GlobeNewswire

Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Share

Basel, June 2, 2020 —  Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.”

Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.

About ofatumumab
Ofatumumab (OMB 157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously1,2,7. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion3. The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and may preserve the B-cells in the spleen, as shown in preclinical studies4. Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility5. Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20156.

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

References
1.    Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Conference; September 11–13, 2019; Stockholm, Sweden.
2.    Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell Depletion with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Results from the APLIOS Bioequivalence Study. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis Forum; February 27–29, 2020.
3.    Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presented at ECTRIMS; September 2016; London, UK.
4.    Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presented at ECTRIMS; September 14–17, 2016; London, UK.
5.    Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-Cell Recovery Time Following Discontinuation of Anti-CD20 Therapies. ePoster presented at ECTRIMS; October 25–28, 2017; Paris, France.
6.    GSK press release. GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis. December 21, 2015. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/ [Last accessed: June 2020].
7.    Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I & II clinical trials), data on file, Novartis. https://clinicaltrials.gov/ct2/show/NCT02792218; https://clinicaltrials.gov/ct2/show/NCT02792231.

# # #

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

Antonio Ligi
Novartis External Communications
+41 79 723 3681 (mobile)
antonio.ligi@novartis.com



Eric Althoff
Novartis US External Communications
+1 862 778 3243
+1 646 438 4335
eric.althoff@novartis.com
Michael Amos
Novartis Global Pharma Communications
+41 79 123 7806 (mobile)
michael.amos@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+41 61 324 8425Cory Twining+1 862 778 3258
Isabella Zinck+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