BMS and Pfizer sign collaboration with Portola Pharmaceuticals to develop and commercialize investigational andexanet alfa in Japan
![](/46/pdcnewsitem/03/89/18/BMS.jpg)
Andexanet alfa is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).
Bristol-Myers Squibb (BMS) and Pfizer have announced 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 US and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis (apixaban).
“We are committed to reducing the risk of stroke in nonvalvular atrial fibrillation patients and treating deep vein thrombosis and pulmonary embolism,” said Douglas Manion, head of Specialty Development, BMS. “BMS and Pfizer’s agreement with Portola is an important step forward toward the goal of delivering the first reversal agent for Factor Xa inhibitors, including Eliquis, to patients in Japan. The ability to reverse the anticoagulation effect of Eliquis and other Factor Xa inhibitors may be helpful for some patients who experience a major bleeding event or require emergency surgery while on Eliquis or another Factor Xa inhibitor.”
“This agreement in Japan is another great example of the alliance’s commitment to the patients we serve. Eliquis has proven to be an important treatment option for patients at risk for stroke and blood clots due to nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism, but currently there is no approved reversal agent,” said Rory O’Connor, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. “With our partner, BMS, we look forward to working with Portola to develop andexanet alfa as a reversal agent for Eliquis in Japan.”
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. BMS 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 the FDA for andexanet alfa and was awaiting acceptance for filing. The FDA assigned a PDUFA date of 17 August 2016, under an Accelerated Approval pathway. Portola has stated that it plans to submit an EU application in 2017.
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance