Across all domains

ST. LOUIS, Mo. With a focus on expanding the breadth of itstechnology offerings to drug developers, Certara has reached an agreement toacquire Simcyp Ltd. for $32 million.

The acquisition enhances Certara's portfolio and provideskey, extensible technologies that support Certara's translational scienceinitiatives.

Other terms of the acquisition were not released.

St. Louis-based Certara, which was formed through the mergerof scientific software providers Tripos and Pharsight, is a provider of drugdiscovery and development software. U.K.-based Simcyp is a research companythat provides a modeling and simulation platform for predicting the fate ofdrugs in virtual populations, including pediatric populations.

In making the announcement, Certara President and CEO JimHopkins says the capabilities offered by Simcyp's preclinical technologies,combined with Certara's existing software products and scientific consultingservices, "will provide significant drug development advantages to our mutualand prospective clients."

"From a translational science perspective, Simcyp'spreclinical simulation technologies, which include prediction of drug-druginteractions, fit perfectly between Certara's existing discovery and clinicalresearch offerings, thus enabling an end-to-end solution," he adds. "Forexample, this means broader capabilities to predict drug disposition as a functionof molecular structure, and the ability to utilize a single unified suite oftools to facilitate preclinical and clinical PB/PK and PK/PD modeling andanalysis."

John Evans, managing director at Simcyp, says theacquisition by Certara will allow Simcyp to focus on its core competence whiledrawing on the broader drug development expertise available within the Certarafamily.

"Clients from across the spectrum of drug discovery anddevelopment will have access to an expanded and integrated range of productsand 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 vicepresident and general manager of software, the buyout builds on Certara'sTripos software used in drug discovery and its Pharsight solution for usersconducting preclinical and clinical drug research.

"Simcyp is an ideal fit between Certara's existingtechnology in molecular modeling and QSAR from Tripos and PK/PD modeling fromPharsight, making Certara the only company that has predictive science methodsin discovery, preclinical and clinical drug research, along with an R&Dinformatics solution to integrate data across all domains," he says.

Many drug development organizations are looking for ways tointegrate the currently divided silos in research and development and toimprove decision-making between and among discovery, preclinical and clinicalproviders.

The Simcyp Simulator is a physiologically basedpharmacokinetic simulation tool, known as PB/PK simulation. It is primarilyused by preclinical teams to predict key clinical decisions around drug safety,ADME and drug-drug interactions.

The capabilities offered by Simcyp's preclinicaltechnologies, combined with Certara's existing software products and scientificconsulting services, will provide significant drug development advantages topharma and biotech organizations seeking an "end-to-end" solution in drugdevelopment.

Weiner adds that the addition of Simcyp's technologiesallows Certara "to create in-silicoworkflows that reduce the need for costly and time-consuming lab and clinicalwork 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 theaccuracy of in-vitro/in-vivoextrapolation depends on the inclusivity and quality of the input data for aparticular compound.

"With good data, the prediction, for example, of the extentof drug-drug interactions, is of the order of 80 percent within a factor oftwo," he explains. "Extensive performance verification both within Simcyp andexternally through the experience and publications of its consortium members hasprovided significant confidence in the approach."

Moreover, as a testament to the impact of PB/PK modeling indrug development, Tucker notes that the current draft of the U.S. Food and DrugAdministration Guidance for Industry on Drug-Drug Interactions provides strongendorsement of the approach, indicating that simulation can be used as a basisfor waiving real studies when the predicted extent of an interaction is small.

The acquisition by Certara means that Simcyp will continueto operate as before, developing algorithms and databases, providing extensiveeducation on PB/PK-PD modeling through its workshops and offering high-levelconsultancy.

Tucker adds that there will now be considerable effort toalign and integrate its products with those of Tripos (linkage of exposure totarget and off-target effects) and Pharsight (linkage through to PhoenixWinNonlin and NLME and the Clinical Trials Simulator).

Weiner says the goal of this acquisition is to positionCertara as the leading provider of tools and an informatics infrastructure tosupport translational drug development.

"The success will be measured by clients' willingness toinvest in the solution we are providing," he says.