Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for
patients worldwide, and JAMP Pharma Group (“
JAMP
Pharma”), a Canadian owned pharmaceutical organization
headquartered in the Greater Montreal area, announced today that
Health Canada has granted JAMP Pharma marketing authorization for
AVT04, a biosimilar to Stelara® (ustekinumab) developed by
Alvotech. AVT04 will be marketed under the brand name JamtekiTM.
The currently approved presentations of
JamtekiTM are a 45mg/0.5mL pre-filled syringe with a passive safety
device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD.
This is the second biosimilar to receive marketing authorization,
developed under an exclusive commercialization partnership between
Alvotech and JAMP Pharma. Last year, the partners launched
Simlandi®, a biosimilar to Humira® (adalimumab).
“The introduction of JamtekiTM is in line with
our current biosimilar product offering and showcases JAMP Pharma’s
commitment to evolve in this market,” said Louis Pilon, President
and CEO at JAMP Pharma. “Alvotech is an innovative and strategic
partner, enabling Canadian patients to benefit from ustekinumab at
a lower cost. Patients will also benefit from the expertise of our
Patient Support Program – JAMP CareTM – for an optimal and seamless
transition.”
“We are very pleased to receive marketing
authorization for our second biosimilar in Canada with JAMP
Pharma,” said Robert Wessman, Chairman and CEO of Alvotech. “Strong
demand for biosimilars in Canada indicates that there is a need for
affordable quality biologics in the Canadian market. This is an
important step for us and for our joint objective to offer broader
access to more affordable healthcare.”
In February 2022, JAMP Pharma announced the
creation of BioJAMPTM as part of its goal to establish itself as a
leader in the Canadian biosimilars market. BioJAMPTM and the JAMP
CareTM patient support programs are both designed to simplify the
transition process to biosimilar medicines for patients and
caregivers.
JAMP Pharma and Alvotech announced their
exclusive partnership for the commercialization of biosimilars in
Canada in January 2022 then expanded the agreement in October 2022.
In addition to Simlandi® (adalimumab), which was launched in Canada
in April 2022, and JamtekiTM (ustekinumab), the partnership also
includes four biosimilar candidates in clinical development, as
well as two biosimilar candidates in pre-clinical development.
About AVT04 (ustekinumab) AVT04
is a monoclonal antibody and a biosimilar of Stelara®
(ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23,
that are involved in inflammatory and immune responses [1]. AVT04
has been approved in Japan, Canada and the European Medicines
Agency (EMA) has recommended market authorization in the 27 member
states of the European Union, as well as Norway, Iceland and
Liechtenstein, pending a final decision by the European
Commission.
[1] Product information (canada.ca)
Use of trademarksHumira® is a
registered trademark of AbbVie Biotechnology Ltd. Stelara® is a
registered trademark of Johnson & Johnson
About JAMP Pharma GroupJAMP
Pharma Group is Canadian based with its head office located in the
Greater Montreal area. Having experienced exceptional growth over
the past 10 years, JAMP Pharma Group is present in all segments of
the pharmaceutical market with a portfolio of more than 325
molecules and is one of the leaders in the industry in terms of
annual prescription volume [2]. With more than 130 new products
authorized for sale by Health Canada in the last 3 years, the JAMP
Pharma Group is the Canadian leader in product launches [3],
enhancing the new treatment options available in Canada, including
many specialty drugs. In addition to its generic division, the JAMP
Pharma Group has several divisions such as Orimed, BioJAMP,
Wampole, Laboratoire Suisse and Cosmetic Import, also offering
prescription and branded products, biosimilar products, 180
over-the-counter products with a diverse range of vitamins,
supplements, and natural products. The JAMP Care® patient support
program is designed to assist patients, as well as healthcare
professionals, in taking specialty medications and biosimilars
offered by the JAMP Pharma Group. Website: JAMP Pharma Group
(https://www.jamppharma.ca/en/)
[2] Source: Pharmaceutical manufacturers with
the highest volume of prescriptions in Canada between January 2018
and September 2023 Based in part on data obtained under license
from IQVIA Solutions Canada, regarding the following service: CDH,
MAT August 2018 to September 2023 All rights reserved. This
statement is not necessarily that of IQVIA Solutions Canada Inc. or
any of its affiliates or subsidiaries.[3] Source: Pharmaceutical
manufacturers with the highest volume of reported product launches
in Canada between 2016 and 2022 Based in part on data obtained
under license from IQVIA Solutions Canada, regarding the following
service: CDH, MAT 2016/01 to 2022/12. All rights reserved. This
statement is not necessarily that of IQVIA Solutions Canada Inc. or
any of its affiliates or subsidiaries.
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. 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.
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 its expected future
business, financial performance, the use of proceeds from the
private placement, and the future utilization of the Yorkville
facility. 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
outcome of any legal proceedings that may be instituted against
Alvotech or others following the business combination between
Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech;
(2) changes in applicable laws or regulations; (3) the possibility
that Alvotech may be adversely affected by other economic,
business, and/or competitive factors; (4) Alvotech’s estimates of
expenses and profitability; (5) Alvotech’s ability to develop,
manufacture and commercialize the products and product candidates
in its pipeline; (6) actions of regulatory authorities, which may
affect the initiation, timing and progress of clinical studies or
future regulatory approvals or marketing authorizations; (7) the
ability of Alvotech or its partners to gain approval from
regulators for planned clinical studies, study plans or sites; (8)
the ability of Alvotech’s partners to conduct, supervise and
monitor existing and potential future clinical studies, which may
impact development timelines and plans; (9) 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; (10) the success of Alvotech’s
current and future collaborations, joint ventures, partnerships or
licensing arrangements; (11) Alvotech’s ability, and that of its
commercial partners, to execute their commercialization strategy
for approved products; (12) Alvotech’s ability to manufacture
sufficient commercial supply of its approved products; (13) the
outcome of ongoing and future litigation regarding Alvotech’s
products and product candidates; (14) the potential impact of the
ongoing COVID-19 pandemic on the FDA’s review timelines, including
its ability to complete timely inspection of manufacturing sites;
(15) the impact of worsening macroeconomic conditions, including
rising inflation and interest rates and general market conditions,
war in Ukraine and global geopolitical tension, and the ongoing and
evolving COVID-19 pandemic on the Alvotech’s business, financial
position, strategy and anticipated milestones; (16) future
liquidity and financing needs, which may impact the anticipated
utilization of the Yorkville facility or other financing sources;
and (17) 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.
CONTACTSJAMP
PharmaAlexandra Lewicki, M.Sc. Marketing &
Communication Directoralewicki@jamppharma.com
Alvotech Benedikt
StefanssonInvestor Relations and Global
Communicationsalvotech.ir@alvotech.com
Alvontech (NASDAQ:ALVO)
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から 11 2024 まで 12 2024
Alvontech (NASDAQ:ALVO)
過去 株価チャート
から 12 2023 まで 12 2024