September 13 2017
Vistogard® and Voraxaze® Added to Revised Guidelines for Stocking of Antidotes in US Hospitals

13 September 2017

BTG plc (LSE: BTG), the global specialist healthcare company, announces the inclusion of two of its oncology-related antidote products in the revised ‘Expert Consensus Guidelines for Stocking of Antidotes in Hospitals That Provide Emergency Care’ published online by the Annals of Emergency Medicine (AEM).

The previous version of the stocking guidelines was published in 2009, prior to the approval and availability of Voraxaze® (glucarpidase) and Vistogard® (uridine triacetate), which are used to reverse toxicities that can occur from particular chemotherapy treatments. These two BTG products have now been added to the guidance.

The recommendations have been updated by a multidisciplinary expert healthcare panel that have experience with the medical and logistical nature of using emergency care products to promptly treat patients exposed to a number of poisons. In total, 45 antidotes were considered and 44 were recommended for stocking, including the timeframe in which the products should be available to administer to patients.

Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, states: “Many studies have shown that hospitals with emergency departments often fail to stock important antidotes. Our hope is that these guidelines will provide them the guidance needed to stock emergency antidotes appropriately.”

BTG’s Specialty Pharmaceuticals’ product portfolio includes four products categorized as antidotes designed for use in hospital settings and emergency rooms.  BTG’s antidote products address conditions for which there are limited or no existing treatment options. They are listed below, along with the recommendation of the expert panel:

Acute care

CroFab® (crotalidae polyvalent immune fab (ovine)) – a drug approved in the US for the treatment of North American Crotalid snakebites. If left untreated, the snake venom may cause severe pain and tissue damage that may result in the loss of a limb or even death. The guidance states that CroFab® should be stocked and available within 60 minutes of an envenomated patient’s arrival.

DigiFab® (digoxin immune fab (ovine)) – the product is approved in the US, Canada, UK, Switzerland and Australia to treat patients with life-threatening, or potentially life-threatening, digoxin toxicity or overdose. Digoxin (digitalis) is used to treat heart failure and to slow heart rate in some cardiac disturbances. The guidance states that DigiFab® should be stocked and available immediately.

Oncology

Vistogard® (uridine triacetate) – approved by FDA in the US, Vistogard® is the first and only antidote 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. BTG acquired US marketing rights from the manufacturer, Wellstat Therapeutics. The expert panel recommends that Vistogard® should be stocked by the hospital.

Voraxaze® (glucarpidase) – granted US approval to treat patients with toxic plasma methotrexate concentrations (>1 micromole per liter) with delayed methotrexate clearance due to impaired renal function and is available in certain other territories on a named patient basis. The guideline recommends that Voraxaze® should be stocked by the hospital.

To read the expert panel’s recommendations in full, please follow this link: http://www.annemergmed.com/article/S0196-0644(17)30657-1/pdf

About BTG
BTG is a global 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 cancer, severe 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: btgplc.com.

For further information contact:

BTG
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178

FTI Consulting
Ben Atwell/Simon Conway
+44(0)20 3727 1000

Vistogard is a registered trademark of Wellstat Therapeutics Corporation.