LAVAL, QC and CAMBRIDGE, England, Aug. 9, 2021 /PRNewswire/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company"), announced today that, its subsidiary Prometic Biotherapeutics Inc. ("PBT") has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher ("PRV") for USD105M.
The PRV was granted by the U.S. Food and Drug Administration ("FDA") with the approval of Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®"), for treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).
Pursuant to the terms of the agreement, PBT will receive an upfront payment of USD105M upon closing of the transaction. The closing is subject to customary closing conditions, including expiration of applicable waiting period under U.S. antitrust clearance requirements. Under the terms of the previously announced Share Purchase Agreement entered into with Kedrion S.p.A ("Kedrion") dated June 22, 2021 (the "SPA"); Liminal Biosciences is entitled to retain an amount equal to 70% of the net sales proceeds of the sale of the PRV. Concurrent with the signature of the definitive agreement for the sale of the PRV, the Company entered into a guaranty agreement to guaranty the performance of PBT's obligations under the agreement up to the closing of the SPA.
"We are pleased to announce the sale of the PRV, which will provide an important source of non-dilutive capital to advance the continued development of our small molecule pipeline," said Bruce Pritchard, CEO of Liminal BioSciences. "This transaction is also another key milestone in completing the divestiture of our remaining plasma-derived therapeutics business to Kedrion."
Mr. Pritchard added, "Our priorities now are to move to a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial for fezagepras, which will help determine the choice of any other potential indications for further development with that compound, as well as continuing with the development of our GPR84 and OXER1 programs. We look forward to providing a more comprehensive update on these programs in due course."
Jefferies LLC acted as exclusive financial advisor to Liminal BioSciences Inc. on this transaction.
Warnings and Precautions
- Bleeding: RYPLAZIM administration may lead to bleeding at lesion sites or worsen active bleeding. Discontinue RYPLAZIM if serious bleeding occurs. Monitor patients during and for 4 hours after infusion when administering RYPLAZIM to patients with bleeding diatheses and patients taking anticoagulants, antiplatelet drugs, and other agents which may interfere with normal coagulation.
- Tissue Sloughing: Respiratory distress due to tissue sloughing may occur in patients with mucosal lesions in the tracheobronchial tree following RYPLAZIM administration. Please monitor appropriately.
- Transmission of Infectious Agents: RYPLAZIM is made from human blood and therefore carries a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
- Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with RYPLAZIM. If symptoms occur, discontinue RYPLAZIM and administer appropriate treatment.
- Neutralizing Antibodies: Neutralizing antibodies (inhibitors) may develop, although were not observed in clinical trials. If clinical efficacy is not maintained (e.g., development of new or recurrent lesions), then determine plasminogen activity levels in plasma.
- Laboratory Abnormalities: Patients receiving RYPLAZIM may have elevated blood levels of D-dimer. D-Dimer levels will lack interpretability in patients being screened for venous thromboembolism (VTE).
Adverse Reactions
- The most frequent (incidence ≥ 10%) adverse reactions in clinical trials were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.
Patient Counseling Information
- Advise patients and/or caregiver to read the FDA-approved patient labeling
- Counsel patients and/or caregiver to discontinue RYPLAZIM and immediately contact their physicians if signs or symptoms of a possible hypersensitivity reaction occur, such as hives, generalized urticaria, angioedema, chest tightness, wheezing, tachycardia, and hypotension
- Inform patients that bleeding from active mucosal disease-related lesions and worsening of active bleeding not related to those lesions during RYPLAZIM therapy may occur. Depending on the lesion sites, this may manifest as gastrointestinal bleeding, hemoptysis, epistaxis, vaginal bleeding, or hematuria. Prior to initiation of treatment with RYPLAZIM, lesions or wounds suspected as the source of recent bleeding events should be confirmed to have healed. RYPLAZIM may prolong or worsen bleeding in patients with bleeding diatheses and/or taking anticoagulants or antiplatelet drugs. If a patient develops serious bleeding, seek emergency care and discontinue RYPLAZIM immediately.
- Inform patients that tissue sloughing at mucosal sites may occur at initiation of RYPLAZIM therapy as lesions resolve. Patients with respiratory lesion are at risk for respiratory compromise and initial treatment with RYPLAZIM should be performed in a clinical setting with close monitoring. Patients with lesions in gastrointestinal and genitourinary systems may experience tissue sloughing that may cause pain, mucosal bleeding, or passage of tissue referable to those organ systems. Patients should report persistent abdominal, flank or pelvic pain to their physicians if not resolved.
- Inform patients and/or caregiver that RYPLAZIM is made from human plasma and may contain infectious agents that can cause disease (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically the CJD agent). Explain that the risk that RYPLAZIM may transmit an infectious agent has been reduced by screening the plasma donors, by testing donated plasma for certain virus infections, and by inactivating or removing certain viruses during manufacturing. Counsel patients and/or caregiver to report any symptoms that concern them.
- Advise patients and/or caregivers that antibodies may develop during treatment that make RYPLAZIM less effective.
- Advise female patients who are pregnant or may become pregnant that the potential effects of RYPLAZIM on pregnancy and breastfeeding are unknown. They should notify their physicians if they become or intend to become pregnant, or if they plan to breastfeed.
- Self-administration: ensure patient/caregiver has received detailed instructions and training and has shown the ability to safely and independently administer RYPLAZIM.
Contact Liminal BioSciences at +1(800) 735-4086 and prometicsmb@continuumindia.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About the Rare Pediatric Disease Priority Review Voucher Program
The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PRV upon approval of the rare pediatric disease product application and it can be sold without limitation, subject to applicable FDA requirements for filing and use.