Collaboration expands and underscores
commitment to biosimilars portfolio and focus on women’s health
with biosimilar candidates for osteoporosis and breast cancer
Organon (NYSE: OGN), a global women’s health company with deep
expertise in biosimilar commercialization, today announced that it
has entered into an agreement with Shanghai Henlius Biotech, Inc.
(2696.HK), whereby Organon will license commercialization rights
for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11)
and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire
exclusive global commercialization rights except for China;
including Hong Kong, Macau and Taiwan.
Pertuzumab is used for the treatment of certain patients with
HER2+ breast cancer in combinations with trastuzumab and
chemotherapy. In the US, 20% of people with breast cancer are
HER2+. Denosumab is used for the treatment of certain patients with
osteoporosis with high risk of fracture and for the prevention of
skeletal-related events in patients with multiple myeloma and in
patients with bone metastasis from solid tumors. Osteoporosis
affects over 20% of women over the age of 50 globally.
“Biosimilars are a key growth pillar for Organon, and this
collaboration represents the successful execution of our strategy
to expand our biosimilars portfolio leveraging our strong global
footprint and deep commercial expertise,” said Kevin Ali, CEO of
Organon. “With our experience in biosimilars and women’s health,
our goal is to help more patients gain access to treatments for
breast cancer and osteoporosis, two areas that significantly impact
the health of women.”
The agreement also includes an option to negotiate an exclusive
license for global commercialization rights for a biosimilar
candidate referencing Yervoy ® (ipilimumab, HLX13). Ipilimumab is
used for the treatment of certain patients with unresectable or
metastatic melanoma, as adjuvant treatment of certain patients with
cutaneous melanoma, certain patients with Renal Cell Carcinoma,
Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung
Cancer, Malignant Pleural Mesothelioma and Esophageal Cancer.
Consideration for the transaction includes an upfront payment of
$73 million as well as additional payments upon the achievement of
certain development, regulatory and commercial milestones. Henlius
will be responsible for development and, if approved, will supply
the products to Organon.
As stated on Organon’s first quarter conference call, to align
with views expressed by the US Securities and Exchange Commission,
beginning in 2022 Organon will no longer exclude expenses for
upfront and milestone payments related to collaborations and
licensing agreements, or charges related to pre-approval assets
obtained in transactions accounted for as asset acquisitions, from
its non-GAAP results. Organon’s financial guidance does not assume
an estimate for these expenses associated with business development
not yet executed, and accordingly, the $73 million upfront payment
and an approximate $30 million for milestones expected to be
achieved in 2022 were not included in the full year 2022 guidance
the company provided on May 5, 2022. The company does not plan to
update its guidance inter-quarter based solely on these items.
About HLX11 (pertuzumab biosimilar candidate)
HLX11 (anti-HER2 domain II humanized monoclonal antibody
injection) is a biosimilar candidate of pertuzumab and is
independently developed by Henlius. Pertuzumab is used in
combination with trastuzumab and chemotherapy as neoadjuvant or
adjuvant treatment for HER2 positive early breast cancer and in
combination with trastuzumab and docetaxel in certain patients with
HER2 positive metastatic or unresectable locally recurrent breast
cancer. To date, HLX11 has met the primary endpoint in a Phase 1
clinical trial, showing similar pharmacokinetic and safety profiles
to the reference drugs from different sources.
About HLX14 (denosumab biosimilar candidate)
HLX14 (recombinant anti-RANKL human monoclonal antibody
injection) is a biosimilar candidate of denosumab and is
independently developed by Henlius. Denosumab is used for a range
of indications including for the treatment of postmenopausal women
with osteoporosis at high risk for fracture, certain patients with
giant cell tumor of bone, and skeletal-related events in patients
with multiple myeloma and in patients with bone metastases from
solid tumors.
About Organon
Organon is a global healthcare company formed to focus on
improving the health of women throughout their lives. Organon has a
portfolio of more than 60 medicines and products across a range of
therapeutic areas. Led by the women’s health portfolio coupled with
an expanding biosimilars business and stable franchise of
established medicines, Organon’s products produce strong cash flows
that will support investments in innovation and future growth
opportunities in women’s health. In addition, Organon is pursuing
opportunities to collaborate with biopharmaceutical innovators
looking to commercialize their products by leveraging its scale and
presence in fast growing international markets.
Organon has a global footprint with significant scale and
geographic reach, world-class commercial capabilities, and
approximately 9,300 employees with headquarters located in Jersey
City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn and Instagram.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the
vision to offer high-quality, affordable and innovative biologic
medicines for patients worldwide with a focus on oncology,
autoimmune diseases and ophthalmic diseases. Up to date, 5 products
have been launched in China, 1 in Europe, 13 indications approved
worldwide, and 2 New Drug Application (NDA) accepted for review in
China. Since its inception in 2010, Henlius has built an integrated
biopharmaceutical platform with core capabilities of
high-efficiency and innovation embedded throughout the whole
product life cycle including R&D, manufacturing and
commercialization. It has established global innovation centers and
a Shanghai-based manufacturing facility certificated by China and
the EU Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality
product pipeline covering over 20 innovative monoclonal antibodies
(mAbs) and has continued to explore immuno-oncology combination
therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone.
Apart from the launched products HANLIKANG (rituximab), the first
China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac® in
Europe), the first China-developed mAb biosimilar approved both in
China and Europe, HANDAYUAN (adalimumab) and HANBEITAI
(bevacizumab), the innovative product HANSIZHUANG has been approved
by the NMPA for the treatment of MSI-H solid tumors and its NDA for
the treatment of squamous non-small cell lung cancer and extensive
small-cell lung cancer (ES-SCLC) are under review. What's more,
Henlius has conducted over 20 clinical studies for 12 products and
10 combination therapies.
Forward-Looking Statement of Organon
This press release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements about the potential therapeutic benefits of
HLX11 and HLX14; Organon’s ability to improve the lives of women;
Henlius’ ability to offer high-quality, affordable and innovative
biologics for patients worldwide; Henlius’ ability to advance the
clinical development of HLX11 and HLX14; and the potential benefits
of the Henlius License and Supply Agreement. Forward-looking
statements may be identified by words such as “expects,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or
words of similar meaning. These statements are based upon the
current beliefs and expectations of Organon’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include, but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the ongoing COVID-19 pandemic and emergence of
variant strains; the impact of pharmaceutical industry regulation
and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances; new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; Organon’s ability to
accurately predict its future financial results and performance;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; difficulties developing
and sustaining relationships with commercial counterparties;
dependence on the effectiveness of Organon’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Organon undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Organon’s filings with
the Securities and Exchange Commission ("SEC"), including Organon’s
Annual Report on Form 10-K for the year ended December 31, 2021 and
subsequent SEC filings, available at the SEC’s Internet site
(www.sec.gov).
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version on businesswire.com: https://www.businesswire.com/news/home/20220612005061/en/
Organon Media Contacts: Karissa Peer (614) 314-8094
Kate Vossen (732) 675-8448
Organon Investor Contacts: Jennifer Halchak (201) 275-2711
Edward Barger (267) 614-4669
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