US Food and Drug Administration Approves NordiPenMate(R), an Auto-Insertion Accessory for Norditropin(R) Cartridge and NordiPen(R)

Apr 02, 2001, 01:00 ET from Novo Nordisk Pharmaceuticals, Inc.

    PRINCETON, N.J., April 2 /PRNewswire/ -- Novo Nordisk Pharmaceuticals,
 Inc. (NNPI), announced today that the United States Food and Drug
 Administration (FDA) has approved its NordiPenMate(R) a durable auto-insertion
 device developed for users of NordiPen who desire added comfort and
 convenience with their Norditropin injections.  Auto-insertion reduces pain
 perception compared with manual injection.(1)  NNPI is the US affiliate of
 Novo Nordisk A/S (NYSE:   NVO).
     Martin Soeters, president, Novo Nordisk Pharmaceuticals, Inc., said, "we
 developed NordiPenMate for children and their parents who may want extra help
 with manual injections or who may have a fear of needles.  We believe the
 enhanced comfort and convenience NordiPenMate offers, along with our new
 premixed growth hormone formulation, will help families better comply with
 their treatment regimens."  The US launch for NordiPenMate is planned for this
 year.  "This latest addition to our Norditropin brand family reinforces our
 commitment to innovative growth hormone therapy in the US," Soeters said.
 
     NordiPenMate/Norditropin Cartridge/NordiPen Basics
     The NordiPen companion pen delivery system is designed for simple, easy
 and accurate dosing of Novo Nordisk's liquid growth hormone.  The NordiPenMate
 auto-insertion accessory was developed to offer NordiPen users additional
 comfort and convenience.  Both NordiPen and NordiPenMate are used with
 NovoFine(R) 30 disposable needles.  NovoFine needles benefit from thin wall
 technology, which allows for thinner needles with a wider bore than standard
 needles, resulting in less discomfort during injection.
     Norditropin cartridge is the first premixed growth hormone with a
 dedicated pen delivery system and is indicated for treatment of growth failure
 due to growth hormone deficiency in children.  The cartridges contain liquid
 Norditropin, making reconstitution unnecessary.  The Norditropin cartridge has
 a 15 mg/1.5mL capacity, which is suitable for use by all patients diagnosed
 with growth hormone insufficiency.
     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.  Soeters adds,
 "NordiPenMate can make it easier for children to take their Norditropin
 injections and hopefully reach their optimum growth and development
 potential."
 
     Full prescribing information for Norditropin Cartridges is available by
 contacting the manufacturer or by visiting  http://www.novonordisk-us.com
 
     NovoFine, Norditropin, NordiPen and NordiPenMate are registered trademarks
 of Novo Nordisk A/S
 
     References:
     (1) Main KM, Jorgensen JT, Hertel NT, et a. Automatic needle insertion
         diminishes pain during growth hormone injection. Acta Paediatr 1995;
         84:331-4.
 
     Novo Nordisk is a focused healthcare company and the world leader in
 diabetes care.  In addition, Novo Nordisk has a leading position within areas
 such as coagulation disorders, growth disorders and hormone replacement
 therapy.  Novo Nordisk manufactures and markets pharmaceutical products and
 services that make a significant difference to patients, the medical
 profession and society. With headquarters in Denmark, Novo Nordisk employs
 approximately 14,000 people in 68 countries and markets its products in
 179 countries.  For further company information visit
 http://www.novonordisk.com
 
 

SOURCE Novo Nordisk Pharmaceuticals, Inc.
    PRINCETON, N.J., April 2 /PRNewswire/ -- Novo Nordisk Pharmaceuticals,
 Inc. (NNPI), announced today that the United States Food and Drug
 Administration (FDA) has approved its NordiPenMate(R) a durable auto-insertion
 device developed for users of NordiPen who desire added comfort and
 convenience with their Norditropin injections.  Auto-insertion reduces pain
 perception compared with manual injection.(1)  NNPI is the US affiliate of
 Novo Nordisk A/S (NYSE:   NVO).
     Martin Soeters, president, Novo Nordisk Pharmaceuticals, Inc., said, "we
 developed NordiPenMate for children and their parents who may want extra help
 with manual injections or who may have a fear of needles.  We believe the
 enhanced comfort and convenience NordiPenMate offers, along with our new
 premixed growth hormone formulation, will help families better comply with
 their treatment regimens."  The US launch for NordiPenMate is planned for this
 year.  "This latest addition to our Norditropin brand family reinforces our
 commitment to innovative growth hormone therapy in the US," Soeters said.
 
     NordiPenMate/Norditropin Cartridge/NordiPen Basics
     The NordiPen companion pen delivery system is designed for simple, easy
 and accurate dosing of Novo Nordisk's liquid growth hormone.  The NordiPenMate
 auto-insertion accessory was developed to offer NordiPen users additional
 comfort and convenience.  Both NordiPen and NordiPenMate are used with
 NovoFine(R) 30 disposable needles.  NovoFine needles benefit from thin wall
 technology, which allows for thinner needles with a wider bore than standard
 needles, resulting in less discomfort during injection.
     Norditropin cartridge is the first premixed growth hormone with a
 dedicated pen delivery system and is indicated for treatment of growth failure
 due to growth hormone deficiency in children.  The cartridges contain liquid
 Norditropin, making reconstitution unnecessary.  The Norditropin cartridge has
 a 15 mg/1.5mL capacity, which is suitable for use by all patients diagnosed
 with growth hormone insufficiency.
     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.  Soeters adds,
 "NordiPenMate can make it easier for children to take their Norditropin
 injections and hopefully reach their optimum growth and development
 potential."
 
     Full prescribing information for Norditropin Cartridges is available by
 contacting the manufacturer or by visiting  http://www.novonordisk-us.com
 
     NovoFine, Norditropin, NordiPen and NordiPenMate are registered trademarks
 of Novo Nordisk A/S
 
     References:
     (1) Main KM, Jorgensen JT, Hertel NT, et a. Automatic needle insertion
         diminishes pain during growth hormone injection. Acta Paediatr 1995;
         84:331-4.
 
     Novo Nordisk is a focused healthcare company and the world leader in
 diabetes care.  In addition, Novo Nordisk has a leading position within areas
 such as coagulation disorders, growth disorders and hormone replacement
 therapy.  Novo Nordisk manufactures and markets pharmaceutical products and
 services that make a significant difference to patients, the medical
 profession and society. With headquarters in Denmark, Novo Nordisk employs
 approximately 14,000 people in 68 countries and markets its products in
 179 countries.  For further company information visit
 http://www.novonordisk.com
 
 SOURCE  Novo Nordisk Pharmaceuticals, Inc.