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Thursday, September 20, 2007


Snakebite Season Still Cause for Concern This Fall
Post-Summer Antivenom Availability Remains Critical

Melville, NY - August 23, 2007 - Labor Day may mark the unofficial end of summer, but snakebite season is still going strong. In fact, approximately 20 percent of reported venomous bites take place during the months of September and October. Although the majority of snakebite incidents occur in the southern half of the U.S., every state had at least one reported bite last year.
Thanks in part to the availability of antivenom, widespread educational efforts and heightened media attention, only about a dozen North American crotalid bites result in death each year. An estimated 8,000 people are bitten annually, and the number of bites in any given season depends on a variety of factors including geography, rainfall and temperature.
"Some areas of the country have experienced higher than average rain fall this year, while others are experiencing drought. Both situations can persuade snakes to move into populated areas in search of food or water," said Erica L. Liebelt M.D. FACMT, Associate Professor of Pediatrics and Emergency Medicine Director, Medical Toxicology Services UAB School of Medicine.
"Unfortunately, we see numerous cases of a snake biting someone twice or biting two people because of a botched effort to catch or kill it after the first bite. People often want to capture the snake for identification purposes, but we don't need to see the snake to treat the patient. And, we don't want people bringing a snake into an ambulance or a hospital, even a dead one, especially since snakes still have a bite reflex for a short time after death," stated Dr. Liebelt. "The important thing is to get the victim to a hospital as quickly and calmly as possible. Infants, children and adults should all be treated with antivenom if they have a mild to moderate envenomation."
CroFabR Crotalidae Polyvalent Immune Fab (Ovine) is the only widely available antivenom for the management of patients with minimal or moderate North American crotalid snakebite envenomations in the United States (this includes pit vipers such as rattlesnakes, copperheads and cottonmouths/water moccasins). "We are working in partnership with the poison control centers to encourage every hospital to stock adequate supplies of antivenom, even if they expect to see just one snakebite patient a year," said Jackie Beltrani, Director of Institutional Sales and Specialty Marketing for Fougera, the marketer of CroFab. "Our goal is to ensure that no patient has to lose valuable treatment time being transferred to another hospital because the initial hospital didn't stock antivenom."

About CroFabR
CroFabR is indicated for the management of patients with minimal or moderate North American crotalid envenomation. Early use of CroFabR (within 6 hours of snakebite) is advised to prevent clinical deterioration and the occurrence of systemic coagulation abnormalities. 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. With the exception of coral snakes, CroFabR can treat mild to moderate envenomations from any venomous snake indigenous to the United States.
CroFabR works to stop venom from destroying tissue. It does not reverse the damage already done by the snake venom. The more time that elapses between the time of bite and the time of treatment the greater the chance of complications. The phrase "Time is Tissue" is often used to articulate the need to treat bites quickly to prevent tissue damage.
In October 2002, Fougera assumed responsibility for the distribution of CroFabR from Savage Laboratories. Both companies are divisions of Altana Inc. CroFabR was developed and is manufactured by Protherics PLC.

Important Safety Information
The most common adverse events reported in clinical studies were mild or moderate reactions involving the skin and appendages (primarily urticaria, rash or pruritus), which occurred in 14 out of 42 patients. Two patients experienced severe allergic reactions (severe hives and a severe rash and pruritus) following treatment. One patient experienced recurrent coagulopathy due to envenomation, which required re-hospitalization and additional antivenin administration. 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. Recurrent coagulopathy may persist for 1 to 2 weeks or more. One patient discontinued CroFabR 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. For additional information on adverse events, please refer to the full prescribing information for CroFab available at www.snakebitenews.com.

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.

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