-- 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 
Novartis around the world. Find out more at https://www.novartis.com. 
 
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   Novartis Media Relations 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
Anja von Treskow                     Julie Masow 
Novartis External Communications     Novartis Oncology Communications 
+41 79 392 86 97 (mobile)            +1 862 579 8456 (mobile) 
anja.von_treskow@novartis.com        julie.masow@novartis.com 
 
Eric Althoff 
Novartis US External Communications 
+1 646 438 4335 
eric.althoff@novartis.com 
 
   Novartis Investor Relations 
 
   Central investor relations line: +41 61 324 7944 
 
   E-mail: investor.relations@novartis.com 
 
 
 
 
Central                                 North America 
Samir Shah             +41 61 324 7944  Sloan Simpson  +1 862 778 5052 
Thomas Hungerbuehler   +41 61 324 8425 
Isabella Zinck         +41 61 324 7188 
 
 
 
 
 
 

(END) Dow Jones Newswires

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