- Dr. Reddy’s gets exclusive commercialization rights in the
United States (U.S.) as well as semi-exclusive rights in Europe and
United Kingdom (UK)
- Alvotech will be responsible for development and manufacture of
the product
Alvotech (NASDAQ: ALVO), a global biotech company specializing
in the development and manufacture of biosimilar medicines for
patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories SA,
wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE:
500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with
its subsidiaries hereafter referred to as “Dr. Reddy’s”), today
announced that the companies have entered into a license and supply
agreement for the commercialization of AVT03, Alvotech’s biosimilar
candidate to Prolia® and Xgeva® (denosumab). The collaboration
combines Dr. Reddy’s global commercial presence with Alvotech’s
proven capabilities in developing biosimilars for markets
worldwide.
Prolia® and Xgeva® are indicated for the treatment of various
diseases including osteoporosis in postmenopausal women and
prevention of skeletal-related events in adults with advanced
malignancies*.
Alvotech will be responsible for development and manufacturing
of the product. Dr. Reddy’s will be responsible for registration
and commercialization of the product in the applicable markets. The
license and supply agreement includes an upfront payment to
Alvotech, with additional payments upon certain regulatory and
commercialization milestones as well as sales-based payments. Dr.
Reddy’s commercialization rights are exclusive for the U.S., and
semi-exclusive for Europe and the UK.
Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: “We
are pleased to collaborate with Alvotech to make this denosumab
biosimilar available to patients in the U.S., Europe and UK. Over
the years, we have created a portfolio of biosimilar products,
which are marketed in several emerging markets. Most recently, we
launched bevacizumab, our first biosimilar in the UK. This
strategic collaboration augments our growing portfolio of
biosimilar offerings, and progresses our biosimilar journey further
into the highly regulated markets. We look forward to leveraging
our strong commercial capabilities in these markets to ensure
patients receive access to best-in-class therapies and affordable
treatment options.”
“We are proud to announce this new strategic partnership, that
will enable us to increase the availability of cost-effective,
critical biologic medications across multiple markets worldwide,”
said Robert Wessman, Chairman and CEO of Alvotech. “Dr. Reddy’s
shares our commitment to provide better access to safe and
effective biologics. Biosimilars play an increasingly important
role in global healthcare systems, offering broader access to
best-in-class therapies. Combining our resources will ensure that
patients globally can be better served.”
About AVT03*
AVT03 is a human monoclonal antibody and biosimilar candidate to
Prolia® and Xgeva®, which are both denosumab but in different
presentations. Prolia® is indicated for the treatment of
osteoporosis in postmenopausal women and for bone loss in adult men
and women at increased risk of fracture [1]. Xgeva® is indicated
for prevention of skeletal-related events such as pathological
fractures in adults with advanced malignancies involving bone [2].
In January 2024, Alvotech announced positive top-line results from
a pharmacokinetic (PK) study which assessed the pharmacokinetics,
safety, and tolerability of AVT03 compared to Prolia® in healthy
adult subjects [3]. A confirmatory efficacy and safety study for
AVT03 in patients is currently underway, as well as a PK study
comparing AVT03 to Xgeva® in healthy adult subjects. AVT03 is an
investigational product and has not received regulatory approval in
any country. Biosimilarity has not been established by regulatory
authorities and is not claimed.
*Does not include full list of indications, please refer to the
PIs linked below for complete information.
References
- Amgen Inc. Prolia® (Denosumab): Prescribing Information.
Available from:
https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
- Amgen Inc. Xgeva® (Denosumab): Prescribing Information.
Available from:
https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf
- AVT03 with Prolia in Healthy Male Subjects: Study Overview.
Available from: https://clinicaltrials.gov/study/NCT05126784
Use of trademarks
Prolia® and Xgeva® are registered trademarks of Amgen Inc.
About Dr. Reddy’s Laboratories Ltd:
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company
headquartered in Hyderabad, India. Established in 1984, we are
committed to providing access to affordable and innovative
medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we
offer a portfolio of products and services including APIs,
generics, branded generics, biosimilars and OTC. Our major
therapeutic areas of focus are gastrointestinal, cardiovascular,
diabetology, oncology, pain management and dermatology. Our major
markets include – USA, India, Russia & CIS countries, China,
Brazil, and Europe. As a company with a history of deep science
that has led to several industry firsts, we continue to plan and
invest in businesses of the future. As an early adopter of
sustainability and ESG actions, we released our first
Sustainability Report in 2004. Our current ESG goals aim to set the
bar high in environmental stewardship; access and affordability for
patients; diversity; and governance.
Over the last 25 years, our Biologics team has developed into a
fully integrated organization with robust capabilities in the
development, manufacture and commercialization of a range of
biosimilar products in oncology and immunology. We have a current
portfolio of six commercial products marketed in India, with some
products marketed in more than 25 other countries. In addition, we
have several products in the pipeline in oncology and auto-immune
diseases in various stages of development for global launches
across regulated as well as emerging markets. We are also ramping
up manufacturing capacity to support our global expansion plans. In
2024, we launched our first biosimilar in the United Kingdom,
Versavo® (biosimilar bevacizumab). This follows our launch of
pegfilgrastim in the U.S and Europe through our partner. Our
biosimilars business has a key role to play in driving both
near-term and long-term growth.
For more information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults, currency exchange rates, interest rates, persistency
levels and frequency / severity of insured loss events, (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility
of our industry and the markets addressed by our, and our
customers’, products and services to economic downturns as a result
of natural disasters, epidemics, pandemics or other widespread
illness, including coronavirus (or COVID-19), and (vii) other risks
and uncertainties identified in our public filings with the
Securities and Exchange Commission, including those listed under
the "Risk Factors" and "Forward-Looking Statements" sections of our
Annual Report on Form 20-F for the year ended March 31, 2023. The
company assumes no obligation to update any information contained
herein. There can be no guarantee that the investigational or
approved products described in this press release will be submitted
or approved for sale or for any additional indications or labeling
in any market, or at any particular time. Neither can there be any
guarantee that, if approved, such generic or biosimilar products
will be approved for all indications included in the reference
product’s label. Nor can there be any guarantee that such products
will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among
other things, the uncertainties inherent in research and
development, including clinical trial results and additional
analysis of existing clinical data; regulatory actions or delays or
government regulation generally; the particular prescribing
preferences of physicians and patients; competition in general,
including potential approval of additional generic or biosimilar
versions of such products.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman,
focused solely on the development and manufacture of biosimilar
medicines for patients worldwide. Alvotech seeks to be a global
leader in the biosimilar space by delivering high quality,
cost-effective products, and services, enabled by a fully
integrated approach and broad in-house capabilities. Alvotech’s
current pipeline contains eight biosimilar candidates aimed at
treating autoimmune disorders, eye disorders, osteoporosis,
respiratory disease, and cancer. Alvotech has formed a network of
strategic commercial partnerships to provide global reach and
leverage local expertise in markets that include the United States,
Europe, Japan, China, and other Asian countries and large parts of
South America, Africa, and the Middle East. Alvotech’s commercial
partners include Teva Pharmaceuticals, a US affiliate of Teva
Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU),
Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland,
Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro
(Australia, New Zealand, South Africa/Africa), JAMP Pharma
Corporation (Canada), Yangtze River Pharmaceutical (Group) Co.,
Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia,
Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding
LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada
Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin
America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam,
Philippines, and South Korea). Each commercial partnership covers a
unique set of product(s) and territories. Except as specifically
set forth therein, Alvotech disclaims responsibility for the
content of periodic filings, disclosures and other reports made
available by its partners. For more information, please visit
www.alvotech.com. None of the information on the Alvotech website
shall be deemed part of this press release.
For more information visit Alvotech’s investor portal, and
website or follow Alvotech on social media on LinkedIn, Facebook,
Instagram, X and YouTube.
Forward Looking Statements
Certain statements in this communication may be considered
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements generally relate to future events or the
future financial operating performance of Alvotech and may include,
for example, Alvotech’s expectations regarding competitive
advantages, business prospects and opportunities including pipeline
product development, future plans and intentions, results, level of
activities, performance, goals or achievements or other future
events, regulatory submissions, review and interactions, the
potential approval and commercial launch of its product candidates,
the timing of regulatory approval, and market launches. In some
cases, you can identify forward-looking statements by terminology
such as “may”, “should”, “expect”, “intend”, “will”, “estimate”,
“anticipate”, “believe”, “predict”, “potential”, “aim” or
“continue”, or the negatives of these terms or variations of them
or similar terminology. Such forward-looking statements are subject
to risks, uncertainties, and other factors which could cause actual
results to differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon estimates and assumptions that, while considered
reasonable by Alvotech and its management, are inherently uncertain
and are inherently subject to risks, variability, and
contingencies, many of which are beyond Alvotech’s control. Factors
that may cause actual results to differ materially from current
expectations include, but are not limited to: (1) the ability to
raise substantial additional funding, which may not be available on
acceptable terms or at all; (2) the ability to maintain stock
exchange listing standards; (3) changes in applicable laws or
regulations; (4) the possibility that Alvotech may be adversely
affected by other economic, business, and/or competitive factors;
(5) Alvotech’s estimates of expenses and profitability; (6)
Alvotech’s ability to develop, manufacture and commercialize the
products and product candidates in its pipeline; (7) actions of
regulatory authorities, which may affect the initiation, timing and
progress of clinical studies or future regulatory approvals or
marketing authorizations; (8) the ability of Alvotech or its
partners to respond to inspection findings and resolve deficiencies
to the satisfaction of the regulators; (9) the ability of Alvotech
or its partners to enroll and retain patients in clinical studies;
(10) the ability of Alvotech or its partners to gain approval from
regulators for planned clinical studies, study plans or sites; (11)
the ability of Alvotech’s partners to conduct, supervise and
monitor existing and potential future clinical studies, which may
impact development timelines and plans; (12) Alvotech’s ability to
obtain and maintain regulatory approval or authorizations of its
products, including the timing or likelihood of expansion into
additional markets or geographies; (13) the success of Alvotech’s
current and future collaborations, joint ventures, partnerships or
licensing arrangements; (14) Alvotech’s ability, and that of its
commercial partners, to execute their commercialization strategy
for approved products; (15) Alvotech’s ability to manufacture
sufficient commercial supply of its approved products; (16) the
outcome of ongoing and future litigation regarding Alvotech’s
products and product candidates; (17) the impact of worsening
macroeconomic conditions, including rising inflation and interest
rates and general market conditions, conflicts in Ukraine, the
Middle East and other global geopolitical tension, on the Company’s
business, financial position, strategy and anticipated milestones;
and (18) other risks and uncertainties set forth in the sections
entitled “Risk Factors” and “Cautionary Note Regarding
Forward-Looking Statements” in documents that Alvotech may from
time to time file or furnish with the SEC. There may be additional
risks that Alvotech does not presently know or that Alvotech
currently believes are immaterial that could also cause actual
results to differ from those contained in the forward-looking
statements. Nothing in this communication should be regarded as a
representation by any person that the forward-looking statements
set forth herein will be achieved or that any of the contemplated
results of such forward-looking statements will be achieved. You
should not place undue reliance on forward-looking statements,
which speak only as of the date they are made. Alvotech does not
undertake any duty to update these forward-looking statements or to
inform the recipient of any matters of which any of them becomes
aware of which may affect any matter referred to in this
communication. Alvotech disclaims any and all liability for any
loss or damage (whether foreseeable or not) suffered or incurred by
any person or entity as a result of anything contained or omitted
from this communication and such liability is expressly disclaimed.
The recipient agrees that it shall not seek to sue or otherwise
hold Alvotech or any of its directors, officers, employees,
affiliates, agents, advisors, or representatives liable in any
respect for the provision of this communication, the information
contained in this communication, or the omission of any information
from this communication.
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version on businesswire.com: https://www.businesswire.com/news/home/20240521174553/en/
DR. REDDY’S CONTACTS Usha Iyer Head of Corporate
Communications ushaiyer@drreddys.com
Richa Periwal Head of Investor Relations
richaperiwal@drreddys.com
ALVOTECH CONTACT Benedikt Stefansson Senior Director of
Investor Relations and Global Communications
alvotech.ir@alvotech.com
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