PITTSBURGH and ST. PAUL, Minn., March
8, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ:
VTRS) and Kindeva Drug Delivery L.P. today announced that the
U.S. Food and Drug Administration (FDA) granted tentative approval
of budesonide/formoterol fumarate dihydrate products, the first
generic version of Symbicort®
based on an Abbreviated New Drug Application
(ANDA). Symbicort is indicated for certain patients with
asthma or chronic obstructive pulmonary disease (COPD).
Viatris CEO Michael
Goettler commented: "The FDA's tentative approval of
generic Symbicort represents yet another significant milestone for
Viatris in advancing access to treatment for respiratory patients.
It also further demonstrates our deep commitment to continuing to
leverage our scientific and regulatory expertise for a wide range
of noncommunicable and infectious
diseases. Our success with this partnership and approval
underscores how Viatris intends to execute and optimize our Global
Healthcare Gateway® as a Partner of Choice™
for companies such as Kindeva to expand access to medicines for
patients worldwide."
Viatris President Rajiv
Malik added: "I am very proud of this important
regulatory milestone as it once again demonstrates our strong
scientific and regulatory teams' continued success. This only
further enhances our confidence that through the Global Healthcare
Gateway® and partnerships, like this one with Kindeva,
we will continue to build and commercially launch robust branded
and complex generic portfolios."
The FDA provided tentative approval at this time due to ongoing
patent litigation. On March 2, 2021,
the U.S. District Court for the Northern District of West Virginia found that the asserted claims
of AstraZeneca's Symbicort patents, U.S. Patent Nos. 7,759,328,
8,143,239, and 8,575,137, are not invalid for obviousness. Viatris
and Kindeva disagree with the district court decision. While the
trial court decision prevents commercial launch at this time, the
companies intend to file an appeal to continue vigorously defending
their position that the patents are invalid. Viatris and Kindeva
are committed to bringing a generic Symbicort to market as soon as
possible.
"This FDA tentative approval reflects the strength of the
partnership between Viatris and Kindeva, and further demonstrates
Kindeva's industry-leading capabilities in formulation,
development, and manufacturing of complex combination products,"
said Aaron Mann, CEO of Kindeva Drug
Delivery. "Once final FDA approval is achieved, Kindeva looks
forward to providing Viatris with reliable, quality supply from our
state-of-the-art commercial filling and packaging lines in our
Northridge, California
facility."
Viatris has not planned any revenue for 2021 from generic
Symbicort, and the product's potential launch revenue was not
included in the company's recently announced 2021 financial
guidance.
Symbicort had U.S. branded sales of $3.5
billion for the 12 months ending January 2021, according to IQVIA.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new
kind of healthcare company, empowering people worldwide to live
healthier at every stage of life. We provide access to medicines,
advance sustainable operations, develop innovative solutions and
leverage our collective expertise to connect more people to more
products and services through our one-of-a-kind Global Healthcare
Gateway®. Formed in November
2020 through the combination of Mylan and Pfizer's Upjohn
business, Viatris brings together scientific, manufacturing and
distribution expertise with proven regulatory, medical and
commercial capabilities to deliver high-quality medicines to
patients in more than 165 countries and territories. Viatris'
portfolio comprises more than 1,400 approved molecules across a
wide range of therapeutic areas, spanning both non-communicable and
infectious diseases, including globally recognized brands, complex
generic and branded medicines, a growing portfolio of biosimilars
and a variety of over-the-counter consumer products. With a global
workforce of approximately 45,000, Viatris is headquartered in the
U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at
viatris.com and investor.viatris.com, and connect with us on
Twitter at @ViatrisInc, LinkedIn and YouTube.
About Kindeva Drug Delivery
Headquartered in
St. Paul, Minnesota, Kindeva Drug
Delivery is a leading global contract development and manufacturing
organization (CDMO) in the pharmaceutical industry. Kindeva
provides unique technologies and quality services to its customers,
ranging from formulation and product development to commercial
manufacturing. Kindeva focuses on complex drug programs, and its
current offering spans inhalation drug delivery, transdermal drug
delivery, microstructured transdermal systems (microsystems), and
connected drug delivery. Kindeva employs over 1,000 people
worldwide. For more information, visit www.kindevadd.com.
Forward-Looking Statements: Viatris
This press release
includes statements that constitute "forward-looking statements."
These statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such forward
looking statements may include statements about the FDA's tentative
approval of budesonide/formoterol fumarate dihydrate products, the
first generic version of Symbicort® based on an ANDA; that this
further demonstrates Viatris deep commitment to continuing to
leverage our scientific and regulatory expertise for a wide range
of non-communicable and infectious diseases; the success with this
partnership and approval underscores how Viatris intends to execute
and optimize its Global Healthcare Gateway® as a Partner of
Choice™ for companies such as Kindeva to expand access
to medicines for patients worldwide; that this only further
enhances Viatris' confidence that through the Global Healthcare
Gateway® and partnerships, like this one with Kindeva, we will
continue to build and commercially launch robust branded and
complex generic portfolios; statements about ongoing patent
litigation; that while the trial court decision prevents commercial
launch at this time, the companies intend to file an appeal to
continue vigorously defending their position that the patents are
invalid; that Viatris and Kindeva are committed to bringing a
generic Symbicort to market as soon as possible; that once final
FDA approval is achieved, Kindeva looks forward to providing
Viatris with reliable, quality supply from their state-of-the-art
commercial filling and packaging lines in our Northridge, California facility; and that
Viatris has not planned any revenue for 2021 from generic
Symbicort, and the product's potential launch revenue was not
included in the company's recently announced 2021 financial
guidance. Because forward-looking statements inherently involve
risks and uncertainties, actual future results may differ
materially from those expressed or implied by such statements.
Factors that could cause or contribute to such differences include,
but are not limited to: the potential impact of public health
outbreaks, epidemics and pandemics, including the ongoing
challenges and uncertainties posed by the COVID-19 pandemic; the
integration of Mylan N.V. and Pfizer Inc.'s Upjohn business (the
"Upjohn Business"), which combined to form Viatris (the
"Combination") and the implementation of our global restructuring
initiatives being more difficult, time consuming or costly than
expected, or being unsuccessful; the ability to achieve expected
benefits, synergies and operating efficiencies in connection with
the Combination or its restructuring initiatives within the
expected timeframe or at all; actions and decisions of healthcare
and pharmaceutical regulators; changes in healthcare and
pharmaceutical laws and regulations in the U.S. and abroad; any
regulatory, legal or other impediments to Viatris' ability to bring
new products to market, including but not limited to "at-risk"
launches; Viatris' or its partners' ability to develop, manufacture
and commercialize products; the scope, timing and outcome of any
ongoing legal proceedings and the impact of any such proceedings;
any significant breach of data security or data privacy or
disruptions to our information technology systems; risks associated
with international operations, including our operations in
China; the ability to protect
intellectual property and preserve intellectual property rights;
changes in third-party relationships; the effect of any changes in
Viatris' or its partners' customer and supplier relationships and
customer purchasing patterns; the impacts of competition; changes
in the economic and financial conditions of Viatris or its
partners; uncertainties and matters beyond the control of
management; and the other risks Viatris' filings with the
Securities and Exchange Commission. Viatris routinely uses its
website as a means of disclosing material information to the public
in a broad, non-exclusionary manner for purposes of the SEC's
Regulation Fair Disclosure (Reg FD). Viatris undertakes no
obligation to update these statements for revisions or changes
after the date of this release other than as required by law.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/viatris-inc-and-kindeva-drug-delivery-announce-fda-tentative-approval-of-the-first-abbreviated-new-drug-application-generic-version-of-symbicort-budesonideformoterol-fumarate-dihydrate-inhalation-aerosol-301242107.html
SOURCE Viatris Inc.