PHILADELPHIA, January 8, 2019 /PRNewswire/ --
Distributed ledger technology is a game changer
for managing stock levels of critical antidote
BTG, the global healthcare company, is partnering with OMNY to
improve visibility of inventory data for its antivenom product
CroFab® using distributed ledger technology.
(Logo:
https://mma.prnewswire.com/media/805600/BTG_Logo.jpg )
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."
About OMNY:
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:
CONTRAINDICATIONS
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).
ADVERSE REACTIONS
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
Please see the full Prescribing Information for
CroFab®
For further information contact:
BTG
Chris Sampson, Corporate
Communications Director
+44-(0)-20-7575-1595; Mobile: +44-(0)-7773-251-178
OMNY
G Sunny Grewal, COO
join@omnyhealth.com
Refernces:
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.