Castelvecchio Pascoli (Lucca, Italy), 23 June 2021 – Kedrion S.p.A. announced today the exercise of the option to acquire the remainder of the plasma-derived business under the terms of the Share Purchase Agreement entered by the Company and Liminal Bioscience. This acquisition would include the Ryplazim® (plasminogen, human-tvmh) (“Ryplazim®”) business operated through Prometic Bioproduction Inc., the Liminal’s plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc. (“PBT”), holder of the biological license application (“BLA”) for Plasminogen and associated Rare Pediatric Disease Priority Review Voucher (“PRV”).
On June 4, 2021, Ryplazim was approved by the U.S. Food and Drug Administration (FDA) as the first treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).
The Share Purchase Agreement provides for a purchase price of USD 5 million payable upon closing for the purchase of the shares of PBP (the “First Closing”) and, after and subject to the sale of the PRV, the purchase of the shares of PBT (the “Second Closing”).
Upon closing of the two transactions, Kedrion would assume all development, manufacturing and commercialization activities and operating costs for Plasminogen.
“This transaction – explained Paolo Marcucci, Chairman of Kedrion – represents an opportunity for the future growth of our company: in fact, it gives us immediate access to more plasma, it allows us to expand our global operations to Canada and, above all, to enrich our product portfolio with high-impact treatment for patients. For Kedrion it is a further example of commitment in the fight against rare or ultra-rare diseases and dedication to orphan drugs.”
“This agreement represents an important step toward strengthening the Company’s position in North America – stated Val Romberg, CEO of Kedrion – and toward further growth in the US, which will be the main primary end-market for the product as soon as we are able to start commercialization. We are eager to make this drug available to patients who need it: this represents a further and progressive development in the field of rare and ultra-rare diseases destined to enhance Kedrion’s role as a company dedicated to the needs of patients.”
Plasminogen is a protein synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis, and embryogenesis.
Kedrion Biopharma is an international biopharmaceutical company based in Italy that collects and fractionates plasma to produce and distribute worldwide plasma-derived products for the prevention and treatment of rare and debilitating diseases and conditions such as Hemophilia, Primary Immunodeficiencies and Rh sensitization.
Headquartered in Tuscany with more than 2,500 employees worldwide, Kedrion has a commercial presence in 100 countries and is the 5th largest player in the world, and Italy’s 1st.
Kedrion has manufacturing plants in Italy, the United States and Hungary and North America, and its subsidiary KEDPLASMA operates plasma collection centers in North America.
Kedrion acts as a bridge between donors and the people who need treatments and works on a global scale to expand patient access to available plasma-derived therapies.