India Pharma Outlook Team | Tuesday, 18 July 2023
Advent Therapeutics, Inc., a biotechnology company pioneering an optimized retinol palmitate (vitamin A) drug product as a breakthrough non-invasive inhaled neonatal lung therapy, has been awarded a $3 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB grant. This grant allows the Company to position its novel aerosolized vitamin A formulation for commercialization in 2025 to prevent Bronchopulmonary Dysplasia (BPD). BPD is a rare disease and the most common serious complication facing premature infants, resulting in significant morbidity and mortality.
There are currently no approved therapies. “This NIH award will allow us to greatly accelerate the development and advance towards approval of our optimized vitamin A drug product,” commented David L. Lopez, Chief Executive Officer, Advent Therapeutics. “Advent’s novel, precisely optimized products are intended to address the unmet medical need of BPD facing premature infants and reduce morbidity and mortality in this fragile patient population. Our primary focus is to accelerate the path to commercialization, first in the US, then EU and worldwide. US launch of Advent’s initial vitamin A drug product for injection is possible in early 2025 with potential peak annual revenues in excess of $100 million for the prevention of BPD.
In addition, we intend to pursue broader applications for our novel retinol palmitate drug product that have significant market potential.” This SBIR Phase IIB grant, awarded under the auspices of both the National Heart, Lung, and Blood Institute (NHLBI) and National Center for Advancing Translational Sciences (NCATS), will support development of Advent’s proprietary aerosolized formulation of vitamin A. The $3 million provided under the SBIR Phase IIB grant will be used to complete preclinical requirements and manufacturing scale-up leading to pivotal human clinical trials with Advent’s inhalable retinol palmitate product to potentially gain US and other worldwide marketing approvals.