On May 31, 2022 Immedica Pharma AB ("Immedica") and Japanese company OrphanPacific, Inc. ("OrphanPacific") reported that they on May 2, 2022, entered an agreement under which OrphanPacific gains the exclusive rights to Ravicti in Japan (Press release, Immedica Pharma, MAY 31, 2022, View Source [SID1234615240]).

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The pharmaceutical drug product Ravicti is approved in Europe and North America for treatment of urea cycle disorders (UCD).

Under the announced partnership, OrphanPacific is granted a license to develop, register and commercialize the product in UCD in Japan. OrphanPacific will initiate a clinical trial for obtaining approval for glycerol phenylbutyrate in Japan. OrphanPacific is already Immedica’s commercial partner in Japan for the commercialization of the drug product Buphenyl.

"It is with great pleasure that we announce this expanded partnership with OrphanPacific, under which we will be able to make Ravicti available to UCD patients also in Japan. The entered agreement also further strengthens Immedica’s geographical footprint, by introducing yet another product collaboration in Japan," says Anders Edvell, CEO of Immedica.

About Urea Cycle Disorders (UCD)

Urea cycle disorders are a group of metabolic diseases that affect a specific enzyme or transporter in the urea cycle leading to elevated ammonia or glutamine levels in the circulation. Symptoms of the disorder can begin at any age, with more severe defects beginning early in life. UCD patients may experience episodes, called hyperammonemic crises, when ammonia levels in the blood become excessively high, which can result in irreversible brain damage, coma or death. In Japan, UCDs occurs in 1 in 8,000 to 44,000 people and is one of the designated intractable diseases.