SFJ expects to file the Biologics License Application for Bentracimab with the U.S. Food and Drug Administration in mid-2023.
SFJ Pharmaceuticals (“SFJ” or the “company”) today announced the closing of the sale and transfer of assets related to Bentracimab from PhaseBio Pharmaceuticals, Inc. (“PhaseBio”) to SFJ. The sale and transfer was approved on December 31, 2022 by the U.S. Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”), where PhaseBio’s chapter 11 case has been pending since October 2022.
Since 2020, SFJ and PhaseBio have worked on co-developing Bentracimab (formerly known as PB2452), which has the potential to address a significant unmet need for patients in major bleeding and urgent surgery situations, and SFJ retains deep clinical and commercial expertise related to the Bentracimab program.
SFJ expects to file the Biologics License Application for Bentracimab with the U.S. Food and Drug Administration in mid-2023. The company, with its global drug development and regulatory expertise and past success in accelerating and advancing late-stage development programs, seeks to achieve U.S. regulatory approval for Bentracimab within the first-half of 2024.
Robert DeBenedetto, Chief Executive Officer of SFJ, said, “We appreciate the diligent work of all parties to reach agreement on the transfer of Bentracimab assets to SFJ. The closing of this transfer gives us great optimism that we can efficiently and expeditiously move Bentracimab through the final stages of U.S. regulatory approval and, most importantly, bring a potentially life-saving drug to patients.”
To the extent that any of PhaseBio’s contracts related to Bentracimab with third parties are designated for inclusion in the transfer of Bentracimab assets to SFJ, separate notice of such designation will be provided to applicable contractual counterparties in accordance with the Bankruptcy Court’s approval order.
About the SFJ Pharmaceuticals Group SFJ is a global drug development company backed by Blackstone Life Sciences and Abingworth and offers a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of pharmaceutical and biotechnology companies. SFJ’s mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve.
Source: SFJ Pharmaceuticals _______________________________________________________
To have your news published and distributed by Medical and Pharma Insider, go to BCI News Service. https://bcinewsservice.com
Check out Medical and Pharma Insider for the latest industry news.
Check out InsiderNews https://insidernews.globalIf your company has business or financial objectives check out:
1. Advisory services provided by FC Global Strategies
2 . Medical and Pharma Insider's AI Connect Marketing Program