– KORSUVA™ (CR845/difelikefalin) injection Approved as First and Only Treatment for Chronic Kidney Disease-associated Pruritus (CKD-aP) in Adult Hemodialysis Patients by U.S. Food and Drug Administration (FDA) –
– Christopher Posner Appointed President and Chief Executive Officer Effective November 9th, 2021 –
– Conference call today at 4:30 p.m. ET –
STAMFORD, Conn., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the third quarter ended September 30, 2021.
“I am excited to be joining Cara at a transformational point for the Company as it prepares for the commercial launch of KORSUVA injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients in the first half of 2022,” said Christopher Posner, Cara’s newly appointed President and Chief Executive Officer. “As Cara continues to develop Oral KORSUVA across multiple patient populations, I believe the Company is well-positioned to become the leader in the treatment of itch-dominant medical conditions such as atopic dermatitis.”
“In the third quarter of 2021, Cara made significant progress across our development programs, culminating with the FDA approval of KORSUVA injection for moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We are also making important clinical and regulatory progress with our Oral KORSUVA programs. Following recent guidance from the FDA, we aim to initiate Phase 3 programs with Oral Korsuva for the treatment of moderate to severe pruritus in both atopic dermatitis and non-dialysis dependent chronic kidney disease patients in the first quarter of 2022. Finally, I would like to welcome Chris as Cara’s new President and CEO. Having worked closely with Chris as a Cara board member, I am confident in his ability to lead the Company through its next phase of development as an early commercial-stage biopharmaceutical company.”
Third Quarter and Recent Developments:
Leadership Appointments
In November 2021, the Company announced the appointment of Christopher Posner as President and Chief Executive Officer of Cara Therapeutics, effective November 9, 2021. Mr. Posner joins the Company from LEO Pharma, Inc., the US affiliate of LEO Pharma A/S, a global leader in medical dermatology, where he was President and Chief Executive Officer. Mr. Posner succeeds Dr. Derek Chalmers, who will transition to a Senior Advisor Role to the Company.
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis
In August 2021, the FDA approved KORSUVA injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, making it the first and only therapy currently approved by the FDA for treatment of this indication. The New Drug Application for KORSUVA injection received Priority Review by the FDA, granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications, and was supported by positive data from two pivotal Phase 3 trials and supportive data from an additional 32 clinical studies.
Following the FDA approval of KORSUVA injection, the Company has been collaborating with its commercial partner, Vifor Pharma, on the promotional launch of KORSUVA injection in the United States. In September 2021, Vifor Pharma and Cara submitted the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to secure reimbursement for KORSUVA injection. Vifor Pharma expects to initiate the commercial launch of KORSUVA injection in the first half of 2022, subject to CMS timelines.
In October 2020, Vifor Pharma and Cara agreed to an exclusive license to commercialize KORSUVA in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under the terms of this agreement, the Company received a $50.0 million common stock investment from Vifor in October 2021 at a 20% premium to the 30-day trailing average price of the Company’s common stock for achievement of U.S. regulatory approval of KORSUVA injection. In addition, the Company is eligible to receive up to $240.0 million upon the achievement of certain sales-based milestones. Under another existing agreement, Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) and the Company agreed to market KORSUVA injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement. In October 2021, the Company received a $15.0 million cash payment based on the achievement of U.S. regulatory approval of KORSUVA injection.
In March 2021, the Company and VFMCRP announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under the centralized marketing authorization procedure. If approved, difelikefalin would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway. The EMA is expected to render a decision on the EU MAA in the second quarter of 2022.
Oral KORSUVA: Atopic Dermatitis (AD)
In April 2021, the Company announced top-line results from its Phase 2 KARE dose-ranging clinical trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients. While the study did not meet its primary endpoint, in a pre-specified analysis of mild-to-moderate (BSA