Across all domains
ST. LOUIS, Mo. With a focus on expanding the breadth of its technology offerings to drug developers, Certara has reached an agreement to acquire Simcyp Ltd. for $32 million.
The acquisition enhances Certara’s portfolio and provides key, extensible technologies that support Certara’s translational science initiatives.
Other terms of the acquisition were not released.
St. Louis-based Certara, which was formed through the merger of scientific software providers Tripos and Pharsight, is a provider of drug discovery and development software. U.K.-based Simcyp is a research company that provides a modeling and simulation platform for predicting the fate of drugs in virtual populations, including pediatric populations.
In making the announcement, Certara President and CEO Jim Hopkins says the capabilities offered by Simcyp’s preclinical technologies, combined with Certara’s existing software products and scientific consulting services, “will provide significant drug development advantages to our mutual and prospective clients.”
“From a translational science perspective, Simcyp’s preclinical simulation technologies, which include prediction of drug-drug interactions, fit perfectly between Certara’s existing discovery and clinical research offerings, thus enabling an end-to-end solution,” he adds. “For example, this means broader capabilities to predict drug disposition as a function of molecular structure, and the ability to utilize a single unified suite of tools to facilitate preclinical and clinical PB/PK and PK/PD modeling and analysis.”
John Evans, managing director at Simcyp, says the acquisition by Certara will allow Simcyp to focus on its core competence while drawing on the broader drug development expertise available within the Certara family.
“Clients from across the spectrum of drug discovery and development will have access to an expanded and integrated range of products and services, which will be enhanced by combining the attributes of Tripos, Simcyp and Pharsight science and functionality,” he says.
According to Daniel L. Weiner, Certara’s senior vice president and general manager of software, the buyout builds on Certara’s Tripos software used in drug discovery and its Pharsight solution for users conducting preclinical and clinical drug research.
“Simcyp is an ideal fit between Certara’s existing technology in molecular modeling and QSAR from Tripos and PK/PD modeling from Pharsight, making Certara the only company that has predictive science methods in discovery, preclinical and clinical drug research, along with an R&D informatics solution to integrate data across all domains,” he says.
Many drug development organizations are looking for ways to integrate the currently divided silos in research and development and to improve decision-making between and among discovery, preclinical and clinical providers.
The Simcyp Simulator is a physiologically based pharmacokinetic simulation tool, known as PB/PK simulation. It is primarily used by preclinical teams to predict key clinical decisions around drug safety, ADME and drug-drug interactions.
The capabilities offered by Simcyp’s preclinical technologies, combined with Certara’s existing software products and scientific consulting services, will provide significant drug development advantages to pharma and biotech organizations seeking an “end-to-end” solution in drug development.
Weiner adds that the addition of Simcyp’s technologies allows Certara “to create in-silico workflows that reduce the need for costly and time-consuming lab and clinical work by focusing experimental effort only on compounds with the desired PK, safety and efficacy, thus improving yields throughout the process.”
Geoff Tucker, chairman of Simcyp, points out that the accuracy of in-vitro/in-vivo extrapolation depends on the inclusivity and quality of the input data for a particular compound.
“With good data, the prediction, for example, of the extent of drug-drug interactions, is of the order of 80 percent within a factor of two,” he explains. “Extensive performance verification both within Simcyp and externally through the experience and publications of its consortium members has provided significant confidence in the approach.”
Moreover, as a testament to the impact of PB/PK modeling in drug development, Tucker notes that the current draft of the U.S. Food and Drug Administration Guidance for Industry on Drug-Drug Interactions provides strong endorsement of the approach, indicating that simulation can be used as a basis for waiving real studies when the predicted extent of an interaction is small.
The acquisition by Certara means that Simcyp will continue to operate as before, developing algorithms and databases, providing extensive education on PB/PK-PD modeling through its workshops and offering high-level consultancy.
Tucker adds that there will now be considerable effort to align and integrate its products with those of Tripos (linkage of exposure to target and off-target effects) and Pharsight (linkage through to Phoenix WinNonlin and NLME and the Clinical Trials Simulator).
Weiner says the goal of this acquisition is to position Certara as the leading provider of tools and an informatics infrastructure to support translational drug development.
“The success will be measured by clients’ willingness to invest in the solution we are providing,” he says.