Merck Animal Health Receives FDA Approval of VetPen®
First Insulin Pen for Dogs and Cats Makes Managing Diabetes More Convenient
SUMMIT, NJ—March 19, 2014 – Merck Animal Health today announced that the U.S. Food and Drug Administration (FDA) has recently approved VetPen®, the first insulin pen for use in diabetic dogs and cats. For years, insulin pens have made managing diabetes more convenient for human diabetics. Merck Animal Health, a leader in pet diabetes management, has now brought the same technology to veterinary medicine. VetPen is used with VETSULIN® (porcine insulin zinc suspension) insulin cartridges. VETSULIN is the only veterinary insulin product approved for use in both dogs and cats.
“VetPen was developed to make giving insulin injections more convenient for pet owners, and precision dosing makes it easier to consistently deliver an accurate dose of insulin compared to syringes,” said Kathleen Heaney, D.V.M., director of technical services for Merck Animal Health. “VetPen initially will be offered in a number of veterinary clinics throughout the country. This will provide us with the opportunity to work with veterinarians on its use – helping to ensure pet owners are administering VETSULIN safely and effectively.”
VETSULIN is the world’s most trusted veterinary insulin, proven safe and effective for more than 20 years in hundreds of thousands of diabetic pets. Recent advances have made treating diabetes in dogs and cats easier. Today, along with proper diet and exercise, VETSULIN and VetPen play an important role in successfully managing diabetes in both dogs and cats.
“At Merck Animal Health, we are committed to providing veterinarians and pet owners with innovative products to meet the ever changing healthcare needs of animals,” Dr. Heaney said. “VetPen is an exciting breakthrough, which will help in the treatment of pet diabetes – a serious and growing issue in dogs and cats.”
The prevalence of diabetes mellitus in dogs and cats ranges from one in 1001 to one in 5002, and the number of dogs diagnosed with the disease has tripled during the past 30 years.3 Getting the disease under control is paramount to survival. In a study of dogs treated with VETSULIN, investigators reported adequate glycemic control was achieved an average of 81 percent of the time during the study period4, and in a pivotal U.S. study of diabetic cats, VETSULIN reduced all major diabetes indicators to within normal range by day 60 of treatment.4, 5
Today, dogs receiving the proper treatment have the same expected lifespan as a non-diabetic dog of the same age and gender,3 while only 50 percent of dogs used to survive the first 60 days following a diagnosis of diabetes. With effective treatment, lifestyle changes and monitoring, a diabetic cat also can have the same expected life span as a non-diabetic cat of the same age.
Merck Animal Health is committed to supporting veterinarians in the ongoing treatment of their patients, including making diabetes professionals available to answer questions. An informational website (www.Vetsulin.com) provides tools for both veterinarians and pet owners to make managing pet diabetes easier.
Vetsulin should not be used in dogs or cats known to have a systemic allergy to pork or pork products. Vetsulin is contraindicated during periods of hypoglycemia. Keep out of reach of children. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia is essential to attain and maintain adequate glycemic control and prevent associated complications. Overdosage can result in profound hypoglycemia and death. The safety and effectiveness of Vetsulin in puppies and kittens, breeding, pregnant, and lactating dogs and cats has not been evaluated. See package insert for full information regarding contraindications, warnings, and precautions.
About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck.Through its commitment to the Science of Healthier Animals™, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
VETSULIN® and VetPen® are registered trademarks of Merck Animal Health.
1.Nelson RW. Canine diabetes mellitus. In: Ettinger SJ, Feldmen EC, eds. Textbook of Veterinary Internal Medicine. 7th ed. St. Louis, MO: Saunders; 2010: 1782-1796.
2.Reusch C. Feline diabetes mellitus. In: Ettinger SJ, Feldmen EC, eds. Textbook of Veterinary Internal Medicine. 7th ed. St. Louis, MO: Saunders; 2010: 1796-1816.
3.Fleeman, Linda; Rand, Jacqueline (2005). Beyond Insulin Therapy: Achieving Optimal Control in Diabetic Dogs”. Centre for Companion Animal Health, School of Veterinary Science, the University of Queensland, Brisbane, Australia.
4.Data on file, Merck Animal Health.
5.Vetsulin (porcine insulin suspension) Freedom of Information Summary, Millsboro, DE; Intervet Inc; 2008.