“Effectively Collect Real World Evidence for Early Access Programs”. We have asked Stuart a few questions to reflect on the topic …
Inceptua and Portola enter exclusive distribution agreement for Ondexxya®
- by Inceptua
- | February 7, 2020
LUXEMBOURG / SAN FRANCISCO – 7th February 2020 – Inceptua, a global pharmaceutical company and service partner and Portola – US developer and manufacturer of therapeutic agents focusing on thrombosis and other haematological conditions – have entered into an agreement whereby Inceptua will become Portola’s exclusive distribution partner for Ondexxya® in selected countries.
Ondexxya® has been approved by the US FDA, and was also approved by the EMA on 26th April 2019. Ondexxya® (andexanet alfa) is a recombinant modified human factor Xa (FXa) protein intended for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Through this agreement Inceptua becomes the exclusive distributor of Ondexxya® in; Belgium, France, Ireland, Luxembourg, Norway, Portugal and Spain. Inceptua Medicines Access will be providing access to Ondexxya® in these countries until the point at which Ondexxya® becomes commercially-available in each country.
Healthcare professionals can obtain information about the Ondexxya® pre-approval access program by contacting Inceptua by telephone +44 20 3910 7600 or by email access@inceptua.com
For more information
Mark Corbett Executive Vice President, Inceptua Medicines Access: mark.corbett@inceptua.com +44 20 3910 7600
About Inceptua Group and Portola:
Portola
Portola Pharmaceuticals is a global, commercial-stage biopharmaceutical company focused on the discovery, development and commercialisation of novel therapeutics that could significantly advance the fields of thrombosis and other haematologic conditions. The Company’s first two commercialised products are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed in Europe as Ondexxya® (andexanet alfa), and Bevyxxa® (betrixaban).
The company also is advancing cerdulatinib, a SYK/JAK inhibitor being developed for the treatment of haematologic cancers. Founded in 2003 in South San Francisco, California, Portola has operations in the United States and Europe.
About Inceptua
Inceptua is a pharmaceutical company and service partner spanning throughout the product lifecycle – from comparator sourcing for clinical trials, through early access programs to licensing and commercialization for products.
We partner with life science companies of all sizes, drawing on over 20 years of industry experience. Our pharma and biotech offering includes registration and commercialization of products through in-licensing and flexible partnerships. We have leading expertise in strategy and operational implementation of pre-approval access programs making pharmaceutical products under clinical development available for patients and Inceptua’s clinical trial services business offers high quality clinical comparator sourcing and manufacturing services with an agile global supply chain to ensure that products are delivered exactly when needed.
Inceptua Medicines Access is a business unit of the Inceptua Group. It offers full access solutions for the design, implementation and delivery of Pre-approval and Medicines Access Programs on behalf of biopharmaceutical companies.
Inceptua has global operations with local offices across Europe, USA, and Asia.
Cycle Pharmaceuticals and Inceptua Group Partner for a Free Goods Programme
Vesey Street Capital Partners, LLC has agreed to join us as investor and majority shareholder