Pharma Focus Asia

Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB™

Monday, August 28, 2017

Kedrion Biopharma and Kamada Ltd., 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.

“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™.

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