Sanofi and POZEN sign a license agreement for the commercialization of omeprazole and aspirin combination product.
Sanofi and the biopharmaceutical company POZEN, have signed a license agreement for the commercialization of POZEN's tablets combining immediate-release omeprazole, a proton pump inhibitor, and enteric-coated aspirin in a single tablet (i.e, PA), PA8140 and PA32540. Under the agreement, Sanofi will have rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15 million and be eligible for precommercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales.
Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing, and future development for the licensed PA products in the US. POZEN will retain responsibility for obtaining approval of the new drug application (NDA), after which time POZEN will transfer the NDA to Sanofi US. The NDA was submitted in March 2013 and accepted for filing in May 2013 by FDA.
Source: Sanofi
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: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Entering New Domains for 3D Printing of Drug Products
April 6th 20253D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.