December 6, 2021
Saol Therapeutics Announces FDA Approval of LYVISPAHTM (baclofen) Oral Granules and the Divesture of its Plasma-derived Hyperimmune Portfolio
Saol Therapeutics announces the approval of LYVISPAHTM (baclofen) oral granules. The company also announces the strategic transaction to divest the plasma-derived hyperimmune portfolio to Kamada Ltd. for a total value of up to $160M
ROSWELL, GA US/Dublin, IE/Hamilton, BM Dec. 6, 2021 – Saol Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved Saol’s LYVISPAH™ (baclofen) oral granules. LYVISPAH™ (lye-vis’-pah) is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH™ may also be of some value in patients with spinal cord injuries and other spinal cord diseases. LYVISPAH™ is a strawberry-flavored, dissolvable granular formulation of baclofen and will be available for patients 12 years and above in 5mg, 10mg, and 20mg packets. Unlike other formulations of baclofen, it is approved for administration with or without water, with soft foods and with enteral feeding tubes. Patients suffering from spasticity may concurrently develop swallowing difficulties. Nearly one million people in the United States are living with multiple sclerosis1, and the prevalence of spasticity within this
patient population has been estimated to be as high as 67%2. Additionally, the prevalence of dysphagia in the multiple sclerosis population has been reported to be between 34-43%3,4, with aspiration pneumonia frequently cited as a contributing factor in deaths of these patients5 .
Dr Michael Saulino, Chair of Physical Medicine and Rehabilitation at Cooper University Hospital commented, “LYVISPAH™ represents an important treatment option for individuals with spasticity who have dysphagia. The bioequivalence between LYVISPAH™ and traditional oral baclofen products should allow for straightforward prescribing by clinicians who manage patients with both clinical problems.” David Penake, CEO of Saol Therapeutics stated, “We are tremendously excited by the approval of LYVISPAH™. Spasticity is a challenging condition to treat, and we have commonly heard that no two patients are alike. Because of this, clinicians stressed to us that there is a need for new formulations designed to benefit their patients who have difficulty swallowing. I’m incredibly proud of the work our team has done to get this approved, and our hope is that this is the first in the line of many new therapies we can bring to market to support health care providers and the patients they treat.” Following this approval, Saol Therapeutics is preparing for a full commercial launch of LYVISPAH™ in 2022.
Additionally, Kamada LTD announced on November 22nd , 2021, the acquisition of our four plasmaderived hyperimmune products for:
• CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) is indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and heart.
• WINRHO® SDF is a Rho(D) Immune Globulin Intravenous (Human) is indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomies, for Rho(D)-positive children with chronic or acute immune thrombocytopenia (ITP), adults with chronic ITP, and children and adults with ITP secondary to HIV infection. WinRho SDF is also used for suppression of Rhesus (Rh) Isoimmunization during pregnancy and other obstetric conditions in non-sensitized, Rho(D)-negative women.
• HEPAGAM B® is a hepatitis B Immune Globulin (Human) (HBIg) product indicated to both prevent hepatitis B virus (HBV) recurrence following liver transplantation in hepatitis B surface antigen positive (HBsAg- positive) patients and provide post-exposure prophylaxis.
• VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women. VARIZIG is intended to reduce the severity of chickenpox infections in these patients.
Under the terms of the agreement, Kamada will pay Saol up to $160 million, with a $95 million upfront payment, and up to an additional $50 million in sales milestones during 2022-2034. In addition, Kamada will acquire from Saol existing inventory at an estimated value of approximately $15 million, which will be paid over 10 equal quarterly installments. “The proceeds from the sale of the hyperimmune products will be invested to expand our commercial infrastructure to launch LYVISPAH™ and further development of our pipeline assets SIL-1002 for Spasticity, SIL-1009 for Pyruvate Dehydrogenase Complex Disorder and SIL-1010 for Chronic Pain associated with Osteoarthritis. The approval of LYVISPAH™ on the same day as the announcement of the transaction highlights our company’s ability to execute on multiple priorities. Moving forward, we have a clear path to growth and continued profitability” concluded Mr. Penake.
About Saol Therapeutics
Saol Therapeutics (pronounced “Sail”) is a privately held, biopharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on commercial and clinical development activity in CNS disorders such as spasticity, pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com.
About LYVISPAHTM (baclofen) oral granules
LYVISPAHTM is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. LYVISPAH™ may also be of some value in patient with spinal cord injuries and other spinal cord diseases. LYVISPAH™ is a strawberry-flavored, dissolvable granular formulation of baclofen and will be available for patients 12 years and above in 5mg, 10mg, and 20mg packets.
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