Novartis Accelerates Cancer Immunotherapy Efforts with Aduro Biotech Alliance and Launch of New Immuno-Oncology Research Group

Article

Collaboration with Aduro is focused on discovery and development of next generation cancer immunotherapies targeting the STING signaling pathway.

PRESS RELEASE

Basel, March 30, 2015 - Novartis announced today that it is stepping up its efforts to harness the body's immune system to combat cancer. The company has entered into a major multiyear alliance with Aduro Biotech that is focused on the discovery and development of next generation cancer immunotherapies targeting the STING (Stimulator of Interferon Genes) pathway and launched a new immuno-oncology research group led by renowned cancer vaccine expert Glenn Dranoff, MD.

The addition of STING agonists adds firepower to Novartis' diverse portfolio of immunotherapies that includes chimeric antigen receptor T-cell (CART) technology and novel checkpoint inhibitors. Currently the CART program, CTL019, is in phase 2 clinical trials and checkpoint inhibitors targeting PD1, LAG3, and TIM3 are expected to enter the clinic in mid-2015.

STING is a signaling pathway that when activated is known to initiate broad innate and adaptive immune responses in tumors. Aduro's novel small molecule cyclic dinucleotides (CDN's) have proven to generate an immune response in preclinical models that specifically attacks tumor cells.

"Immunotherapy is one of the exciting frontiers in oncology today. Current approaches with checkpoint inhibitors and T-cell modulation are potent but only in select tumor types. STING agonists have the potential to fully activate the immune system to attack a broader range of tumors," said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "Under Glenn Dranoff's leadership our new immuno-oncology research group will aggressively drive our current programs to the clinic and explore new directions for both mono and combination therapies."

Under the terms of the agreement with Aduro, Novartis will make an upfront payment of $200 million to Aduro and will make an initial equity investment in the company for $25 million, with a commitment for another $25 million equity investment at a future date. Aduro will lead commercialization activities and book sales in the US, with Novartis leading commercialization and recognizing sales in the rest of the world. The companies will share in profits in the US, Japan and major European countries. Novartis will pay Aduro a royalty for sales in the rest of the world.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "accelerates," "launch," "focused on," "dedicated," "launched," "expected," "potential," "will," "commitment," or similar terms, or by express or implied discussions regarding potential marketing approvals for STING agonists, CTL019, and checkpoint inhibitors targeting PD-1, LAG-3 and TIM-3, or regarding potential future revenues from such research and development projects, or regarding potential benefits, synergies and opportunities from the announced alliance with Aduro Biotech and the new immuno-oncology research group. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 STING agonists, CTL019, or checkpoint inhibitors targeting PD-1, LAG-3 or TIM-3 will be submitted or approved for use in any market, or at any particular time. Neither can there be any guarantee that Novartis will be able to realize any or all of the potential benefits, synergies or opportunities from the announced alliance with Aduro Biotech or the new immuno-oncology research group. Nor can there be any guarantee that the research and development projects discussed in this release will be commercially successful in the future. In particular, management's expectations could be affected by, among other things, the potential that the benefits, synergies and opportunities anticipated from the announced alliance with Aduro Biotech or the new immuno-oncology research group may not be fully realized or may take longer to realize than expected; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, 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 provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). As of December 31, 2014 Novartis Group companies employed approximately 133,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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