DUBLIN and NEW YORK, Dec. 23,
2019 /PRNewswire/ -- Theravance Biopharma Ireland
Limited, a subsidiary of Theravance Biopharma, Inc. (NASDAQ: TBPH)
("Theravance Biopharma") and Pfizer Inc. (NYSE: PFE) ("Pfizer")
today announced that the companies have entered into a global
license agreement for Theravance Biopharma's preclinical program
for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors
that can be rapidly metabolized. The compounds in this program
target validated pro-inflammatory pathways and are specifically
designed to possess skin-selective activity with minimal systemic
exposure.
Under the terms of the agreement, Theravance Biopharma will
receive an upfront cash payment of $10
million and will be eligible to receive up to an additional
$240 million in development and sales
milestone payments from Pfizer. In addition, Theravance Biopharma
will be eligible to receive royalties on worldwide net sales of any
potential products emerging from the program.
"We believe that this global agreement with Pfizer provides
further validation of our unique expertise in the discovery and
development of innovative, organ-selective JAK inhibitors. As a
clear global leader in the field of JAK inhibition, Pfizer is
ideally positioned to advance this program and unlock its
therapeutic potential," said Rick E Winningham, chief executive
officer of Theravance Biopharma.
"Theravance Biopharma's skin-targeted JAK inhibitor program will
nicely complement Pfizer's portfolio of preclinical and
clinical-stage molecules, which have unique selectivity profiles
and are matched to conditions in which we believe they have the
greatest potential to address unmet need," said Michael Vincent, chief scientific officer,
Inflammation & Immunology, Pfizer. "Topical JAK inhibitors that
can be rapidly metabolized have potential to reach more patients
with mild-to-moderate skin conditions, for whom treatment is
currently limited."
About Organ-Selective Pan-Janus (JAK) Kinase
Inhibition
JAK inhibitors function by inhibiting the activity of one or
more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2)
that play a key role in cytokine signaling. Inhibiting these JAK
enzymes interferes with the JAK/STAT signaling pathway and, in
turn, modulates the activity of a wide range of pro-inflammatory
cytokines. JAK inhibitors are currently approved for the treatment
of a range of inflammatory diseases including rheumatoid arthritis,
psoriatic arthritis, myelofibrosis, and ulcerative colitis.
About Theravance Biopharma
Theravance Biopharma, Inc. ("Theravance Biopharma") is a
diversified biopharmaceutical company primarily focused on the
discovery, development and commercialization of organ-selective
medicines. Our purpose is to create transformational medicines to
improve the lives of patients suffering from serious illnesses. Our
research is focused in the areas of inflammation and
immunology.
In pursuit of our purpose, we apply insights and innovation at
each stage of our business and utilize our internal capabilities
and those of partners around the world. We apply organ-selective
expertise to biologically compelling targets to discover and
develop medicines designed to treat underserved localized diseases
and to limit systemic exposure, in order to maximize patient
benefit and minimize risk. These efforts leverage years of
experience in developing lung-selective medicines to treat
respiratory disease, including FDA-approved YUPELRI®
(revefenacin) inhalation solution indicated for the maintenance
treatment of patients with chronic obstructive pulmonary disease
(COPD). Our pipeline of internally discovered programs is targeted
to address significant patient needs.
We have an economic interest in potential future payments from
Glaxo Group Limited or one of its affiliates (GSK) pursuant to its
agreements with Innoviva, Inc. relating to certain programs,
including TRELEGY ELLIPTA.
For more information, please visit www.theravance.com.
THERAVANCE® and the Cross/Star logo are registered
trademarks of the Theravance Biopharma group of companies.
YUPELRI® is a United
States registered trademark of Mylan Specialty L.P.
Trademarks, trade names or service marks of other companies
appearing on this press release are the property of their
respective owners.
This press release contains "forward-looking" statements as
that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives, expectations and future events.
Theravance Biopharma intends such forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Securities Exchange Act
of 1934 and the Private Securities Litigation Reform Act of 1995.
Examples of such statements include statements relating to: the
Company's strategies, plans and objectives, the Company's
regulatory strategies and timing of clinical studies (including the
data therefrom), the potential characteristics, benefits and
mechanisms of action of the Company's product and product
candidates, the potential that the Company's research programs will
progress product candidates into the clinic, the Company's
expectations for product candidates through development, potential
regulatory approval and commercialization (including their
differentiation from other products or potential products), product
sales or profit share revenue and the Company's expectations for
its 2019 operating loss, excluding share-based compensation. These
statements are based on the current estimates and assumptions of
the management of Theravance Biopharma as of the date of the press
release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Theravance Biopharma to be materially different
from those reflected in the forward-looking statements. Important
factors that could cause actual results to differ materially from
those indicated by such forward-looking statements include, among
others, risks related to: potential future disagreements with
Innoviva, Inc. and TRC LLC, the uncertainty of arbitration and
litigation and the possibility that an arbitration award or
litigation result could be adverse to the Company, delays or
difficulties in commencing, enrolling or completing clinical
studies, the potential that results from clinical or non-clinical
studies indicate the Company's compounds or product candidates
are unsafe or ineffective, risks that product candidates do
not obtain approval from regulatory authorities, the feasibility of
undertaking future clinical trials for our product candidates based
on policies and feedback from regulatory authorities, dependence on
third parties to conduct clinical studies, delays or failure to
achieve and maintain regulatory approvals for product candidates,
risks of collaborating with or relying on third parties to
discover, develop, manufacture and commercialize products, and
risks associated with establishing and maintaining sales, marketing
and distribution capabilities with appropriate technical expertise
and supporting infrastructure. Other risks affecting Theravance
Biopharma are described under the heading "Risk Factors" contained
in Theravance Biopharma's Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 8,
2019 and Theravance Biopharma's other filings with the
SEC. In addition to the risks described above and in
Theravance Biopharma's filings with the SEC, other unknown or
unpredictable factors also could affect Theravance Biopharma's
results. No forward-looking statements can be guaranteed and actual
results may differ materially from such statements. Given
these uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance Biopharma assumes no
obligation to update its forward-looking statements on
account of new information, future events or otherwise, except as
required by law.
Pfizer Inc.: Breakthroughs that Change Patients'
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
PFIZER DISCLOSURE NOTICE: The information
contained in this release is as of December 23, 2019. Pfizer
assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about a
global license agreement between Pfizer and Theravance Biopharma,
and Theravance Biopharma's program for skin-targeted,
locally-acting pan-Janus kinase (JAK) inhibitors that can be
rapidly metabolized, including its potential benefits, that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for our clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications may be filed in any jurisdictions for any of the
product candidates with Theravance Biopharma's JAK inhibitors;
whether and when any such applications may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product's
benefits outweigh its known risks and determination of the
product's efficacy and, if approved, whether any of the product
candidates with Theravance Biopharma's JAK inhibitors will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of any of the product candidates with Theravance Biopharma's JAK
inhibitors; and competitive developments.
A further description of risks and uncertainties can be found
in Pfizer's Annual Report on Form 10-K for the fiscal year
ended December 31, 2018 and in its subsequent reports on
Form 10-Q, including in the sections thereof captioned "Risk
Factors" and "Forward-Looking Information and Factors That May
Affect Future Results", as well as in its subsequent reports on
Form 8-K, all of which are filed with the U.S. Securities and
Exchange Commission and available
at www.sec.gov and www.pfizer.com.
Contact Information:
Theravance Biopharma
Jessica Stitt
650-808-4045
investor.relations@theravance.com
Vida Strategic Partners (Theravance Biopharma media)
Tim Brons
646-319-8981
tbrons@vidasp.com
Pfizer Media Relations:
Patricia Kelly
212-733-3810
patricia.kelly@pfizer.com
Pfizer Investor Relations:
Chuck Triano
212-733-3901
charles.e.triano@pfizer.com
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SOURCE Theravance Biopharma, Inc.