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) in a new presentation, 130
mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous
infusion. This approval paves the way for SELARSDI to further align
its label with the indications of the reference product Stelara®
(ustekinumab) in the U.S. at launch, which is expected in the first
quarter of 2025.
“We welcome this step which is fully in line with our plan to
align the SELARSDI label with the indications of the reference
product, prior to launch next year,” said Robert Wessman, Chairman
and CEO of Alvotech. “We are looking forward to the U.S. launch,
after very successful launches of the first biosimilar ustekinumab
in Canada, Japan and Europe. This demonstrates our commitment to
increasing availability and access to ustekinumab, and other
biosimilars in our growing pipeline, for patients worldwide.”
“We are thrilled with the expansion of SELARSDI's indications,
marking another significant milestone in Teva’s commitment to
increasing access to biosimilars in the U.S.,” said Thomas Rainey,
Senior Vice President, U.S. Biosimilars. “This development allows
us to serve patients battling gastrointestinal diseases as the U.S.
launch of SELARSDI approaches in early 2025. Teva’s dedication to
increasing uptake of biosimilars remains steadfast, and we are
proud to continue this partnership with Alvotech across a portfolio
of nine partnered products.”
In April 2024, the FDA approved SELARSDI 45 mg/0.5 mL and 90
mg/mL injection in a prefilled syringe for subcutaneous use, for
the treatment of moderate to severe plaque psoriasis and for active
psoriatic arthritis in adults and pediatric patients 6 years and
older. In June 2023, Alvotech and Teva announced that they had
reached a settlement and license agreement with the manufacturer of
the reference biologic, granting a license entry date for SELARSDI
in the United States no later than February 21, 2025.
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 the reference product
Stelara.1
Ustekinumab is a human monoclonal antibody 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, psoriatic arthritis,
ulcerative colitis and Crohn’s disease.
In August 2020, Alvotech and Teva entered into a strategic
partnership for the exclusive commercialization of five of
Alvotech’s biosimilar product candidates, including SELARSDI. The
partnership has since expanded and now includes a total of nine
products. Alvotech handles development and manufacturing using its
purpose-built end-to-end platform, while Teva is responsible for
commercialization in the U.S., which leverages Teva’s experience
and extensive sales and marketing infrastructure. Two biosimilars
developed under the partnership have been given FDA approval:
SELARSDI, and in February 2024, the FDA approved SIMLANDI®
(adalimumab-ryvk), the first high-concentration, citrate-free
interchangeable biosimilar to Humira® (adalimumab). SIMLANDI was
launched in the U.S. in May 2024.
About SIMLANDI® (adalimumab-ryvk) SIMLANDI is a
monoclonal antibody and has been approved as a biosimilar to
Humira® (adalimumab) in over 50 countries globally, including the
U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South
Africa. The biosimilar is currently marketed in the U.S. as
SIMLANDI and under private label as adalimumab-ryvk, in Europe as
HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALACIP.
Applications are also under review in multiple countries
globally.
About SELARSDI™ (ustekinumab-aekn) SELARSDI is
a monoclonal antibody and a biosimilar to Stelara® (ustekinumab).
Ustekinumab binds to two cytokines, IL-12 and IL-23, that are
involved in inflammatory and immune responses.2 The biosimilar has
been launched in Canada as JAMTEKI, in Europe as UZPRUVO and in
Japan as USTEKINUMAB BS (F). It has been approved in the U.S. as
SELARSDI. Applications are also under review in multiple countries
globally.
Use of TrademarksStelara® is a registered
trademark of Johnson & Johnson. Humira® is a registered
trademark of AbbVie Biotechnology Ltd.
About AlvotechAlvotech 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. Two biosimilars to Humira® (adalimumab) and Stelara®
(ustekinumab) are already approved and marketed in multiple global
markets. The current development pipeline includes nine 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), Dr.
Reddy’s (EEA, UK and US), Biogaran (FR), 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
https://www.alvotech.com. None of the information on the Alvotech
website shall be deemed part of this press release.
For more information, please visit our investor portal, and our
website or follow us on social media on LinkedIn, Facebook,
Instagram, X and YouTube.
About TevaTeva 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.
SELARSDI INDICATIONS AND SAFETY INFORMATION
INDICATIONS
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.• the treatment of adult patients with moderately to
severely active Crohn's disease.• the treatment of adult patients
with moderately to severely active ulcerative colitis.
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.
InfectionsUstekinumab 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 plaque
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. In
patients with Crohn’s disease, these included anal abscess,
gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria
meningitis. In patients with ulcerative colitis, these included
gastroenteritis, ophthalmic herpes zoster, pneumonia, and
listeriosis.
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
InfectionsIndividuals genetically deficient in IL-12/IL-23
are particularly vulnerable to disseminated infections from
mycobacteria (including nontuberculous, environmental
mycobacteria), Salmonella (including nontyphi 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. Consider diagnostic testing, 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 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.
MalignanciesUstekinumab 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 ReactionsHypersensitivity
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, psoriatic arthritis, and Crohn’s
disease. 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.
ImmunizationsPrior 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. Avoid
administering BCG vaccines during treatment with SELARSDI or for
one year prior to initiating treatment or one year following
discontinuation of treatment. Caution is advised when administering
live vaccines to household contacts of patients receiving SELARSDI
because of the potential risk for shedding from the household
contact and transmission to patient. Non-live vaccinations received
during a course of SELARSDI may not elicit an immune response
sufficient to prevent disease.
Concomitant TherapiesThe 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 PneumoniaCases 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 ImmunotherapyUstekinumab 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 ReactionsThe most common
adverse reactions for plaque psoriasis (greater than or equal to
3%) were nasopharyngitis, upper respiratory tract infection,
headache, and fatigue. The safety profile in pediatric patients
with plaque psoriasis was similar to that of adults with plaque
psoriasis. The most common adverse reaction for Crohn's disease
induction (greater than or equal to 3%) was vomiting. The most
common adverse reactions for Crohn's disease maintenance (greater
than or equal to 3%) were nasopharyngitis, injection site erythema,
vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus,
urinary tract infection, and sinusitis. The most common adverse
reaction for ulcerative colitis induction (greater than or equal to
3%) was nasopharyngitis. The most common adverse reactions for
ulcerative colitis maintenance (greater than or equal to 3%) were
nasopharyngitis, headache, abdominal pain, influenza, fever,
diarrhea, sinusitis, fatigue, and nausea.
Please click here for
full Prescribing Information for SELARSDI.
Alvotech Forward Looking StatementsCertain
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
StatementsThis 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 develop and
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, in our Quarterly Report on Form 10-Q for the
second quarter of 2024 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.
Sources
- Stelara FDA product label.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf.
Accessed on October 18, 2024.
- Selarsdi FDA product label.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf.
Accessed on October 18, 2024.
Contacts for the Media and Investor
Relations
Alvotech IR and PRBenedikt Stefansson,
VPalvotech.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 |
|
+1 (973) 832-2810 |
|
|
Yonatan Beker |
|
+1 (973) 264-7378 |
|
|
Eden Klein |
|
+972 (3) 906 2645 |
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