Market Overview

Certara Software or Services Supported 95% of the US FDA Novel Drug Approvals in First Half of 2018

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Modeling and simulation's positive impact on NDA and BLA approvals
through July 1, 2018 has included first use, orphan and priority review
drugs for multiple indications

Certara®, the global leader in model-informed drug development,
regulatory science, market access and real-world evidence services,
today reported that 95% of novel new drug approvals by the US Food and
Drug Administration (FDA) in the first half of 2018 were supported by
Certara software or services. Those results emphasize how much modeling
and simulation has become an integral part of regulatory submissions and
highlight Certara's leadership role in the field.

"Certara congratulates all of the biopharmaceutical companies that have
achieved this hard-earned regulatory milestone and thanks them for
giving us the opportunity to contribute to this success," said Certara's
CEO Dr. Edmundo Muniz. "Our mission is to revolutionize the drug
development paradigm by leveraging modern quantitative approaches such
as modeling and simulation and real-world evidence solutions to optimize
R&D productivity, commercial value and patient outcomes. These
technologies' positive impact is evident in the accelerated development
cycles for these approved drugs and the innovation adoption by the FDA."

FDA has been a leader promoting modeling and simulation as an integral
part of drug development and review, highlighting it specifically in the
21st Century Cures Act, PDUFA VI and GDUFA II. Further
illustrating that point, FDA Commissioner Scott Gottlieb, MD, cited "the
more widespread use of modeling and simulation, the greater use of
real-world evidence in the pre- and post-market setting, and the
adoption of better tools for collecting and evaluating more real-time
safety information after products are approved" among the new scientific
domains that have been introduced into the development and review
process in a recent statement.

Among the 2018 novel drug approvals for which Certara's modeling and
simulation technology-enabled services were leveraged, the following
examples are illustrative of innovation:

  • Medicines
    Development for Global Health's (MDGH's) approval for moxidectin

    for onchocerciasis (river blindness). River blindness is caused by the
    filarial worm Onchocerca volvulus, which is transmitted through
    infected black fly bites. At least 25 million people are infected with Onchocerca
    volvulus
    worldwide, according to the World Health Organization.
    Moxidectin is the first new drug approved for river blindness in 20
    years. MDGH is also the first not-for-profit company to be awarded a
    priority review voucher by the FDA.
  • Ultragenyx
    Pharmaceutical Inc's approval of Crysvita (burosumab-twza)
    , the
    first drug approved to treat adults and children ages 1 year and older
    with x-linked hypophosphatemia (XLH), a rare, inherited form of
    rickets. According to Dr. Julie Beitz of the FDA, "XLH differs from
    other forms of rickets in that vitamin D therapy is not effective.
    This is the first FDA-approved medication for the treatment of XLH and
    a real breakthrough for those living with this serious disease."
  • GW
    Pharmaceuticals' approval for Epidiolex (cannabidiol) [CBD]
    oral
    solution for the treatment of seizures associated with two rare and
    severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome,
    in patients two years of age and older. This is the first FDA-approved
    drug that contains a purified drug substance derived from marijuana.
    It is also the first FDA-approved drug for the treatment of patients
    with Dravet syndrome.

About Certara

Certara enables superior drug development and patient care
decision-making through model-informed drug development, regulatory
science, real-world evidence and knowledge integration. As a result, it
optimizes R&D productivity, commercial value and patient outcomes. Its
clients include hundreds of global biopharmaceutical companies, leading
academic institutions, and key regulatory agencies across 60 countries.
For more information, visit www.certara.com.

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