Upsher-Smith Divests Three Women's Health Products To Vertical Pharmaceuticals

Mar 24, 2014, 13:54 ET from Upsher-Smith Laboratories, Inc.

MAPLE GROVE, Minn., March 24, 2014 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), a fully integrated pharmaceutical company committed to the development of new treatments for diseases of the central nervous system (CNS), today announced that it has entered into a definitive agreement under which New Jersey-based Vertical Pharmaceuticals, LLC has acquired Upsher-Smith's rights to Divigel® (estradiol gel) 0.1%, Nexa® Plus Rx Prenatal Vitamin, and Provella®, a probiotic dietary supplement.  As part of the transaction, Upsher-Smith has transferred the New Drug Application (NDA) for Divigel to Vertical Pharmaceuticals. Additional terms related to the deal have not been disclosed. Mizuho Securities served as exclusive advisor to Upsher-Smith on this transaction.

"We are pleased to reach this agreement with Vertical Pharmaceuticals, a company that is strategically focused on Women's Health," said Mark Evenstad, President and Chief Executive Officer of Upsher-Smith. "We are excited to drive our base business forward and pursue our strategic objective of providing therapies that empower people living with CNS conditions to lead healthy, productive lives through our commercial and developmental efforts."

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

Important Safety Information for Divigel®

What is the most important information I should know about Divigel® (an estrogen hormone)?
- Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of 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 Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, 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 Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors ("fibroids").

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information including Boxed Warning for Divigel® at

You are encouraged to report negative side effects to the FDA by visiting or calling 1-800-FDA-1088.

Upsher-Smith's Central Nervous System Pipeline
On March 11, 2014 Upsher-Smith received approval from the U.S. Food and Drug Administration (FDA) for Qudexy™ XR (topiramate) extended-release capsules. In addition to the recently-approved Qudexy™ XR, Upsher-Smith's clinical development pipeline includes two investigational drugs that are being studied for the management of seizure disorders.  The pipeline includes USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters, which is the subject of an ongoing international Phase 3 clinical trial (ARTEMIS1) with an open-label safety extension study.  In addition, USL260 (tonabersat) is in early clinical development as a potential first-in-class neuronal gap junction modulator.

About Upsher-Smith
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing pharmaceutical company dedicated to its mission of Advancing Pharmacotherapy. Improving Life™. With capabilities ranging from early-stage research to delivering on-market products, Upsher-Smith is committed to offering quality products that enable people to live life to its greatest potential. Upsher-Smith's approach to product development and partnering has resulted in a broad range of both branded and generic therapeutic solutions to address patients' needs. The Company has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders, and has a robust pipeline of promising CNS compounds in various stages of development.  For more information, visit

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