MELVILLE, N.Y., March 20, 2006 (PRIMEZONE) -- Fougera(r) Inc. has marked its sixth season of supplying CroFab(r) Crotalidae Polyvalent Immune Fab (Ovine), the primary antivenom for snakebites from the crotalid snake species common to the United States. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes that comprise the vast majority of common North American snakes, including rattlesnakes, copperheads and cottonmouths/water moccasins. When CroFab was launched in 2001, it was the first new snakebite antivenom to be made available in nearly 50 years. CroFab is currently the only widely available antivenom for crotalid snakes.
"Last year, Fougera had its third straight year without shortages of antivenom; however, 2005 presented a unique challenge because of the natural disasters that our country endured. We worked extensively with federal, state and local governments after Katrina and Rita to make sure that CroFab was readily available to emergency personnel in New Orleans and the other areas that were hardest hit," said Paul G. McGarty, CEO, Altana, Inc.
Fougera, and its partner Protherics, continues to supply hospitals in hurricane-affected areas with CroFab and stands ready to meet demands in the case of any future natural disaster or event. The need for antivenin to be available in these areas is extremely important. Upon being forced from their natural habitat, snakes often find storm debris to be a good hiding place. As clean up efforts continue, the potential for coming in contact with a snake is more likely.
Snakebite experts continue to be concerned about the level of misinformation surrounding the diagnosis and treatment of snakebites, particularly in the wake of these natural disasters. Snakebite experts advocate more prompt treatment of snakebites and more widespread treatment of milder bites.
"CroFab changed the way we treat victims of snakebite. Unfortunately, significant misinformation about the treatment of snakebites persists," said Sean Bush, MD, Staff Emergency Physician and Envenomation Specialist, Loma Linda Medical University Center. "The most important step to take when you are bitten is to get to an emergency room as soon as possible. Time is Tissue(tm); the longer you wait, the more damage the venom can do."
Since the launch of CroFab in 2001, the understanding, acceptance and use of the product by the medical community have become more widespread. Numerous studies and reports have contributed to a broader knowledge base of effective snakebite treatment. In addition to extensive efficacy and safety experience with CroFab, the medical establishment now also has guidelines for the treatment of children bitten by rattlesnakes as well as clarification on the use of CroFab for bites from copperheads and Southern Pacific rattlesnakes and on the repeated administration of CroFab in the same patient.
"Though all snakebites are unique, we know more about the safety and efficacy of CroFab through organized studies and general use," said Dr. Bush. "We have extended our medical knowledge and awareness about snakebite, and we can now effectively treat a diverse range of patients."
Early Intervention Provides Better Outcomes
The most important thing a snakebite victim can do is go to the nearest emergency room as quickly as possible. Experts also advise not trying to capture the snake, which wastes valuable time and puts a person at risk of being bitten again for no particular gain. In the vast majority of cases, the identity of the snake will have no bearing on the treatment. Snakebite experts do not advise applying tourniquets, making any kind of cut near the wound, using ice at the site of the bite or trying to suck out the venom.
Snakebite is associated with both a risk of death and significant morbidities, including loss of limb, decreased mobility and tissue death or necrosis at the site of the injury. These morbidities are exacerbated by delays in treatment. Transferring patients to hospitals with a supply of antivenom or waiting for antivenom to be shipped can significantly delay treatment, which can increase tissue loss and other morbidities associated with snakebites.
"Fougera and our partner, Protherics, have worked extremely hard to meet the demand for antivenom. In 2003, we more than doubled our 2002 production and we exceeded those levels in 2004 and 2005," said David Klaum, Senior Vice President, Commercial Operations, Fougera. "Because of the critical nature of snakebite, every hospital that may see a snakebite case should have CroFab in stock," Klaum added.
Important Safety Information
CroFab has been used successfully to treat several thousand snakebites in the U.S. to date. In clinical studies, the majority of adverse reactions to CroFab(r) were mild to moderate in severity. The most common adverse events were hives and rash. One patient experienced recurrent coagulopathy due to envenomation. Two patients experienced severe allergic reactions (severe hives and a severe rash and itching) following treatment. All patients made a complete recovery. One patient discontinued CroFab therapy due to an allergic reaction. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab(r). For additional information on adverse events, precautions or warnings, please refer to the full prescribing information for CroFab available at www.fougera.com.
About CroFab
CroFab is indicated for the management of patients with minimal or moderate North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly know as Crotalidae) of venomous snakes that includes rattlesnakes, copperheads and cottonmouths/water moccasins.
Of the estimated 45,000 snakebites each year in the United States, approximately 7,000 to 8,000 involve venomous species. Additional information about snakebites and snakebite treatments can be found at www.snakebitenews.com.
In October 2002, Fougera assumed responsibility for the distribution of CroFab from Savage Laboratories. Both companies are divisions of Altana Inc. CroFab was developed and is manufactured by Protherics PLC.
About Fougera
Fougera is a leading manufacturer and distributor of a wide range of multi-source topical and ophthalmic pharmaceuticals in prescription and over-the-counter dosage forms, as well as treatments for emergency/critical care.