NESS ZIONA, Israel and SILVER
SPRING, Md., Oct. 22, 2018
/PRNewswire/ -- CollPlant (NASDAQ: CLGN, TASE: CLGN) and
United Therapeutics Corporation (NASDAQ:UTHR) today announced that
they have entered into a license, development and commercialization
agreement for 3D bioprinted lung transplants. The agreement
combines CollPlant's proprietary recombinant human collagen
(rhCollagen) and BioInk technology with the regenerative medicine
and organ manufacturing capabilities of United Therapeutics.
Under terms of the agreement, CollPlant granted United
Therapeutics, through its wholly owned organ manufacturing and
transplantation-focused subsidiary Lung Biotechnology PBC, an
exclusive license to its technology for the production and use of
rhCollagen-based BioInk for 3D bioprinted lung transplants
throughout the universe. CollPlant will manufacture and supply
BioInk for a few years to meet development process demand, and will
provide technical support to United Therapeutics as it establishes
a U.S. facility for the manufacture of CollPlant's rhCollagen and
BioInk. In addition to the initial focus on lung manufacturing, the
agreement grants United Therapeutics an option, in its sole
discretion, to expand the field of its license to add up to three
additional organs.
Under financial terms of the agreement, once effective,
CollPlant will receive an upfront payment of $5 million and milestone payments of up to
$15 million based on the achievement
of certain operational and regulatory milestones related to the
development of manufactured lungs. The agreement also provides for
option exercise payments of up to $9
million, and additional developmental milestone payments of
up to $15 million if United
Therapeutics elects to develop manufactured organs other than lungs
using CollPlant's technology. CollPlant will also be entitled to
receive royalties on sales of commercialized products covered by
patents licensed from CollPlant, as well as reimbursement for
certain costs. Effectiveness of the agreement is subject to
certain closing conditions, including receipt of approval of the
agreement by the Israel Innovation Authority (formerly, the Office
of Chief Scientist).
Commenting on today's news, Yehiel
Tal, Chief Executive Officer of CollPlant, stated, "We
strongly believe that our proprietary and proven rhCollagen is the
finest building block for regenerative medicine scaffolds available
today, and will play a critical role in the organ manufacturing
process. As a pioneer in the field, United Therapeutics is the
perfect partner for us. This strategic agreement is a major
achievement for CollPlant as it aligns us with a global leader,
validates our technology and creates value for our shareholders. We
are honored to have established this important collaboration with
United Therapeutics and look forward to working together to bring
lifesaving organs to humanity."
"We are excited to work with CollPlant's extraordinary Israeli
technology to transform the tobacco plant that is so associated
with lung disease into a collagen-expressing plant that will be
essential to the production of an unlimited number of
transplantable lungs," said Martine Rothblatt, Ph.D., Chairman
and Chief Executive Officer of United Therapeutics."
About United Therapeutics Corporation
United
Therapeutics Corporation focuses on the strength of a balanced,
value-creating biotechnology model. We are confident in our future
thanks to our fundamental attributes, namely our obsession with
quality and innovation, the power of our brands, our
entrepreneurial culture and our bioinformatics leadership. We also
believe that our determination to be responsible citizens – having
a positive impact on patients, the environment and society – will
sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we
are focused on 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 CollPlant
CollPlant is a regenerative medicine
company focused on 3D bioprinting of tissues and organs, developing
and commercializing tissue repair products for orthobiologics, and
advanced wound care markets. The Company's products are based on
its rhCollagen (recombinant human collagen) that is produced with
its proprietary plant-based genetic engineering technology.
CollPlant's products address indications for diverse fields of
organ and tissue repair and are ushering in a new era in
regenerative medicine. The Company's flagship BioInk product line
provides an ideal building block for 3D bioprinting of tissues and
organs, and its unique Vergenix line of rhCollagen products
includes a soft tissue repair matrix for treating tendinopathy and
a wound repair matrix to promote a rapid optimal healing of acute
and chronic wounds.
For more information, visit http://www.collplant.com.
Safe Harbor for Forward-Looking Statements
This
press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to CollPlant's and United Therapeutics'
objectives, plans and strategies, as well as statements, other than
historical facts, that address activities, events or developments
that CollPlant and United Therapeutics each intends, expects,
projects, believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Many factors could cause CollPlant's and United
Therapeutics' actual activities or results to differ materially
from the activities and results anticipated in forward-looking
statements, including, but not limited to, the following: the
CollPlant's history of significant losses and its need to raise
additional capital and its inability to obtain additional capital
on acceptable terms, or at all; CollPlant's and United
Therapeutics' expectations regarding the timing and cost of
commencing clinical trials with respect to tissues and organs which
are based on its rhCollagen-based BioInk; the CollPlant's and
United Therapeutics' ability to obtain favorable pre-clinical and
clinical trial results; regulatory action with respect to
rhCollagen-based BioInk, including but not limited to acceptance of
an application for marketing authorization, review and approval of
such application, and, if approved, the scope of the approved
indication and labeling; commercial success and market acceptance
of the CollPlant's rhCollagen-based BioInk and United Therapeutics'
manufactured organs; CollPlant's ability to establish sales and
marketing capabilities or enter into agreements with third parties
and its reliance on third-party distributors and resellers; the
CollPlant's and United Therapeutics' ability to establish and
maintain strategic partnerships and other corporate collaborations;
CollPlant's and United Therapeutics' reliance on third parties to
conduct some aspects of its product manufacturing; the scope of
protection CollPlant and United Therapeutics are able to establish
and maintain for intellectual property rights and the companies'
ability to operate their business without infringing the
intellectual property rights of others; the overall global economic
environment; the impact of competition and new technologies;
general market, political, and economic conditions in the countries
in which the companies operate; projected capital expenditures and
liquidity; changes in the companies' strategy; and litigation and
regulatory proceedings. More detailed information about the risks
and uncertainties affecting CollPlant and United Therapeutics is
contained under the heading "Risk Factors" included in CollPlant's
and United Therapeutics' most recent annual report on Form 20-F and
Form 10-K, respectively, filed with the SEC, and in other filings
that CollPlant and United Therapeutics have made and may make with
the SEC in the future. The forward-looking statements contained in
this press release are made as of the date of this press release
and reflect CollPlant's and United Therapeutics' current views with
respect to future events, and neither company undertakes, and each
company specifically disclaims, any obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
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SOURCE United Therapeutics Corporation; CollPlant