First Neutering Drug for Puppies Gains FDA Approval.

Business Editors/Pet Care & Veterinary Writers

COLUMBIA, Mo.--(BUSINESS WIRE)--May 19, 2003

Neutersol(R) (Zinc Gluconate Neutralized by Arginine) Is First

Approved Non-Surgical, Injectable Sterilant for Safe, Effective

Neutering of Male Puppies Ages 3 to 10 Months

Puppy owners will now be offered a choice for neutering their male puppies. The federal Food and Drug Administration has approved Neutersol(R) (Zinc Gluconate Neutralized by Arginine) as the world's first injectable neutering drug for puppies 3 to 10 months of age.

Procedure Is Brief

With the puppy lying on its back and properly restrained (chemical restraint may be used, if necessary, to prevent the dog from moving during the injection), the veterinarian gently injects Neutersol into each of the testicles using a very fine needle. The exact dose is pre-calibrated by measuring the width of the puppy's testicles using a custom dosing caliper. Neutersol is 99.6% effective in achieving sterilization.

Benefits Prompt Immediate Understanding of Choice

Owners are relieved of their worries of subjecting the puppy to surgery and the time it takes, thus providing an attractive choice. "When presented with the time savings, speed and ease of the Neutersol procedure, owners immediately understand the advantages of choosing Neutersol as the neutering approach," notes Jim Howard, D.V.M., owner of Howard Veterinary Hospital in Jefferson City, Mo., one of the five test sites for the neutering product. "They now have a choice between surgery or an injection that takes only a few minutes."

Study Findings

Neutersol (Zinc Gluconate Neutralized by Arginine) for pharmaceutical sterilization of 3-to-10-month-old male dogs was developed by the late Dr. Mostafa S. Fahim, Director of the Center of Reproductive Science and Technology, School of Medicine, University of Missouri-Columbia. The research and development of Neutersol and other technology was conducted by Dr. Fahim and his staff and was sponsored by Technology Transfer, Inc. (a Missouri corporation) since 1990. The long process of obtaining FDA approval of Neutersol began in 1991, and Technology Transfer, Inc. licensed Addison Biological Laboratory, Inc. to market Neutersol after receiving FDA approval.

Pilot, dose determination, and target animal safety studies were completed prior to the field study that was conducted at five test sites throughout the U.S. The test sites enrolled 270 puppies, ages 3 to 10 months, according to pre-determined protocols involving testicle widths and good general testicular health. Post-injection, the participating puppies were monitored for general attitude, appetite, ability to walk, scrotal pain on testes manipulation, rectal temperature, and general scrotum description. Complete physical exams were conducted at three days, two months, and six months post-injection. Of the 224 dogs that completed the study, 223 (99.6%) were permanently sterile. Mild, temporary swelling of the testicles is an expected reaction to the injection noticed within 24-48 hours after injection. Other possible side effects include vomiting, anorexia, lethargy, diarrhea, scrotal pain, and scrotal inflammation.

Min Wang, M.D., Senior Research Associate, Center of Reproductive Science and Technology, School of Medicine, University of Missouri-Columbia, conducted the study and presented the field trial findings in "Neutersol: Intratesticular Injection Induces Sterility In Dogs" at the April 2002 International Symposium of Non-Surgical Methods for Pet Population Control. See www.neutersol.com/fieldstudy for detailed study protocols and report of findings.

For more information about Neutersol, contact your local veterinarian.

About Addison Biological Laboratory, Inc.

Addison Biological Laboratory, Inc., Fayette, Missouri, is the exclusive marketer of Neutersol. Addison is a privately held company that improves the lives of animals through its variety of animal health products and diagnostic services used by veterinarians worldwide. The company is widely known for its Maxi/Guard(R) line of proprietary vaccines and small animal products for dermatology, otology, and veterinary dentistry. For further company information, visit www.addisonlabs.com.