PHILADELPHIA, January 8, 2019
PHILADELPHIA, January 8, 2019 /PRNewswire/ --
Distributed ledger technology is a game changer for managing stock levels of critical antidote
For the estimated 7,000[i] individuals bitten by rattlesnakes, copperheads, and cottonmouths in the US each year, "time is tissue" and timely treatment is critical. Patients that are not quickly and appropriately treated are at risk of skin and tissue damage, limb function disability or loss, neurotoxic effects, dangerous internal bleeding, and systemic injury to the heart, stomach, and other organs. This makes it important to understand and manage antivenom stock levels.
CroFab® is the only FDA-approved product to treat all North American pit viper envenomations in adult and pediatric patients.[ii],[iii] It is proven to control local, systemic, and hematologic effects of envenomation[ii], [iv], * and 95% of patients showed a clinical response 1 hour after initial control[v]. The product has been used for more than 15 years to treat over 50,000 patients.[ii]
Using the OMNY platform, near real-time data about CroFab® stock levels at participating healthcare institutions will be captured and securely shared with BTG and the Rocky Mountain Poison & Drug Center (RMPDC), and in time will expand to additional healthcare providers and poison control centers.
"OMNY's technology will help us get patients treated as quickly and safely as possible," says Amanda Goltz, Vice President of Digital at BTG. "This is a game changing application of new tech with a real, meaningful impact. It's about getting CroFab® where it needs to go and keeping everyone in the chain informed."
Founded by Dr. Mitesh Rao (CEO), Sean O'Brien (CTO) and Sunny Grewal (COO), OMNY helps drive supply chain efficiencies in healthcare. Their novel distributed ledger technology can help track the lifecycle of a product from receipt to dispensation, and can share that data securely in near real-time among multiple constituents. The OMNY platform has the ability to revolutionize the healthcare supply chain and create unique and powerful partnerships between hospitals and pharmaceutical manufacturers.
"As an Emergency Medicine physician, I've experienced first-hand how difficult it is to provide patient care without access to the treatment," says Dr. Rao. "Our platform's ability to quickly and securely share data and ensure its provenance for all involved, can ensure hospitals are adequately stocked, and poison control centers like RMPDC can help coordinate care for hospitals and first responders."
Goltz said, "Two years ago, we released SnakeBite911, an app for First responders, Emergency clinicians, and bite victims with the goal of getting information where it needed to go. OMNY is helping us get to the next stage in the evolution in making sure our medicines are where it matters for patients."
OMNY leverages distributed ledger technology to enable near real-time visibility of pharmaceutical inventory and trial data. Data is recorded and stored securely, and can be shared across multiple parties (i.e., trading parties, clinical trial constituents) flexibly and with ease. OMNY has offices in San Francisco and Atlanta, and is backed by leading investors including Social Capital, Kevin Ryan and DNA Capital. To learn more about OMNY, please visit www.omnyhealth.com.
About BTG Pharmaceuticals
BTG Pharmaceuticals provides antidotes that counteract the potentially life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom there are limited or no existing treatment options. We are dedicated to delivering quality medicines that make a real difference to patients through the development, manufacture, and commercialisation of pharmaceutical products. To learn more about BTG Pharmaceuticals, please visit: btgplc.com/pharmaceuticals.
IMPORTANT SAFETY INFORMATION:
Do not administer CroFab® to patients with a known history of hypersensitivity to any of its components, or to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.
WARNINGS AND PRECAUTIONS
Coagulopathy: In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterized by decreased fibrinogen, decreased platelets, and elevated prothrombin time, occurred in approximately half of the patients studied; one patient required re-hospitalization and additional antivenin administration. Recurrent coagulopathy may persist for 1 to 2 weeks or more. Patients who experience coagulopathy due to snakebite should be monitored for recurrent coagulopathy for up to 1 week or longer. During this period, the physician should carefully assess the need for re-treatment with CroFab® and use of any type of anticoagulant or anti-platelet drug.
Hypersensitivity Reactions: Severe hypersensitivity reactions may occur with CroFab®. In case of acute hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, discontinue infusion and institute appropriate emergency treatment. Patients allergic to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also have an allergic reaction to CroFab®. Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia).
The most common adverse reactions (incidence ≥ 5% of subjects) reported in the clinical studies were urticaria, rash, nausea, pruritus and back pain. Adverse reactions involving the skin and appendages (primarily rash, urticaria, and pruritus) were reported in 12 of the 42 patients. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment and one patient discontinued CroFab® due to an allergic reaction. Recurrent coagulopathy due to envenomation and requiring additional treatment may occur.
To report suspected adverse reactions, contact 1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
For further information contact:
Chris Sampson, Corporate Communications Director
+44-(0)-20-7575-1595; Mobile: +44-(0)-7773-251-178
G Sunny Grewal, COO
i. CDC https://www.cdc.gov/niosh/topics/snakes/ [https://www.cdc.gov/niosh/topics/snakes ], last reviewed: May 31, 2018
ii. Efficacy determined using the snakebite severity score (SSS), a validated objective tool for the clinical evaluation of North American pit viper snakebite in adults. The total score reflects patient evaluation on 6 dimensions: cardiovascular system, local wound, gastrointestinal system, hematologic symptoms, pulmonary system, and central nervous system. The higher the total score, the more severe the snakebite.1
CroFab® [prescribing Information]. BTG International Inc; May 2017.
iii. Data on file. Conshohocken, PA; BTG International Inc. 2015.
iv. Dart RC, Seifert SA, Boyer LV, et al. A randomized multicenter trial of crotalinae polyvalent immune Fab (ovine) antivenom for the treatment for crotaline snakebite in the United States. Arch Intern Med. 2001;161(16):2030-2036.
v. In study 1, patients were given up to 2 doses of 4 vials each to gain initial control. In study 2, patients were given up to 6 vials each to gain initial control. Initial control is achieved when local signs of envenomation are arrested (leading edge of local injury is not progressing), systemic symptoms are resolved, and coagulation parameters have normalized or are trending toward normal. Clinical response = pretreatment signs and symptoms of envenomation were arrested or improved. Studies excluded envenomation by copperhead snakes.