Immedica Pharma AB announced today that Immedica became the Market Authorisation Holder (MAH) for Ammonaps® (Sodium phenylbutyrate) and Ravicti® (Glycerol phenylbutyrate), in 28 EU member countries, Norway and Iceland on 6 June 2019. Ammonaps® and Ravicti®, indicated for the treatment of Urea Cycle Disorders (UCD).
In December 2018, Immedica acquired the rights for the products Ammonaps® and Ravicti®, in all territories outside North America and Japan from Horizon Therapeutics.
” We are very happy to now take the full MAH responsibility for these important products in the European Union. This is an important step in establishing Immedica as a capable specialty pharma partner in the territory” says Anders Edvell, CEO of Immedica.
Ammonaps® has been a reference product for many years in patients suffering from UCD. Ravicti® is an innovative product with an indication highly overlapping with that of Ammonaps and with relevant compliance benefits, which are critical in the treatment of these patients.
About Urea Cycle Disorders (UCD)
The urea cycle is a process in which waste (ammonia) is removed from the body. When you eat proteins, the body breaks them down into amino acids. Ammonia is produced from leftover amino acids, and it must be removed from the body.
Several inherited conditions can cause problems with this waste-removal process. People with a urea cycle disorder are missing a gene that makes the enzymes needed to break down ammonia in the body. As a group, these disorders occur in 1 in 30,000 newborns in the territories where Immedica has acquired rights.
Typically, symptoms such as confusion, nausea, vomiting, decreased food intake and increased sleepiness occur within the first week after birth.
About Immedica Pharma
Immedica is a fast-growing private European niche pharma group. Its legal entities are based in Stockholm, Sweden, and it has pan-European commercial coverage, with the Nordics as its stronghold.
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 3.6 billion in committed capital from leading Nordic and international investors. More information is available at www.immedica.com.
For more information
Anders Edvell, CEO, Immedica
+46 705 44 61 26