- Since 2018 Kedrion has had exclusive distribution rights in
the US for KEDRAB®, a Human Rabies Immune Globulin
(HRIG) developed in partnership with Kamada Ltd.
- New agreement becomes effective in January 2024 and includes potential expansion of
Kedrion's distribution of KEDRAB® in additional
territories beyond the US
- Rabies is a global public health concern that is responsible
for more than 59,000 human deaths per year in the world; an
estimated 60,000 Americans receive Rabies post exposure prophylaxis
each year
- Kedrion confirms its commitment to fighting Rabies and other
serious and life-threatening diseases and conditions
CASTELVECCHIO PASCOLI,
Italy, Dec. 7, 2023
/PRNewswire/ -- Kedrion Biopharma, a
leading global biopharmaceutical company that develops,
manufactures and commercializes therapeutic products derived from
blood plasma, announces the execution of a binding
memorandum of understanding with Kamada Ltd.
(NASDAQ: KMDA;
TASE: KMDA.TA), an Israeli
commercial stage global biopharmaceutical company and leader in the
specialty plasma-derived field, for the amendment and the 8-year
extension of the KEDRAB® US
distribution agreement between the two companies.
KEDRAB® is a Human Rabies Immune Globulin (HRIG)
developed in partnership with Kamada Ltd. Kedrion started the
distribution of this product in the US in 2018.
This new commercial agreement, which begins in January 2024, includes potential expansion of
Kedrion's distribution of KEDRAB® in additional
territories beyond the US. In addition, the two companies will
collaborate to expand distribution of Kedrion products by Kamada in
Israel.
Ugo Di Francesco, CEO of Kedrion,
said, "This agreement marks another relevant milestone in the
growth of Kedrion in the US, which remains our most important
market. At Kedrion, we firmly believe in the power of our long-term
partnership with Kamada to help people who have been exposed to
Rabies. This agreement will allow us to continue to serve patients
in the US, leveraging the expertise and the extensive know-how we
have acquired over the years. Kedrion's commitment to providing
relief from conditions requiring hyperimmune plasma-derived
therapies remains strong."
"We are thrilled to secure this strategic agreement with Kedrion
as it represents our largest commercial agreement since Kamada's
inception," said Amir London, CEO of
Kamada. "Based on Kedrion's extensive market coverage and on-going
success in marketing KEDRAB® in the US, as well as the significant
market share growth achieved to date, we are confident that the
continuation of this partnership maximizes the future growth and
value potential of this important product."
Rabies is a serious and life-threatening disease but is easily
preventable. It is contracted from the bite of a rabid wild animal
– primarily bats, raccoons, skunks and foxes – as well as rabid
pets. Human Rabies Immune Globulin is administered at the
bite-wound site and is a part of the post exposure prophylaxis
(PEP) protocol, along with vaccine, and is recommended when there
is an exposure to a rabid or a possibly rabid animal.
Still today, Rabies is a global public threat that causes more
than 59,000 human deaths per year in the world. PEP treatment is
administered an estimated 60,000 per year each year in the United States.
About KEDRAB®
KEDRAB® [Rabies Immune Globulin (Human)] is a human rabies
immune globulin (HRIG) indicated for passive, transient
post-exposure prophylaxis (PEP) of rabies infection in persons of
all ages when given immediately after contact with a rabid or
possibly rabid animal. KEDRAB should be administered concurrently
with a full course of rabies vaccine.
KEDRAB was approved by the FDA in August
2017. KEDRAB is supplied in single-dose vials containing 2
mL or 10 mL of ready-to-use solution with a nominal potency of 150
IU/mL.
Important Safety Information
- Severe hypersensitivity reactions, including anaphylaxis, may
occur with KEDRAB. IgA deficient patients with antibodies against
IgA are at greater risk. Have epinephrine available immediately to
treat any acute severe hypersensitivity reactions.
- KEDRAB administration may interfere with the development of an
immune response to live attenuated virus vaccines. If feasible,
delay immunization with measles vaccine for 4 months, and other
live attenuated virus vaccines for 3 months, after KEDRAB
administration.
- 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. Passive
transmission of antibodies to erythrocyte antigens, e.g., A, B, and
D, may interfere with serologic tests for red cell antibodies such
as the antiglobulin test (Coombs' test).
- KEDRAB is made from human plasma donors and may carry a risk of
transmitting infectious agents, e.g., viruses, the variant
Creutzfeld-Jacob disease (vCJD) agent and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
Please see KEDRAB full prescribing
Information for complete prescribing details. You are encouraged to
report negative side effects of prescription drugs to the FDA.
Visit
www.fda.gov/medwatch
or call
1-800-FDA-1088.
About Kedrion
Kedrion Biopharma is a biopharmaceutical company that collects
and fractionates blood plasma to produce and distribute worldwide
plasma-derived therapies for use in treating and preventing rare
and debilitating conditions like Coagulation and Neurological
Disorders, Primary and Secondary Immunodeficiencies, and Rh
sensitization, which can lead to Hemolytic Disease of the Fetus and
Newborn.
In 2022, Kedrion joined forces with BPL (Bio Products
Laboratory). Based in the United
Kingdom, BPL has over 60 years of experience in the supply
of high-quality plasma-derived medicines to treat rare
diseases.
With the combination of Kedrion and BPL, Kedrion becomes a
global player in plasma derivatives and rare disease medicines
employing more than 5,000 people worldwide. The company has a
plasma collection footprint of more than 70 centers operated by
KEDPLASMA in the United States,
and of 5 centers operated by UNICAplasma in the Czech Republic, and a portfolio of 37 products
distributed in over 100 countries around the world. With these
figures, Kedrion is the world's 5th largest player in the field of
plasma-derived products.
Kedrion places a high value on the welfare of those who benefit
from its products, as well as the communities and individuals with
whom it works and collaborates.
We act as a bridge between donors and the people who need
treatment, and work on a global scale to expand patient access to
plasma-derived therapies.
For information:
Duccio Manetti | Chief Communication
Officer
d.manetti@kedrion.com
Mob. +39 340 9016191
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SOURCE Kedrion Biopharma