Lucca, 17 May 2021 – Kedrion and Liminal BioSciences, a clinical-stage biopharmaceutical company based in Canada, announced today that they have signed a Share Purchase Agreement for the sale from Liminal BioSciences to Kedrion of two plasma collection centers, one operated in Winnipeg (Manitoba, Canada) and one in Amherst (New York, USA) through Liminal BioSciences’ subsidiaries, Prometic Plasma Resources Inc., and Prometic Plasma Resources (USA) Inc.
Under the Share Purchase Agreement, the parties have agreed that upon closing of the proposed sale, Kedrion will enter into an option agreement with Liminal BioSciences for the right to acquire the remainder of Liminal BioSciences’ plasma-derived business, including the Plasminogen business operated through its subsidiaries, Prometic Bioproduction Inc., Liminal BioSciences’ plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc. (“PBT”), holder of the biological license application (“BLA”) for Ryplazim® (Plasminogen).
Upon closing of the transaction, Kedrion would pay a purchase price of USD 17 million.
Subject to its terms and conditions, the Option would grant Kedrion the right to acquire all of the shares of PBP and PBT and would entitle Liminal BioSciences to receive up to seventy percent (70%) of the net proceeds which may be received from the sale of a Pediatric Rare Disease Priority Review Voucher (“PRV”), if granted, associated with a potential FDA approval of Ryplazim®. The acquisition of all of the shares of PBP would occur by June 15, 2021, for an exercise price of USD 5 million payable upon closing of the sale of the shares of PBP under the Option. The acquisition of all of the shares of PBT would occur upon the sale of the PRV.
If the Option is exercised Kedrion would assume all development, manufacturing and commercialization activities and, operating costs for Ryplazim. Kedrion can extend the Option for a maximum of three months in exchange for a payment of up to USD3M per month.
The closing of the Transaction is subject to the fulfilment of certain customary conditions precedent.
“This acquisition – explained Paolo Marcucci, Chairman of Kedrion – is an important opportunity for our future growth: it allows us immediate access to more plasma, expand our global operations to Canada and gives us an option to enrich our product portfolio with a potential therapy against a disease like the Congenital Plasminogen Deficiency (C-PLGD), if approved by the FDA. Through this deal Kedrion strengthens its leading position in the global plasma protein sector and confirms its care toward rare diseases and orphan drugs”.
“The sale of our plasma collection business and the grant of the Option – stated Mr. Bruce Pritchard, Chief Executive Officer of Liminal BioSciences – are a testament to the dedication of our plasma collection team, highlighting the rapidly scaled quality business we have created, and to our plasma-derived therapeutics team that has brought a quality biological drug candidate, Ryplazim, to late-stage development and the final stages of regulatory review”.
“Patients living with congenital plasminogen deficiency (C-PLGD) have the potential for a long-awaited treatment option”, stated Mr. Patrick Sartore, President of Liminal BioSciences. “We are very pleased to work with Kedrion whose experience and leadership in the plasma collection and plasma-derivatives market has the capability to further advance patient care for this rare disease if Kedrion exercises the Option and FDA approves Ryplazim.”
About Ryplazim® (Plasminogen)
Ryplazim® (Plasminogen) is an investigational drug based on a naturally occurring protein that is 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.
Through its US subsidiary, Prometic Biotherapeutics Inc., Liminal BioSciences resubmitted a Biologic License Application (“BLA”) in September 2020 with the U.S. Food and Drug Administration (FDA) seeking approval of Ryplazim for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency (“C-PLDG”). The FDA has provided a Prescription Drug User Fee Act (“PDUFA”) target action date of June 5, 2021.
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 its subsidiary KEDPLASMA operates plasma collection centers in the United States.
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.
About Liminal BioSciences Inc.
Liminal BioSciences is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases of high unmet medical need, primarily related to fibrosis, including respiratory, liver and kidney diseases. Liminal BioSciences’ lead small molecule product candidate, fezagepras (PBI-4050), is being evaluated in a Phase 1 multi-ascending dose clinical trial in in the UK to evaluate multiple-ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. A global Phase 2 clinical trial evaluating fezagepras for the treatment of patients with idiopathic pulmonary fibrosis (IPF) is anticipated to be initiated in the first half of 2022, subject to the results from the Phase 1 study.
Fezagepras was previously granted Orphan Drug Designation by the FDA and the European Medical Agency (EMA) for the treatment of IPF. Fezagepras has also been granted a Promising Innovative Medicines (PIM) designation by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of IPF.
Liminal BioSciences’ resubmitted a BLA in September 2020 with the FDA seeking approval to treat patients with clinical signs and symptoms associated with congenital plasminogen deficiency with its lead plasma-derived product candidate Ryplazim®(plasminogen) (“Ryplazim®”). The PDUFA target action date for Ryplazim® is June 5, 2021. Ryplazim® was previously granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency.
Liminal BioSciences has active business operations in Canada, the United Kingdom and the United States.