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.
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