Vitamin A Palmitate

Reinventing Vitamin A for neonatal and pediatric unmet medical needs Bronchopulmonary Dysplasia (BPD) is most frequent serious complication of preterm birth – US preterm births highest in 15 years Advent plans FDA PDUFA Meeting late-2023 to establish pathway for US approval of lead injectable product DOYLESTOWN, Pa., July 20, 2023 (GLOBE NEWSWIRE) -- Advent Therapeutics, Inc., a late-stage biotechnology company developing precisely optimized retinol palmitate (vitamin A) drug products as both injectable and breakthrough non-invasive inhaled neonatal lung therapies, announced today that it has received U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Designation (RPDD) for its vitamin A metabolic and reparative respiratory drugs for the prevention of Bronchopulmonary Dysplasia (BPD) in premature infants. FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases. Companies that receive approval for a New Drug Application (NDA) for a rare pediatric disease may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product or sold to another sponsor for priority review of their marketing application. This program is intended to encourage the development of new drugs and biologics for the treatment of rare pediatric diseases. “We are acutely focused on BPD as an area of high unmet medical need that presently has no FDA-approved therapies for prevention or treatment. The FDA Rare Pediatric Disease Designation is an important addition to the Orphan Drug designations previously granted by the US FDA and the European EMA for our vitamin A metabolic and reparative respiratory drugs,” said Dave L. Lopez, CEO of Advent Therapeutics. ABOUT BPD BPD is a rare disease and the most common serious complication facing premature infants, resulting in significant morbidity and mortality. It is an extremely costly respiratory disorder afflicting premature infants for which there is currently no approved drugs worldwide. Annually, in both US and Europe, there are approximately 100,000 premature infants at-risk for BPD and many more in Asia-Pacific, Latin America and throughout the world. In the US, hospital costs for treating a BPD infant in the first year average $442,000 with an average hospital stay of 103 days. US healthcare costs of treating babies with BPD have been estimated as approaching $2.5 billion per year. FORWARD LOOKING STATEMENTS This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Media and investor contact: David L. Lopez david.lopez@advent-therapeutics.com

CAMBRIDGE, Mass., July 18, 2023 /PRNewswire/ -- Particles for Humanity has closed investments from King Philanthropies and the Mulago Foundation. The funding will be used to test in humans the absorption of vitamin A from PFH-VAP, a stable form of vitamin A palmitate for large-scale food fortification (LSFF). The instability of current forms of vitamin A limits the effectiveness of LSFF. When incorporated in bouillon tablets and stored in hot and humid conditions common in Africa, PFH-VAP has 4X greater stability than a leading commercially available form. When used to fortify staple foods like wheat flour, sugar, and bouillon, PFH-VAP has the potential to reduce vitamin A deficiency in hundreds of millions of people throughout Africa. Diversifying funds is important because it helps improve financial stability and fosters innovation. It encourages meaningful collaboration within the philanthropic community by bringing in a variety of perspectives, ideas, and expertise. To date, Particles for Humanity has raised $20 million in the fight against malnutrition. "Mulago finds and funds organizations with scalable solutions to the basic needs of the very poor. Over a billion people don't get essential micronutrients. Food fortification — think iodized salt — can make a huge difference in nutrition. PFH-VAP uses an innovative encapsulation technology to get stable vitamin A into staple food products. It has potential for exponential health impact over time by leveraging existing broad distribution networks to reach the people who need it most," said Kevin Starr, CEO of Mulago Foundation. "We are thrilled to work with King Philanthropies, the Mulago Foundation, and the Gates Foundation to improve nutrition in Africa. Their confidence in our work has led all three to provide follow-on funding after their initial grants. With their help, we hope to expand the group of investors who are supporting our important work," said Sherri C. Oberg, CEO of Particles for Humanity. King and Mulago have fully funded an absorption study that is currently awaiting Institutional Review Board approval. The study will take place at the University of Wisconsin-Madison in the United States and the Tropical Disease Research Centre in Zambia. Particles for Humanity transforms early-stage medical technology into products for people living in low and lower-middle income countries. It is developing a portfolio of products with funding from the Bill & Melinda Gates Foundation, Mulago Foundation, and King Philanthropies. Its rigorous product development process is based on end-user input and is focused on financially sustainable product opportunities. For more information, visit the company's website . Please contact [email protected] for inquiries. SOURCE Particles for Humanity