Noven Pharmaceuticals Announces Issuance of New U.S. Patent, an Important Addition to its Intellectual Property Portfolio for

  Noven Pharmaceuticals Announces Issuance of New U.S. Patent, an Important
 Addition to its Intellectual Property Portfolio for Brisdelle® (Paroxetine)
                               Capsules, 7.5 mg

PR Newswire

MIAMI and NEW YORK, March 25, 2014

MIAMI and NEW YORK, March 25, 2014 /PRNewswire/ --Noven Pharmaceuticals, Inc.
today announced the U.S. Patent and Trademark Office has issued U.S. Patent
No. 8,658,663, entitled "Method Of Treating Thermoregulatory Dysfunction With
Paroxetine." This method of use patent covers the company's Brisdelle^®
(paroxetine) capsules, 7.5 mg, for the treatment of moderate to severe
vasomotor symptoms (VMS) associated with menopause, commonly referred to as
hot flashes.

Noven Pharmaceuticals, Inc.

The patent, listed recently in the U.S. Food and Drug Administration (FDA)'s
Orange Book, provides additional protection until April 2029, six years beyond
the last to expire of the other listed Brisdelle patents.

Brisdelle is the first and only non-hormonal treatment specifically studied
and FDA-approved for moderate to severe VMS associated with menopause.
Although it has the same ingredient as the antidepressant paroxetine,
Brisdelle is a lower dose (7.5 mg) that is not approved to treat depression or
any other psychiatric condition. The method of use patent covers the use of
paroxetine at this lower dose in treating moderate to severe VMS associated
with menopause as a novel approach.

About Brisdelle^®
Brisdelle^® (paroxetine) capsules, 7.5 mg, was approved by the FDA in June
2013 for the treatment of moderate to severe VMS associated with menopause,
commonly referred to as hot flashes. Prior to the approval of Brisdelle,
hormone therapy was the only FDA-approved treatment for VMS. Many women are
unable or unwilling to take hormone therapy to treat their VMS associated with
menopause, often leaving symptoms untreated.

Brisdelle was studied in one Phase 2 and two Phase 3 randomized,
placebo-controlled trials in 1,276 women with moderate to severe VMS
associated with menopause and was clinically proven to reduce frequency and
severity of these symptoms. Brisdelle has similar warnings and precautions to
the higher doses of paroxetine used to treat a number of psychiatric
disorders, including a Boxed Warning about Suicidal Thoughts or Behaviors. The
most common adverse reactions, defined as those experienced by at least 2
percent of patients taking Brisdelle compared to placebo, were headache (6.3
vs. 4.8 percent), fatigue/malaise/lethargy (4.9 vs. 2.8 percent) and
nausea/vomiting (4.3 vs. 2.3 percent).

Visit www.Brisdelle.com to learn more about Brisdelle, hot flashes, and
savings and support, and for the full Prescribing Information, including the
Medication Guide.

INDICATION
BRISDELLE^® [ ](paroxetine) capsules is a prescription medicine used to reduce
moderate to severe hot flashes associated with menopause.

BRISDELLE contains a lower dose of paroxetine, a medicine also used to treat a
number of psychiatric disorders. The lower dose of paroxetine in BRISDELLE has
not been studied in any psychiatric conditions and BRISDELLE is not approved
for any psychiatric uses.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BRISDELLE?

Call your healthcare provider right away if you have any of the following
symptoms, or go to the nearest emergency room:

Suicidal thoughts or actions:
   oBRISDELLE, and related antidepressant medicines, may increase suicidal
     thoughts or actions within the first few months of treatment.
   oDepression or other serious mental illnesses are the most important
     causes of suicidal thoughts or actions.
   oWatch for these changes and call your healthcare provider right away if
     you notice:

        oNew or sudden changes in mood, behavior, actions, thoughts, or
          feelings, especially if severe.
        oPay particular attention to such changes when BRISDELLE is started

 Keep all follow-up visits with your healthcare provider and call between
 visits if you are worried about symptoms.

 Call your healthcare provider right away or go to the nearest emergency room
 if you have any of the following symptoms, especially if they are new, worse,
 or worry you:

   oAttempts to commit suicide; acting on dangerous impulses; acting
     aggressive or violent; thoughts about suicide or dying; new or worse
     depression; new or worse anxiety or panic attacks; feeling agitated,
     restless, angry, or irritable; trouble sleeping; an increase in activity
     or talking more than what is normal for you or other unusual changes in
     behavior or mood.

Serotonin Syndrome. This condition can be life-threatening and may include:
Nervousness, hallucinations, coma, or other changes in mental status;
coordination problems or small movements of the muscles that you cannot
control; racing heartbeat, high or low blood pressure; sweating or fever;
nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors;
seizures.

Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast
cancer) may not work as well if it is taken at the same time as BRISDELLE. If
you are taking tamoxifen, tell your healthcare provider before starting
BRISDELLE.

Abnormal bleeding: BRISDELLE may increase your risk of bleeding or bruising,
especially if you take the blood thinner warfarin, or non-steroidal
anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen, or aspirin.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk
for this. Symptoms may include: headache; weakness or feeling unsteady;
confusion, problems concentrating or thinking or memory problems.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone
fractures.

Manic episodes: Greatly increased energy; severe trouble sleeping; racing
thoughts; reckless behavior; unusually grand ideas; excessive happiness or
irritability; talking more or faster than usual.

Seizures or convulsions.

Restlessness: Women who take BRISDELLE may feel an inner restlessness,
nervousness, or be unable to sit still or stand still especially when they
start taking BRISDELLE.

Visual symptoms.

Who should not take BRISDELLE?
Do not take BRISDELLE if you:

  oTake a Monoamine Oxidase Inhibitor (MAOI).  Ask your healthcare provider
    or pharmacist if you are not sure if you take an MAOI, including the
    antibiotic linezolid.

       oDo not take an MAOI within 14 days of stopping BRISDELLE unless
         directed to do so by your healthcare provider.
       oDo not start BRISDELLE if you stopped taking an MAOI in the last 14
         days unless directed to do so by your healthcare provider.
       oPeople who take BRISDELLE close in time to an MAOI may have serious
         or life-threatening side effects. Get medical help right away if you
         have any of these symptoms:

            +High fever, uncontrolled muscle spasms, stiff muscles, rapid
              changes in heart rate or blood pressure, confusion, loss of
              consciousness (pass out).

  oTake thioridazine or pimozide. Do not take thioridazine or pimozide
    together with BRISDELLE because this can cause serious heart problems or
    sudden death. 
  oAre allergic to paroxetine or any of the ingredients in BRISDELLE.
  oAre pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm
    your unborn baby.

What should I tell my healthcare provider before starting BRISDELLE?
Before starting BRISDELLE, tell your healthcare provider if you:

  oHave liver or kidney problems; bipolar disorder or mania; low sodium
    levels in your blood; glaucoma (high pressure in the eye); have or had
    seizures, convulsions, or bleeding problems; have any other medical
    conditions; are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines that you take, including
prescription and non-prescription medicines such as migraine headache
medication (triptans), other antidepressants and antipsychotics, vitamins, and
herbal supplements.

If you take BRISDELLE, you should not take any other medicines that contain
paroxetine, including Paxil^®, Paxil CR^®, and Pexeva^®.

What should I avoid while taking BRISDELLE?
You should not drive, operate heavy machinery, or do other dangerous
activities until you know how BRISDELLE affects you.

What are the most common side effects of BRISDELLE?
The most common possible side effects of BRISDELLE include: headache;
tiredness; nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or
does not go away. These are not all the possible side effects of BRISDELLE.

Please read the Medication Guide within the full Prescribing Information
before taking BRISDELLE. Call your doctor for medical advice about side
effects. You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Menopause
During perimenopause, the transition period before a woman reaches menopause,
estrogen levels gradually decline and periods may become irregular. Natural
menopause is typically confirmed when a woman has missed her menstrual periods
for 12 consecutive months. The average age of a woman entering natural
menopause is 51 years old. Some women may undergo surgical menopause, which
can take place at any age. Surgical menopause occurs when both ovaries are
surgically removed (called an oophorectomy), often along with the uterus
(called a hysterectomy). Because ovaries are the body's main source of
estrogen production, a woman enters menopause when they are removed. The
severity of symptoms associated with 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, with a focus on treatment options for women
experiencing menopausal vasomotor symptoms. 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.

Brisdelle^® and Pexeva^® are registered trademarks of Noven Therapeutics, LLC.
All other registered trademarks are the property of their respective owners.

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

Ashley Buford
Director
GolinHarris
212-373-6045

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SOURCE Noven Pharmaceuticals, Inc.

Website: http://www.noven.com
 
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