Press Release: Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene

-- Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for

monotherapy and potential proprietary PD-1 combinations, driving mid- and

long-term growth

-- Novartis secures development and commercialization rights in North

America, Europe, and Japan

-- Accelerates Novartis immuno-oncology combination strategy with multiple

potential tislelizumab plus Novartis therapy combinations

-- Tislelizumab already approved for patients with classical Hodgkin's

lymphoma and metastatic urothelial carcinoma in China; 15

registration-enabling clinical trials under way in non-small cell lung

cancer (NSCLC) and other solid tumors

Basel, January 11, 2021 -- Novartis has signed a strategic collaboration

agreement to in-license tislelizumab from BeiGene, Ltd. in major markets

outside of China, accelerating the potential for Novartis to enter the

large and growing checkpoint inhibitor field. Tislelizumab is an

anti-PD-1 monoclonal antibody specifically designed to minimize binding

to FcR on macrophages. In pre-clinical studies, binding to

FcR on macrophages has been shown to compromise the anti-tumor

activity of PD-1 antibodies through activation of antibody-dependent

macrophage-mediated killing of T effector cells.

Under the terms of the agreement, Novartis will obtain the development

and commercialization rights to tislelizumab in the United States,

Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland,

Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront

payment of USD 650 million plus royalties and milestone payments.

BeiGene will retain the rights to tislelizumab in China and other

countries. The transaction has been approved by the Boards of Directors

of both companies.

More than 7,700 patients have been enrolled in 15 potentially

registration-enabling clinical trials with tislelizumab in a dozen

indications, including non-small cell lung cancer (NSCLC),

hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma,

gastric cancer and nasopharyngeal carcinoma. The first ex-China

regulatory filing is expected in 2021. In addition, Novartis and BeiGene

have identified multiple tislelizumab plus Novartis therapy combination

clinical trial opportunities in solid tumors.

"Novartis has a bold ambition to reimagine medicine and find new cures

for cancer and blood disorders. This agreement expands on our strategy

as the only company pursuing four different approaches to treating

cancer: targeted therapy, radioligand therapy, cell and gene therapy,

and immunotherapy. No other company has this range of therapeutic

approaches, and the opportunity to combine them to offer the best

outcomes for each patient," said Susanne Schaffert, PhD, President,

Novartis Oncology. "We are excited about collaborating with BeiGene, a

leading global biotechnology company with roots in China, to bring

tislelizumab to patients around the world, and pair it with our

extensive portfolio and pipeline to develop transformative combination

therapies for patients."

Tislelizumab is approved by the China National Medical Products

Administration (NMPA) as a treatment for certain patients with classical

Hodgkin's lymphoma and metastatic urothelial carcinoma. In addition,

BeiGene has filed three supplemental new drug applications for

tislelizumab in China for first-line treatment of patients with advanced

squamous NSCLC in combination with chemotherapy, first-line treatment of

patients with advanced non-squamous NSCLC in combination with

chemotherapy, and previously treated unresectable HCC.

Closing of the transaction is subject to expiration or early termination

of the waiting period under the Hart-Scott-Rodino Antitrust Improvements

Act.

Disclaimer

This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

such as "potential," "can," "will," "plan," "may," "could," "would,"

"expect," "anticipate," "seek," "look forward," "believe," "committed,"

"investigational," "pipeline," "launch," "to develop," "development,"

"ambition," or similar terms, or by express or implied discussions

regarding potential marketing approvals, new indications or labeling for

tislelizumab, or regarding potential future revenues from tislelizumab;

or regarding the agreement to in-license tislelizumab from BeiGene in

major markets outside of China. You should not place undue reliance on

these statements. Such forward-looking statements are based on our

current beliefs and expectations regarding future events, and are

subject to significant known and unknown risks and uncertainties. Should

one or more of these risks or uncertainties materialize, or should

underlying assumptions prove incorrect, actual results may vary

materially from those set forth in the forward-looking statements. There

can be no guarantee that the transaction described in this press release

will be completed in the expected time frame, or at all. Neither is

there any guarantee that the expected benefits and synergies from such

transaction will be achieved in the expected timeframe, or at all. Nor

can there be any guarantee that tislelizumab will be submitted or

approved for sale in any market, or at any particular time. Neither can

there be any guarantee that tislelizumab will be commercially successful

in the future. In particular, our expectations regarding the transaction

described in this press release and tislelizumab could be affected by,

among other things, the expiration or termination of the waiting period

under the Hart-Scott-Rodino Antitrust Improvements Act; 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; global

trends toward health care cost containment, including government, payor

and general public pricing and reimbursement pressures and requirements

for increased pricing transparency; our ability to obtain or maintain

proprietary intellectual property protection; the particular prescribing

preferences of physicians and patients; general political, economic and

business conditions, including the effects of and efforts to mitigate

pandemic diseases such as COVID-19; safety, quality, data integrity or

manufacturing issues; potential or actual data security and data privacy

breaches, or disruptions of our information technology systems, and

other risks and factors referred to in Novartis AG's current Form 20-F

on file with the US Securities and Exchange Commission. Novartis is

providing the information in this press release as of this date and does

not undertake any obligation to update any forward-looking statements

contained in this press release as a result of new information, future

events or otherwise.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives.

As a leading global medicines company, we use innovative science and

digital technologies to create transformative treatments in areas of

great medical need. In our quest to find new medicines, we consistently

rank among the world's top companies investing in research and

development. Novartis products reach nearly 800 million people globally

and we are finding innovative ways to expand access to our latest

treatments. About 110,000 people of more than 140 nationalities work at

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(END) Dow Jones Newswires

January 11, 2021 16:30 ET (21:30 GMT)