REHOVOT, Israel and
SILVER SPRING, Maryland,
Sept. 21, 2020 /PRNewswire/
-- CollPlant Biotechnologies (NASDAQ: CLGN) and United
Therapeutics Corporation (NASDAQ: UTHR) today announced an
expansion of their collaboration with the exercise by United
Therapeutics of its option to cover a second lifesaving organ,
human kidneys. United Therapeutics paid CollPlant $3 million for the option exercise.
The collaboration agreement combines CollPlant's proprietary
recombinant human collagen (rhCollagen) and BioInk technology with
the regenerative medicine and organ manufacturing capabilities of
United Therapeutics.
The option exercise grants United Therapeutics through its
wholly owned organ manufacturing and transplantation-focused
subsidiary, Lung Biotechnology PBC, an exclusive license to
CollPlant's technology for the production and use of
rhCollagen-based BioInk for 3D bioprinting of human kidneys. This
expanded collaboration is aimed at helping reduce global organ
shortages and thereby potentially saving lives of millions of
patients on kidney waiting lists.
"Organ shortages are an unmet global health need and by
partnering with United Therapeutics for the past couple of years,
we have made significant progress with this pivotal organ
manufacturing initiative," stated Yehiel Tal, the Chief Executive Officer of
CollPlant. "United Therapeutics is pioneering the emerging organ
manufacturing field, and we are honored to be part of this effort
via this partnership. This option exercise demonstrates another
important validation of our rhCollagen platform technology,
performing as an optimal building block for regenerative medicine.
We remain committed to exploring new innovative applications in the
fields of medical aesthetics and 3D bioprinting of tissues and
organs."
"We are excited to expand our collaboration with CollPlant's
extraordinary technology to transform the tobacco plant – one that
is so associated with devastating diseases – into a
collagen-expressing plant that will be essential to the production
of an unlimited number of transplantable organs," said Martine Rothblatt, Ph.D., Chairman and Chief
Executive Officer of United Therapeutics. "Our collagen-expressing
plants are already flourishing in Texas where we enjoy three growing
seasons."
The collaboration agreement itself, which was signed in
October 2018, granted United
Therapeutics an exclusive license to CollPlant's technology for the
production and use of rhCollagen-based BioInk for 3D bioprinted
lung transplants. 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.
Under financial terms of the original collaboration
agreement, CollPlant received an upfront payment of
$5 million and will receive 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 United Therapeutics with an option to extend the
license to two remaining additional life-saving organs with option
exercise payments of up to $6
million. As a result of the option exercise for human
kidneys these options have been extended for an additional one year
through November 9, 2021. The
agreement also provides 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
royalties on sales of commercialized products covered by patents
licensed from CollPlant.
About CollPlant
CollPlant is a regenerative and aesthetic medicine company
focused on 3D bioprinting of tissues and organs, and medical
aesthetics. CollPlant's products are based on its rhCollagen
(recombinant human collagen) that is produced with CollPlant's
proprietary plant based genetic engineering technology.
CollPlant's products address indications for the diverse fields
of tissue repair, aesthetics and organ manufacturing, and are
ushering in a new era in regenerative and aesthetic medicine.
CollPlant's flagship rhCollagen BioInk product line is ideal for
3D bioprinting of tissues and organs. In October 2018, CollPlant entered into a licensing
agreement with United Therapeutics, whereby United Therapeutics is
using CollPlant's BioInks in the manufacture of 3D bioprinted lungs
for transplant in humans.
In January 2020, CollPlant entered
into a Joint Development Agreement with 3D Systems Corporation, or
3D Systems, pursuant to which CollPlant and 3D Systems jointly
develop tissue and scaffold bioprinting processes for third party
collaborators. CollPlant's industry collaboration also includes the
Advanced Regenerative Manufacturing Institute, or ARMI.
For more information, visit http://www.collplant.com.
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.
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;
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.
Contacts at CollPlant:
Eran Rotem
Deputy CEO & Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com
Sophia Ononye-Onyia, PhD MPH MBA
Founder & CEO, The Sophia Consulting Firm
Tel: +1-347-851-8641
E-mail: sophia@sophiaconsultingfirm.com
Contact at United Therapeutics:
Dewey Steadman
Head of Investor Relations
Tel: + 1 (202) 919-4097
Email: ir@unither.com
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SOURCE CollPlant; United Therapeutics Corporation