Novartis adds clinical and preclinical anti-inflammatory programs to portfolio with acquisition of IFM Tre

• Acquisition will give Novartis one clinical and two preclinical programs targeting the NLRP3 inflammasome, a key component of the innate immune system
   
• Selective inhibition of the NLRP3 inflammasome is a potentially potent approach for treating several metabolic, fibrotic, autoimmune, and neurological diseases

Basel, April 1, 2019 - Novartis announced today that it is adding to its broad portfolio of immunomodulatory medicines with the planned acquisition of IFM Tre, a subsidiary of IFM Therapeutics LLC focused on developing anti-inflammatory medicines targeting the NLRP3 inflammasome. The acquisition will give Novartis full rights to IFM Tre's portfolio of NLRP3 inhibitors.

The NLRP3 (nucleotide-binding domain, leucine-rich repeat-containing receptor pyrin domain containing 3) pathway plays a critical role in the body's innate immune system, serving as a danger sensor for pathogens like bacteria and viruses as well as for endogenous signals of tissue damage or metabolic disorders. When activated, NLRP3 triggers an inflammatory response via the assembly of a multi-protein complex called the inflammasome.

While the NLRP3 inflammasome plays a critical role in the innate immune system by fighting off potentially dangerous pathogens and endogenous disorders, pathologic chronic activation is associated with several metabolic, fibrotic, autoimmune, and neurological diseases. Preclinical studies have shown that IFM Tre's molecules can selectively suppress inflammation caused by the NLRP3 inflammasome while allowing the rest of the immune system to continue normal operations.

"IFM Tre's compounds have demonstrated that they can fine-tune the immune system, offering a potentially potent approach for treating a large variety of diseases associated with inflammation," said Jay Bradner, President of the Novartis Institutes for BioMedical Research. "We look forward to applying our deep expertise in this field to advancing these medicines through the clinic and to patients who need them.

"The three inhibitors in the IFM Tre pipeline include: IFM-2427, a clinical-stage systemic antagonist for an array of chronic inflammatory disorders, including gout, atherosclerosis and nonalcoholic steatohepatitis (NASH); a preclinical-stage gut-directed molecule for the treatment of inflammatory bowel disease; and a preclinical-stage central nervous system (CNS)-penetrant molecule.These programs complement the existing Novartis pipeline of anti-inflammatory medicines.

Under the terms of the agreement, Novartis will acquire all of the outstanding capital stock of IFM Tre. In addition, IFM Tre will receive an upfront payment and will be eligible for downstream milestone payments.

IFM and Novartis anticipate the transaction will close during the second quarter of 2019. Closing of the transaction is subject to customary closing conditions, including clearance 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 "portfolio," "will," "potentially," "planned," "focused," "look forward," "pipeline," "eligible," "anticipate," "subject to," "potential," "can,"  "expect," "investigational," or similar terms, or by express or implied discussions regarding the completion of the planned acquisition of IFM Tre; regarding potential strategic benefits, synergies or opportunities from the proposed acquisition; regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products; or by discussions of strategy, plans, expectations or intentions. 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 proposed acquisition of IFM Tre will be completed in any particular form, within any particular time frame, or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the acquisition, within any particular time frame, or at all. Nor can there be any guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products and the planned acquisition of IFM Tre could be affected by, among other things, an unexpected failure to satisfy the required closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, or unexpected delays in meeting these requirements; the potential that the strategic benefits, synergies or opportunities expected from the planned acquisition may not be realized or may take longer to realize than expected; 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 and economic conditions; safety, quality 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.

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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 more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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