Albireo Announces Exclusive Licensing Agreement With Jadeite Medicines 

Albireo Pharma, Inc. recently entered into an exclusive licensing agreement with Jadeite Medicines, Inc. for the development and commercialization of Bylvay (odevixibat) in Japan for progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and biliary atresia.

Under the terms of the agreement, Albireo will receive an upfront payment of $15 million and will be eligible to receive up to $120 million in milestones as well as double-digit royalties. Jadeite Medicines, a biopharmaceutical platform company focused on developing global innovative pharmaceutical products for Japan, will be responsible for clinical development, regulatory approval, and commercialization of Bylvay in Japan, where there is significant market opportunity. Jadeite Medicines is backed by CBC Group (www.cbridgecap.com), who has partnered with the world’s top entrepreneurs and scientists and, leveraging its unique “investor-operator” approach, has empowered global leading healthcare companies to widen access to affordable medical care, catalyze innovations and improve efficiency in fulfilling unmet medical needs worldwide.

“This agreement exemplifies Albireo’s commitment to providing global availability of Bylvay, particularly in areas like Japan where high prevalence translates to a sizable number of patients who currently have no approved treatment option. Jadeite Medicines entrepreneurial, biotech approach makes them the right type of partner to successfully commercialize Bylvay in Japan,” said Ron Cooper, President and Chief Executive Officer of Albireo. “The agreement allows for success of both companies, while strengthening Albireo’s financial position with the $15 million payment added to our strong balance sheet.”

Bylvay is the first drug approved in Europe for the treatment of all types of PFIC and in the US for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods. Bylvay is currently being evaluated in the ASSERT Phase 3 study for ALGS, the BOLD Phase 3 study for patients with biliary atresia and the ongoing PEDFIC 2 open-label trial in patients with PFIC.

“We are excited to partner with Albireo to accelerate delivery of odevixibat to children living with rare liver diseases, initially targeting PFIC, followed by potentially biliary atresia and Alagille syndrome, which all represent significant unmet medical needs in Japan,” said Eiichi Takahashi, MD, PhD, Chief Executive Officer of Jadeite Medicines. “This agreement reinforces Jadeite’s commitment and vision to develop highly differentiated and innovative medicines to improve the health and quality of life of patients in Japan.”

“CBC remains steadfast in our commitment to widening access to medical care globally, and Jadeite is our cornerstone in Japan, and the partnership with Albireo represents important progress toward that goal by expanding more cure options, initially for children living with rare liver diseases in Japan,” added Sean Cao, PhD, Managing Director of CBC Group. “By leveraging our extensive investor-operator experience in Asia, we will continue to partner with the world’s top pharmaceutical companies and scientists and identify opportunities to broaden global reach for patients with unmet medical needs.”

Bylvay is the first drug approved in the US for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). The European Commission (EC) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. Bylvay is available for sale in Germany and will be available for sale in other European countries following pricing and reimbursement approval. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay acts locally in the small intestine. Bylvay can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of PFIC. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit www.bylvay.com.

In the US and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT Phase 3 study for Alagille syndrome.

Jadeite Medicines is a biopharmaceutical company focused on developing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in Japan. The management team of Jadeite Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Japan and with leading global pharmaceutical companies. Jadeite Medicines plans to build a portfolio of global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. For more information, www.jadeitemedicines.co.jp.

CBC Group, Asia’s largest healthcare-dedicated investment firm, commits to creating value and integrating global resources. In partnering with the world’s top entrepreneurs and scientists, our unique “investor-operator” approach has empowered global leading healthcare companies to widen access to affordable medical care, catalyze innovations, and improve efficiency in fulfilling unmet medical needs worldwide. Founded in 2014, CBC has a leading team of investment, industry and portfolio management professionals headquartered in Singapore with global offices in Shanghai, Beijing, Hong Kong and New York, and presence in Boston, San Diego, San Francisco, and Tokyo. CBC focuses on platform-building, buyout, credit and growth-focused opportunities across multiple core areas within the healthcare sector, including pharmaceutical and biotech, medical technology and healthcare services. For more information, visit www.cbridgecap.com.

Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the US FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, MA, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. For more information, visit www.albireopharma.com.