EQS-News: PAION AG / Key word(s): Regulatory Admission
PAION ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BY ITS LICENSEE CRISTÁLIA IN BRASIL
Aachen (Germany), 19 January 2023 – PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative compounds for use in outpatient and in-hospital sedation, anesthesia and intensive care, has reached an important milestone for the commercialization of remimazolam in Latin America. Thus, the Latin American remimazolam licensee Cristália Produtos Quimicos Farmaceuticos Ltda, Brazil (“Cristália”) informed PAION about the submission of a New Drug Application (NDA) to the Brazilian Health Regulatory Agency (ANVISA) for remimazolam in both indications general anesthesia and procedural sedation.
The NDA submission triggers a milestone payment of EUR 1 million from Cristália. After approval Cristália will pay PAION 20% royalties on net sales.
Gregor Siebert, CEO of PAION AG, commented: “We congratulate our partner Cristália on the submission of a marketing authorization application for remimazolam in Brazil. We are very proud of this first submission in the biggest pharma market in Latin America, which once again demonstrates the global potential of remimazolam. We look forward to building a successful and long-term partnership between our companies and eagerly await the decision of ANVISA, which is expected for 2024.”
Dr Ricardo S. Pacheco, Chairman of Cristália stated: “With the NDA application in Brazil, Cristália is now one step closer towards our goal of bringing this innovative product for Latin America. We will be working closely with PAION and ANVISA to facilitate completion of the review in a timely manner. Once remimazolam is approved, we will go full steam ahead with commercialization.”
CRISTÁLIA is a private owned Brazilian biopharmaceutical company, with 50 years of operation and a broad footprint across the main Latin America markets. Currently a leader in anesthetics and critical care products, CRISTALIA supplies more than 95% of Brazilian hospitals and Healthcare services with a broad range of high-quality and affordable products.
In addition to the biopharmaceutical business, CRISTÁLIA also ranks between the biggest API manufacturers in Latin America, with state-of-the-art facilities dedicated to the manufacturing of synthetic, oncologic and biotech active ingredients.
CRISTÁLIA is headquartered in Campinas (Brazil).
PAION AG is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. PAION is rolling out remimazolam (Byfavo®) in selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.
In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA®), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA®), a novel fluorocycline type of antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.
PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany).
Senior Vice President Investor Relations & Corporate Communications
52078 Aachen – Germany
Phone +49 241 4453-152
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION AG's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
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