September 19, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Boston – Juniper Pharmaceuticals (JNP), after a strategic evaluation, has decided to prioritize its resources on its core businesses of Crinone progesterone gel and Juniper Pharma Services. As a result of the changes, Juniper plans to lay off 8 percent of its staff, mostly in the new product research-and-development areas.
“This initiative streamlines expenses and provides us with financial flexibility as we assess growth opportunities to advance our strategy,” said Alicia Seccor, Juniper’s president and chief executive officer, in a statement. “Growth of Crinone in key markets, combined with our efforts to expand both the JPS technical and geographical reach, are expected to deliver continued margin expansion and increased cash flows. In addition, we are also working to drive additional growth for the long-term by extending our Crinone relationship with Merck KgaA . In support of our strategic prioritization, we also plan to execute a more focused approach to our IVR portfolio and look to business development strategies to advance non-core areas of our pipeline.”
The company’s R&D efforts will narrow to focus on JNP-0201, a hormone replacement therapy (HRT), as the company’s possible lead intravaginal ring (IVR) program. It will also look for possible partners for its other IVR programs.
The changes are expected to result in cost savings that will give it a cash flow neutral position for 2018. Crinone and JPS combined had revenues of $25.2 million in the first half of this year. It had 17 percent annual growth for its combined core businesses last year, and expects a similar level of growth for this year. It reported a cash balance of $21.5 million at the end of this year’s second quarter.
The job cuts are expected to result in about $1.9 million in savings starting next year, as well as a reduction in overall new product R&D. It expects aggregate charges of $0.6 million to $0.7 million related to severance and other employee-related costs, as well as future obligations under manufacturing and development contracts in the third quarter of this year.
In addition, the research-and-development headcount cuts, Bridget Martell, the company’s chief medical officer, is resigning effective September 18, 2017.
Juniper has three IVR pipeline candidates, JNP-0101, JNP-0201, and JNP-0301, which are still on schedule to release topline preclinical data by the end of the year. JNP-0101 is in preclinical development for overactive bladder (OAB). JNP-0201 is being studied in hormone replacement therapy (HRT), and JNP-0301 is being evaluated for the prevention of pre-term birth.
JNP-0201, a combination of Estradiol plus natural progesterone IVR for HRT to address symptoms of menopause, is the top priority. Once the in vivo preclinical studies are completed, Juniper expects to advance it toward an investigational new drug (IND) application in 2018.
It was determined by the company and the U.S. Food and Drug Administration (FDA) that JNP-0301 will require a partnership for successful development and commercialization. JNP-0101 is being suspended. The company is looking for a development partner.
“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,” Secor said in a statement. “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.”
