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Novo Nordisk Inc. Announces Exclusive Agreement With Upsher-Smith Laboratories, Inc. to Market Vagifem® 10 mcg
Date:8/23/2010

PRINCETON, N.J., Aug. 23 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. today announced that it has signed an exclusive agreement with Upsher-Smith Laboratories, Inc. to market Vagifem® (estradiol vaginal tablets) 10 mcg.  Under the terms of the agreement, Upsher-Smith will exclusively market Vagifem® 10 mcg to physicians in the U.S. beginning August 2 through the company's existing field sales force.

Novo Nordisk introduced Vagifem® 10 mcg to the U.S. market earlier this year.  The new dose replaces Vagifem® 25 mcg dose, which was discontinued on July 30, 2010.

"This partnership with Upsher-Smith supports the launch and conversion of the U.S. market to Vagifem® 10 mcg," said Eddie Williams, Vice President of Biopharmaceuticals at Novo Nordisk.  "Leveraging Upsher-Smith's experienced sales force, we are able to maintain our commitment to patient care and the medical community by making sure that physicians are aware of Vagifem® 10 mcg for treating menopausal women with symptoms of atrophic vaginitis."

"The alignment of our two organizations and our products, which offer low-dose estrogen treatments for menopausal women, make this a unique partnership opportunity," said Tom Burke, Executive Vice President, Commercial Operations at Upsher-Smith.  "The combined history of our two companies offers more than two centuries of experience bringing meaningful pharmaceutical products to the marketplace."

Financial terms of the agreement are not being disclosed.

Important Safety Information

What is the most important information I should know about Vagifem® (an estrogen hormone)?

  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) Report any unusual vaginal bleeding right away while you are using Vagifem®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find the cause
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
  • Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older
  • You and your health care provider should talk regularly about whether you still need treatment with Vagifem®

Vagifem® is used after menopause to treat menopausal changes in and around the vagina.

Do not start using Vagifem® if you: have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, are allergic to Vagifem® or any of its ingredients, or think you may be pregnant.

The most commonly reported side effects of Vagifem® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care.  The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success.  Headquartered in Denmark, Novo Nordisk employs more than 29,650 employees in 76 countries, and markets its products in 179 countries.  Novo Nordisk's B shares are listed on the stock exchange in Copenhagen and its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.

About Upsher-Smith Laboratories

Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that manufactures and markets branded and branded generic prescription and over-the-counter products. Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and central nervous system diseases. For more information, visit www.upsher-smith.com

© 2010 Novo Nordisk Printed in the U.S.A. August 2010


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