Press release -
Immedica Pharma and Innovative Medicines announces ANMAT (Argentina) and INVIMA (Colombia) filing acceptance of RAVICTI® (glycerol phenylbutyrate)
Stockholm, August 15, 2022
Immedica Pharma and Innovative Medicines announces ANMAT (Argentina) and INVIMA (Colombia) filing acceptance of RAVICTI® (glycerol phenylbutyrate), a adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs)
Immedica Pharma AB, and Innovative Medicines SA, announces two submissions of marketing authorization applications to:
- The National Agency of Medicines, Food and Medical Technology (ANMAT) in Argentina.
- The Colombia National Food and Drug Surveillance Institute (INVIMA)
Both applications are to seek approval for treatment with RAVICTI® (glycerol phenylbutyrate) as an adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) – who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
“It’s a natural step for us to continue the expansion of RAVICTI® to ensure the best possible treatment for patients with urea cycle disorders in different parts of the world,” says Anders Edvell, CEO of Immedica.
In 2021 Innovative Medicines and Immedica Pharma signed an agreement for the exclusive distribution and marketing of Ravicti and Ammonaps (sodium phenylbutyrate) for Argentina, Colombia and other territories in Latin America.
Legal warning
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
About Innovative Medicines AS
Innovative Medicines AS also called iMed Group is a privately held company created with the objective of filling the very specific and special medical needs of a small population of adults and children seeking life-preserving therapeutics for rare diseases.
Following the leadership of our partners around the world and under the management of a highly experienced team, iMed Group pursues the objective of becoming the leader biopharmaceutical research company in Latin America. To learn more about Innovative Medicines, please visit http://imedicinesgroup.com/
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. As a group, these disorders occur in 1 in 30,000 newborns in the territories where Immedica has the product rights.
For more information please contact:
Anders Edvell
Chief Executive Officer
anders.edvell@immedica.com
Phone: +46 705446126
Topics
- Diseases
Immedica is a fast-growing private niche pharma group. Its headquarter is based in Stockholm, Sweden, and it has 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.
