Vifor Pharma and Cara Therapeutics sign US license agreement for IV Korsuva™* to treat dialysis patients with pruritus
October 20 2020 - 1:00AM
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq:CARA) today
announced that both companies have signed a license agreement for
commercialization of Korsuva (difelikefalin) Injection (“IV
Korsuva”) for the treatment of chronic kidney disease-associated
pruritus (CKD-aP) in the US dialysis market for non-Fresenius
Medical Care clinics under a Cara 60%, Vifor Pharma 40%
profit-sharing arrangement.
“With an established fully dedicated nephrology sales force in
the US, Vifor Pharma is an ideal commercialization partner to bring
IV Korsuva to dialysis patients across the country,” said
Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara
Therapeutics. “In addition, we believe Vifor Pharma’s
existing relationships with US dialysis providers will provide
significant momentum for the launch and adoption of IV Korsuva, if
approved. As a result of this agreement, we expect to focus Cara’s
internal resources on our clinical programs for Oral Korsuva in
atopic dermatitis, pre-dialysis CKD and additional pruritic
conditions.”
“Vifor Pharma has a strong market position and deep expertise in
the nephrology space. This agreement further strengthens our US
nephrology presence. The Vifor Pharma Group now has the
commercialization rights for IV Korsuva in the full dialysis
segment by adding all non-FMC dialysis clinics, representing
approximately 66% of the US market,” said Stefan Schulze,
CEO of Vifor Pharma
Group. "Moderate to severe haemodialysis-associated
pruritus is a debilitating condition that impacts up to 40% of
dialysis patients around the world and for which there is currently
no approved treatment in the US or Europe. IV Korsuva is an
important, innovative new therapeutic that has the potential to
address this significant unmet need. We remain committed to making
IV Korsuva available next year to dialysis patients, who urgently
need an effective therapy.”
Under the terms of the agreement, Cara will receive an upfront
payment of USD 100 million in cash and an equity investment of USD
50 million. In addition, Cara will be eligible to receive an
additional equity investment upon US regulatory approval of IV
Korsuva, as well as milestone payments dependent on achieving
commercial targets, which together could total up to USD 290
million. Additional information regarding the terms of the
agreements between Cara and Vifor announced today will be set forth
in a Current Report on Form 8-K to be filed by Cara with the U.S.
Securities and Exchange Commission on October 20, 2020.
In May 2018, Cara Therapeutics and Vifor Fresenius Medical Care
Renal Pharma (VFMCRP) signed an initial agreement that granted the
rights to develop and commercialize IV Korsuva for the treatment of
chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis
and peritoneal dialysis patients worldwide, excluding the US, Japan
and South Korea. At that time Cara retained full development and
commercialization rights for IV Korsuva for the treatment of CKD-aP
in the US except in the dialysis clinics of Fresenius Medical Care
North America (FMCNA), where VFMCRP and Cara were to promote IV
Korsuva under a profit-sharing arrangement based on net FMCNA
clinic sales recorded by Cara. Under the agreement, Cara had sole
responsibility to promote IV Korsuva in the US in non-Fresenius
Medical Care clinics.
Contact and further
information: |
|
|
|
Vifor
Pharma Group |
|
Media
Relations |
Investor
Relations |
Nathalie Ponnier |
Julien Vignot |
Global Head Corporate
Communications |
Head of Investor Relations |
+41 79 957 96 73 |
+41 58 851 66 90 |
media@viforpharma.com |
investors@viforpharma.com |
|
|
Cara
Therapeutics |
|
Media
Contact |
Investor
Contact |
Annie Starr |
Janhavi Mohite |
6 Degrees |
Stern Investor Relations,
Inc. |
973-415-8838 |
212-363-1200 |
astarr@6degreespr.com |
janhavi.mohite@sternir.com |
Conference CallCara management
will host a conference call today at 8:30 am EDT to discuss the
licensing agreement. To participate in the conference call, please
dial (855) 445-2816 (domestic) or (484) 756-4300 (international)
and refer to conference ID 1891110. A live webcast of the call can
be accessed under "Events and Presentations" in the News &
Investors section of Cara’s website at www.CaraTherapeutics.com. An
archived webcast recording will be available on the Cara website
beginning approximately two hours after the call.
Vifor Pharma Group is a global
pharmaceuticals company. It aims to become the global leader in
iron deficiency, nephrology and cardio-renal therapies. The company
is a partner of choice for pharmaceuticals and innovative
patient-focused solutions. Vifor Pharma Group strives to help
patients around the world with severe and chronic diseases lead
better, healthier lives. The company develops, manufactures and
markets pharmaceutical products for precision patient care. Vifor
Pharma Group holds a leading position in all its core business
activities and consists of the following companies: Vifor Pharma
and Vifor Fresenius Medical Care Renal Pharma (a joint company with
Fresenius Medical Care).Vifor Pharma Group is headquartered in
Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN, ISIN: CH0364749348). For more information, please
visit viforpharma.com
Cara Therapeutics is a clinical-stage
biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus by selectively
targeting peripheral kappa opioid receptors, or KORs. Cara is
developing a novel and proprietary class of product candidates, led
by KORSUVA™ (difelikefalin), a first-in-class KOR agonist that
targets the body’s peripheral nervous system, as well as certain
immune cells. In two Phase 3 trials, IV KORSUVA has demonstrated
statistically significant reductions in itch intensity and
concomitant improvement in quality of life measures in hemodialysis
patients with moderate-to-severe chronic kidney disease-associated
pruritus (CKD-aP). Cara has successfully completed its Phase 2
trial of Oral KORSUVA for the treatment of pruritus in patients
with CKD and is currently conducting Phase 2 trials of Oral KORSUVA
in atopic dermatitis and primary biliary cholangitis patients with
moderate-to-severe pruritus.
CKD-aP is an intractable
systemic itch condition that occurs with high frequency and
intensity in patients with chronic kidney disease undergoing
dialysis. Pruritus has also been reported in patients with stage
III-V CKD who are not on dialysis. Aggregate, longitudinal,
multi-country studies estimate the weighted prevalence of CKD-aP to
be approximately 40 percent in patients on dialysis, with
approximately 25 percent of patients reporting severe pruritus. The
majority of dialysis patients (approximately 60-70 percent) report
pruritus, with 30 to 40 percent reporting moderate or severe
pruritus.1,2 Recent data from the ITCH National Registry Study
showed that among those with pruritus, approximately 59 percent
experienced symptoms daily or nearly daily for more than a year.
Given its association with CKD/ESRD, most afflicted patients will
continue to have symptoms for months or years, with currently
employed antipruritic treatments, such as antihistamines and
corticosteroids, unable to provide consistent, adequate relief.
Moderate-to-severe chronic pruritus has repeatedly been shown to
directly decrease quality of life, contribute to symptoms that
impair quality of life (such as poor sleep quality), and is
associated with depression.3 CKD-aP is also an independent
predictor of mortality among haemodialysis patients, mainly related
to increased risk of inflammation and infections.
References:1. Pisoni RL, et al. Pruritus in haemodialysis
patients: international results from the Dialysis Outcomes and
Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006;
21:3495-3505.2. Ramakrishnan K, et al. Clinical characteristics and
outcomes of end-stage renal disease patients with
selfreported pruritus symptoms. International Journal of
Nephrology and Renovascular Disease. 2014; 7: 1-12.3. Mathur VS, et
al.
Forward-looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Examples of these forward-looking statements include
statements concerning plans, strategies and expectations for the
future, including statements concerning the potential
commercialization of IV KORSUVA by Vifor Pharma, the potential
benefits of Vifor Pharma’s marketing IV KORSUVA in the United
States through arrangement announced today, the potential of IV
KORSUVA to address a significant unmet need, the potential equity
investment, milestone and profit-sharing payments payable to Cara
Therapeutics pursuant to the agreement and the expected timelines
for planned regulatory submissions. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Some of these risks and uncertainties include, but are
not limited to, those related to the initiation and conduct of
clinical trials, the receipt of data sufficient to support
regulatory submissions and required regulatory approvals of
KORSUVA, and uncertainties regarding the rate and degree of market
acceptance of IV KORSUVA, if approved for marketing, as well as
those risks and uncertainties described more fully in Cara’s
filings with the Securities and Exchange Commission, including the
"Risk Factors" section of Cara’s Annual Report on Form 10-K for the
year ended December 31, 2019, its Quarterly Report on Form 10-Q for
the quarter ended June 30, 2020 and its other documents
subsequently filed with or furnished to the Securities and Exchange
Commission. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Cara
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
*The FDA has conditionally accepted KORSUVA™ as the trade name
for difelikefalin injection. CR845/difelikefalin is an
investigational drug product and its safety and efficacy have not
been fully evaluated by any regulatory authority.
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