Fougera Marks Seventh Snakebite Season With CroFab Crotalidae Polyvalent Immune Fab (Ovine)

Urbanization and Climate Change Driving More Snakebites and New Strategies for Stocking Antivenom in 2007


MELVILLE, N.Y., March 13, 2007 (PRIME NEWSWIRE) -- Fougera Inc. begins the 2007 snakebite season further ensuring adequate availability of CroFab(r) Crotalidae Polyvalent Immune Fab (Ovine), the only widely available antivenom for North American crotalid snakebite envenomations in the United States. Approximately 7,000 to 8,000 of the estimated 45,000 snakebites seen each year in the United States involve a venomous species. Snakebite season begins in mid-March and runs through the fall, the time of year when snakes are most active and people are most likely to encounter them. When a snakebite victim enters a hospital and requires treatment with antivenom, delaying care can be dangerous. Therefore, hospitals should have adequate stocks of antivenom to prevent treatment delays, even if they expect to see just one snakebite patient this year.

"Health and hospital professionals that make stocking decisions should not wait for national disasters or other emergencies to stock antivenom," said Mark Ryan, RPh, Managing Director for the Louisiana Poison Control Center. "Every hospital where snakebites are prevalent should stock antivenom, even rural hospitals, which sometimes transfer rather than treat. The most critical factor for snakebite victims is time -- they need to get to the hospital quickly and hope that the hospital has antivenom if they need it. Time is Tissue(tm) -- every second lost can translate into increased risk of disability or even death."

According to snakebite experts, provoking snakes -- whether intentionally or not -- is the top cause of snakebite. Snakebite victims vary widely, from children playing in their backyards to families enjoying the outdoors, to hikers in unsafe footwear stepping on or startling a snake. Many new homes, parks, and shopping centers have recently been built on what were once isolated snake habitats just a few years ago. In addition to such intrusions into snake territory, climate changes also disrupt natural snake habitats and create circumstances more likely to result in bites.

"Fougera's distribution and stocking strategies have become much more proactive over the last six years in recognition of the risks associated with snakebite treatment delays and in response to climate events that raise the risk of people coming into contact with snakes," said David Klaum, Senior Vice President, Commercial Operations, Fougera.

About CroFab(r)

CroFab(r) 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. With the exception of coral snakes, CroFab(r) can treat mild to moderate envenomations from all known venomous snakes indigenous to the United States.

CroFab(r) 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(tm)" is often used to articulate the need to treat bites quickly to prevent tissue damage.

In October 2002, Fougera(r) assumed responsibility for the distribution of CroFab(r) from Savage Laboratories. Both companies are divisions of Altana Inc. CroFab(r) was developed and is manufactured by Protherics PLC.

Additional information about snakebites and snakebite treatments can be found at www.snakebitenews.com.

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. Recurrent coagulopathy may persist for 1 to 2 weeks or more. One patient discontinued CroFab(r) 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, please refer to the full prescribing information for CroFab(r) available at www.snakebitenews.com.

About Fougera(r)

Fougera(r) 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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