1. Kedrion
United states
Keep Life Flowing
Executive Summary
2. Kedrion
• Privately owned Biopharmaceutical company
focusing on life saving therapies derived from
human plasma.
• Kedrion Biopharma established on June 2,2011, is
a wholly owned subsidiary of Kedrion.
• 500-1000 Employees
• Kedrion Biopharma strives to ensure that the
highest quality manufacturing is utilized to
provide safe and efficacious products.
4. Kedrion History
• Kedrion is a biopharmaceutical company specializing in the development, production and distribution of
life saving therapies.
•
• Kedrion is an international company with a strong expertise in collection, manufacturing, and research
worldwide.
•
• Kedrion's world headquarters is in Tuscany, Italy and the company has 3 production plants:
Bolognana, Lucca; S.Antimo, Naples; and Godollo, Hungary.
•
• With a production capacity of more than 1.2 million liters of plasma per year, Kedrion is one of the leading
plasma fractionation companies in the world.
•
• Kedrion Biopharma, our new and wholly owned US subsidiary, has its headquarters in Fort Lee, NJ.
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• Kedrion today operates in more than 40 countries worldwide.
Kedrion Keep life flowing
5. The Kedrion Commitment
• Kedrion's corporate culture is based on the social importance of providing safe purified plasma
proteins for the treatment of serious illnesses such as hemophilia and immunodeficiencies.
• Kedrion actively supports patients and patient advocacy organizations. Kedrion recently donated
over 1 million units of Coagulation Factor to Save One Life. The organization used the medicines to
treat patients in need in Pakistan. Kedrion also was sponsor of the recent Jeffrey Model "Spring
Ahead Gala".
• Kedrion continuously seeks the highest standards in quality, safety, and processes.
• Patient confidence and assurance are most critical to all that we do.
• The company believes in social and ethical responsibilities and with that purpose, Kedrion has
implemented an organizational structure including an ethical committee, an ethical officer and
code of conduct to ensure its values are practiced throughout the organization.
• Kedrion Keep life flowing
6. Kedrion Quality Program
• In order to guarantee the
quality, effectiveness and safety of
its products and
processes, Kedrion has developed
a multi-step program – Kedrion
Quality Program (KQP) – for the
ongoing monitoring of every step
of the manufacturing process.
• Kedrion’s plants are regularly
inspected by the Health
Authorities to check and certify
that they comply with world class
standards.
7. Therapeutic Areas
• Kedrion Biopharma's portfolio focuses on life saving products
derived from human plasma. There are many benefits of plasma
products for the medical community. The plasma proteins are
isolated and processed for final distribution. These proteins are
used for people with congenital disorders such as Hemophilia A or
Primary Immune Deficiency. Other plasma derived products like
albumin may be used in critical situations to treat wounds, burns
and trauma.
• Kedrion focuses its resources in 3 specific areas:
• Hematology
• Immunology
• Critical Care
8. Immunology
• Immune deficiency
disorders occur when one
or more components of
the human immune system
is deficient or not
functioning properly.
9. Gammaked
• Gammaked is an immune globulin injection (human) 10% liquid that is indicated for the
treatment of:
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• CIDP is a greatly underestimated acquired demyelinating neuropathy. Although the exact
cause is not known, CIDP is considered an autoimmune disorder. Symptoms are caused by
damage to the myelin sheath of the peripheral nerves.
• FDA approved for CIDP
• Gammaked is indicated for the treatment of CIDP to improve neuromuscular ability and
decrease impairment, and for maintenance therapy to prevent relapse
• The most common adverse reactions with Gammaked in CIDP were headache, fever, chills,
hypertension, rash, nausea, and asthenia. The most serious adverse reaction was pulmonary
embolism (PE) in one subject with a history of PE.
• Primary Immunodeficiency (PI)
• PI diseases are genetic defects that occur in the immune system and comprise a diverse
group of illnesses. To date, there are more than 130 diseases that are categorized as primary
immunodeficiencie
• Gammaked is an IG therapy with both IV and SC routes of administration in PI
• Gammaked is not approved for subcutaneous use in patients with ITP or CIDP. Due to
potential risk of hematoma formation, Gammaked should not be administered
subcutaneously in patients with ITP.
