SAN DIEGO and SILVER SPRING, Md., Sept. 17, 2018 /PRNewswire/ -- Samumed LLC has
entered an exclusive license agreement with United Therapeutics
Corporation (Nasdaq: UTHR) for North American rights to Samumed's
SM04646, being developed for the treatment of idiopathic pulmonary
fibrosis (IPF). Deal terms include $10
million up-front, plus up to $340
million in developmental milestones and up to low
double-digit royalties.
"We are excited to partner with United Therapeutics because of
its culture of integrity, level of commitment, and expertise in
pulmonology and drug-device combinations. We look forward to
delivering what could be a first-in-class, disease-modifying
treatment option for IPF patients," commented Osman Kibar, Ph.D., Chief Executive Officer of
Samumed.
SM04646, a Wnt pathway inhibitor, is currently undergoing a
phase 1 clinical trial. Under the terms of the agreement, United
Therapeutics' subsidiary, Lung Biotechnology PBC, will conduct and
fund all further development, regulatory and commercialization
activities in the U.S. and Canada. Samumed retains development
and commercialization rights for all markets outside of North
America.
"I've been impressed with Samumed's exhaustive work on the
pleiotropic Wnt pathway from the time I met Dr. Kibar at this
year's Cura Foundation conference on regenerative medicine, held at
the Vatican," said Martine
Rothblatt, Ph.D., Chairman and Chief Executive Officer of
Lung Biotechnology PBC. "Our months of due diligence have energized
our belief in SM04646's fibrosis-modulating properties, and hence
unique potential for addressing IPF."
About SM04646
SM04646 is a small-molecule Wnt
signaling pathway inhibitor currently being developed for the
treatment of IPF. Preclinical data on SM04646 has demonstrated
anti-fibrotic properties in numerous in vitro and in
vivo studies, including a bleomycin-induced model of pulmonary
fibrosis where aerosolized SM04646 significantly reduced fibrosis
in the lungs compared with vehicle. A phase 1 study of SM04646
assessing the safety of the molecule is currently ongoing. FDA has
granted orphan drug designation for SM04646 for the treatment of
IPF. Additional information on Samumed's SM04646 IPF program can be
found here: https://www.samumed.com/pipeline/detail.aspx?id=19
About Lung Biotechnology PBC
Lung Biotechnology PBC is
a public benefit corporation addressing the acute national shortage
of transplantable lungs and other organs with a variety of
technologies that either delay the need for such organs or expand
the supply. Lung Biotechnology is the first public benefit
corporation subsidiary of a public biotechnology or pharmaceutical
company. [uthr-g]
About United Therapeutics
United Therapeutics is a
biotechnology company focused on the development and
commercialization of innovative products to address the unmet
medical needs of patients with chronic and life-threatening
conditions.
About Samumed
Samumed's small-molecule drug platform
is harnessing the innate restorative power of the Wnt pathway to
reverse the course of severe and prevalent diseases. Samumed's
clinical pipeline can be found here:
https://www.samumed.com/pipeline/default.aspx
Forward-looking Statements
Statements included in this
press release that are not historical in nature are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include, among others, statements regarding the
development of SM08686 for treatment of IPF. These forward-looking
statements are subject to certain risks and uncertainties, such as
those described in United Therapeutics' periodic and other reports
filed with the Securities and Exchange Commission that
could cause actual results to differ materially from anticipated
results. In addition, the forward-looking statements in this press
release are qualified by the cautionary statements, cautionary
language and risk factors set forth in United Therapeutics'
periodic reports and documents filed with the Securities and
Exchange Commission, including its most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K. We claim the protection of the safe harbor contained in
the Private Securities Litigation Reform Act of 1995 for
forward-looking statements. United Therapeutics and Samumed are
providing this information as of September 17, 2018, and
assume no obligation to update or revise the information contained
in this press release whether as a result of new information,
future events or any other reason.
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SOURCE United Therapeutics Corporation; Samumed, LLC