Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

Rhea-AI Summary

Certara, a leader in biosimulation, announced on December 21, 2021, that the FDA has renewed and expanded its licenses for more than 400 user licenses of Certara's Simcyp and Phoenix software across 12 divisions. This software plays a critical role in drug development, helping the FDA analyze investigational therapies, new drug applications, and generic applications. The renewal indicates the FDA's growing reliance on Certara's tools, which are used by 37 of the top 40 biopharmaceutical companies. This expansion reflects Certara's influential position in ensuring the safety and efficacy of medicines.

Positive

• FDA has renewed and expanded licenses for Certara’s Simcyp and Phoenix software, indicating strong demand.
• More than 400 licenses for Certara's software across 12 divisions of the FDA suggest a growing reliance on their technology.
• Certara's software is utilized by 37 of the top 40 global pharmaceutical companies, highlighting its industry leadership.

Negative

• None.

FDA holds more than 400 Simcyp™ and Phoenix™ software licenses across 12 divisions and offices

PRINCETON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 user licenses of Simcyp and Phoenix software. In total, there are 12 divisions and offices of the FDA using Certara’s software for internal research and to independently analyze, verify and review regulatory submissions.

Certara’s Simcyp Simulator, an industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions. The FDA has renewed its licenses for the Simcyp Simulator, Simcyp Paediatric and Simcyp Cardiac Safety Simulator, which the agency uses to independently analyze, verify and review investigational therapies, new drug applications and generic drug applications.

“It is a privilege to continue providing software that global regulatory agencies can rely on to inform their reviews of regulatory submissions,” said William F. Feehery, Ph.D., CEO of Certara. “We are pleased that more scientists at the FDA are using our biosimulation software to support the development of safe and effective medicines.”

Additionally, the FDA has renewed and expanded its user licenses of Certara’s Phoenix Software, which is widely used for pharmacokinetic, pharmacodynamic and toxicokinetic modeling and simulation. Phoenix is used extensively to perform data analyses for new drug and biologics license applications by drug developers, including 37 of the top 40 global pharmaceutical companies by R&D spend. The FDA uses Certara’s Phoenix software including WinNonlin, NLME and In Vitro-In Vivo Correlation (IVIVC) toolkit as well as the Company’s Trial Simulator software.

For more information on Certara’s software platforms, please visit https://www.certara.com/software/.

About Certara
Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.

Certara Contact
Jieun W. Choe
jieun.choe@certara.com

Media Contacts:
Daniel Yunger
Kekst CNC
daniel.yunger@kekstcnc.com

Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com

Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com

FAQ

What recent announcement did Certara make regarding the FDA?

Certara announced that the FDA has renewed and expanded its licenses for over 400 user licenses of its Simcyp and Phoenix software.

How many divisions of the FDA use Certara's software?

Certara’s software is utilized across 12 divisions and offices of the FDA.

What is the significance of the renewal of Certara's software licenses by the FDA?

The renewal signifies the FDA's growing reliance on Certara's software for drug development and regulatory analysis.

Which top pharmaceutical companies use Certara's software?

Certara's software is used by 37 of the top 40 global pharmaceutical companies based on R&D spending.

When was the FDA's renewal of Certara's software licenses announced?

The renewal was announced on December 21, 2021.