Shionogi Inc. Announces Co-Promotion Agreement with Noven Pharmaceuticals For Brisdelle™ (Paroxetine) Capsules

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Jan 13, 2014, 09:00 ET

FLORHAM PARK, N.J., Jan. 13, 2014 /PRNewswire/ -- Shionogi Inc. today announced that it has entered into an exclusive, multi-year agreement with Noven Pharmaceuticals to co-promote Brisdelle™ (paroxetine) capsules, 7.5 mg, the first and only non-hormonal prescription drug approved for the treatment of moderate to severe hot flashes associated with menopause. Under the terms of the agreement, Shionogi will promote Brisdelle, along with Osphena™ (ospemifene), its non-estrogen oral treatment for moderate to severe painful intercourse due to menopause. The co-promote agreement will begin in the first quarter of 2014 and Shionogi will receive royalties on Brisdelle sales it generates.

"This collaboration reinforces our strategic focus in women's health and strengthens our portfolio of innovative oral treatments for the disruptive symptoms associated with menopause," said John Keller, Ph.D., President and Chief Executive Officer at Shionogi Inc. "As the large baby-boom generation reaches midlife, a substantial number of women are reaching the postmenopausal stage of life, and there will be a significant need for these important alternatives."

About Osphena™
Osphena (ospemifene) is a non-estrogen oral pill for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Osphena, as an estrogen agonist/antagonist with tissue selective effects, is the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with moderate to severe dyspareunia due to menopause.

Important Safety Information for Osphena^™

Most Important Information you should know about Osphena

Osphena works like estrogen in the lining of the uterus, but can work differently in other parts of the body.

Taking estrogen alone or Osphena may increase your chance for getting cancer of the lining of the uterus, strokes, and blood clots. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell them right away if this happens while you are using Osphena.

You and your healthcare provider should talk regularly about whether you still need treatment with Osphena.

Call your healthcare provider right away if you get changes in vision or speech, sudden new severe headaches, and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue. Osphena should not be used if you have unusual vaginal bleeding; have or have had certain types of cancers (including cancer of the breast or uterus); have or had blood clots; had a stroke or heart attack; have severe liver problems; or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.

Possible side effects of Osphena

Serious but less common side effects can include stroke, blood clots, and cancer of the lining of the uterus.

Common side effects can include hot flashes, vaginal discharge, muscle spasms and increased sweating.

Tell your healthcare provider about all of the medicines you take as some medicines may affect how Osphena works. Osphena may also affect how other medicines work.

Click here for Full Prescribing Information for Osphena^™ (ospemifene) tablets, including Boxed WARNING and Patient Information. For more information, please visit www.Osphena.com.

About Shionogi
Shionogi Inc. is the U.S.-based subsidiary of Shionogi & Co., Ltd., a Japanese pharmaceutical company with a distinguished 135-year history of discovery and development of innovative therapies. Shionogi Inc. continues this focus on the development and commercialization of high quality medicines to meet patient needs while recognizing and addressing the highly personal nature of healthcare. In the U.S., Shionogi is currently focused on women's health and pipeline products are in the additional areas of pain, allergy, oncology, anti-infectives and endocrinology. For more information, please visit www.shionogi.com. For more information on Shionogi & Co., Ltd, please visit www.shionogi.co.jp.

About Brisdelle™
Brisdelle (paroxetine) capsules, 7.5 mg, is the first and only non-hormonal prescription drug approved for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes. When used as directed, Brisdelle is clinically proven to reduce moderate to severe hot flashes so that they are less frequent and less intense.

To learn more about Brisdelle and for the full Prescribing Information, including the Medication Guide, visit www.Brisdelle.com.

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:

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Pay 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:

Attempts 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:

Take 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.
- Do not take an MAOI within 14 days of stopping BRISDELLE unless directed to do so by your healthcare provider.
- Do not start BRISDELLE if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.
- People 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).
Take thioridazine or pimozide. Do not take thioridazine or pimozide together with BRISDELLE because this can cause serious heart problems or sudden death.
Are allergic to paroxetine or any of the ingredients in BRISDELLE.
Are 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:

Have 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.

Brisdelle™ is a trademark of Noven Therapeutics, LLC.
Pexeva® is a registered trademark of Noven Therapeutics, LLC.
All other registered trademarks are the property of their respective owners.

SOURCE Shionogi Inc.