IDEXX Laboratories Receives FDA Approval of New EPM Treatment -- NAVIGATOR(R)
Horse Health Press Release
IDEXX Laboratories, Inc. (Nasdaq: IDXX), announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market and sell NAVIGATOR(R) (32%
nitazoxanide) Antiprotozoal Oral Paste, a new treatment for equine protozoal
myeloencephalitis (EPM), a progressive, degenerative disease of the central
nervous system that can cause serious or even fatal neurological problems in
"NAVIGATOR Paste is a powerful new treatment for this potentially
devastating disease," commented IDEXX President and CEO Jonathan Ayers.
"NAVIGATOR is a significant component of our strategy to provide innovative
diagnostic and therapeutic solutions to equine veterinarians."
IDEXX Laboratories, Inc., is a worldwide leader in the development and
commercialization of innovative, technology-based products and services for
animal health. 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 is also 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 over 2,400 people and offers products to customers in
more than 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, 2002, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2003, 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.
Please consult the full package insert for more information.
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
Indications: NAVIGATOR(R) (32% nitazoxanide) Antiprotozoal Oral Paste is
indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
Contraindications: This product is contraindicated for use in horses less
than one year of age and in horses that are sick or debilitated for reasons other than EPM.
Warnings: Administration of nitazoxanide can disrupt the normal microbial flora of the gastrointestinal tract, leading to enterocolitis. Deaths due to enterocolitis have been observed while administering the recommended dose in field studies.
Obtain an accurate body weight and calculate the dose weekly during treatment. Overdosing of nitazoxanide must be avoided. Read the Dosage & Administration and Precautions sections of the package insert before dosing the horse. It is important to monitor the horse for adverse clinical signs during treatment. Read the Adverse Reactions section of the package insert for more information on adverse reactions.
Precautions: If a horse develops any of the following: a high fever (>103 degrees F), scant or loose feces, diarrhea, colic or signs of laminitis, nitazoxanide treatments should be stopped immediately and appropriate veterinary care should be initiated. Horses on nitazoxanide treatment should be monitored for adverse reactions at least once daily for the duration of treatment. Stallions may be more prone to develop laminitis while on nitazoxanide as compared to mares and geldings.
Adverse Reactions: The following adverse reactions have been reported following the use of nitazoxanide in horses: fever, anorexia/reduced appetite, lethargy/depression, edematous head/limbs, worsening of neurological signs, sore/warm feet, increased digital pulses, colic,
decreased gut sounds, scant/loose feces, diarrhea, stiffness, discolored (bright yellow) urine or malodorous/discolored feces, increased water consumption and weight loss. See the Precautions and Adverse Reactions sections of the package insert for a complete list of adverse reactions.
To report suspected adverse reactions or for a copy of the Material Safety Data Sheet (MSDS), call 1-800-374-8006.
Storage Information: Store below 30 degrees C (86 degrees F). Do not freeze.
How Supplied: NAVIGATOR(R) (32% nitazoxanide) Antiprotozoal Oral Paste for
horses contains 32% w/w nitazoxanide and is available in an oral dose syringe. The NAVIGATOR dispensing box contains 26 syringes, which provides sufficient paste to treat one 1,200-pound horse for 28 days (five days at 11.36 mg/lb and 23 days at 22.72 mg/lb).
NAVIGATOR is a registered trademark of IDEXX Pharmaceuticals, Inc.