BOSTON, July 28, 2015 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP), a women’s health specialty pharmaceutical company, today announced that the regulatory bodies of nine new European Union (EU) countries, including Poland and France, have granted marketing authorization to CRINONE® (progesterone gel) under the mutual-recognition procedure (MRP).
“These approvals further expand the global CRINONE® franchise, giving women in these nine countries a new, patient-friendly therapeutic option for their progesterone replacement or supplementation needs,” said Frank Condella, Juniper’s CEO. “We look forward to supporting Merck KGaA, Darmstadt, Germany, with the launch of CRINONE® in these countries, beginning with the expected launch in France in September and Poland in the fourth quarter of 2015.”
The recently-approved countries are: Bulgaria, Estonia, France, Iceland, Latvia, Lithuania, the Netherlands, Poland, and Romania. The reference member state for this MRP is Germany.
Merck KGaA, Darmstadt, Germany (XETRA: MRK.DE), has worldwide marketing rights to CRINONE® except in the United States, where CRINONE® is marketed by Allergan, Inc. (NYSE:AGN). Outside the U.S., CRINONE® is sold by Merck KGaA, Darmstadt, Germany, in over 90 countries, including China, Turkey, Italy, Brazil, and the U.K.
Juniper Pharmaceuticals is the exclusive supplier of CRINONE® to Merck KGaA, Darmstadt, Germany.
About CRINONE
CRINONE® 8% (progesterone gel) is a bioadhesive progesterone vaginal gel indicated for progesterone supplementation of the luteal phase in adults as part of an ART (assisted reproductive technology) procedure, among other indications depending upon the country.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (formerly Columbia Laboratories) is a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women’s health. Juniper has a successful heritage in developing pharmaceutical products, including CRINONE® 8% (progesterone gel), which is marketed by Allergan, Inc. in the U.S. and by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide. The Company is leveraging in-house pharmaceutical development, clinical trial manufacturing, and analytical capabilities to advance an internal development pipeline, while also providing valuable consultative services to its pharmaceutical industry customers. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals and Juniper Pharma Services are trademarks of Juniper Pharmaceuticals, Inc., in the U.S. and EU.
CRINONE® is a registered trademark of Allergan, Inc. in the U.S. and of Merck KGaA, Darmstadt, Germany, outside the U.S.
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/juniper-pharmaceuticals-announces-regulatory-approvals-for-crinone-progesterone-gel-in-nine-new-eu-countries-300119438.html
SOURCE Juniper Pharmaceuticals, Inc.
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