Juniper Pharmaceuticals Announces Strategic Reprioritization

• Juniper expects to prioritize JNP-0201, a combination of Estradiol plus natural progesterone IVR for HRT to address symptoms of menopause, for internal development. Pending the outcome of the in vivo preclinical studies, the Company plans to advance JNP-0201 toward an investigational new drug (IND) filing next year.
• Following a Type C meeting with the U.S. Food and Drug Administration (FDA), the Company has determined that the clinical data and funding requirements to support a registration pathway for JNP-0301 will require the support of a partner to ensure successful development and commercialization.
• Based on assessments of the clinical and commercial investment required to advance a program in OAB, the Company will suspend further investment in JNP-0101 and seek a development partner for this candidate.

"The current FDA guidance around the clinical and regulatory pathway for the development of JNP-0201 as a hormone replacement therapy is clearly defined and provides a strong rationale for prioritizing this program," stated Ms. Secor. "With no FDA-approved combination product for HRT, and the differentiating aspect of a combination natural hormone IVR for monthly administration, focusing our resources on the advancement of JNP-0201 provides us with the highest potential return on investment. For JNP-0301 and JNP-0101, the completion of the on-going in vivo studies will enable us to generate important data in a cost-effective manner in support of our partnering efforts."

Driving Continued Growth in Core Businesses

Juniper's core businesses consist of Crinone, which is partnered with Merck KGaA for sale in markets outside of the U.S, and JPS, which provides world-class, fee-for-service contract development and manufacturing services to pharmaceutical and biotechnology companies around the world. Juniper expects continued growth in these businesses, supported by the following:

• For Crinone, Juniper expects that Merck KGaA will continue to drive growth in existing markets while also supporting launches in key markets, including Japan.
• To support the long-term potential of Crinone, Juniper will evaluate opportunities to increase supply chain capacity to meet growing demand.
• Through continued expansion and investment in the JPS technical team and manufacturing capability, the Company has successfully increased its client base, including U.S.-based clients, and the scope of projects.

"We have delivered double-digit growth for both Crinone and JPS, and we will continue to focus our efforts to drive additional growth in these key businesses," stated Ms. Secor. "We have doubled the amount of Crinone we have produced for our partner Merck KGaA in the past four years, and are committed to ensuring that we are well-positioned to meet the growing demand for this product. Through JPS, we have quickly established a strong reputation as being a trusted and expert provider for the development of challenging and complex molecules. With our increased capacity and offerings, we are well-positioned to capture additional growth as the pace of outsourcing of product development activities increases."

About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. core businesses include its CRINONE^® (progesterone gel) franchise and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development and clinical trials manufacturing to clients. The Company is also leveraging its differentiated intravaginal ring technology, which offers the potential to address unmet needs in women's health. 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 plc in the U.S. 

Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the corporate reprioritization, reduction in force and restructuring charges, the potential cost savings resulting from these changes and the ability to achieve at least a cash flow neutral position in 2018, the timing of an IND for JNP-201, the potential to partner Juniper's other product candidates, the potential to complete a contract extension under Juniper's CRINONE supply contract with Merck, the ability to continue to grow the JPS business, the strength of Juniper's core business, product candidates and future results.  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 potential employee retention challenges following our restructuring; 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, particularly with respect to JPS and CRINONE.  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, 2016 and subsequent filings with the SEC. 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.

Investor Contact:   
Argot Partners
Laura Perry or Heather Savelle
212-600-1902
laura@argotpartners.com
heather@argotpartners.com

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SOURCE Juniper Pharmaceuticals, Inc.