Cara Therapeutics Enters into Commercial License Agreement with Enteris BioPharma, Inc. for Peptelligence® Oral Formulation ...
August 21 2019 - 7:00AM
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
with a primary focus on the treatment of pruritus by selectively
targeting peripheral kappa opioid receptors, today announced that
it has entered into a non-exclusive commercial license agreement
with Enteris BioPharma, Inc. for oral formulation rights to
Enteris’ Peptelligence® Technology.
“We are pleased to take another important step
in advancing Oral KORSUVA™ as a potential novel treatment for
chronic pruritus by entering into this commercial formulation
license,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “With three ongoing Phase 2
trials across a range of patient populations for whom pruritus
remains a significant unmet need, we are now well positioned to
continue Oral KORSUVA’s development and potential future
commercialization.”
Summary of the License
Agreement
Under the terms of the License Agreement,
Enteris granted Cara a non-exclusive license to its Peptelligence
Technology to develop and commercialize Oral KORSUVA in any
indication worldwide, excluding South Korea and Japan. Enteris will
receive an upfront payment of $8 million, including $4 million in
cash and $4 million in Cara common stock. Enteris is also eligible
to receive development, regulatory and tiered commercial milestone
payments, as well as low, single-digit royalties based on net sales
in the licensed territory. Cara retains the right to buy out the
royalty obligation for a period of two years under prespecified
conditions.
About Cara TherapeuticsCara
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 (CR845/difelikefalin),
a first-in-class KOR agonist that targets KORs located in the
peripheral nervous system, and on immune cells. In a Phase 3 and
two Phase 2 trials, KORSUVA (CR845/difelikefalin) Injection has
demonstrated statistically significant reductions in itch intensity
and concomitant improvement in pruritus-related quality of life
measures in hemodialysis patients with moderate-to-severe chronic
kidney disease-associated pruritus (CKD-aP), and is currently being
investigated in Phase 3 trials in hemodialysis patients with
CKD-aP. Oral KORSUVA is in Phase 2 trials for the treatment of
pruritus in patients with chronic kidney disease, atopic
dermatitis, and primary biliary cholangitis.
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.
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 the
potential for Oral KORSUVA to be a therapeutic option for pruritus
and the advantages of entering into the license agreement with
Enteris. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Risks are
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, 2018 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. Except to the extent required by law, 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.
MEDIA CONTACT: Annie Starr 6 Degrees
973-415-8838 astarr@6degreespr.com
INVESTOR CONTACT: Jane Urheim Stern Investor
Relations, Inc. 212-362-1200 Jane.Urheim@SternIR.com
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