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2015-10-05

Molecular Health : Molecular Health to Offer Early Access Program for SafetyMAP(TM)

Enrollment Now Open for Early Access Program (EAP) Set to Launch in November 2015CAMBRIDGE, Mass., Oct. 5, 2015 (GLOBE NEWSWIRE) -- Molecular Health, a leader
in cloud-based healthcare decision support technology to optimize the
selection of therapies for improved patient outcomes, today announced that it
will initiate an early access program (EAP) offering its SafetyMAPTMsoftware
to pharmaceutical companies and clinical professionals involved in drug
safety starting in November 2015.

Molecular Health recently entered into a commercial license to provide the
U.S. Food and Drug Administration (FDA) with use of its SafetyMAP software,
which the FDA considers a "mission critical" capability for assessing the
importance of possible safety issues of drugs pre- and post-approval.

SafetyMAP is a comprehensive and dynamic analytical solution for the detection
and molecular analysis of drug-induced adverse events for all marketed drugs
and for predicting safety issues of new drug candidates. It is designed to
help users further understand and discover relationships between scientific
findings and diverse events and confirm relationships between drugs, toxicity
mechanisms, patient susceptibility, and clinical effects. SafetyMAP provides
an integrated approach not available in any single other tool to identify the
safety interactions and adverse events related to specific drugs, drug
classes, disease, and molecular targets and pathways.

Lutz Voelker, President and CEO of Molecular Health, said, "Ideal patient
treatment selection is based upon the optimal efficacy of the therapy
balanced against its optimal safety. Understanding and effectively managing
treatment selection and the inherent safety profile of those treatments can
alleviate considerable cost to the healthcare system. We are excited to offer
an early access program for SafetyMAP to help support this complex issue and
address drug development challenges. SafetyMAP, first available through the
soon-to-launch EAP, is an instrumental value-add for pharmaceutical
developers or clinical professionals making decisions in researching,
developing and managing therapeutic treatments."

Laura T. Housman, Global Head of Molecular Health's Therapeutics Business,
added, "Drug safety and adverse drug events (ADEs) are a serious public
health issue. Each year in the United States approximately 700,000 emergency
department visits and 120,000 hospitalizations are due to ADEs and more than
$3.5 billion is spent on extra medical costs as a result of ADEs1.
Furthermore, at least 40% of the costs of ambulatory (non-hospital settings)
ADEs are estimated to be preventable2. These numbers are staggering. We're
eager to offer a solution to this growing problem and to provide EAP users
with the opportunity to provide feedback for further customizing SafetyMAP
during and following the early access period."

This EAP is a unique opportunity to engage with Molecular Health scientists in
consultation on a specific program or drug safety research question while
having early access to the comprehensive SafetyMAP database and computational
modeling software.

Pharmaceutical companies, systems pharmacologists and clinical professionals
interested in the SafetyMAP Early Access Program may contact Molecular Health
atSafetyMapEAP@molecularhealth.comor the Cambridge, MA office at (617)
453-3938 for more information and to join the EAP, which is scheduled to
launch in November 2015.

Leveraging Molecular Health's platform technology of biomedical and molecular
databases, analytical methods and visualization tools, SafetyMAP was
developed by integrating clinical information from more than five million
reports from the FDA Adverse Event Reporting System (FAERS), with information
about targets and drug mode action and disease pathways at the molecular
level. This drug-centric data integration process enables the molecular
transformation of clinical information, enabling human clinical information
to now be analyzed from the perspective of molecular parameters (e.g.,
targets or pathways).

Molecular Health is marketing SafetyMAP to pharmaceutical regulatory agencies
such as the U.S. FDA and to the pharmaceutical and health insurance
industries worldwide.

References

1 Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest
JL.National surveillance of emergency department visits for outpatient
adverse drug events.JAMA 2006;296:1858-66.
2 Institute of Medicine. Committee on Identifying and Preventing Medication
Errors. Preventing Medication Errors, Washington, DC: The National
Academies Press 2006.

About Molecular Health

Molecular Health is a leading biomedical company that is transforming
molecular data and medical knowledge into actionable clinical information for
more efficient and safe targeted therapies for each individual patient.
SafetyMAPTMis a content and analytics solution for drug de-risking and drug
safety analysis and for analysis to be used for research by regulatory
authorities and the pharmaceutical and health insurance industries. Molecular
Health also generates individualized tumor analysis and clinical
interpretation for evidence-based targeted therapy identification utilizing
published medical knowledge in a clinical context. This analysis is offered
in the U.S., utilizing an end-to-end CLIA laboratory test grounded in
next-generation sequencing technology. In Europe, Molecular Health has the
first registered medical device of its kind for personalized cancer medicine.
Molecular Health Inc., headquartered in Cambridge, Massachusetts, with a
laboratory and support center in Greater Houston, Texas, is a wholly owned
subsidiary of Molecular Health GmbH, headquartered in Heidelberg, Germany. To
learn more, please visit:www.molecularhealth.com.

CONTACT: Media Contacts
U.S.: Mark Rodgers 832-247-3068 mark.rodgers@molecularhealth.com
EU: Carla Mertens +49 6221 43851-2275 carla.mertens@molecularhealth.com
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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Molecular Health via Globenewswire

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