GlobeNewswire by notified

Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA

Share
  • Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EU

  • Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that can drastically affect an individual’s everyday life and requires life-long treatment

  • Sandoz is committed to accelerating patient access to potentially life-changing, high-quality treatments, while generating savings for healthcare systems and patients

Basel, July 25, 2022 – Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

The application includes all indications covered by the reference medicine Tysabri® (natalizumab)* for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn´s Disease.1

The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for reference medicine Tysabri®*.2

The submitted biosimilar was developed to have the same intravenous (iv) dosage form, route of administration, dosing regimen and presentation as the reference medicine.

MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system (brain and spinal cord) 3 that can drastically affect an individual’s everyday life and requires life-long treatment. The disease has a wide range of symptoms, beginning with blurred vision, fatigue, weak limbs, unsteadiness and tingling sensations and leading to limited mobility and neurological decline.4 Treatment cost and lack of access to effective treatment can create an additional burden for people with MS, their families and healthcare systems.5

“Thanks to advances in medicine over the last 20 years, we now have DMTs, which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems.”

The BLA and MAA include a comprehensive analytical, preclinical and clinical data package. The Phase I and Phase III Antelope studies in RRMS patients met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity. Sandoz is committed to all aspects of the safe use of, and patient experience with, its proposed biosimilar natalizumab. This includes a JCV test and either a REMS (for the US) or RMP (for the EU) program, both of which will be subject to approval by the relevant health authority.

Sandoz entered into a global commercialization agreement for proposed biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply. Through an exclusive global license, Sandoz has the rights to commercialize and distribute the product in all markets.

Sandoz is committed to helping millions of patients access biologic medicines sustainably in many different disease areas, including oncology and immunology. These submissions build on the already approved and well-established Sandoz global portfolio of eight marketed biosimilars and a further 15+ in various stages of development.

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,” “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. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. 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; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; 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 Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References

  1. Food and Drug Administration. Tysabri® Highlights of Product Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf. Accessed May 17, 2022.
  2. European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed June 2022] .
  3. MS International Federation. What is MS? October 2021. Accessed May 17, 2022. https://www.msif.org/about-ms/what-is-ms/
  4. Mayo Clinic. About Multiple Sclerosis. 2022. Available from: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269. [Accessed July 2022]
  5. Research Outreach. The Financial Toxicity of Multiple Sclerosis. August 2021. Accessed March 30, 2022. https://researchoutreach.org/articles/financial-toxicity-multiple-sclerosis/

*Tysabri® is a registered trademark of Biogen MA, Inc.

# # #

Sandoz and Novartis Global Communications


Sandoz Communications Global

Chris Lewis
+49 174 244 9501 (mobile)
chris.lewis@sandoz.com



Sandoz US Communications
Leslie Pott
+1 201 354 0279 (mobile)
leslie.pott@sandoz.com

Novartis Communications and Engagement
Richard Jarvis
+41 79 584 2326 (mobile)
richard.jarvis@novartis.com

Novartis Media Relations
E-mail: media.relations@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
Nicole Zinsli-Somm+41 79 325 2084
Isabella Zinck+41 61 324 7188
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

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

https://notified.com

GlobeNewswire by notified 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 by notified

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

Latest releases from GlobeNewswire by notified

Maha Energy AB enters into a Farmout Agreement with Mafraq Energy LLC for Block 70 in Oman8.8.2022 11:00:00 CEST | Press release

Maha Energy AB (publ) (“Maha” or the “Company”), through its wholly owned subsidiary Maha Energy (Oman) Ltd., has entered into an Agreement with Mafraq Energy LLC for Maha to reduce the Participating Interest in the Block 70 Exploration and Production Sharing Agreement (“EPSA”) in Oman from 100% to 65%. Maha will continue to be the Operator of the Block. The Agreement is subject to Government approval in Oman. Maha has decided to reduce its working interest in the onshore oil-bearing Block 70 in Oman by bringing in a strategic Omani partner. The Agreement requires Mafraq Energy LLC to reimburse Maha for their prorated share of all past costs including the signature bonus. Mafraq Energy LLC will also be required to pay their share of all future expenditures on Block 70. Jonas Lindvall, Maha’s CEO said: “We are delighted to have Mafraq Energy LLC join us on Block 70. Mafraq Energy LLC brings extensive experience of the Mafraq field and the surrounding areas in Oman. The fact that Mafraq

Maha Energy AB ingår utfarmningsavtal med Mafraq Energy LLC för Block 70 i Oman8.8.2022 11:00:00 CEST | Pressemelding

Maha Energy AB (publ) (”Maha” eller ”Bolaget”), genom sitt helägda dotterbolag Maha Energy (Oman) Ltd., har tecknat avtal med Mafraq Energy LLC för att Maha ska minska intresseandelen i prospekterings- och produktionsdelningsavtalet (EPSA) för Block 70 i Oman från 100 till 65 procent. Maha kommer att fortsätta att vara operatör för blocket. Avtalet kräver sedvanligt godkännande från myndigheterna i Oman. Maha har beslutat att reducera sin intresseandel i oljeförande Block 70 i Oman genom att ta in en strategisk partner från Oman. Avtalet innebär att Mafraq Energy ersätter Maha för deras proportionella andel av alla tidigare kostnader inklusive deras andel av signaturbonusen. Mafraq Energy kommer också att behöva betala sin del av alla framtida utgifter för blocket. ”Vi är glada över att ha Mafraq Energy med oss på Block 70. Mafraq Energy tillför värdeful erfarenhet och kunskap om Mafraqfältet och närliggande oljefält i Oman. Det faktum att Mafraq Energy ansluter sig till oss är kanske

Notice of Nexstim Plc’s Half-Yearly Report H1 20228.8.2022 09:00:00 CEST | Press release

Companyannouncement,Helsinki,8 August2022at10 AM(EEST) Noticeof NexstimPlc’sHalf-Yearly Report H1 2022 Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") will publish its half-yearly report for the six months ended 30 June 2022 on Friday 12 August 2022 at approximately 9:00 am Finnish time. The company will hold two live webinars for media, investors and analysts on Friday 12 August 2022. Mikko Karvinen CEO, and Joonas Juokslahti CFO, will present the financial and operational results followed by a Q&A session. The first live webinar will be in Finnish, and it will take place at 10:30 am EEST. The second live webinar will be in English at 3 pm EEST. Webinardetails: To attend the webinars, please register via the links below. Registered participants will receive more information to their e-mail. Live Webinar in Finnish on 12 August 2022 at 10:30 am (EEST): Sign up here >> Live Webinar in English on 12 August 2022 at 3 pm (EEST): Sign up here >> NEXSTIM PLC Mikko Karvinen, CEO F

Publicering av Nexstim Abp:s halvårsrapport för H1 20228.8.2022 09:00:00 CEST | Pressemelding

Företagsmeddelande,Helsingfors,8augusti2022 kl.10(EEST) Publicering av Nexstim Abp:s halvårsrapport för H1 2022 Nexstim Abp (NXTMH:HEX, NXTMS:STO) (”Nexstim” eller ”bolaget”) kommer att meddela sitt halvårsresultat för det gångna halvåret som avslutades den 30 juni 2022, på fredagen den 12 augusti 2022 cirka kl. 9.00 finsk tid. Bolaget ordnar två webbsända möten för analytiker, investerare och medier fredagen 12 augusti 2022. Verkställande direktör Mikko Karvinen och ekonomichef Joonas Juokslahti presenterar det finansiella resultatet och rörelseresultatet verifier deltagarna ges möjlighet att ställa frågor. Den första webbsändningen på finska börjar klockan 10.30 (EEST). Den andra webbsändningen på engelska börjar klockan 15.00 (EEST). Uppgifteromwebbsändningarna: Anmälning till webbsändningarna sker via länkarna nedan. De deltagare som anmält sig får närmare anvisningar per e-post. Webbsänt informationsmöte på finska 12 augusti 2022 klockan 10.30 (EEST): Till anmälan >> Webbsänt info

Sampo plc’s share buybacks 05/08/20228.8.2022 07:30:00 CEST | Press release

SAMPO PLC STOCK EXCHANGE RELEASE 08/08/2022 at 08:30 am Sampo plc’s share buybacks 05/08/2022 On 05/08/2022 Sampo plc (business code 0142213-3, LEI 743700UF3RL386WIDA22) has acquired its own A shares (ISIN code FI0009003305) as follows: Sampo plc’s share buybacksAggregated daily volume (in number of shares)Daily weighted average price of the purchased shares*Market (MIC Code)14,33944.37AQEU14,45644.38CEUX7,48944.42TQEX78,18844.36XHELTOTAL114,47244.37 *rounded to two decimals On 9 June 2022, Sampo announced a share buyback programme of up to a maximum of EUR 1 billion in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052. The programme, which started on 10 June 2022, is based on the authorization granted by Sampo's Annual General Meeting on 18 May 2022. After the disclosed transactions, the company owns in total 5,603,062 Sampo A shares representing 1.05 per cent of the total number of shares in Sampo plc. Details of ea