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Fougera Marks Fifth Snakebite Season with CroFab(TM); Crotalidae Polyvalent Immune Fab (Ovine) Available; Snakebite Myths and Misconceptions Remain Barrier to Treatment.


MELVILLE, N.Y. -- Fougera(R) Inc. announced today that CroFab(TM) - Crotalidae Polyvalent polyvalent /poly·va·lent/ (-va´lent) multivalent.

pol·y·va·lent
adj.
1. Acting against or interacting with more than one kind of antigen, antibody, toxin, or microorganism.

2.
 Immune Fab (Ovine ovine

pertaining to, characteristic of, or derived from sheep.


ovine atopic dermatitis
symmetrical erythema, alopecia, lichenification, excoriation on woolless areas; sporadic cases, recur each summer.
) has marked its fifth season of use as the primary antivenom antivenom Antivenin Toxicology A vehicle that contains an antibody or other substance that binds specifically to a toxin, deactivating it * for crotalid snakebites from snake species common to the United States. Crotalid is used to describe the Crotalinae subfamily subfamily /sub·fam·i·ly/ (sub´fam-i-le) a taxonomic division between a family and a tribe.

sub·fam·i·ly
n.
A taxonomic category ranking between a family and a genus.
 (formerly know as Crotalidae) of venomous snakes that compose the vast majority of common North American snakes, including rattlesnakes, copperheads Copperheads, in the American Civil War, a reproachful term for those Northerners sympathetic to the South, mostly Democrats outspoken in their opposition to the Lincoln administration. They were especially strong in Illinois, Indiana, and Ohio, where Clement L.  and cottonmouths/water moccasins. When CroFab was launched in 2001, it was the first new snakebite snakebite, wound inflicted by the teeth of a snake. The bite of a nonvenomous snake is rarely serious. Venomous snakes have fangs, hollow teeth through which poison is injected into a victim.  antivenom to be made available in nearly 50 years. It is currently the only widely available antivenom for Crotalid snakes. Snakebite experts remain concerned, however, about the level of misinformation mis·in·form  
tr.v. mis·in·formed, mis·in·form·ing, mis·in·forms
To provide with incorrect information.



mis
 about the diagnosis and treatment of snakebites. Experts advocate more prompt treatment of snakebites and more widespread treatment of milder bites.

"CroFab changed the way we treat victims of snakebite. Unfortunately, misinformation in the general public about the treatment of snakebites persists," said Richard C. Dart, MD, PhD, Director, Rocky Mountain Poison and Drug Center, Denver Health Authority and Professor of Medicine, Surgery and Pharmacy, University of Colorado Health Sciences Center The University of Colorado Health Sciences Center (UCHSC) is part of the University of Colorado System. It has recently been merged with the University of Colorado at Denver (UCD) to form the University of Colorado at Denver and Health Sciences Center. .

Understanding of How to Treat Snakebites with CroFab Has Increased

Since CroFab was launched in 2001, numerous studies and reports have contributed to a better understanding of how to treat snakebites, including:

--Extensive efficacy and safety experience with CroFab

--Guidelines for the treatment of children bitten by rattlesnakes

--Use of CroFab for bites from copperheads and Southern Pacific rattlesnakes

--Repeated administration of CroFab in the same patient

--The management and control of adverse reactions

A full list of recent snakebite publications is available at www.snakebitenews.com.

"All snakebites are unique. Through organized studies and general use, we know more about the safety and efficacy of CroFab and how to effectively treat a diverse range of patients. We now have experience on how to treat children, how to treat bites from species that differ from those originally studied for CroFab and how to treat patients who have been bitten multiple times or who have received CroFab more than once," said Dr. Dart.

Early Intervention Gives Better Outcomes

The most important thing a snakebite victim can do is get to the nearest emergency room as quickly as possible. Experts also advise not trying to capture the snake. Snakes can make multiple venomous bites. Trying to capture a snake wastes valuable time and puts a person at risk of being bitten again. Snakebite experts do not advise applying tourniquets, making any kind of cut near the wound or trying to suck out to draw out with the mouth; to empty by suction.

See also: Suck
 the poison.

"Snake venom is filled with digestive enzymes. The longer you wait to introduce the antivenom, the more destruction the enzymes can do. If you've been bitten by a snake, get to the hospital as quickly as you can," said Dr. Sean Bush, Staff Emergency Physician and Envenomation envenomation /en·ven·om·a·tion/ (en-ven?o-ma´shun) poisoning by venom.

en·ven·om·a·tion
n.
The injection of a poisonous material by sting, spine, bite, or other similar means.
 Specialist, Loma Linda Medical University Center.

In addition to the risk of death, there is significant morbidity associated with snakebites, 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 production partner, Protherics, have worked extremely hard to meet the demand for antivenom. In 2003, we more than doubled our 2002 production and we have maintained or exceeded those levels in 2004 and 2005," said David Klaum, Senior Vice President, Commercial Operations, Fougera.

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(TM) were mild to moderate in severity. The most common adverse events were urticaria and rash. One patient experienced recurrent coagulopathy due to envenomation. Two patients experienced severe allergic reactions (severe hives and a severe rash and pruritus pruritus /pru·ri·tus/ (proo-ri´tus) itching.prurit´ic

pruritus a´ni  intense chronic itching in the anal region.

pruritus hiema´lis  xerotic eczema.
) following treatment. All patients made a complete recovery. One patient discontinued CroFab(TM) therapy due to an allergic reaction. Patients with allergies to papain papain: see papaya. , chymopapain chymopapain /chy·mo·pa·pain/ (ki?mo-pah-pan´) a cysteine endopeptidase from the tropical tree Carica papaya; it catalyzes the hydrolysis of proteins and polypeptides with a specificity similar to that of papain and is used in , other papaya papaya (pəpī`ə), soft-stemmed tree (Carica papaya) of tropical America resembling a palm with a crown of palmately lobed leaves.  extracts, or the pineapple enzyme bromelain bromelain /bro·me·lain/ (bro´me-lan) any of several endopeptidases that catalyze the cleavage of specific bonds in proteins. Different forms are derived from the fruit (fruit b.) and stem (stem b.  may also be at risk for an allergic reaction to CroFab(TM). 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(TM)

CroFab(TM) 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(R) 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(R)

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.

* CroFab(TM) is indicated for the management of patients with minimal or moderate North American crotalid envenomation.
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Publication:Business Wire
Date:Aug 9, 2005
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