Merck KgaA receives Japanese regulatory approval for OneCrinone

Juniper Pharmaceuticals, a women’s health therapeutics company, announced that for the Japanese market Merck KGaA, Darmstadt, Germany, acting through its biopharma business, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone® 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.

“This approval further expands the global Crinone® progesterone gel franchise into the world’s’ third largest pharmaceutical market, giving women and couples struggling with infertility in Japan a new, patient-friendly therapeutic option for luteal phase support,” said Frank Condella, Juniper’s CEO. “We look forward to supporting the launch of OneCrinone® in Japan later this year.”

Merck KGaA, Darmstadt, Germany, has worldwide marketing rights to Crinone® except in the United States, where Crinone® is marketed by Allergan, Inc. (AGN).  Outside the U.S., Merck KGaA, Darmstadt, Germany, holds the marketing authorization for Crinone® in over 90 countries.

Juniper Pharmaceuticals is the exclusive supplier of Crinone® and OneCrinone® to Merck KGaA, Darmstadt, Germany.  The Company’s annual revenues from the sale of Crinone® to Merck KGaA, Darmstadt, Germany, were up 16% in 2015 over the prior year. This growth reflects continued in-market growth and new market sales of Crinone® by Merck KGaA, Darmstadt, Germany.