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FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children

November 4, 2008

PRINCETON, N.J., Nov. 4 /PRNewswire-FirstCall/ — Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years.

The U.S. Food and Drug Administration (FDA) approved Norditropin(R) based on data from a 13-year clinical trial in children SGA. The study showed that 63 percent of children who reached adult height were in the normal range of their peers.

“Growth hormone therapy is the only treatment currently available to increase the height of a child with SGA,” said Dianne Andrews, Executive Director of Major Aspects of Growth in Children (MAGIC) Foundation. “We are thrilled and supportive of a treatment option that may help these children achieve normal height and reduce the risk of physical and psychosocial problems associated with this condition.”

Approximately 100,000 children in the U.S. are born annually with this condition. At birth, babies diagnosed SGA weigh less than approximately 97 percent of all other babies of the same gestational age. Some of these children will not catch up with the normal growth rates by the time they turn two.

“It is important for physicians to understand the potential for growth hormone treatment for children born SGA,” said Dr. Robert Rapaport, Professor of Pediatrics, Emma Elizabeth Sullivan Professor of Pediatric Endocrinology and Diabetes, and Director of the Division of Pediatric Endocrinology and Diabetes at Mount Sinai School of Medicine. “The availability of Norditropin(R), a product with a 13-year study showing efficacy and safety in the treatment of SGA patients, offers an important additional treatment option for children born SGA.”

Children diagnosed SGA may also be at increased risk of developing a number of long-term health consequences, including obesity, insulin resistance, carbohydrate intolerance, dyslipidemia, and psychosocial disadvantages. If untreated, SGA children account for nearly 15 percent of short adults.

In conjunction with this indication approval, and in support of the Novo Nordisk Triple Bottom Line; a commitment to economic success, environmental soundness, and social responsibility to employees and customers; the company will donate up to $15,000 to local charities in New Jersey, where the company has its U.S. headquarters.

“For 40 years, Novo Nordisk has helped to make children’s lives better through an unwavering commitment to the field of endocrinology and growth-related disorders,” said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. “In the past two years, Novo Nordisk has made Norditropin(R) available to a wider range of patients through the approval of three indications: treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner syndrome, and now, the treatment of patients born SGA.”

About SGA

Children born SGA are born shorter and/or weigh less than 97 percent of children of the same gestational age, regardless of whether or not they are born premature. SGA may be caused by fetal abnormalities, placental insufficiency, and maternal factors.

The natural growth hormone level of children born SGA varies from normal to deficient. Decreased growth is likely due to insensitivity to the body’s own growth hormone and/or other growth factors. Growth hormone therapy is thought to overcome this insensitivity, enabling children to reach their full height potential.

About Norditropin(R)

Norditropin(R) (somatropin [rDNA origin] injection) is indicated for the treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner Syndrome, treatment of children with growth failure due to inadequate secretion of endogenous growth hormone, and treatment of short stature in children born SGA with no catch-up growth by age 2. It is also indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

1) Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

2) Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Important Safety Information

Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.

Norditropin(R) (somatropin [rDNA origin] injection) is used to treat children with growth failure caused by very low or no production of growth hormone. It is also used to treat adults who do not make enough growth hormone.

Do not use Norditropin(R) if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.

Children should not use Norditropin(R) if they have any of the following conditions: closed epiphyses (closed bone growth plates), Prader-Willi syndrome with severe obesity, or Prader-Willi syndrome with significant respiratory impairment.

Be sure to tell your doctor if you have diabetes mellitus; have had cancer or other forms of tumor; are pregnant, planning to be pregnant or are breastfeeding; or if you have had a kidney transplant.

Be sure to tell your doctor about all medications you are taking especially if they are: a glucocorticoid medication such as hydrocortisone or cortisone acetate, thyroid hormone, insulin and/or oral diabetes medicines, drugs metabolized by the liver (for example, corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement.

Adult height can be influenced if you are on Norditropin(R) for growth failure and at the same time using glucocorticoids or thyroid hormone.

If you are treated with insulin and/or oral diabetes medicines, the dose of your insulin/oral diabetes medicines may need to be adjusted.

Side effects are usually mild and temporary. Side effects may include headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject.

If you have any of these symptoms, discuss them with your doctor.

If you have headaches, eyesight problems, nausea and/or vomiting, these may be symptoms of raised pressure in the brain. Contact your doctor right away.

In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by a slippage of the growth plate in the hip (slipped capital femoral epiphysis).

Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Because growth hormone increases growth rate, children should be monitored for progression of scoliosis.

   Thyroid function tests should be performed periodically.    Skin lesions should be checked carefully for any unusual changes.    Talk to your doctor if you think you have any of these conditions.    Please see the Prescribing Information at http://www.norditropin-us.com/.    About Novo Nordisk  

Novo Nordisk is a healthcare company with an 85-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. 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 more than 26,000 employees in 80 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 novonordisk.com; for United States information, visit http://www.novonordisk-us.com/.

   Media Contact:   Ambre Morley   Novo Nordisk, Inc.   T: (609) 987-5898    Investors:   Mads Veggerby Lausten   (+45) 4443 7919  

Novo Nordisk

CONTACT: Media Contact: Ambre Morley, +1-609-987-5898 or Investors: MadsVeggerby Lausten, +45-4443-7919, both for Novo Nordisk, Inc.

Web Site: http://www.novonordisk-us.com/




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