Vagifem

Underscoring its commitment to the health and safety of its patients, Novo Nordisk A/S (NYSE: NVO) today announced that effective immediately it will assume US marketing activities, including product fulfillment and distribution, for its hormone therapy products Activella® (1mg estradiol/0.5 mg norethindrone acetate tablets) and Vagifem® (estradiol vaginal tablets), as legal negotiations over Pfizer's early termination of the product licensing agreement continue.

Novo Nordisk is challenging Pfizer's move earlier this year to terminate a multi-year licensing agreement originally between Novo Nordisk and Pharmacia & Upjohn (P&U), granting P&U the US marketing rights to Activella and Vagifem in 2000. Pfizer assumed P&U's rights under the license agreement upon its recently completed acquisition of Pharmacia and Upjohn.

According to Martin Soeters, president of Novo Nordisk Pharmaceuticals Inc., the company will ensure continued product supply to hormone therapy customers and has put into place a variety of information channels to support the products. Novo Nordisk has established two toll-free numbers for women and their healthcare providers to call for further information regarding the availability of Activella and Vagifem.

"There is no reason for women to suffer the symptoms associated with menopause. Hormone therapies, such as Activella, a low dose product, and Vagifem, an estrogen for local administration, are important for women to help control the undesirable effects of menopause, which can sometimes last for a number of years," said Martin Soeters. "We at Novo Nordisk remain committed to offering women and their healthcare providers these significant treatment choices, and we have assured a smooth transition for seamless access to supply and information. Both Activella and Vagifem are the fastest growing products in their segments. We are committed to meeting the growing demand for these important products in the US marketplace," he said.

About Menopause

Natural menopause reflects the biologic change in a woman's body function that usually happens between the ages of 45 and 55. A woman reaches natural menopause when she has not had a menstrual period for twelve consecutive months, thereby marking the end of fertility. As a part of aging, a woman's ovaries gradually stop producing the hormones estrogen and progesterone. As a result, the menstrual cycle changes, and eventually women stop having periods. As blood levels of estrogen and progesterone begin to decline, women may experience symptoms such as irregular menstrual cycles, hot flashes, night sweats, vaginal atrophy, or atrophic vaginitis, the thinning and shrinking of vaginal tissue and decreased lubrication of vaginal walls. Menopause also increases risk of osteoporosis, a condition characterized by a decrease in bone mass that leads to fragile bones susceptible to fracture. Hormone therapy is a clinically effective and proven treatment for relieving menopausal symptoms.

"Changes that accompany menopause such as moderate to severe hot flashes, night sweats, vaginal dryness and osteoporosis do not have to be an inevitable part of a woman's life," said Olga Santiago, medical director at Novo Nordisk. "Shown to be well-tolerated, safe and efficacious, low-dose hormone preparations such as Activella and Vagifem have made a positive difference for millions of women for whom menopause has been particularly difficult. Novo Nordisk has been providing hormone therapy products worldwide for more than 20 years translating into over 22 million women years of experience. It is our responsibility to continue to meet the needs of patients and the physicians who care for them."

About the Hormone Therapy Portfolio

Activella, packaged in a 28-day calendar dial, is a continuous-combined once daily tablet combining 1 mg estrogen and 0.5 mg progestin (norethindrone acetate) for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus. It is the only hormone therapy that combines 17beta-estradiol (an estrogen) and norethindrone acetate (a progestin), both of which are derived from plant sources. The 17beta-estradiol is chemically identical to the estrogen naturally produced in a woman's body before menopause. Activella was approved in the U.S. in November 1998 and is marketed in countries outside the U.S. by Novo Nordisk under the brand, Activelle®.

In clinical studies, Activella has been proven to:

    - Provide effective relief from moderate to severe hot flashes
      and night sweats, which are among the most common and
      bothersome menopausal symptoms
    - Relieve vaginal dryness and discomfort by providing the
      natural estrogen the body loses during menopause
    - Prevent the bone loss that leads to osteoporosis, a
      potentially disabling disease that affects more than 8 million
      American women

Vagifem is approved in the U.S. for the treatment of atrophic vaginitis resulting from estrogen deficiency. Vagifem is a tablet containing natural estrogen, which is administered intravaginally by a disposable applicator. As the first and only vaginal tablet, it offers a clean, no mess, convenient delivery, eliminating the messiness of other vaginal therapies available only as creams. Intravaginal administration allows dosages to be significantly reduced compared to oral estrogen tablets while achieving the efficacy for localized symptoms. Vagifem has been marketed by Novo Nordisk in countries outside the U.S. since 1988.

Novo Nordisk has established two toll-free numbers that women and their healthcare providers may call for further information regarding the availability of Activella, 866-668-6336; and Vagifem, 888-824-4336; or they can visit www.novonordisk-us.com.

As with all estrogen and progestin therapies, unopposed estrogen therapy has been associated with an increased risk of endometrial hyperplasia. The risk of developing uterine cancer depends on such factors as length, type of treatment and dosage strength and concomitant use of a progestin can reduce this risk for women with an intact uterus. In clinical trials, the most commonly reported adverse events were breast pain, headache, postmenopausal bleeding and nausea for Activella and headache, abdominal and back pain for Vagifem.

Novo Nordisk does not anticipate a significant impact to its overall financial results for 2003 as a result of Pfizer's reduction in promotion activity and disputed termination of the agreement and related consequences.

Full prescribing information for Activella and Vagifem is available by contacting the manufacturer.