Saol Therapeutics News
Saol Therapeutics Acquires Three Hyperimmune Products from Aptevo Therapeutics
ROSWELL, GA - SEPTEMBER 1, 2017 –- Saol Therapeutics today announced it had reached an agreement with Aptevo Therapeutics Inc. (Nasdaq: APVO) to acquire three marketed hyperimmune products, WinRho® SDF (Rh0(D) Immune Globulin Intravenous (Human)), HepaGam B® (Hepatitis B Immune Globulin Intravenous (Human)) and VARIZIG® (Varicella Zoster Immune Globulin (Human)). The deal includes both upfront and milestone payments.
Under the terms of a purchase agreement executed by the companies, Saol Therapeutics will acquire the global rights to three hyperimmune products currently marketed by Aptevo: WinRho® SDF for autoimmune platelet disorder and hemolytic disease of the newborn; HepaGam B® for the prevention of Hepatitis B following liver transplantation and for treatment following hepatitis B exposure; and VARIZIG® for treatment following exposure to varicella zoster virus for individuals with compromised immune systems.
“This is a very important day for our company,” said Saol Therapeutics Chief Executive Officer David Penake. “These three products are tremendous strategic fits for us, as we look to build out our orphan business unit. They each have strong clinical value to the patient populations they serve, and we look forward to supporting each product and the clinicians that count on them around the world.”
The transaction, which is expected to be completed in 2017, is subject to certain customary closing conditions.
Please see BOX WARNING for WinRho® SDF below, and find full prescribing information here.
For prescribing information of HepaGam B®, please click here.
For prescribing information of VARIZIG®, please click here.
WARNING for WinRho® SDF: INTRAVASCULAR HEMOLYSIS (IVH) IN IMMUNE THROMBOCYTOPENIC PURPURA (ITP)
See full prescribing information for complete boxed warning. This warning does not apply to Rh0 (D)-negative patients treated for the suppression of Rh isoimmunization.
- Intravascular hemolysis (IVH) leading to death has been reported in patients treated for ITP with WinRho SDF.
- IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS)
- Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
- Closely monitor patients treated with WinRho SDF for ITP in a healthcare setting for at least eight hours after administration (5.2.1). Perform dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. Perform post-treatment laboratory tests if signs and/or symptoms of IVH are present or suspected after WinRho SDF administration.