Minivelle (Estradiol Transdermal System), The Smallest Estrogen Patch, Now Available in U.S. Pharmacies

Minivelle (Estradiol Transdermal System), The Smallest Estrogen Patch, Now Available in U.S. Pharmacies

MIAMI  and  NEW YORK,  Jan. 29, 2013  /PRNewswire/ -- Noven Pharmaceuticals,
Inc., the manufacturer of Vivelle-Dot® (estradiol transdermal system), today
announced the availability of Minivelle (estradiol transdermal system) by
prescription in U.S. pharmacies. On  October 29, 2012, the U.S. Food and Drug
Administration (FDA) approved Minivelle for the treatment of moderate to severe
vasomotor symptoms due to menopause, commonly known as hot flashes and night
sweats. 

Minivelle is the smallest estrogen patch currently available. It is 34 percent
smaller than Vivelle-Dot®  and, at its lowest strength (0.0375 mg/day), has
nearly the same surface area as a dime.

"Hot flashes and night sweats are the most commonly reported symptoms of
menopause among women, said  Mary Jane Minkin, M.D.,*  clinical professor of
obstetrics and gynecology at  Yale University School of Medicine. "The
availability of Minivelle in its unique size is significant as it offers women a
discreet option to help manage these menopause symptoms."

Minivelle is round with smooth, curved edges that may help prevent lifting or
snagging associated with everyday wear. It leaves almost no sticky residue and
causes almost no skin irritation. During clinical pharmacology studies with
Minivelle, 35 percent or less of subjects experienced barely perceptible
erythema. Minivelle stays in place during showering and exercising and 100
percent of the subjects reported that their patch stayed on completely over the
wear period.

"The launch of Minivelle is an example of our commitment to providing innovative
products tailored to women's active and busy lifestyles, and adds to our growing
portfolio - established more than 16 years ago - of treatment options for
menopausal women," said  Jeffrey F. Eisenberg, Noven's President and Chief
Executive Officer.

As a part of its commitment, Noven offers a savings program to help reduce
Minivelle co-pays for eligible patients. On co-pays up to  $70, patients pay no
more than  $15  for a one-month supply. On co-pays in excess of  $70, patients
may qualify for up to  $55  in savings for a one-month supply. Patients can take
advantage of this offer each month, for up to 12 uses. Restrictions apply.
Physicians and patients should review the full terms and conditions at
www.minivelle.com.

"I'm excited to talk to my doctor about Minivelle, which is from the
manufacturer of the patch I've known and trusted to help relieve my menopausal
hot flashes and night sweats," said  Karen Giblin,* founder of Red Hot Mamas, a
menopause education and support program. "I never want to feel like menopause
defines me, and the small size of Minivelle is appealing as it can help
alleviate my symptoms, yet no one has to know I'm wearing it."

About Minivelle
Minivelle is indicated for the treatment of moderate to severe vasomotor
symptoms due to menopause, commonly known as night sweats and hot flashes. At
2.48 cm2, the patch, at its lowest strength (0.0375 mg/day), has nearly the same
surface area as a dime, making it the smallest estrogen therapy patch currently
available. Minivelle has been approved with four dosing options - 0.0375 mg/day,
0.05 mg/day, 0.075 mg/day and 0.1 mg/day. Minivelle is manufactured by Noven
Pharmaceuticals, Inc. (the manufacturer of Vivelle-Dot®), and is marketed and
sold through the Women's Health unit of Noven's subsidiary, Noven Therapeutics,
LLC. 

Minivelle contains bioidentical estradiol, a plant-based estrogen that is
chemically identical to the estrogen produced naturally by a woman's body. This
does not mean there are differences in safety or efficacy compared to other
estrogen therapies. Minivelle is designed to release estradiol continuously upon
application, increasing estradiol levels above baseline within four hours, and,
with its DOT Matrix technology, allows for efficient delivery of estradiol.

Minivelle is bioequivalent to Vivelle® (estradiol transdermal system), with the
same demonstrated safety and efficacy for the treatment of moderate to severe
vasomotor symptoms due to menopause, commonly known as hot flashes and night
sweats. No clinical trials were conducted with Minivelle. The most commonly
reported adverse events for Vivelle® (≥5 percent) were headache, breast
tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation
of the sinuses, and irregular vaginal bleeding or spotting.

For more information, including the full Prescribing Information, visit
www.minivelle.com  and read the Important Safety Information below.

INDICATION
MINIVELLETM  (estradiol transdermal system) is a prescription medicine patch
that contains estradiol (an estrogen hormone). MINIVELLE is used to treat
moderate to severe hot flashes due to menopause.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MINIVELLE (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 MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause  
* Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in 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 65 years of age or older                                                                                                                                                                                                                                
* Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia                                                                                                                                                                                                                                                   
* Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots                                                                                                                                                                                                                           
* Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older                                                                                                                                                                                                                     
* You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE                                                                                                                                                                                                                                         


* 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
MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of
the uterus (womb). Your healthcare provider should check any unusual vaginal
bleeding to find out the cause
* Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or
dementia (decline in 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 65 years of age or older
* Do not use estrogens with progestins to prevent heart disease, heart attacks,
strokes, or dementia
* Using estrogens with progestins may increase your chances of getting heart
attacks, strokes, breast cancer, or blood clots
* Using estrogens with progestins may increase your chance of getting dementia,
based on a study of women 65 years of age or older
* You and your healthcare provider should talk regularly about whether you still
need treatment with MINIVELLE

MINIVELLE should not be used 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, have been
diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its
ingredients, or think you may be pregnant.

The most common side effects that may occur with MINIVELLE are headache, breast
tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation
of the sinuses and irregular vaginal bleeding or spotting.

MINIVELLE should be used at the lowest effective dose and for the shortest
duration consistent with your treatment goals and risks. 

About Menopause
Menopause is a natural part of every woman's life. The average age of a woman
entering menopause is 51 years old. Menopause is typically confirmed when a
woman has missed her menstrual periods for 12 consecutive months. During
perimenopause, the transition period before a woman reaches menopause, estrogen
levels gradually decline and periods may become irregular. The severity of
symptoms associated with going through menopause varies from woman to woman. Hot
flashes are the most common symptom of menopause. Because the journey is unique
for each woman, it is important for women going through menopause to have a
thorough discussion about the transition with their doctors and determine if
treatment is appropriate.

 

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.

*Mary Jane Minkin, M.D. and  Karen Giblin  are paid consultants for Noven
Pharmaceuticals, Inc.

All opinions stated are those of the individual.

Contacts
Joseph C. Jones
Vice President - Corporate Affairs
Noven Pharmaceuticals, Inc.
305-253-1916

Samantha Schwarz
Executive Director
GolinHarris
312-729-4370

SOURCE  Noven Pharmaceuticals, Inc.
MIAMI  and  NEW YORK,  Jan. 29, 2013  /PRNewswire/ -- Noven Pharmaceuticals,
Inc., the manufacturer of Vivelle-Dot® (estradiol transdermal system), today
announced the availability of Minivelle (estradiol transdermal system) by
prescription in U.S. pharmacies. On  October 29, 2012, the U.S. Food and Drug
Administration (FDA) approved Minivelle for the treatment of moderate to severe
vasomotor symptoms due to menopause, commonly known as hot flashes and night
sweats. 

Minivelle is the smallest estrogen patch currently available. It is 34 percent
smaller than Vivelle-Dot®  and, at its lowest strength (0.0375 mg/day), has
nearly the same surface area as a dime.

"Hot flashes and night sweats are the most commonly reported symptoms of
menopause among women, said  Mary Jane Minkin, M.D.,*  clinical professor of
obstetrics and gynecology at  Yale University School of Medicine. "The
availability of Minivelle in its unique size is significant as it offers women a
discreet option to help manage these menopause symptoms."

Minivelle is round with smooth, curved edges that may help prevent lifting or
snagging associated with everyday wear. It leaves almost no sticky residue and
causes almost no skin irritation. During clinical pharmacology studies with
Minivelle, 35 percent or less of subjects experienced barely perceptible
erythema. Minivelle stays in place during showering and exercising and 100
percent of the subjects reported that their patch stayed on completely over the
wear period.

"The launch of Minivelle is an example of our commitment to providing innovative
products tailored to women's active and busy lifestyles, and adds to our growing
portfolio - established more than 16 years ago - of treatment options for
menopausal women," said  Jeffrey F. Eisenberg, Noven's President and Chief
Executive Officer.

As a part of its commitment, Noven offers a savings program to help reduce
Minivelle co-pays for eligible patients. On co-pays up to  $70, patients pay no
more than  $15  for a one-month supply. On co-pays in excess of  $70, patients
may qualify for up to  $55  in savings for a one-month supply. Patients can take
advantage of this offer each month, for up to 12 uses. Restrictions apply.
Physicians and patients should review the full terms and conditions at
www.minivelle.com.

"I'm excited to talk to my doctor about Minivelle, which is from the
manufacturer of the patch I've known and trusted to help relieve my menopausal
hot flashes and night sweats," said  Karen Giblin,* founder of Red Hot Mamas, a
menopause education and support program. "I never want to feel like menopause
defines me, and the small size of Minivelle is appealing as it can help
alleviate my symptoms, yet no one has to know I'm wearing it."

About Minivelle
Minivelle is indicated for the treatment of moderate to severe vasomotor
symptoms due to menopause, commonly known as night sweats and hot flashes. At
2.48 cm2, the patch, at its lowest strength (0.0375 mg/day), has nearly the same
surface area as a dime, making it the smallest estrogen therapy patch currently
available. Minivelle has been approved with four dosing options - 0.0375 mg/day,
0.05 mg/day, 0.075 mg/day and 0.1 mg/day. Minivelle is manufactured by Noven
Pharmaceuticals, Inc. (the manufacturer of Vivelle-Dot®), and is marketed and
sold through the Women's Health unit of Noven's subsidiary, Noven Therapeutics,
LLC. 

Minivelle contains bioidentical estradiol, a plant-based estrogen that is
chemically identical to the estrogen produced naturally by a woman's body. This
does not mean there are differences in safety or efficacy compared to other
estrogen therapies. Minivelle is designed to release estradiol continuously upon
application, increasing estradiol levels above baseline within four hours, and,
with its DOT Matrix technology, allows for efficient delivery of estradiol.

Minivelle is bioequivalent to Vivelle® (estradiol transdermal system), with the
same demonstrated safety and efficacy for the treatment of moderate to severe
vasomotor symptoms due to menopause, commonly known as hot flashes and night
sweats. No clinical trials were conducted with Minivelle. The most commonly
reported adverse events for Vivelle® (≥5 percent) were headache, breast
tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation
of the sinuses, and irregular vaginal bleeding or spotting.

For more information, including the full Prescribing Information, visit
www.minivelle.com  and read the Important Safety Information below.

INDICATION
MINIVELLETM  (estradiol transdermal system) is a prescription medicine patch
that contains estradiol (an estrogen hormone). MINIVELLE is used to treat
moderate to severe hot flashes due to menopause.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MINIVELLE (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 MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause  
* Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in 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 65 years of age or older                                                                                                                                                                                                                                
* Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia                                                                                                                                                                                                                                                   
* Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots                                                                                                                                                                                                                           
* Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older                                                                                                                                                                                                                     
* You and your healthcare provider should talk regularly about whether you still need treatment with MINIVELLE                                                                                                                                                                                                                                         


* 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
MINIVELLE. Vaginal bleeding after menopause may be a warning sign of cancer of
the uterus (womb). Your healthcare provider should check any unusual vaginal
bleeding to find out the cause
* Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or
dementia (decline in 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 65 years of age or older
* Do not use estrogens with progestins to prevent heart disease, heart attacks,
strokes, or dementia
* Using estrogens with progestins may increase your chances of getting heart
attacks, strokes, breast cancer, or blood clots
* Using estrogens with progestins may increase your chance of getting dementia,
based on a study of women 65 years of age or older
* You and your healthcare provider should talk regularly about whether you still
need treatment with MINIVELLE

MINIVELLE should not be used 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, have been
diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its
ingredients, or think you may be pregnant.

The most common side effects that may occur with MINIVELLE are headache, breast
tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation
of the sinuses and irregular vaginal bleeding or spotting.

MINIVELLE should be used at the lowest effective dose and for the shortest
duration consistent with your treatment goals and risks. 

About Menopause
Menopause is a natural part of every woman's life. The average age of a woman
entering menopause is 51 years old. Menopause is typically confirmed when a
woman has missed her menstrual periods for 12 consecutive months. During
perimenopause, the transition period before a woman reaches menopause, estrogen
levels gradually decline and periods may become irregular. The severity of
symptoms associated with going through menopause varies from woman to woman. Hot
flashes are the most common symptom of menopause. Because the journey is unique
for each woman, it is important for women going through menopause to have a
thorough discussion about the transition with their doctors and determine if
treatment is appropriate.

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.

*Mary Jane Minkin, M.D. and  Karen Giblin  are paid consultants for Noven
Pharmaceuticals, Inc.

All opinions stated are those of the individual.

Contacts
Joseph C. Jones
Vice President - Corporate Affairs
Noven Pharmaceuticals, Inc.
305-253-1916

Samantha Schwarz
Executive Director
GolinHarris
312-729-4370

SOURCE  Noven Pharmaceuticals, Inc.

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