Noven Acquires Commercial Rights to Minivelle™ (Estradiol Transdermal System)

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Noven Acquires Commercial Rights to Minivelle™ (Estradiol Transdermal System)

MIAMI, Fla. & NEW YORK -- Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has acquired commercialrights to Minivelle™ (estradiol transdermal system) in the U.S. and Canada.

Noven acquired the rights from Novogyne Pharmaceuticals, a women's health
joint venture between Noven and Novartis Pharmaceuticals Corporation.
Financial terms of the transaction were not disclosed.

The U.S. Food and Drug Administration approved Minivelle™ for the treatment of
moderate to severe vasomotor symptoms due to menopause on October 29, 2012.
Noven expects that Minivelle™ will be available in U.S. pharmacies in the
first quarter of 2013.

Noven will market and sell Minivelle™ through the Women's Health unit of its
subsidiary, Noven Therapeutics, LLC. Noven developed the Minivelle™ patch
using its proprietary DOT Matrix™ transdermal delivery technology, and the
product will be manufactured at Noven's facility in Miami, Florida.

INDICATION

MINIVELLE™ (estradiol transdermal system) is indicated for treatment of
moderate to severe vasomotor symptoms due to menopause.

IMPORTANT SAFETY INFORMATION

   WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND
                              PROBABLE DEMENTIA

         See full prescribing information for complete boxed warning.

Estrogen-Alone Therapy

  * There is an increased risk of endometrial cancer in a woman with a uterus
    who uses unopposed estrogens
  * Estrogen-alone therapy should not be used for the prevention of
    cardiovascular disease or dementia
  * The Women's Health Initiative (WHI) estrogen-alone substudy reported
    increased risks of stroke and deep vein thrombosis (DVT)
  * The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI
    reported an increased risk of probable dementia in postmenopausal women 65
    years of age and older

Estrogen Plus Progestin Therapy

  * Estrogen plus progestin therapy should not be used for the prevention of
    cardiovascular disease or dementia
  * The WHI estrogen plus progestin substudy reported increased risks of
    stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
  * The WHI estrogen plus progestin substudy reported increased risks of
    invasive breast cancer
  * The WHIMS estrogen plus progestin ancillary study of WHI reported an
    increased risk of probable dementia in postmenopausal women 65 years of
    age and older

Estrogens should not be used in women with undiagnosed abnormal genital
bleeding; known, suspected, or history of breast cancer; known or suspected
estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism,
or history of these conditions; active or history of arterial thromboembolic
disease (e.g., stroke or MI); known anaphylactic reaction or angioedema with
MINIVELLE™, liver dysfunction or disease; known protein C, protein S, or
antithrombin deficiency, or other known thrombophilic disorders; or known or
suspected pregnancy.

Estrogens with or without progestins should be prescribed at the lowest
effective doses and for the shortest duration consistent with treatment goals
and risks for the individual woman. Postmenopausal women should be
re-evaluated periodically as clinically appropriate to determine if treatment
is still necessary.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if
severe hypercalcemia, loss of vision, severe hypertriglyceridemia or
cholestatic jaundice occurs. Monitor thyroid function in women on thyroid
replacement therapy.

In clinical trials with Vivelle^® (estradiol transdermal system), the most
common side effects (≥5%) were headache, breast tenderness, back pain, pain in
limb, nasopharyngitis, dyspepsia, nausea, sinusitis, and intermenstrual
bleeding.

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in
the research, development, manufacturing, marketing and sale of prescription
pharmaceutical products. Noven is committed to developing and offering
products and technologies that meaningfully benefit patients, its customers
and its industry partners. Noven is a stand-alone operating subsidiary of
Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu's U.S.
growth platform in prescription pharmaceuticals. For more information about
Noven, visit www.noven.com. For information about Hisamitsu, visit
www.hisamitsu.co.jp/english.

Contact:

Noven Pharmaceuticals, Inc.
Joseph C. Jones, 305-253-1916
Vice President – Corporate Affairs
or
GolinHarris
Samantha Schwarz, 312-729-4370
Executive Director