· KEDRAB™ [rabies immune globulin (Human)], a plasma-derived human
rabies immune globulin (HRIG), represents new entry into $100 million-plus U.S.
rabies prevention market where only two other products exist.
·
· Rabies,
a serious public health concern, is one of world’s oldest and most deadly
diseases.
·
· Approval
of KEDRAB is based on positive data from a prospective, randomized,
double-blind, non-inferiority Phase 2/3 study of 118 healthy subjects,
conducted in the U.S.
·
· Approval
of KEDRAB is the second product of Kamada approved by the FDA.
·
· Kedrion Biopharma is a world leading
supplier of high-titer rabies plasma, the raw material used in the manufacture
of human rabies immune globulin (HRIG).
FORT LEE, N.J. and REHOVOT,
Israel, Aug. 25, 2017 (GLOBE NEWSWIRE) –
Kedrion Biopharma and Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), two leading human-derived protein therapeutics
companies, today announced that KEDRAB™ [rabies immune globulin (Human)]
has received U.S. Food and Drug Administration (FDA) approval for passive,
transient post-exposure prophylaxis of rabies infection, when given immediately
after contact with a rabid or possibly rabid animal. KEDRAB should be
administered concurrently with a full course of rabies vaccine. Rabies is a
life-threatening condition that impacts approximately 40,000 people in the U.S.
each year, representing an annual market opportunity of $100
million-plus. KEDRAB will launch in the U.S. in early 2018.
Prior to FDA approval
of KEDRAB, U.S. healthcare professionals had only two human rabies immune
globulin (HRIG) therapy options from which to choose to prevent the onset of
rabies in someone who may have been exposed to the deadly virus. KEDRAB, a
human plasma-derived immunoglobulin, is entering a rabies market that has
experienced inconsistent supply in recent years. (https://www.cdc.gov/rabies/resources/availability.html)
“The approval
of KEDRAB by the FDA marks an exciting and important milestone in the
evolution of Kedrion Biopharma as we continue to grow our U.S. business,” said
Paolo Marcucci, President and Chief Executive Officer of Kedrion. “The approval
of KEDRAB represents the first product that Kedrion Biopharma has had
a role in developing throughout its clinical development and through to
commercialization in the U.S. Rabies is a deadly, but entirely preventable
disease, and we are pleased to offer physicians another safe and effective
option. As Kedrion Biopharma is one of the world’s leading suppliers of
high-titer rabies plasma, we are well-positioned to maximize the potential of
this product, and we look forward to working with Kamada to
launch KEDRAB in the U.S.
“This significant
achievement for Kamada represents the second FDA approval for the Company,”
said Amir London, Kamada’s Chief Executive Officer. “We are proud that our
unique and advanced immune globulin purification technology was used in the
development of KEDRAB, and look forward to a successful launch of the
product with Kedrion Biopharma. The BLA approval may also serve as basis for
registration in other countries. This treatment represents an annual market
opportunity of over $100 million in the U.S., of which we expect to take a
significant market share. Moreover, this has the potential to be a highly
profitable product for our companies. Meaningful sales from KEDRAB are expected
to ramp up in 2018, during its first full year of launch. Revenues from this
product are not included in our guidance of reaching $100 million in total
revenue in 2017.”
Kamada has been selling the
HRIG product since 2006 in numerous territories outside of the U.S. under the
brand name KamRAB™. Kamada has sold more than 1.4 million vials of KamRAB
to date, demonstrating significant clinical experience with the
product. Under the clinical development and marketing agreement between
Kedrion Biopharma and Kamada, upon receipt of FDA marketing approval, Kamada
holds the license for KEDRAB, and Kedrion Biopharma has exclusive rights
to commercialize the product in the U.S.
With the approval
of KEDRAB, Kedrion Biopharma expands its portfolio of immune globulin
products, which includes RhoGAM® and GAMMAKED™.
About KEDRAB™
KEDRAB [Rabies Immune
Globulin (Human)] is a human rabies immunoglobulin (HRIG) indicated for
passive, transient post-exposure prophylaxis (PEP) of rabies infection, when
given promptly after contact with a rabid or possibly rabid
animal. KEDRAB should be administered concurrently with a full course
of rabies vaccine.
Important
Safety Information
· Patients
who can document previous complete rabies pre-exposure prophylaxis or complete
post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB,
because KEDRAB may interfere with the anamnestic response to the vaccine.
· KEDRAB should
not be injected into a blood vessel because of the risk of severe allergic or
hypersensitivity reactions, including anaphylactic shock.
· Patients
with a history of prior systemic allergic reactions following administration of
human immune globulin preparations should be monitored for hypersensitivity.
· KEDRAB contains
a small quantity of IgA. Patients who are deficient in IgA have the potential
to develop IgA antibodies and may have anaphylactic reactions following
administration of blood components containing IgA.
· Patients
at increased risk of thrombosis or thrombotic complications should be monitored
for at least 24 hours after KEDRAB administration.
· Hemolysis
may occur in patients receiving immune globulin products, particularly those
who are determined to be at increased risk.
· KEDRAB administration
may interfere with the development of an immune response to live attenuated
virus vaccines.
· A
transient rise of the various passively transferred antibodies in the patient’s
blood may result in misleading positive results of serologic tests
after KEDRAB administration.
· KEDRAB is
derived from human plasma; therefore, the potential exists
that KEDRABadministration may transmit infectious agents.
· In
clinical trials, the most common adverse reactions in subjects treated
with KEDRABwere injection site pain, headache, muscle pain, and upper
respiratory tract infection.
About the Phase II/III
KEDRAB™ Clinical Study
The efficacy
of KEDRAB administered concurrently with rabies vaccine was studied
in a single-center, randomized, comparator HRIG-controlled clinical study.
Study subjects were healthy adults 18 to 72 years of age who were without
significant acute or chronic illness. A total of 118 subjects (59 per treatment
group) received KEDRAB or comparator HRIG at a dose of 20 IU/kg
intramuscularly on Day 0, and rabies vaccine on Days 0, 3, 7, 14 and 28. The
mean age of study subjects was 45 years. The efficacy variable was rabies virus
neutralizing antibody (RVNA) titer, as assessed by rapid fluorescent focus
inhibition test (RFFIT), on Day 14. Efficacy analyses were performed on the
As-Treated Population, which comprised the 116 study subjects who
received KEDRAB or comparator HRIG and at least 3 of the 5 doses of
rabies vaccine before Day 14.
About Rabies
Rabies is a preventable viral
disease of mammals most often transmitted through the bite of a rabid animal.
It is a serious, and nearly always fatal, infection. In the U.S., rabies
in wild animals, especially raccoons, skunks, foxes and bats, accounts for most
cases of rabies passed on to humans, pets, and other domestic animals. An
acute, progressive viral encephalomyelitis, rabies carries the highest case
fatality rate of any conventional etiological agent. Rabies is one of the
oldest described infectious diseases, known for over 5,000 years.
About Kedrion Biopharma
Kedrion Biopharma is an
international company that collects and fractionates blood plasma to produce
and distribute plasma-derived therapeutic products for use in treating and
preventing serious diseases, disorders and conditions such as hemophilia,
primary immune system deficiencies and Rh-sensitization. Kedrion Biopharma
Inc., the U.S. subsidiary of Kedrion Biopharma, is headquartered in Fort Lee,
New Jersey. Kedrion Biopharma launched U.S. operations in 2011, but the
company’s international roots stretch back several decades in the production of
blood and plasma-derived products. Kedrion Biopharma places a high value on the
welfare of those who benefit from its products, as well as on the people and
the communities it serves. Additional information about Kedrion Biopharma can
be found at www.kedrion.com and www.kedrion.us.
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 (formerly Baxter International Inc.’s
BioScience business and 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 Kamada
completed a pivotal Phase 2/3 clinical trial in Europe. Kamada has also
completed its Phase 2 clinical trial 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, sales volume, timing
and results of clinical trials and EMA and U.S. FDA 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 and Rabies
markets or other markets in which Kamada operates or intends to operate, 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.
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