Intercept Announces Advanz Pharma to Acquire Ocaliva in PBC in Markets Outside the U.S. for up to $450MM, including $405MM Upfront and an Additional $45MM in Contingent Payments
GlobeNewswire “Press Releases”
Agreement includes rights for Advanz to commercialize orphan drug Ocaliva for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept
Additionally, Intercept will receive royalties on any future ex-U.S. net sales of obeticholic acid in NASH
Intercept to discuss further details during Q1 2022 earnings call on Friday, May 6th at 8:30 a.m. ET
A biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced it has entered into an agreement to sell to Advanz Pharma, a pharmaceutical company with a strategic focus on specialty and hospital pharmaceuticals in Europe, certain foreign subsidiaries and rights regarding Intercepts international operations, including a license to commercialize Ocaliva (obeticholic acid) outside of the U.S.
This agreement marks an important step forward for Intercept as the value it brings to our company allows us to significantly strengthen our balance sheet while providing us with greater strategic optionality during this transformational year and beyond, said Jerry Durso, President and Chief Executive Officer of Intercept. We are committed to investing in our core focus areas in the U.S., including our PBC business, potential future activities in NASH, and our advancing and expanding pipeline. At the same time, we are confident that the strong international team will continue to build on our successful PBC business as they transition to Advanz Pharma.
Upon closing of the transaction:
- Intercept will receive consideration in the amount of $405 million upfront, subject to customary working capital and other adjustments. The company will receive an additional $45 million from Advanz Pharma contingent upon receipt of an extension of pediatric orphan exclusivity in Europe.
- Intercept will receive royalties on any future net sales of obeticholic acid in NASH outside of the U.S., should Advanz Pharma pursue marketing authorization for this indication in ex-U.S. regions.
- Intercept will continue to be responsible for the manufacturing and supply of obeticholic acid globally and Advanz Pharma will be responsible for packaging, distribution and commercialization of the therapy in all markets outside of the U.S.
- The majority of Intercept employees outside of the U.S. will transfer to Advanz Pharma. The remaining international employees will continue to work for Intercept.
- Intercept will maintain an office in the UK to manage its global supply chain, support its quality organization, and support its global clinical trials.
Intercept and Advanz Pharma will work closely together to help ensure a seamless transition of Intercepts ex-U.S. business to Advanz Pharma. The transaction is subject to customary legal and regulatory closing conditions and is expected to be completed in two to three months.
Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA and is currently approved in more than 40 countries worldwide.
Piper Sandler acted as exclusive financial advisor, and DLA Piper acted as legal counsel to Intercept.
The conference call on Friday, May 6, will be available on the investor page of Intercepts website athttp://ir.interceptpharma.comor by calling (855) 232-3919 (toll-free) with passcode 7738727. Archived webcasts will be available on Intercepts website for approximately two weeks.
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For more information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn. Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn.
About Ocaliva (obeticholic acid)
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
- without cirrhosis or
- with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.