Oakrum Pharma and Aucta Pharma Announce U.S. FDA Approval of Generic Version of JADENU® Sprinkle (Deferasirox Granules)
SAINT LOUIS, MO - March 22, 2021 (GLOBE NEWSWIRE) - Oakrum Pharma, LLC ("Oakrum Pharma"), in collaboration with Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of JADENU®1 Sprinkle (Deferasirox Granules) in 90mg, 180mg, and 360mg strengths.
Deferasirox granules had annual sales in the U.S. exceeding $31 million in the aggregate for the 12-month period ending January 2021 according to available data from IQVIATM.
Marco Polizzi, CEO of Oakrum Pharma, stated, "The investments that we have made in our product development pipeline since starting this business are expected to provide significant contributions to the growth of Oakrum Pharma over the next couple of years. The launch of Deferasirox Granules is the first of several products that we expect to commercialize over the next 12-18 months. A few of these near-term launches are products developed by Aucta Pharmaceuticals."
Shoufeng Li, CEO of Aucta Pharmaceuticals stated, "We are excited to bring another Aucta Pharmaceuticals developed product to the U.S. market through this partnership with Oakrum Pharma. Aucta Pharmaceuticals continues to expand its product portfolio in niche generics and branded specialty products and is anticipating additional approvals and launches in the next 12 months."
Please see full Prescribing Information including Boxed WARNING available at www.dailymed.nlm.nih.gov.
About Oakrum Pharma, LLC
Oakrum Pharma, LLC is a privately-owned biopharmaceutical company focusing on development and commercialization of affordable drug therapies. For more information, visit www.oakrumpharma.com.
About Aucta Pharmaceuticals, Inc.
Aucta Pharmaceuticals, Inc. is a research and technology based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company’s corporate strategy is to focus on proven molecules, and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in CNS, Dermatology, and Other Specialty fields. For more information, visit www.auctapharma.com.
Statements in this press release that are not historical facts, including statements about future expectations of Oakrum Pharma are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Oakrum Pharma intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Oakrum Pharma’s actual results to be materially different from its historical results or from any results expressed or implied by said statements. Oakrum Pharma’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions and the need for regulatory approvals, Oakrum Pharma’s ability to fund development of its technology and to successfully complete clinical trials, the length of time and costs required to complete clinical trials and to submit applications for regulatory approvals, products developed by competing companies, commercial acceptance of Oakrum Pharma's products, and other factors. Oakrum Pharma is not responsible for updating events occurring after the date of this press release.
1 JADENU® is a registered trademark of Novartis AG.