Immedica and OrphanPacific enter agreement giving OrphanPacific rights to Ravicti® (glycerol phenylbutyrate) in Japan

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Stockholm, May 31, 2022 – Immedica Pharma AB (“Immedica”) and Japanese company OrphanPacific, Inc. (“OrphanPacific”) are happy to announce that they on May 2, 2022, entered an agreement under which OrphanPacific gains the exclusive rights to Ravicti® in Japan.

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.

About Immedica

Immedica is a fast-growing private European niche pharma group with the headquarter based in Stockholm, Sweden. Today, the company has strong direct pan-European and Middle East commercial coverage. In addition, Immedica provides some of its products to other parts of the world via a network of regional partners.

Immedica provides significant know-how and experience from commercialization of niche/specialty care products across Europe and the Middle East, and the company’s management team has an outstanding track record of partnering and operating niche pharma products internationally. Immedica has capabilities to provide optimal access of specialty care medicines to patients with significant medical needs, including key areas such as regulatory affairs, pharmacovigilance, medical affairs, pricing & reimbursement, and product distribution.

About OrphanPacific

OrphanPacific is a Japanese pharmaceutical company that brings new therapeutic drugs to patients with rare diseases through the development, manufacturing, and sale of orphan drugs. The company’s mission is to “deliver smiles and happiness to patients with rare diseases and their families.”  With the determination of “Leave No One Behind”, OrphanPacific is actively working on the development and distribution of drugs for the treatment of rare diseases with a very small number of patients. OrphanPacific is a wholly owned subsidiary of CMIC Holdings, a pioneer and leading CRO (Contract Research Organization) in Japan. Making the best use of the CMIC Group’s experience, and know-how of drug development, manufacturing and sales, the company aims to enable as many patients with rare diseases as possible to access to therapeutic drugs.

Contact

Immedica Pharma AB
Anders Edvell – Chief Executive Officer
anders.edvell@immedica.com
Phone:  +46 705446126