Teva and Bioeq Announce Commercial Partnership for Biosimilar
28 June 2021 - 10:00PM
Business Wire
Agreement includes commercializing biosimilar
candidate of ophthalmology drug ranibizumab (Lucentis®) in Europe,
Canada, Israel and global markets
Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) and
Bioeq AG ("Bioeq") today announced that they have entered into a
strategic partnership for the exclusive commercialization of
Bioeq's FYB201, a biosimilar candidate to Lucentis® (ranibizumab)
in Europe, Canada, Israel and New Zealand.
This strategic partnership combines Teva’s long-standing
commercial presence, extensive distribution network and
wide-reaching sales and marketing activities across Europe and
international markets with Bioeq’s capabilities in the development
of biosimilar drugs for highly regulated countries with stringent
quality standards. Bioeq has in-licensed the exclusive global
commercialization rights to FYB201 from the German biosimilar
developer Formycon AG.
“Unlocking the value of biologics with biosimilars is an
important new frontier in drug development that offers patients
safe and effective treatment options through more affordable
alternatives to branded biological products that have lost their
exclusivity rights,” says Sven Dethlefs, PhD, Executive Vice
President, Global Marketing & Portfolio and International
Markets Commercial. “This collaboration expands Teva’s biosimilar
portfolio and again demonstrates the company’s firm commitment to
creating greater access to quality medications to help improve the
lives of more patients."
Commenting on the agreement, Nicola Mikulcik, Board Member at
Bioeq, says, “We are proud of having secured Teva as our partner of
choice for these markets. This agreement is an important milestone
in bringing a highly effective treatment option for retinopathies,
including age-related macular degeneration, to patients.”
According to the terms of the agreement, Bioeq will be
responsible for the development, registration and supply of the
biosimilar, while Teva will be responsible for commercializing the
product. Teva and Bioeq will share revenue from the
commercialization of the biosimilar. All other financial terms and
product details remain confidential.
Biosimilars are intended for use in place of existing,
branded biologics to treat a range of chronic and often
life-threatening diseases, with the potential to reduce costs and
expand patient access. Biosimilars exhibit proven analytical and
clinical similarity to their respective branded reference
products.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
About Bioeq
Bioeq is a Swiss biopharmaceutical joint venture between
the Polpharma Biologics Group and the Strüngmann Group. Bioeq
develops, licenses and commercializes biosimilars. www.bioeq.ch
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding our biosimilar portfolio, which are based on management’s
current beliefs and expectations and are subject to substantial
risks and uncertainties, both known and unknown, that could cause
our future results, performance or achievements to differ
significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- the commercial success of our biosimilar portfolio;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; our ability to successfully execute and
maintain the activities and efforts related to the measures we have
taken or may take in response to the COVID-19 pandemic and
associated costs therewith; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; costs and delays resulting from the extensive
pharmaceutical regulation to which we are subject or delays in
governmental processing time due to travel and work restrictions
caused by the COVID-19 pandemic; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; significant sales to a limited number
of customers; our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United States); and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, including in the sections captioned "Risk Factors” and
“Forward Looking Statements.” Forward-looking statements speak only
as of the date on which they are made, and we assume no obligation
to update or revise any forward-looking statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262
PR Contacts United States Grace Ann Arnold (201)
739-2064
Israel Yonatan Beker 972 (54) 888 5898
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