The PRIME scheme is designed to provide enhanced regulatory support for the development of medicines that target an unmet medical need.
“Being accepted into the PRIME scheme recognizes the potential of our program and the important endeavor of preventing chikungunya, a severe disease with global outbreak potential and no available treatments,” said Dr. Erich Tauber, CEO of Themis. “As we near the data read-out from our Phase 2 trial, we are currently gearing up for Phase 3 manufacturing and continuing interactions with the regulatory agencies will support a streamlined review and development process.”
The PRIME initiative was launched by EMA in 2016 to facilitate the development of medicines that target an important unmet medical need and may offer a major therapeutic advantage or benefit to patients without treatment options. These medicines are considered priority medicines within the European Union (EU). PRIME offers enhanced support to medicine developers to strengthen clinical trial designs, facilitate the generation of high-quality data and enable accelerated assessment of medicine applications.
About Themis
Themis Bioscience is developing urgently needed vaccines to prevent death and disability around the world. We lead in the development of a vaccine against chikungunya, a serious debilitating disease with global outbreak potential. Our innovation in vaccine technology has created a powerful platform and a growing pipeline addressing a broad range of infectious diseases. Together with industrial and academic leaders we work to prevent illness across the globe. For more information, visit http://www.themisbio.com.
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Contacts
For Themis:
Dr. Erich Tauber, CEO
Phone: +43 1 236 7151
erich.tauber@themisbio.com
or
Media requests for Themis:
Gretchen Schweitzer or Dr. Stephanie May
Trophic Communications
Phone: +49 89 2388 7730 or +49 171 185 56 82
may@trophic.eu
Source: Themis