Market Overview

Ology Bioservices and RAFA Laboratories Announce FDA Approval of the Atropine Autoinjector as a Medical Countermeasure for Chemical Nerve Agents


Ology Bioservices, Inc., a biologics contract development and
manufacturing organization (CDMO), and Rafa Laboratories, Ltd. (Rafa), a
leading Israeli pharmaceutical company, today announced that on July 9,
2018, they received full approval from the U.S. Food and Drug
Administration (FDA) for the Atropine Injection, 2mg/0.7mL, Single-Dose
Autoinjector. The Atropine Autoinjector initially received Emergency Use
Authorization from the FDA in April 2017. Atropine is one of the most
commonly used drugs for the treatment of chemical nerve agent poisoning.
With the approved autoinjector, U.S. troops can rapidly inject atropine
into the thigh muscle following nerve agent exposure.

This FDA approval decreases reliance on a sole source drug product and
device manufacturer and ensures that the Department of Defense (DoD),
U.S. Government stakeholders, and international partners can quickly and
cost-effectively procure the Atropine Autoinjector in the event of a
nerve agent threat. There is substantial potential for a public health
emergency involving nerve agents and certain insecticides. The usage of
these agents can affect national security as well as the health and
security of U.S. citizens living abroad.

The Joint Project Management Office for Medical Countermeasure Systems
(JPM-MCS) Chemical Defense Pharmaceuticals (CDP) Project Management
Office, funded and led the collaboration for development of the Atropine
Autoinjector, which also included the FDA, Centers for Disease Control
and Prevention (CDC) and Battelle.

"FDA approval of the Atropine Autoinjector serves to further demonstrate
the strength of our expertise, as well as our ongoing commitment to
bringing medical countermeasures to the U.S. military," said Dr. Doris
Snow, Vice President, Global Regulatory Affairs at Ology Bioservices.
"Moreover, having worked successfully alongside Rafa since 2015, we are
delighted to have the opportunity to expand this important partnership
as the company's U.S. Agent."

About Rafa

Rafa Laboratories, Ltd., incorporated in 1937, is one
of Israel's leading pharmaceutical companies. The company specializes in
marketing, manufacture and distribution of proprietary and generic
formulations, prescription and over-the-counter medicines, as well as
therapeutic products in various medical fields such as pain,
gastroenterology, respiratory diseases and dermatology.

One of Rafa's fields of expertise is the manufacture of drugs for other
companies, implementing the contract manufacturing method, and it offers
a range of services under a one-stop-shop concept.

Rafa has an advanced manufacturing facility approved for production
in Israel, Europe and additional countries in the world. To date, Rafa
is the only company in Israel having the capacity for mass production of
sterile and aseptic ampoules, and it manufactures, markets and exports
ampoules for use in hospitals and clinics as well as syringes for
military and civil defense uses.

About Medical Countermeasure Systems Chemical Defense Pharmaceuticals
Product Management Office

MCS-CDP delivers Food and Drug Administration-approved, lifesaving
medical countermeasure therapeutics against emerging chemical,
radiological, and nuclear threats. It is a program within JPM-MCS, which
facilitates the advanced development and acquisition of medical
countermeasures and systems to enhance the nation's biodefense response
capability. The JPM-MCS is a component of the U.S. DoD.

About Ology Bioservices

Ology Bioservices is a full-service Contract Development Manufacturing
Organization (CDMO) serving both government and commercial clients,
specializing in biologic drug substance manufacturing, from early stage
through commercial product. The company has 183,000 square feet of
manufacturing, process development and QA/QC space in its
state-of-the-art, Department of Defense Advanced Development and
Manufacturing Facility in Florida. The company's infrastructure provides
unique services to its clients, including full regulatory support from
preclinical through licensure, clinical trial operational support and
bioanalytical testing, as well as cGMP manufacturing up to Biosafety
Level 3 (BSL3). Ology Bioservices has 20 years of experience developing
and manufacturing drugs and biologics for the U.S. Government, with over
$500M in government contracts awarded over that time. The team at Ology
Bioservices has decades of experience manufacturing, developing and
licensing vaccines and protein/antibody therapeutics.

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