KEDRION ANNOUNCES AN EIGHT-YEAR EXTENSION OF THE DISTRIBUTION AGREEMENT WITH KAMADA IN THE US FOR KEDRAB®

• 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
[email protected]
Mob. +39 340 9016191

SOURCE Kedrion Biopharma