CARY, NC — March 3, 2016 —Biologics, Inc. is pleased to announce the company has been selected by BTG International Inc. as the exclusive specialty pharmacy provider for Vistogard® (uridine triacetate).
In addition to accessing the drug via specialty distribution, BTG International Inc. will offer physicians and healthcare practices the opportunity to order Vistogard® through Biologics’ specialty pharmacy as an alternative option. To ensure care continuity, a case management program will also be available for Vistogard® patients through Biologics to support patients transitioning from inpatient to outpatient care.
Approved by the U.S. Food and Drug Administration on December 11, 2015, Vistogard® is indicated for the emergency treatment of adult and pediatric patients who receive an overdose of fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. Wellstat Therapeutics developed Vistogard® and BTG will market, sell and distribute the drug for this indication in the US.
“We are pleased to include Biologics as our exclusive specialty pharmacy partner, providing an additional option for accessing Vistogard® for patients and providers. Their focus on oncology therapies and high-touch approach to patient-centered care is a critical factor and valuable service for our patients and providers,” said Christine Coyne, BTG International Inc.
Vistogard® blocks cell damage and cell death caused by fluorouracil chemotherapy. In clinical studies, overall survival of patients with 5-FU toxicity receiving Vistogard® was 96 percent, compared with 16 percent in historical cases employing standard supportive care measures. Vistogard® also helped patients resume chemotherapy sooner, with 33 percent resuming their cancer treatment within 30 days.
Biologics provides a high-touch, personal care team by assigning each patient their own dedicated pharmacist and nurse. Care plans are created to support the unique clinical, financial and emotional profile of individual patients.
“Vistogard® is the first of its kind, and we’re honored to help launch this important therapy,” said Shayne Malone, Vice President, Biopharma Services at Biologics.
Ninety-six percent of patients described their overall experience with Biologics as exceptional in an independent survey.
Physicians may submit prescriptions to Biologics via phone (1-844-374-0604), fax (1-844-374-0605) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.
Vistogard® Clinical Development Program
The FDA approval of Vistogard® is based on data from a development program in 135 patients designed to demonstrate the efficacy and safety of a single course of 10 grams given orally every six hours for a total of 20 doses (patients in the studies had either received an overdose of 5-FU or capecitabine, or presented with severe or life-threatening toxicities within 96 hours following the end of 5-FU or capecitabine administration). In clinical studies, overall survival of patients with 5-FU toxicity receiving Vistogard® was 96 percent, compared with 16 percent in historical cases employing standard supportive care measures. Vistogard® also helped patients resume chemotherapy sooner, with 33 percent resuming their cancer treatment within 30 days.
Adverse events that occurred in greater than 2 percent of patients were vomiting (10%), nausea (5%), and diarrhea (3%).
Following approval, Vistogard® will be made available to the US market as soon as possible. In the interim, physicians treating patients in need of Vistogard® treatment are encouraged to follow the current emergency access protocol and contact Wellstat Therapeutics.
Selected Important Safety Information for Vistogard® (Uridine Triacetate) oral granules
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% patients receiving Vistogard® were vomiting (10%), nausea (5%) and diarrhea (3%).
- One patient receiving uridine triacetate experienced grade 3 nausea and vomiting.
Please see full Prescribing Information.
About Vistogard® (uridine triacetate) oral granules
Vistogard® (uridine triacetate) is an orally administered drug approved by the FDA to treat patients following an overdose of 5-fluorouracil (5-FU) or capecitabine or in patients exhibiting 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. Vistogard® received orphan drug designation from the FDA as an antidote in the treatment of 5-FU poisoning and from the European Medicines Agency (EMA) as a treatment for 5-FU overdose. In Europe, under a named patient program, Vistogard® is currently provided to patients at risk of excess 5-FU toxicity due to overdose and patients exhibiting severe toxicities to 5-FU within 96 hours of 5-FU administration.
For more information, including Prescribing Information, please visit www.vistogard.com.
About 5-Fluorouracil (5-FU)
5-FU is on the World Health Organization’s List of Essential Medicines, a compilation of the most important medications needed in a basic health system. Because 5-FU is administered in different doses and schedules as a frequent component of standard chemotherapy regimens for a variety of cancers, patients can experience dramatically different patterns of toxicity.
Used in combination with other chemotherapy agents and/or radiation, 5-FU has been for decades a mainstay of various treatment regimens for solid tumors, including those of the colon, pancreas, stomach, esophagus, breast, and head and neck. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Expected side effects of 5-FU include myelosuppression (a reduction in white-blood-cell counts and thus increased risk of infection), diarrhea, nausea, vomiting, and mucositis (a painful inflammation and ulceration of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, cardiac and neurological complications, and death.
Capecitabine is an orally administered chemotherapy prodrug 5-FU that is enzymatically activated within the body and transformed into 5-FU. When capecitabine comes into contact with a naturally occurring protein called thymidine phosphorylase, capecitabine is transformed into 5-FU. Because many cancers have higher levels of thymidine phosphorylase than do normal tissues, more 5-FU is delivered to the tumor than to other tissue.
About Biologics: Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payors and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk. For more information, visit biologicsinc.com or follow us on Twitter (@BiologicsInc).
About Wellstat Therapeutics
Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. For more information, please visit the website at http://www.wellstattherapeutics.com. Wellstat Therapeutics is part of the Wellstat group of companies (http://www.wellstat.com).
BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumors, advanced emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com.