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IDEXX Laboratories Receives FDA Approval of New Equine Pain Treatment—SURPASS Topical Anti-Inflammatory Cream [Trade]

SURPASSWESTBROOK, Maine, May 17, 2004—IDEXX Laboratories, Inc. (NASDAQ: IDXX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market and sell SURPASS™ (1% diclofenac sodium) Topical Anti-Inflammatory Cream, a new treatment for horses with pain and lameness due to osteoarthritis. SURPASS topical cream represents the first equine pharmaceutical use of a topical liposomal formulation of the FDA-approved nonsteroidal anti-inflammatory drug, diclofenac. The product is labeled as a veterinary-only prescription medication to be used under the supervision of a licensed, practicing veterinarian.

"Used in a comprehensive pain management program, SURPASS topical cream offers localized pain relief without many of the side effects seen with systemic products," commented IDEXX President and CEO, Jonathan Ayers. "SURPASS is manufactured to exacting standards for incorporation of the powerful pain reliever, diclofenac, in a proprietary liposomal formulation. This means practitioners can count on consistency in every tube."

SURPASS topical cream can be administered twice a day for ten days, and is formulated in a liposomal-based cream that is applied to the horse's leg. SURPASS topical cream is packaged in a 124-gram tube for easy dispensing. SURPASS will be available through your authorized IDEXX distributor.

For more information regarding SURPASS topical cream and its effectiveness in a pain management program, visit idexx.com/surpass.

IDEXX Laboratories, Inc., is a worldwide leader in the development and commercialization of innovative, technology-based products and services for veterinary, food and water applications. The Company's largest business is focused on companion animal health, combining biotechnology, medical device technology and information technology to aid veterinarians in providing better medicine while building successful practices. IDEXX Laboratories' food and water businesses are focused on employing innovative technologies to monitor production animal health and the safety and quality of drinking water and milk. Headquartered in Westbrook, Maine, IDEXX Laboratories employs more than 2,500 people and offers products to customers in over 100 countries.

 

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations of future events, which are subject to risks and uncertainties. If underlying assumptions prove inaccurate, actual results could vary materially from management's expectations. Risks and uncertainties include timing and success of new product introductions, competition and technological change, government regulation and obtaining government approvals, product demand and market acceptance of products, availability of products and raw materials, and litigation. A further description of these risks and uncertainties and other factors can be found in the Company's Annual Report on Form 10-K for the year ended December 31, 2003 (4,003 KB) and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2004 (2,054 KB), in the section captioned "Management's Discussion and Analysis of Financial Condition and Results of Operations." The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

 
Contact: Scott Moffitt, Marketing Director, (336) 834-6505

 
Product Information

SURPASS™ (1% diclofenac sodium)
Topical Anti-Inflammatory Cream for Use in Horses
Brief Summary

Please consult the full package insert for more information.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description: SURPASS™ topical cream contains 1% diclofenac sodium in a liposomal formulation.

Indications: SURPASS topical cream is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses.

Contraindications: SURPASS topical cream is contraindicated in animals with known hypersensitivity to diclofenac.

Warnings: Not for horses intended for human consumption. Keep out of reach of children. Not for human use.

Precautions: Treatment with SURPASS should be terminated if signs such as inappetence, colic, fecal abnormalities, anemia or depression are observed. The safety of SURPASS has not been investigated in breeding, pregnant or lactating horses or in horses under one year of age.

Adverse Reactions: During the field study one diclofenac horse developed colic on day four of the study. Adverse reactions during the safety study included a gastric ulcer in one horse that received 5.6X the recommended dosage, diarrhea and uterine discharge in one horse that received 2.8X the recommended dosage, and weight loss in four of the six horses in the 5.6X dosage group.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-800-374-8006.

Storage Information: Store at up to 25"C (77"F). Protect from freezing.

How Supplied: SURPASS topical cream is white to pinkish-white and is packaged in 124-gram trilaminate tubes.

 

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