GlobeNewswire

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

Share

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.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

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

CentralNorth America
Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052
Thomas Hungerbuehler 
Isabella Zinck
+41 61 324 8425
+41 61 324 7188

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

DIAC S.A.: UPDATE OF NEU MTN PROGRAMME3.7.2020 19:32:13 CESTPress release

July, 3rd 2020 DIAC S.A.: UPDATE OF NEU MTN PROGRAMME DIAC S.A. updated the Information Memorandum of its Negotiable Medium Term Notes (NEU MTN Programme). This documentation was approved by the Banque de France is available on its website under the following link: https://eucpmtn.banque-france.fr/public/#/liste-des-emetteurs/5f8b9dec-b611-ea11-80f7-001dd8b71ea9 DIAC S.A. Etablissement de crédit et intermédiaire d’assurances, au capital de 659 334 050 EUR. Siège social : 14, avenue du Pavé Neuf – 93168 Noisy-le-Grand cedex SIREN 702 002 221 RCS Bobigny – N° TVA : FR02 702002221 – Code APE 6492Z – N° ORIAS : 07 004 966 – www.orias.fr Attachment Update DIAC programme NEU MTN 2020

Maha Energy AB (publ) Announce June Production Volumes3.7.2020 17:13:36 CESTPress release

­­­Maha Energy AB (publ) Strandvägen 5A SE-114 51 Stockholm www.mahaenergy.ca Press release Stockholm July 3, 2020 Maha Energy AB (publ) Announce June Production Volumes Production Volumes The Company's aggregate sales production for the month of June totaled 112,1511 barrels of oil and 57.090 million scf of gas for a combined average production of approximately 4,056 BOE/day2, before royalties and taxes. Other than some minor unplanned shutdowns, production continues to be affected by the impact of the Covid-19 pandemic. 1 Subject to minor standard industry adjustments at the time of custody transfer. 2 Barrels of oil equivalent ("BOE") conversion ratio of 6,000 scf: 1 bbl is used. For more information, please contact: Jonas Lindvall (CEO) Tel: +46 8 611 05 11 Email: jonas@mahaenergy.ca or Victoria Berg (Investor Relations) Tel: +46 8 611 05 11 Email: victoria@mahaenergy.ca Maha in Brief Maha Energy AB is a Swedish public limited liability company. FNCA Sweden AB has been engaged as C

Norsk Hydro: Produksjon gjennopptatt ved Paragominas og Alunorte3.7.2020 17:00:00 CESTPressemelding

Strømtilførselen til Hydros bauksittgruve Paragominas i Parà nord i Brasil har blitt gjenopprettet og produksjonen har startet opp igjen. Produksjonen ved Hydros aluminaraffineri Alunorte vil som følge av dette også bli normalisert. Tre høyspentmaster veltet 20. juni og førte til strømbrudd for Paragominas. Strømbruddet stanset midlertidig produksjonen ved gruven. Høyspentmastene har nå blitt reparert og strømtilførelsen er gjenopprettet. Det var ingen personskader, miljøskader eller skader på produksjonsutstyr relatert til strømbruddet. Hydro samarbeider med lokale myndigheter for å finne årsaken til hendelsen. Foreløpige undersøkelser tyder på at deler fra mastene har blitt stjålet og at dette forårsaket at mastene veltet. Investorkontakt: Line Haugetraa +47 41406376 Line.Haugetraa@hydro.com Pressekontakt: Anders Vindegg +47 93864271 Anders.Vindegg@hydro.com

Norsk Hydro: Production resumed at Paragominas and Alunorte3.7.2020 17:00:00 CESTPress release

The power supply to Hydro’s Paragominas bauxite mine, in the state of Pará in northern Brazil, has been restored, allowing production to restart. As a result, production is being ramped up at Hydro’s Alunorte alumina refinery. On June 20, three power transmission towers overturned, cutting the power supply to the mine and temporarily halting production. The transmission towers have been repaired, and the power has been restored. There were no personnel injuries, damage to other production assets or impact on the nearby environment related to the power outage. The company is cooperating with local authorities to determine the cause of the incident. Preliminary findings indicate that parts were stolen from the towers causing them to overturn. Investor contact: Line Haugetraa +47 41406376 Line.Haugetraa@hydro.com Media contact: Anders Vindegg +47 93864271 Anders.Vindegg@hydro.com

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS3.7.2020 16:20:00 CESTPress release

Sveriges Riksbank Bid procedure details Kommuninvest Bonds, 2020-07-07 Maturity dateLoanISIN codeCouponVolume, SEK million2021-09-15 2109 SE00069950641.00 %500+/- 2502024-10-022410 SE0010469205 1.00 %500+/- 250 Settlement date 2020-07-09 Bids have to be entered by 11.00 on JUL 07, 2020 Highest permitted bid volume: A maximum of SEK 500 million per bid in issue 2109 and 2410. Lowest permitted bid volume: 50 SEK million per bid Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 11.15 (CEST) ON JUL 07, 2020 For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se

CONDITIONS FOR RIKSBANK BID PROCEDURES SEK COVERED BONDS3.7.2020 16:20:00 CESTPress release

Sveriges Riksbank Bid procedure details Covered Bonds, 2020-07-09 Maturity dateLoanISIN codeCouponVolume, SEK million2025-09-17 5535 SE0013358413 1.00 %1,000 +/- 5002024-12-18 579 SE00121936211.00 %1,000 +/- 500 2024-12-031589SE00116433861.50 %1,000 +/- 5002025-06-18195SE00135460661.00 %1,000 +/- 5002024-12-182412SE00126218521.00 %400 +/- 2502025-09-17518SE0011309244 1.25 %400 +/- 2502025-06-11 146 SE0013381571 0.50 %400 +/- 250 Settlement date 2020-07-13 Bids have to be entered by 10.00 on JUL 09 2020 Highest permitted bid volume: 1,000 SEK million in issue 5535 1,000 SEK million in issue 579 1,000 SEK million in issue 1589 1,000 SEK million in issue 195 400 SEK million in issue 2412 400 SEK million in issue 518 400 SEK million in issue 146 Maximum volume: 5 billion SEK in total Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.15 (CEST) ON JUL 09, 2020. For more information, pleas