Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate
of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that the U.S. Food and Drug Administration (FDA) has
approved SELARSDI (ustekinumab-aekn) injection for subcutaneous
use, as a biosimilar to Stelara
®, for the treatment of
moderate to severe plaque psoriasis and for active psoriatic
arthritis in adults and pediatric patients 6 years and older. Under
the strategic partnership between Teva and Alvotech, Teva is
responsible for the exclusive commercialization of SELARSDI in the
United States.
“The approval of SELARSDI – which is our second biosimilar
approval this year – underscores Teva’s commitment to expanding the
availability, access and uptake of this important treatment option
to patients in the U.S.,” said Thomas Rainey, Senior Vice
President, U.S. Market Access at Teva. “The biosimilars market is
growing, both globally and in the U.S., and biosimilars are a key
component of delivering on Teva’s Pivot to Growth strategy. The
partnership model that we’ve established enables us to leverage our
commercial presence and experiences globally as we move to bring
additional biosimilars to market.”
Robert Wessman, Chairman and CEO of Alvotech, added, “We are
delighted to announce our second biosimilar approval in the U.S.,
which is the thirty-eighth approved market for our biosimilar to
Stelara globally. Bringing SELARSDI to market in the U.S. early
next year presents a significant opportunity to improve patient
access to a vital biologic in inflammatory disease and contribute
to the reduction of inflationary pressure in healthcare costs. The
development of SELARSDI leveraged our purpose-built end-to-end
development and manufacturing platform for biosimilars. Being able
to develop the biosimilar in the same cell type and continuous
perfusion process as was used for the reference product,
facilitated the development program’s success.”
Ustekinumab is a human monoclonal antibody (mAb) that
selectively targets the p40 protein, a component common to both
interleukin (IL)-12 and IL-23 cytokines, which play crucial roles
in treating immune-mediated diseases like psoriasis and psoriatic
arthritis. Alvotech developed and produces SELARSDI using Sp2/0
cells and a continuous perfusion process, which are the same type
of host cell line and process used in the production of
Stelara.
Sales of the reference product Stelara in the U.S. were nearly
$7 billion in 2023.1 The availability of a Stelara
biosimilar will create opportunities for cost savings across the
healthcare system and introduce additional treatment options for
patients. In the U.S., plaque psoriasis is the most common form of
psoriasis while psoriatic arthritis accounts for approximately six
percent of all cases of juvenile arthritis.2,3
In June 2023, Alvotech and Teva announced that they had reached
a settlement and license agreement with the manufacturer of the
reference biologic, Johnson & Johnson, granting a license entry
date for SELARSDI in the United States no later than February 21,
2025.
In August 2020, Alvotech and Teva entered into a strategic
partnership for the exclusive commercialization of five of
Alvotech’s biosimilar product candidates, and in August 2023, the
collaboration was extended to include two additional biosimilars
and new presentations of two previously partnered products.
Alvotech handles development and manufacturing, while Teva is
responsible for the exclusive commercialization in the U.S., which
leverages Teva’s experience and extensive sales and marketing
infrastructure. SELARSDI is the second biosimilar approved under
the strategic partnership: in February 2024, the FDA approved
SIMLANDI®, the first high-concentration, citrate-free
biosimilar to Humira that has been granted an interchangeability
status by the FDA.
The FDA approval of SELARSDI, referred to as AVT04 during
development, was based on a totality of evidence, including
analytical and clinical data. The clinical development program
included data from: 1) Study AVT04-GL-301, a randomized, double
blind, multicenter, 52-week study to demonstrate equivalent
efficacy and to compare safety and immunogenicity between SELARSDI
and the reference product Stelara in patients with moderate to
severe chronic plaque-type psoriasis. The study was conducted in
four countries in Europe and enrolled 581 patients. The primary
efficacy endpoint was Psoriasis Area and Severity Index (PASI)
percent improvement from Baseline to Week 12; 2) Study
AVT04-GL-101, a Phase I, randomized, double-blind, single-dose,
parallel-group, 3-arm study to compare the pharmacokinetic, safety,
tolerability, and immunogenicity profiles of SELARSDI, administered
as a single 45mg/0.5mL subcutaneous injection with that of the
US-licensed Stelara as well as EU-approved Stelara. The study was
conducted in Australia and New Zealand and enrolled 294 healthy
adult volunteers.
Use of Trademarks
Stelara® is a registered trademark of Johnson &
Johnson.
Humira® is a registered trademark of AbbVie
Biotechnology Ltd.
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 includes
eight disclosed 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global pharmaceutical leader with a category-defying portfolio,
harnessing our generics expertise and stepping up innovation to
continue the momentum behind the discovery, delivery, and expanded
development of modern medicine. For over 120 years, Teva's
commitment to bettering health has never wavered. Today, the
company’s global network of capabilities enables its 37,000
employees across 58 markets to push the boundaries of scientific
innovation and deliver quality medicines to help improve health
outcomes of millions of patients every day. To learn more about how
Teva is all in for better health, visit www.tevapharm.com.
INDICATIONS FOR SELARSDI (ustekinumab-aekn)
SELARSDI™ (ustekinumab-aekn) Injection, is a human interleukin-12
and -23 antagonist indicated for:
- the treatment of adults and pediatric patients 6 years of age
and older with moderate to severe plaque psoriasis who are
candidates for phototherapy or systemic therapy.
- the treatment of adults and pediatric patients 6 years of age
and older with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
SELARSDI™ (ustekinumab-aekn) injection is contraindicated in
patients with clinically significant hypersensitivity to
ustekinumab products or to any of the excipients in SELARSDI.
Infections
Ustekinumab products may increase the risk of infections and
reactivation of latent infections. Serious bacterial,
mycobacterial, fungal, and viral infections were observed in
patients receiving ustekinumab products. Serious infections
requiring hospitalization or otherwise clinically significant
infections were reported. In patients with psoriasis, these
included diverticulitis, cellulitis, pneumonia, appendicitis,
cholecystitis, sepsis, osteomyelitis, viral infections,
gastroenteritis, and urinary tract infections. In patients with
psoriatic arthritis, this included cholecystitis.
Treatment with SELARSDI should not be initiated in patients with
a clinically important active infection until the infection
resolves or is adequately treated. Consider the risks and benefits
of treatment prior to initiating use of SELARSDI in patients with a
chronic infection or a history of recurrent infection. Instruct
patients to seek medical advice if signs or symptoms suggestive of
an infection occur while on treatment with SELARSDI and discontinue
SELARSDI for serious or clinically significant infections until the
infection resolves or is adequately treated.
Theoretical Risk for Vulnerability to Particular
Infections
Individuals genetically deficient in IL-12/IL-23 are
particularly vulnerable to disseminated infections from
mycobacteria (including nontuberculous, environmental
mycobacteria), salmonella(including non typhi strains), and
Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and
fatal outcomes have been reported in such patients. It is not known
whether patients with pharmacologic blockade of IL-12/IL-23 from
treatment with ustekinumab products may be susceptible to these
types of infections. Appropriate diagnostic testing should be
considered (e.g., tissue culture, stool culture) as dictated by
clinical circumstances.
Pre-Treatment Evaluation of Tuberculosis
(TB)
Evaluate patients for TB prior to initiating treatment with
SELARSDI. Do not administer SELARSDI to patients with active TB
infection. Initiate treatment of latent TB before administering
SELARSDI. Consider anti-tuberculosis therapy prior to initiation of
SELARSDI in patients with a past history of latent or active TB in
whom an adequate course of treatment cannot be confirmed. Closely
monitor patients receiving SELARSDI for signs and symptoms of
active TB during and after treatment.
Malignancies
Ustekinumab products are immunosuppressants and may increase the
risk of malignancy. Malignancies were reported among patients who
received ustekinumab in clinical trials. The safety of ustekinumab
products has not been evaluated in patients who have a history of
malignancy or who have a known malignancy. There have been
post-marketing reports of the rapid appearance of multiple
cutaneous squamous cell carcinomas in patients receiving
ustekinumab products who had pre-existing risk factors for
developing non-melanoma skin cancer (NMSC). All patients receiving
SELARSDI, especially those greater than 60 years of age or those
with a history of Psoralen plus ultraviolet A (PUVA )or prolonged
immunosuppressant treatment, should be monitored for the appearance
of NMSC.
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and
angioedema, have been reported with ustekinumab products. If an
anaphylactic or other clinically significant hypersensitivity
reaction occurs, institute appropriate therapy and discontinue
SELARSDI.
Posterior Reversible Encephalopathy Syndrome
(PRES)
Two cases of posterior reversible encephalopathy syndrome
(PRES), also known as Reversible Posterior Leukoencephalopathy
Syndrome (RPLS), were reported in clinical trials. Cases have also
been reported in postmarketing experience in patients with
psoriasis and psoriatic arthritis. Clinical presentation included
headaches, seizures, confusion, visual disturbances, and imaging
changes consistent with PRES a few days to several months after
ustekinumab product initiation. A few cases reported latency of a
year or longer. Patients recovered with supportive care following
withdrawal of ustekinumab products.
Monitor all patients treated with SELARSDI for signs and
symptoms of PRES. If PRES is suspected, promptly administer
appropriate treatment and discontinue SELARSDI.
Immunizations
Prior to initiating therapy with SELARSDI, patients should
receive all age-appropriate immunizations as recommended by current
immunization guidelines. Patients being treated with SELARSDI
should not receive live vaccines. BCG vaccines should not be given
during treatment or for one year prior to initiating or for one
year following discontinuation of SELARSDI. Exercise caution when
administering live vaccines to household contacts of SELARSDI
patients, as shedding and subsequent transmission to SELARSDI
patients may occur. Non-live vaccinations received during a course
of SELARSDI may not elicit an immune response sufficient to prevent
disease.
Concomitant Therapies
The safety of ustekinumab products, in combination with other
biologic immunosuppressive agents or phototherapy has not been
evaluated in clinical trials of psoriasis. Ultraviolet-induced skin
cancers developed earlier and more frequently in mice. In psoriasis
studies, the relevance of findings in mouse models for malignancy
risk in humans is unknown. In psoriatic arthritis studies,
concomitant methotrexate use did not appear to influence the safety
or efficacy of ustekinumab.
Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and
cryptogenic organizing pneumonia have been reported during
post-approval use of ustekinumab products. Clinical presentations
included cough, dyspnea, and interstitial infiltrates following one
to three doses. Serious outcomes have included respiratory failure
and prolonged hospitalization. Patients improved with
discontinuation of therapy and, in certain cases, administration of
corticosteroids. If diagnosis is confirmed, discontinue SELARSDI
and institute appropriate treatment.
Allergen Immunotherapy
Ustekinumab products have not been evaluated in patients who
have undergone allergy immunotherapy. Ustekinumab products may
decrease the protective effect of allergen immunotherapy (decrease
tolerance) which may increase the risk of an allergic reaction to a
dose of allergen immunotherapy. Therefore, caution should be
exercised in patients receiving or who have received allergen
immunotherapy, particularly for anaphylaxis.
Most Common Adverse Reactions
Most common adverse reactions for psoriasis (greater than or
equal to 3%) are: nasopharyngitis, upper respiratory tract
infection, headache, and fatigue.
To report SUSPECTED ADVERSE REACTIONS, contact Teva
Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Please click [here]
for full Prescribing Information for SELARSDI.
ALVOTECH 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.
TEVA 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,
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. You can identify these
forward-looking statements by the use of words such as “should,”
“expect,” “anticipate,” “estimate,” “target,” “may,” “project,”
“guidance,” “intend,” “plan,” “believe” and other words and terms
of similar meaning and expression in connection with any discussion
of future operating or financial performance. Important
factors that could cause or contribute to such differences include
risks relating to: our strategic partnership with Alvotech; our
ability to successfully commercialize SELARSDI in the U.S.; our
ability to successfully commercialize SIMLANDI in the U.S; our
ability to commercialize the additional biosimilar product
candidates under the strategic partnership with Alvotech once U.S.
regulatory approval is obtained; our ability to successfully
compete in the marketplace including our ability to develop and
commercialize additional pharmaceutical products; our ability to
successfully execute our Pivot to Growth strategy, including to
expand our innovative and biosimilar medicines pipeline and
profitably commercialize the innovative medicines and biosimilar
portfolio, whether organically or through business development, and
to sustain and focus our portfolio of generics medicines; and other
factors discussed in this press release, and in our Annual Report
on Form 10-K for the year ended December 31, 2023, including in the
sections captioned "Risk Factors.” 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.
CONTACTS FOR THE MEDIA AND IR
ALVOTECH
Investor Relations and Global Communications
Benedikt Stefansson, Senior Director
alvotech.ir@alvotech.com
TEVA
IR
Contacts |
|
Ran Meir |
+1 (267)
468-4475 |
|
|
Yael Ashman |
+972 (3) 914
8262 |
|
|
Sanjeev
Sharma |
+1 (973) 658
2700 |
PR
Contacts |
|
Kelley
Dougherty
Yonatan Beker
Eden Klein |
+1 (973)
832-2810
+1 (973) 264-7378
+972 (3) 906 2645 |
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