CureVac announces "MERAN" has been approved by the World Health Organization as suffix for mRNA drug substances
TÜBINGEN, Germany, Feb. 18, 2016 /PRNewswire/ -- CureVac AG, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, today announced that the World Health Organization (WHO) has approved "MERAN" as a suffix ("stem") for mRNA drug substances. CureVac initiated the process by sending the proposal with suggestions for the novel nomenclature to the WHO, whose expert advisory panel selected the suffix "MERAN" to indicate "messenger RNA."
The application for a new substance class was submitted by CureVac in connection with the clinical development of the company's mRNA-based, first-in-man prophylactic vaccine against rabies. In discussions with the WHO, CureVac demonstrated that all mRNA vaccines in its pipeline belong to the same class, and thus constitute a new group of pharmacologically related substances, which is a further requirement to justify the introduction of a new stem. Since CureVac's prophylactic vaccines are not classified as gene therapy products, it became obvious that they are not related to the gene therapy suffix "GEN." This was a compelling reason to create a new stem for this substance class. The drug substance of CureVac's rabies vaccine, which is currently being tested in a clinical phase I trial, is now officially listed as "NADORAMERAN."
Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac, said: "To earn a new stem for this novel class of medicine, which is showing increasing potential for multiple indications, is a great accomplishment for CureVac and the mRNA industry. It clearly reflects the progress of the fast-moving field of mRNA-based therapeutics. We look forward to reaching additional milestones on the way to bringing mRNA-based drugs to market."
This makes CureVac the first company to ever successfully apply for an INN (International Nonproprietary Name) concerning mRNA therapeutics.
About International Nonproprietary Names (INN)
International Nonproprietary Names (INN, also known as generic names) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients (APIs). Each INN is a unique name that is globally recognized and is public property. The purpose of defining new substance classes is to inform pharmacists and medical doctors around the globe about the substances contained in a preparation. Therefore, the nomenclature has to be precise. By defining the prefix, infix, and suffix of an INN, one can determine the indication and mechanism of action of each preparation.
About CureVac AG
Founded in 2000 as a spin-off from the University of Tϋbingen in Germany, CureVac is a technology leader in the development of drugs that are based on messenger RNA (mRNA). The company has more than 15 years of expertise in handling and optimizing this versatile molecule for medical purposes, and has the most advanced product pipeline in the industry.
The basic principle of CureVac's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
To date, CureVac has initiated eight clinical trials with about 450 patients and healthy volunteers in eleven countries.
Since its inception, CureVac has received approximately $330 million (€300 million) in equity investments. CureVac has entered into various collaborations with multinational corporations and organizations, including agreements with Boehringer Ingelheim, Sanofi Pasteur, the Bill & Melinda Gates Foundation, and IAVI.
In 2006, CureVac successfully established the first GMP facility worldwide for the manufacturing of mRNA. In 2016, CureVac will begin construction of an industrial scale production facility.
For more information, please visit www.curevac.com.
Media Contacts
Verena Lauterbach, Senior Manager Communications
CureVac AG, Tübingen, Germany
T: +49 (0) 7071 9883 1756
[email protected]
Andrew Mielach, Vice President
Tiberend Strategic Advisors, New York
T: +1 212 375 2694
[email protected]
Rachel Hunter, Account Director
Brunswick Group, New York
T: +1 212 333 3810
[email protected]
SOURCE CureVac AG
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