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Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle

Miami, FL and New York, NY, -- September 24, 2014 -- Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis.

The new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day that is already only about the size of a dime, the planet’s smallest estrogen therapy patch ever. Minivelle is now approved with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them.

“Noven is deeply committed to offering therapies that address women’s menopausal health,” said Joel Lippman, M.D., FACOG, Noven's Executive Vice President – Product Development and Chief Medical Officer. “We’re pleased that we now have an additional indication and the new dosage strength available for Minivelle to allow women and their doctors to individualize their treatment to best fit their needs.”

The new lower dose of 0.025 mg/day is expected to be available in pharmacies in January 2015. Noven offers a savings program to help reduce the Minivelle co-pay for eligible patients. Eligible patients pay no more than $15 each month for up to 12 uses on their Minivelle prescriptions. Restrictions may apply. For more information, including full terms and conditions, visit www.MINIVELLE.com.

About Minivelle

Minivelle is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes, and the prevention of postmenopausal osteoporosis. If a patient uses Minivelle only to prevent osteoporosis from menopause, they should talk with their healthcare provider about whether a different treatment or medicine without estrogens might be better for them.

Minivelle is bioequivalent to Vivelle® (estradiol transdermal system), which demonstrated safety and efficacy for the treatment of moderate to severe vasomotor symptoms due to menopause, commonly known as hot flashes. Efficacy and safety of Vivelle in the prevention of postmenopausal osteoporosis have been demonstrated in a 2-year double-blind, randomized, placebo-controlled, parallel group study. 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.

Minivelle contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman’s body. Minivelle is designed to release estradiol continuously upon application, increasing estradiol levels above baseline within four hours, and, with Noven’s transdermal drug delivery technology, allows for efficient delivery of estradiol through the skin, bypassing first pass metabolism. This does not mean that Minivelle is safer or more effective than other hormone therapies.

Minivelle is round with smooth, curved edges that may help prevent lifting or snagging associated with everyday wear and stays in place during showering and exercising. 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.

At 1.65 cm2, the new 0.025 mg/day patch is 33% smaller than Minivelle 0.0375 mg/day that is already only about the size of a dime. Minivelle is now approved with five dosing options – 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day with the newly approved, lower dose of 0.025 mg/day indicated for the prevention of postmenopausal osteoporosis only.

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products, with a therapeutic focus in women’s health, and substantial expertise in transdermal drug delivery. 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.

Source: Noven Pharmaceuticals, Inc.

Posted: September 2014

Minivelle (estradiol) FDA Approval History

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