Kamada Announces Collaboration with Massachusetts General Hospital for Proof of Concept Study Evaluating Benefit of Liquid Alpha-1 Antitrypsin on Liver Preservation Prior to Transplantation

Feb. 21, 2017

NESS ZIONA, Israel – February 21, 2017 – Kamada Ltd. (NASDAQ and TASE: KMDA), a
plasma-derived protein therapeutics company focused on orphan indications, announced
today a collaboration with Massachusetts General Hospital (MGH) to conduct a proof of
concept study evaluating the potential benefit of the Company’s Liquid Alpha-1 Antitrypsin
(AAT) on liver preservation. The study will be led by James F. Markmann M.D., Ph.D., Chief,
Division of Transplant Surgery, MGH, who is the Claude E. Welch Professor of Surgery at
Harvard Medical School.
AAT has been found to have anti-inflammatory, tissue-protective, immune-modulatory, and
anti-apoptotic properties in direct consequence of its underlying anti-protease capabilities.
These properties may attenuate inflammation by lowering levels of pro-inflammatory
mediators such as cytokines and proteases that are associated with organ transplantation
rejection, including liver transplantation. Liver preservation methods pre-transplant are
improving due to advanced technologies.
The purpose of this study is to evaluate the effect of Kamada’s Liquid AAT on graft quality
and viability, as well as assess the graft for markers of Ischemia-Reperfusion Injury (IRI)
caused to the liver.
“There remains a significant unmet need in reducing the mortality and re-transplantation
rates associated with liver transplants, which in many cases are the result of IRI of the
transplanted organ,” said Dr. Markmann. “While liver preservation methods have
improved in recent years, advancements are still needed to improve patient care. As MGH’s
liver transplant program is one of the largest in the world, this area of research is of
particular interest to our institution, and we look forward to studying the mechanism of IRI
in liver transplant and the potential of AAT in modifying ischemic response.”
“We are delighted to work with MGH, a world-renowned institution that is consistently
ranked as one of the top hospitals in the US, to conduct this proof of concept study,” said
Amir London, Kamada’s Chief Executive Officer. “Based on its known properties, we think
AAT may have significant potential in IRI in the liver. There are over 100,000 solid organ
transplants conducted each year globally, of which over 20,000 are liver transplants. As
such, if AAT is demonstrated to improve graft quality in this study, Kamada intends to
conduct a pivotal study in order to seek approval in liver preservation, which could also
lead in the future to improved preservation of additional solid organ transplants,
representing a potential market opportunity of over $500 million for Kamada’s Liquid
About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and
has a commercial product portfolio and a robust late-stage product pipeline. The Company
uses its proprietary platform technology and know-how for the extraction and purification
of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified,
liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived
from human plasma with known and newly-discovered therapeutic roles given its
immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties.
The Company’s flagship product is GLASSIA®, the first and only liquid, ready-to-use,
intravenous plasma-derived AAT product approved by the U.S. Food and Drug
Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership
with Baxalta (now part of Shire plc) and in other counties through local distributors. In
addition to GLASSIA®, Kamada has a product line of seven other pharmaceutical products
administered by injection or infusion, that are marketed through distributors in more than
15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and
Asia. Kamada has five late-stage plasma-derived protein products in development,
including an inhaled formulation of AAT for the treatment of AAT deficiency for which a
MAA was submitted to the EMA after completing a pivotal Phase 2/3 clinical trials in
Europe. Kamada has also completed its Phase 2 clinical trials in the U.S for the treatment of
AAT deficiency with inhaled AAT. In addition, Kamada's intravenous AAT is in development
for other indications such as type-1 diabetes, GvHD and prevention of lung transplant
rejection. Kamada also leverages its expertise and presence in the plasma-derived protein
therapeutics market by distributing more than 10 complementary products in Israel that
are manufactured by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the
U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of
1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. Forward-looking statements are statements that are not historical
facts, such as statements regarding assumptions and results related to financial results
forecast, commercial results, timing and results of clinical trials and EMA and U.S. FDA
submissions and authorizations. Forward-looking statements are based on Kamada’s
current knowledge and its present beliefs and expectations regarding possible future
events and are subject to risks, uncertainties and assumptions. Actual results and the
timing of events could differ materially from those anticipated in these forward-looking
statements as a result of several factors including, but not limited to, unexpected results of
clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional
competition in the AATD market or further regulatory delays. The forward-looking
statements made herein speak only as of the date of this announcement and Kamada
undertakes no obligation to update publicly such forward-looking statements to reflect
subsequent events or circumstances, except as otherwise required by law.
Gil Efron
Chief Financial Officer
Bob Yedid
LifeSci Advisors, LLC