Pfizer and Bristol-Myers Squibb Enter Into Agreement with Portola
Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.
Bristol-Myers Squibb and Pfizer announced on Feb. 1, 2016 that the companies have entered into a collaboration agreement with Portola Pharmaceuticals to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase III clinical development in the United States and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).
Under the terms of the agreement, Portola will receive an upfront payment of $15 million, potential regulatory milestones of $20 million, and sales-based milestones of $70 million as well as compensation based on andexanet alfa net sales. Bristol-Myers Squibb and Pfizer will co-fund with Portola the development and commercialization of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.
This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the US and Europe. In December 2015, Portola announced it had completed the submission of a biologics license application to FDA for andexanet alfa and was awaiting acceptance for filing. FDA assigned a Prescription Drug User Fee Act date of August 17, 2016, under an accelerated approval pathway. Portola has stated that it plans to submit an European Union application in 2017.
Source: Pfizer
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
