First and only premixed growth hormone with dedicated delivery system
Novo Nordisk A/S (NYSE: NVO) announced today that the United States Food and Drug Administration (FDA) has approved its liquid growth hormone, Norditropin® (somatropin (rDNA origin) injection) in cartridges and an accompanying NordiPen(TM) delivery system. Norditropin® is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of endogenous (pituitary gland produced) growth hormone.
Norditropin® is the first premixed liquid growth hormone to be approved by the FDA in conjunction with a dedicated pen delivery system.
Bill Poole, president, Novo Nordisk Pharmaceuticals, Inc, said, "We are pleased with the FDA approval of liquid Norditropin® cartridges, and we hope that providing a dedicated NordiPen(TM) delivery system establishes Novo Nordisk as the logical first choice for doctors treating growth hormone related disorders. Premixed Norditropin® and its companion pen system was developed to make daily injections even more convenient for patients." The US launch for Norditropin® cartridges and NordiPen(TM) is planned for third quarter, 2000.
Currently, more than 18,000 children are being treated in the US for growth hormone insufficiency, which may cause short stature, reduced muscle and soft tissue mass and altered nutrient metabolism. Poole adds, "Therapy with Norditropin® has been highly successful worldwide in reducing such effects in children and adolescents by maintaining appropriate growth and development to maturity."
In Europe and Japan, the product and delivery system are known as Norditropin® SimpleXx(TM) and NordiPen(TM). The approval will not change the company's financial expectations for year 2000.
Novo Nordisk A/S is the world leader in insulin and diabetes care and also manufactures and markets a variety of other pharmaceutical products. Furthermore, the company is the world's largest producer of enzymes for industrial use. Headquartered in Denmark, Novo Nordisk employs approximately 15,200 people in 68 countries and markets its products in 179 countries. Its B shares are listed on the stock exchanges in Copenhagen and London. Its ADSs are listed on the New York Stock Exchange under the symbol "NVO." A demerger of Novo Nordisk with the intention to spin off the Enzyme Business into a separately listed company is expected to take place around the turn of the year 2000/2001. For further company information, visit Novo Nordisk on the World Wide Web at www.novo.dk or in the US at www.novo-nordisk.com.
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