Ravicti® (glycerol phenylbutyrate) approved by the Department of Health in Hongkong for the treatment of Urea Cycle Disorders

Ravicti® (glycerol phenylbutyrate) approved by the Department of Health in Hongkong for the treatment of Urea Cycle Disorders

Immedica Pharma, a pharmaceutical company focused on commercialisation of rare and specialty care products, and Winhealth Pharma today announce that Ravicti® (Glycerol phenylbutyrate) has been approved by the Department of Health in Hongkong for the treatment of urea cycle disorders.

Anders Edvell, CEO of Immedica comments: “There is significant medical need for better treatment options for people living with urea cycle disorders around the world. With this approval we contribute to advancing the care for patients in Hongkong living with this rare and severe disease.”

In December 2020, Immedica signed an agreement with Winhealth Pharma, under which Winhealth Pharma was granted exclusive commercialisation rights for glycerol phenylbutyrate in Greater China, South Korea, Singapore, Vietnam, Indonesia, Malaysia, the Philippines and Thailand.



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. Beyond hyper hyperammonemic crises there are also more subtle symptoms including vomiting, refusal to feed, irritability, muscular hypotonia as well as delayed motor and psychointellectual development. As a group, these disorders occur in 1 in 35,000 newborns.

Ravicti®
Ravicti® (glycerol phenylbutyrate) is a medicine used to treat patients of all ages with UCDs, including deficiencies of carbamoyl phosphate synthetase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The medicine is used to reduce the amount of ammonia in the blood in order to reduce the risk of neurological consequences.

About Winhealth Pharma
Hong Kong Winhealth Pharma Group ("Winhealth Pharma") is a China-based, global innovative biomedical company founded in 2006, providing novel breakthrough therapies to patients with rare diseases and other unmet medical needs. The Group has established long-term strategic partnership with dozens of world-leading biotechnology companies. It has built a unique, balanced and diversified portfolio with numerous orphan drugs and specialty products at commercial and late clinical stages and will continuously look to bring in more innovative therapies from the globe. Read more at www.winhealthpharma.com

About Immedica Pharma
Immedica is a fast-growing private niche pharma group, headquartered in Stockholm, Sweden with commercial coverage across Europe and the Middle East.

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 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, quality, and product distribution.

Immedica’s main owner is Impilo AB, a private Nordic investment company established in 2017, with more than SEK 10 billion in committed capital from leading Nordic and international investors.

For more information visit www.immedica.com.

Contact

Linda Holmström
Head of Communication
e-mail: linda.holmstrom@immedica.com
Phone: + 46 708 73 40 95