New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1 percent...

New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1
percent for the Treatment of Menopause

Data shows a very high percentage of women responded favorably to a
bioidentical and FDA approved hormone therapy for hot flashes

MAPLE GROVE, Minn., June 30 /PRNewswire/ -- Upsher-Smith Laboratories, Inc.
presented the results of a secondary analysis to determine the response rates
to three doses of transdermal Divigel(R) (estradiol gel) 0.1 percent at the
recent 57th Annual Clinical Meeting of the American College of Obstetricians
and Gynecologists (ACOG) in Chicago. The objectives of this secondary analysis
of a phase III efficacy trial were to determine the percent of postmenopausal
women who achieved a greater than 50 percent reduction in the frequency of
moderate to severe vasomotor symptoms (MSVMS), or hot flashes, and to assess
the change from baseline in a quality of life (Kupperman) index score that
evaluated various menopausal symptoms. Divigel(R) doses studied included 1.0
mg, 0.5 mg and 0.25 mg of estradiol/day - the lowest effective approved dose
of estradiol available for the treatment of MSVMS. The analysis showed a
significantly greater percentage of women in all treatment groups versus
placebo experienced > / = 50 percent reduction in the frequency of MSVMS at
week 12. In the Divigel(R) 1.0 mg estradiol/day dosing group, 90 percent of
women reported at least a 50 percent reduction in the frequency of MSVMS.
Additionally, at 12 weeks, each of the doses of Divigel(R) significantly
reduced the severity of menopausal symptoms identified by a quality of life
index score compared to placebo.

"These data further support the safety, efficacy and tolerability of
Divigel(R) as a bioidentical and FDA-approved hormone therapy for the
treatment of the symptoms of menopause," said Dr. William Koltun, a clinical
investigator from the Medical Center for Clinical Research in San Diego,
Calif. who presented the data at ACOG. "Divigel(R) is an important addition to
the options for women and their physicians in the treatment of hot flashes
associated with menopause."

About the Study
The responder analysis presented at ACOG was a secondary analysis of the
Divigel(R) phase III efficacy and safety study published earlier this year in
the journal Menopause. A total of 488 postmenopausal women were evaluated in
this 12-week efficacy and safety study, comparing placebo to the low-dose
transdermal Divigel(R) at doses of 1.0 mg/day, 0.5 mg/day and 0.25 mg/day
estradiol. Endpoints included the change from baseline in daily frequency and
severity of moderate to severe hot flashes. The study also evaluated common
adverse events and tolerability at the application site. Divigel(R) showed
statistically significant improvements compared with placebo as early as week
two that were maintained throughout treatment. Divigel(R) significantly
decreased the frequency and severity of MSVMS at all doses evaluated in this
trial. The most common treatment-related adverse events were breast tenderness
and postmenopausal bleeding.

"Divigel(R) offers women the lowest effective FDA-approved dose of estrogen
therapy for MSVMS in post-menopausal women and dosing flexibility with
availability of three different strengths (0.25 mg estradiol/day, 0.5 mg
estradiol/day and 1.0 mg estradiol/day) giving physicians greater ability to
individualize treatment for each woman," added Dr. Koltun.

About Divigel(R)
Divigel(R) is indicated for the treatment of MSVMS associated with menopause.
The estrogen in Divigel(R) is derived from plant sources and is identical to
the primary estrogen produced by a woman's ovaries before menopause. Certain
older oral estrogen therapies contain conjugated estrogens derived from the
urine of pregnant mares. Divigel(R) is applied to the skin and takes a more
direct route to the systemic blood stream, bypassing the liver. It is a
quick-drying gel that is odorless when dry and is available in convenient,
individual-use packets. One packet of gel is applied daily to an area that
measures approximately 5 x 7 inches on the thigh, the smallest application
area compared to all other available gel or lotion estrogen products.(1-4)

Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June
2007.

Important Safety Information for Patients

The following are not all the possible risks for Divigel(R). Please see the
full Prescribing Information and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus (womb). Report
any unusual vaginal bleeding right away while you are taking estrogens.
Vaginal bleeding after menopause may be a warning sign of cancer of the
uterus. Your healthcare provider should check any unusual vaginal bleeding to
find out the cause. In general, the addition of a progestin is recommended for
women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease,
heart attacks or strokes. Using estrogens, with or without progestins, may
increase your chance of getting heart attacks, strokes, breast cancer and
blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using
estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel(R), if you have unusual
vaginal bleeding, currently have or have had certain cancers, had a stroke or
heart attack in the past year, currently have or have had blood clots,
currently have or have had liver problems, are allergic to any Divigel(R)
ingredients or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast
pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and
bloating, nausea and vomiting, and hair loss. Less common but serious side
effects include breast cancer, cancer of the uterus, stroke, heart attack,
blood clots, dementia, gallbladder disease and ovarian cancer.

In Divigel(R) clinical trials, the most common side effects were inflammation
of the nasal passages and pharynx, upper respiratory tract infection, vaginal
yeast infection, breast tenderness and vaginal bleeding. Call your healthcare
provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your
treatment and only as long as needed. You and your healthcare provider should
talk regularly about whether you still need treatment with Divigel(R).

For more information, call 1-800-654-2299 or visit www.divigel.com.

Orion Corporation (OMX: ORNAV, ORNBV) has a licensing agreement with
Upsher-Smith Laboratories, Inc. for the development of Divigel(R) in the
United States. Orion is one of the leading pharmaceutical companies in
northern Europe through its development, manufacturing and marketing of
pharmaceuticals, active pharmaceutical ingredients and diagnostic tests for
global markets. The core therapeutic areas in Orion's product and research
strategy are central nervous system disorders, cardiology, critical care, and
hormonal and urological therapies.

Upsher-Smith Laboratories, Inc. is a rapidly growing pharmaceutical company
that manufactures and markets both prescription and consumer products.
Privately held since 1919, the company strives to recognize the unmet
healthcare needs of our customers. Upsher-Smith prides itself in providing
safe, effective, and economical therapies to the ever-challenged healthcare
environment. For additional information about Upsher-Smith, visit
www.upsher-smith.com.

References: 1. Divigel(R) [package insert]. Minneapolis, MN: Upsher-Smith
Laboratories, Inc.; 2007. 2. Estrasorb(R) [package insert]. Bristol, TN:
Graceway Pharmaceuticals, LLC; 2008. 3. EstroGel(R) [package insert]. Herndon,
VA: Ascend Therapeutics, Inc.; 2007. 4. Elestrin(TM) [package insert].
Lincolnshire, IL: BioSante Pharmaceuticals, Inc.; 2007.

SOURCE Upsher-Smith Laboratories, Inc.

Kelly Williams of The Reilly Group, +1-773-348-3800, ext. 205,
kellywilliams@thereillygroup.com, for Upsher-Smith Laboratories, Inc.