SERB Pharmaceuticals acquires Vistogard® and Xuriden® from Wellstat Therapeutics

West Conshohocken, PA, 13 July 2023: SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today that it has acquired two life-saving medicines, Vistogard^® (uridine triacetate) and Xuriden^®(uridine triacetate), from Wellstat Therapeutics. Both medicines are commercially available in the US and currently distributed across Europe on a named patient or compassionate use basis.

Vistogard® is an emergency treatment for adult and pediatric patients following a fluorouracil (5-FU) or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life- threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of 5-FU or capecitabine administration.(i) 5-FU and capecitabine are chemotherapy agents commonly used to treat a wide variety of solid tumors.

Xuriden® is a treatment for adult and pediatric patients with hereditary orotic aciduria (HOA) (ii), an ultra-rare, orphan genetic disorder associated megaloblastic anemia as well as failure to thrive, developmental delay, epilepsy, susceptibility to infection, and orotic acid crystals in the urine.(iii)

Jeremie Urbain, President of SERB Pharmaceuticals, said: “We’re proud to add these two treatments to our expanding portfolio of medicines for complex, life-threatening conditions. Acquiring these medicines is in line with our strategy to focus on emergency care and rare diseases.”

The products will be sold in the US by BTG Pharmaceuticals, SERB’s US entity. The products will transition seamlessly from Wellstat to BTG Pharmaceuticals and will continue to be available from the same distributors via the same ordering processes:

To order Vistogard^®, please call 1-800-914-0071. Vistogard^® is distributed through Cardinal Health Specialty Pharmaceutical Distribution, available 24 hours/day, 7 days/week.
Vistogard® and Xuriden^® are available for dispensing through BioMatrix Specialty Pharmacy. To reach BioMatrix Specialty Pharmacy, please call: 844-374-0604.

BTG Pharmaceuticals, a SERB company, will promote Vistogard^® and continue promoting Voraxaze^® through its oncology field force in the US.

The companies did not disclose specific financial terms. Today’s news follows the announcement in May that SERB has acquired the exclusive US rights to bentracimab, which is in development as a ticagrelor reversal agent.

About Fluorouracil (5-FU) and capecitabine toxicity

5-FU and capecitabine are both trusted chemotherapies received by thousands of patients, often in combination with other chemotherapy agents or radiation. They have a history of success in treating a range of cancers including breast, colorectal (bowel), gastric (stomach), and pancreatic cancer.
According to the National Institute of Health (NIH), about 275,000 patients in the US receive 5-FU every year. Capecitabine, a prodrug that is enzymatically converted to 5-FU within the body, has about 60,000 treatment packages sold per year. Approximately 3% of these patients develop serious toxicities and more than 8,000 toxic reactions and 1,300 deaths every year are attributed to 5-FU and capecitabine. (iv)

About HOA

Hereditary orotic aciduria (HOA) is a very rare inborn error of pyrimidine metabolism caused by mutations reducing the activity of uridine monophosphate synthase (UMPS), which converts orotic acid to UMP. Uridine deficiency underlies many of the symptoms of HOA. When untreated, patients with HOA may develop a blood (hematologic) disorder called megaloblastic anemia as well as exhibiting failure to thrive, developmental delay, epilepsy, susceptibility to infection and orotic acid crystals in the urine (crystalluria).(iii)

About SERB Pharmaceuticals

SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB has the broadest antidote portfolio in the world, including medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB operates in the US as BTG Pharmaceuticals. Learn more at https://SERB.com.

For further information contact:

Chris Sampson, Corporate Communications Director
chris.sampson@serb.com; Tel: +44 (0)7773 251 178

About Vistogard^®

Indication

VISTOGARD^® is indicated for the emergency treatment of adult and pediatric patients:

following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
who exhibit early-onset, severe or life- threatening toxicity affecting the cardiac or central nervous system, and/or early onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Limitations of use

VISTOGARD^® is not recommended for the non–emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

Important Safety Information

In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD^® included vomiting (10%), nausea (5%), and diarrhea (3%).
One person receiving uridine triacetate experienced grade 3 nausea and vomiting.
VISTOGARD^® was discontinued for adverse reactions in 2 (1.4%) patients.

See full prescribing information.

About Xuriden^®