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Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options

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Basel, June 29, 2020 — Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) simultaneously approved five new treatment options for Japanese patients:

  • Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC),
  • Entresto® (sacubitril valsartan sodium hydrate) in chronic heart failure,
  • Mayzent® (siponimod fumaric acid) in secondary progressive MS,
  • Enerzair™ (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and
  • Atectura®  (indacaterol acetate, mometasone furoate) in different forms of asthma

“The simultaneous approval of five new products is remarkable for Japan and our industry. We are pleased to see that our innovative products gain the support from leading regulatory bodies”, said Kazunari Tsunaba, Representative Director and President of Novartis Pharma. “All five medicines are truly novel and transformative treatments and therefore mark an important milestone in our mission to reimagine medicine. I would like to thank our Japanese and global colleagues for all their dedication to make this unprecedented milestone happen.“

To date, Novartis has received seven new product approvals in Japan this year. In addition to today's five approvals, in March, Novartis was granted marketing authorizations for spinal muscular atrophy treatment Zolgensma and for Beovu, an anti-VEGF treatment for wet AMD. These approvals and today’s very unprecedented milestone stand testament to the overall strength of Novartis innovative medicines pipeline and its commitment to ensure patients in Japan have timely access to these life-changing medicines.

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,” or similar terms, or by express or implied discussions 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. 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 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. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, 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 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more at
https://www.novartis.com.

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Novartis Media Relations
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Satoshi Jean-Paul Sugimoto
Director External Communications – Europe/Asia
+41 79 619 20 35 (mobile)



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

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