Healthcare Industry News: Novo Nordisk
News Release - January 11, 2006
Novo Nordisk Introduces New Storage Flexibility for Norditropin(R)New FDA approved growth hormone storage guidelines and expanded product line provide flexibility, choice and convenience
PRINCETON, N.J., Jan. 11 (HSMN NewsFeed) -- Novo Nordisk today announced that Norditropin NordiFlex® (somatropin [rDNA origin] injection) 5 mg and 10 mg, the only prefilled, multi-dose, disposable growth hormone pen, can now be kept unrefrigerated after initial use. The FDA approved storage flexibility guideline is designed to improve patient adherence. The company also added the 10 mg pen to its popular line of Norditropin NordiFlex 5 mg and 15 mg pens, further simplifying treatment with dose increments of 0.05 mg.
For the first time in the United States, patients taking Norditropin NordiFlex in the 5 mg pen or the newly available 10 mg pen have the option to safely store their growth hormone pens at room temperature (up to 77 degrees F) for three weeks after initial use or in the refrigerator (between 36 degrees F - 46 degrees F) for use within four weeks. Previously, all growth hormone pens had to be stored in the refrigerator after initial use. These storage flexibility guidelines also apply to the Norditropin® cartridge 5 mg/1.5 mL. Norditropin NordiFlex 15 mg delivery pen must still be refrigerated both prior to and after the initial injection.
"Between school, chores, extracurricular activities and errands, today's kids are leading busy and active lifestyles, without easy access to refrigeration," said Rosemary Scales, pediatric endocrinology nurse, University of Utah, Utah Diabetes Center. "These new storage flexibility guidelines empower patients and parents to safely take Norditropin NordiFlex, a growth hormone treatment known for its ease of operation, with them on the journey of life, whether at home or on the way to a soccer field. I expect patients and parents to find this a welcome and convenient option."
In addition to the new storage convenience, key unique features of Norditropin NordiFlex include:
* Ease of use:
-- Prefilled: No loading, no mixing (reconstitution) is required. -- Dial-back reset: Dose scale can be dialed back and reset if too big of a dose has been dialed. -- Fine dosing: Increments starting from 0.025 mg allow users to set a precise dose which may lead to reduced waste of growth hormone.
* Ease of training and handling time for the nurse to teach and the parent and patient to use: -- End-of-content feature: When the cartridge is nearly empty the patient can only dial what is left in the cartridge making it easy to see how much growth hormone is being injected. -- Flexible settings: A total of 120 dose settings among three delivery pens allow the same product to cover many patients with different needs.
About Growth Hormone Deficiency
An estimated 50,000 people in the United States have growth failure due to growth hormone deficiency. Growth hormone treatment helps children grow to normal height, ensures strong, healthy bones, regulates the body's metabolism, develops the body's organs and promotes general well-being and energy levels. For adults, the goal of growth hormone replacement therapy is to restore to as great an extent as possible, normal body function, including energy, metabolism and body composition.(1) Patient compliance is crucial to the successful outcome of growth hormone treatment.
Norditropin cartridges from Novo Nordisk contain growth hormone that has been biosynthetically produced to be as close as possible to the growth hormone the body makes naturally.
Novo Nordisk first produced biosynthetic growth hormone in 1985. In 1999, the company introduced a liquid growth hormone formulation that did not require a reconstitution or mixing procedure before injection. This was a major advancement in simplifying growth hormone therapy for patients.
About Norditropin NordiFlex
Norditropin NordiFlex is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone and adults with growth hormone deficiency (GHDA). Norditropin NordiFlex was approved by the Food and Drug Administration (FDA) in October 2004. Norditropin was approved for children in 1997 and for adults in November 2004. Norditropin NordiFlex is available in 5 mg, 10 mg and 15 mg delivery pens.
Norditropin should not be used in patients who are allergic to any of the ingredients in the medicine. Side effects may include headache, muscle pain, weakness, mild hyperglycemia, glucosuria, peripheral edema and fluid retention, and localized reactions at the injection site. Full prescribing information for Norditropin is available by contacting Novo Nordisk Inc. or visiting http://www.norditropin-us.com .
Norditropin NordiFlex comes with the support of the NordiCare® Comprehensive Patient Support Program which provides third party reimbursement assistance, case management services, a complimentary initial supply of Norditropin and educational resources for all people starting on Norditropin regardless of their insurance. NordiCare also manages the Patient Access Program® for people with growth disorders who may qualify for free product due to lack of insurance coverage.
Norditropin, Norditropin NordiFlex and NordiCare are registered trademarks of Novo Nordisk A/S. For more information about Norditropin NordiFlex, healthcare professionals and patients can visit http://www.norditropin-us.com or call 1-888-NOVO-444.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs approximately 21,600 full-time employees in 78 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit http://www.novonordisk.com; for United States information, visit http://www.novonordisk-us.com.
(1) Human Growth Foundation Website - http://www.hgfound.org/adulthormonetherapy.htm. Accessed January 2, 2006
Source: Novo Nordisk
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