BOSTON, July 5, 2016 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women's health therapeutics company, today announced that for the Japanese market Merck KGaA, Darmstadt, Germany (XETRA: MRK.DE), 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. (NYSE: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.
About Juniper Pharmaceuticals Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women's health. The Company is advancing a pipeline of proprietary product candidates that leverage novel intravaginal drug delivery technologies. Juniper's proprietary R&D programs are funded in part by cash flows from Crinone® (progesterone gel) and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development, analytical characterisation, and clinical trials manufacturing to clients. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ is a trademark of Juniper Pharmaceuticals, Inc., in the U.S. and EU.
Crinone® is a registered trademark of Merck KGaA, Darmstadt, Germany, outside the U.S. and of Allergan, Inc. in the U.S.
OneCrinone® is a registered trademark of Merck KGaA, Darmstadt, Germany.
Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the timing of the launch of OneCrinone® by the biopharma business of Merck KGaA, Darmstadt, Germany,in Japan. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include, but are not limited to:risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process; the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies or following commercial launch, if such product candidates are approved; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Juniper Pharmaceuticals' ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Juniper Pharmaceuticals' ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Juniper Pharmaceuticals' dependence on third parties. For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2015 and Quarterly Report on Form 10-Q for the period ended March 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.