DEERFIELD, Ill., April 2 - Baxter International Inc. (NYSE:BAX) and Laboratoire Aguettant SAS, Lyon, France, today announced they have signed an exclusive global licensing and distribution agreement for trace elements, which are essential micronutrients used in parenteral nutrition (PN) therapy. The collaboration allows Baxter to augment its leading PN portfolio, currently available in more than 90 countries, with essential trace elements.
Parenteral nutrition is an intravenous (IV) therapy, which may include a balance of protein, carbohydrates, lipids (fats), electrolytes, vitamins and trace elements for patients who cannot ingest food orally or enterally (tube-fed).
"Providing access to a comprehensive range of parenteral nutrition products is critical for patients who rely on IV administration of these nutrients," said Brik Eyre, president of Baxter's Hospital Products business. "This agreement complements Baxter's existing parenteral nutrition portfolio and provides clinicians with options to meet the individual needs of both chronic and critically ill parenteral nutrition patients."
The agreement includes NUTRYELT® concentrate solution for infusion (a multi-trace element product) for adults, and SELENIUM and ZINC (single-trace element products). NUTRYELT® contains nine essential trace elements consistent with the most recent European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines for trace elements.
NUTRYELT® was approved in France, Germany, Poland and the United Kingdom in 2014, and is pending approval in 15 additional European countries. SELENIUM and ZINC are two of the most commonly used stand-alone trace elements. The companies will work together to pursue even broader global regulatory approvals for these products, including in the United States. Aguettant will retain ownership of the worldwide rights of the trace elements, and will directly market these products in France.
"Aguettant and Baxter have previously partnered to provide trace elements in Europe, and during times of product shortages in the United States," said Eric Rougemond, CEO of Laboratoire Aguettant SAS. "This agreement significantly expands the internationalization of Aguettant. It brings together our companies' unique expertise, channels to market and technologies that will allow us to reach more patients with these essential nutritional products."
Trace elements are necessary for the body to function properly and play an essential role in PN therapy. Dietary deficiencies of these micronutrients can cause a variety of illnesses. Studies indicate adequate amounts of zinc in the body support wound healing and the integrity of cellular membranes.1 According to ESPEN, multivitamins and trace elements are an integral part of a comprehensive nutritional support regimen and should be included in daily PN doses.2
Important Safety Information
These products are not currently approved as safe or effective for use in all countries, including the United States.
Patients weighing less than 40 kg, have elevated blood levels of any of the ingredients in NUTRYELT, including excess of copper or iron, or have pronounced yellowing of the skin or whites of the eyes caused by liver or blood problems should not use NUTRYELT. Patients with kidney, liver problems and repeated blood transfusions should talk to their healthcare provider
before using NUTRYELT. ZINC solution for infusion and SELENIUM solution for infusion should not be used in patients with elevated blood levels of ZINC or SELENIUM. It is important to have regular blood levels monitored for NUTRYELT, ZINC solution for infusion and SELENIUM solution for infusion. For indications and Important Risk Information, refer to the Full Prescribing Information.
About Baxter's Nutrition Business
Baxter has been assisting clinicians in treating patients' diverse nutrient needs since the 1940s, when the company first introduced liquid proteins in the form of amino acids. Since then, Baxter has continued to advance intravenous (IV) nutrition. As an example, Baxter pioneered the world's first "triple-chamber system" for IV nutrition, which provides many of the essential ingredients of balanced nutrition - protein, carbohydrates, lipids and electrolytes in a single container - simplifying the preparation of parenteral nutrition for patients. Today, Baxter provides one of the broadest PN portfolios globally, which includes premix IV solutions, vitamins and lipids, as well as pharmacy workflow management, labeling and compounding technology.
Laboratoire Aguettant SAS is a pharmaceutical company dedicated to the development, manufacturing and commercialization of essential hospital medicines. Its expertise in developing innovative injectable drugs makes Aguettant a duly recognized player in critical care, anesthesiology, micronutrients and neurology. The company has a strong commercial infrastructure in Europe through its subsidiaries and elsewhere in the world through its international distributors.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning a collaboration between Baxter and Aguettant, including expectations with regard to regulatory filings and the potential impact to patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking
statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical results; changes in laws and regulations; product quality, manufacturing or supply issues, or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
NUTRYELT® is a trademark owned by Laboratoire Aguettant SAS.
1Chan S, Gerson B, Subramaniam S. The role of copper, molybdenum, selenium, and zinc in nutrition and health. Clin Lab Med 1998 Dec;18(4):
2ESPEN. Basics in clinical nutrition. 3rd ed. Prague: Galen; 2004.