 2023. It is the third biologics Lilly has developed in its growing immunology segment and will compete with dominant DuPont in a crowded market.

USA News Group Commentary Issued on behalf of BioVaxys Technology Corp. VANCOUVER, BC, Aug. 19, 2024 /PRNewswire/ -- USA News Group – How we take care of the planet, and the food we eat is rapidly shifting. Back in May, the World Economic Forum addressed how countries are redefining their bioeconomy for the future, with each aiming for sustainable solutions. NGOs around the world are calling for urgent action to accelerate nature-based solutions to tackle global challenges, while the World Bank is encouraging sustainable agriculture, not an end to farming. Behind the scenes, several biotech firms are working on solutions that can help foster these types of goals, including BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Zoetis Inc. (NYSE: ZTS), Corteva, Inc. (NYSE: CTVA), Bunge Global SA (NYSE: BG), and BRF S.A. (NYSE: BRFS). Earlier this year, the clinical-stage biotech company BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF) made headlines with its strategic acquisition of a comprehensive clinical development pipeline, which includes the cutting-edge DPX™ immune system educating antigen delivery platform. BioVaxys identified DPX™ as a potential game-changing enabling technology across several areas, including improved mRNA vaccines, multivalent viral vaccines, cancer vaccines, and treatments for immune system disorders. But these uses aren't restricted just to human, as BioVaxys recognizes that animal biotech has a faster regulatory pathway than humans. Partnered with SpayVac for Wildlife (SpayVac), the two companies recently announced the completion of a new expanded research and production facility in Madison, Wisconsin to produce SpayVac's long-lasting, single-dose veterinary contraceptive vaccines. Thanks to BioVaxys' patented liposome-based antigen delivery platform technology, SpayVac can address the significant fertility-control needs in wildlife, agricultural production animals, and aquaculture markets, setting up the potential for BioVaxys to attain royalty revenue from the project in 2025. "This new laboratory will significantly enhance our ability to develop new vaccine formulations for species that would benefit from humane, long-term fertility control," said Dr. Ursula Bechert, Vice-President of Research and Development for SpayVac for Wildlife. SpayVac is preparing to commercialize fertility control vaccines for deer, horses, and other animals, utilizing the patented liposome-based delivery platform technology licensed from BioVaxys. "I'm enthusiastic about the many benefits of this space," said Tom D'Orazio, CEO of SpayVac for Wildlife. "It is flexible enough for us to do both our research and small-scale production. The facility has a number other biopharma tenant companies, such as Kendrick Laboratories and Plumb Pharmaceuticals, creating a biotech hub and collaborative environment." SpayVac originally operated out of the University of Victoria in British Columbia but relocated to Madison, Wisconsin, following the pandemic. Backed by the BrightStar Wisconsin Foundation and angel investors, SpayVac successfully expanded its laboratory and secured space in a facility owned by Lytic Solutions. This new location will enable the company to produce vaccines for both ongoing and future experimental contraceptive trials. "With our licensee SpayVac on track for submitting their filing for regulatory approval in 2025, they expect to see commercial sales, which will generate royalty revenue from our liposome-based antigen delivery platform technology," said Kenneth Kovan, President & Chief Operating Officer of BioVaxys. Though it's being initially implemented for deer, horses, etc., the potential for BioVaxys' antigen delivery platfrom is quite large, in particular in the growing commercial aquaculture vaccines market. Back in April, BioVaxys and SpayVac announced a joint effort in the aquaculture space to field test single-dose, long-lasting immune-contraceptives in farmed rainbow trout—a market that's projected to reach US$7 billion by 2033. As a side note, the duo has also teamed up to test a long-lasting, single-dose contraceptive vaccine, in captive Asian elephants, with a clinical study current,y ongoing in Thailand. When BioVaxys acquired IMV, Inc., it also acquired milestone payments and a royalty bearing license agreement with Zoetis Inc. (NYSE: ZTS), the world's largest producer of medicine and vaccinations for pets and livestock, for their development and sale of various animal health products using BioVaxys antigen delivery technology. Zoetis recently released its Q2 2024 results, which included revenue growth of 8% to $2.4 billion, and 11% operational growth in revenue. Sales of livestock products increased 11% in the quarter, with notable growth in both cattle and swine products year-over-year. "We had another outstanding quarter, demonstrating the strong demand for our trusted, innovative products, our ability to capture and expand markets, and the dedication of our purpose-driven colleagues," said Kristin Peck, CEO of Zoetis. "We achieved 12% revenue growth in the U.S. and 10% operational revenue growth internationally, with both our companion animal and livestock portfolios seeing impressive global operational growth, 12% and 9% respectively." Earlier in the year, Zoetis expanded its stock vaccine production footprint through an 8-hectare land purchase for a new manufacturing site in Melbourne, Australia. It also launched GlanEry 7in1 B12, a new innovation in sheep vaccines. Each of these innovations is in line with Zoetis' commitment to healthier animals and sustainable agriculture. Corteva Agriscience, a wholly-owned subsidiary of global agriculture company Corteva, Inc. (NYSE: CTVA) recently began its promotion of the Direct Seeded Rice (DSR) technique, where rice seeds are directly sown into the field against the traditional method involving seedling nurseries and transplants. The strategy recognizes the urgent need for sustainable and innovative agricultural solutions to address environmental challenges, while providing economic benefits. "We're committed to developing innovative solutions for enhanced DSR adoption in India," said Dr. Raman Babu, Seed Research and Development Leader, South Asia, for Corteva Agriscience. "Our focus remains on developing superior climate resilient DSR seed products, crop protection innovations and agronomic excellence that will contribute to solutions for water scarcity and climate variability, ultimately fostering a more sustainable and productive future for India's rice production." For reference, India is one of the world's largest rice producers, accounting for over 20% of global production, and its rice market is valued at an estimated US$52.8 billion. However, export restrictions on Indian rice continue to disrupt global markets, supplies, and prices. Agrobusiness giant Bunge Global SA (NYSE: BG) recently teamed up with Thai conglomerate CP Foods to test a blockchain-powered traceability platform for shipments of deforestation-free soybean meal. As of June 2024, the two companies had so far shipped three vessels totalling 185,000 metric tons of soybean meal from Brazil to Thailand, with the products fully traceable from farm origin to final delivery. "Adding a layer of blockchain technology improves the transparency in end-to-end traceability that Bunge has been doing for some years," said Rossano de Angelis Jr, Vice President of Agribusiness, South America, of Bunge. "This ability to increase end-consumer confidence in soy projects is only possible thanks to the robust supplier's socio-environmental verification and monitoring system that we have structured over the last decade." The eco-conscious approach to soy has reached Brazilian pork and chicken processor BRF S.A. (NYSE: BRFS), which earlier in August was reported to be willing to pay a 2% premium from market prices for soybeans produced through regenerative agricultural practices. Regenerative agriculture focuses on enhancing soil health and boosting productivity by employing methods like crop rotation and organic fertilization. The project is being managed by a consortium that includes BRF, Germany's Bayer AG, a number of Brazilian companies, and a local research group. Produzindo Certo, a company specializing in establishing sustainable agricultural supply chains and part of the consortium, anticipates that within a year, the project will encompass 30 soy farms—expected to produce over 200,00 metric tons of soybeans verified as regenerative. Meatpackers like BRF use soymeal derived from these soybeans to feed their livestock. Bayer will play a key role in the project by supplying tools to assess the advantages farmers achieve through the adoption of regenerative agricultural practices. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. 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