Baxter Launches NUMETA G13E in Europe: Only Ready-to-Use IV Nutrition for Vulnerable Preterm Newborns at Risk for Malnutrition

  • NUMETA G13E is the only approved, commercially prepared IV
    nutrition product available for preterm newborns in a triple-chamber
    system pioneered by Baxter
  • First patients receiving NUMETA G13E IV nutrition therapy located
    in Sweden

COPENHAGEN, Denmark–(BUSINESS WIRE)–#ESPEN2016–Baxter International Inc. (NYSE: BAX), a global leader in PN therapy,
announced the European launch of NUMETA G13E 300 mL, the only
ready-to-use parenteral (intravenous) nutrition (PN) product available
to treat preterm infants (less than 37 weeks gestation age) who are at
high risk for infection and malnutrition1 in the early hours
and days of their lives. The announcement was made during the 38th ESPEN
(The European Society for Clinical Nutrition and Metabolism) Congress in
Copenhagen, Sept. 17-20, with recognition that the first preterm
patients have received PN therapy on NUMETA G13E in Sweden.


NUMETA G13E is indicated for PN administration in preterm newborn
infants when oral or enteral nutrition is not possible, insufficient or
contraindicated. NUMETA G13E addresses an important medical need to
support preterm neonatal patients who have acute nutritional
requirements by providing a balanced formulation of amino acids
(protein), glucose (carbohydrates), lipids (fats) and electrolytes in a
triple-chamber system that was pioneered by Baxter.

”Baxter’s NUMETA G13E is a well-balanced, ready-to-use formula in a
triple-chamber system that simplifies the preparation process for
healthcare workers and helps reduce the potential risk to patients of
infection and dosing errors,” said Brik Eyre, president of Baxter’s
Hospital Products business. ”NUMETA G13E is truly innovative
nutritional therapy for preterm babies – among the most susceptible
patients – when time and safety are critical factors to their care.”

NUMETA G13E is designed for activation and administration at the
bedside. Research indicates ready-to-use PN may reduce the potential
risk of medication errors and associated infections.2 NUMETA
G13E was reformulated to meet the current pediatric nutritional
guidelines developed by the European Society for Pediatric
Gastroenterology, Hepatology and Nutrition (ESPGHAN) and ESPEN.

Baxter’s NUMETA G13E has Marketing Authorization from the Competent
Authorities in 15 Western European countries, including Austria,
Belgium, France, Germany, Ireland, Malta Netherlands, Poland,
Switzerland, the U.K., and the Nordics where the launch initiated.
Baxter plans to continue pursuing regulatory approvals and launching
NUMETA G13E globally, including in additional European countries and
Latin America in 2017.

Baxter offers additional pediatric triple-chamber PN solutions in Europe
and select Latin American countries, including NUMETA G16E 500mL for
term infants and toddlers (term infants through two years of age); and
NUMETA G19E 1,000mL for children and adolescents (2-18 years of age).

Important Risk Information

The general contraindications for administering NUMETA as an activated
two-chamber container system (with the lipid chamber inactivated for
intravenous infusion) are as follows: hypersensitivity to egg, soy or
peanut proteins, or to any of the active substances, excipients or
components of the container; congenital abnormality of the amino acid
metabolism; pathologically elevated plasma concentrations of sodium,
potassium, magnesium, calcium and/or phosphorous; severe hyperglycemia;
and concomitant treatment with ceftriaxone in newborns (<= 28 days of
age), even if separate infusion lines are used.

The addition of lipids (administering NUMETA as an activated
three-chamber container system for intravenous emulsion) is
contraindicated in the following additional clinical situations: severe
hyperlipidemia and severe disorders of lipid metabolism characterized by
hypertriglyceridemia. Refer to the NUMETA product label for 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.

About Baxter International Inc.

Baxter provides a broad portfolio of essential renal and hospital
products, including home, acute and in-center dialysis; sterile IV
solutions; infusion systems and devices; parenteral nutrition;
biosurgery products and anesthetics; and pharmacy automation, software
and services. The company’s global footprint and the critical nature of
its products and services play a key role in expanding access to
healthcare in emerging and developed countries. Baxter’s employees
worldwide are building upon the company’s rich heritage of medical
breakthroughs to advance the next generation of healthcare innovations
that enable patient care.

This release includes forward-looking statements concerning NUMETA,
including expectations with regard to its availability and future
availability in the European Union, Latin America and other regions, and
expected benefits associated with its use. 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; product quality, manufacturing or supply, or patient safety
issues; changes in law and regulations; 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.

Baxter and NUMETA are trademarks of Baxter International Inc.

__________________________________

1 Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN
Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005.

2 Riskin A, Shiff Y, Shamir R. Parenteral Nutrition in
Neonatology – To Standardize or Individualize? IMAJ 2006;8:641-645.

Contacts

Baxter International Inc.
Media Contact:
Jill
Carey-Hargrave
(224) 948-5353
media@baxter.com
or
Investor
Contact:

Clare Trachtman
(224) 948-3085