Sandoz announces global deal to commercialize proposed biosimilar natalizumab, a key multiple sclerosis medicine
Worldwide agreement with Polpharma gives Sandoz commercialization rights to proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis (RRMS)
RRMS affects ~85% of MS patients and can create a substantial social and economic burden on patients, their families and healthcare systems,
Natalizumab is fifth proposed biosimilar in-licensed by Sandoz in nine months, underscoring commitment to further grow pipeline through collaborations
Holzkirchen, Germany, September 3, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).
Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval, through an exclusive global license. Other specific terms of the agreement are confidential. Polpharma Biologics is a European biopharmaceutical company with a fully integrated R&D and manufacturing footprint.
Reference medicine natalizumab is a disease-modifying therapy (DMT) that was approved for use over 10 years ago, offering patients a valuable therapeutic option for treating RRMS.
In addition to the personal burden of MS for patients and families, affordability is a significant challenge for MS medicines globally. A recent report highlighted affordability as the most common challenge affecting access to MS therapy in 46% of the 90 countries included. Elsewhere it has been highlighted that providing access to DMTs for MS represents a considerable challenge for healthcare systems.
“Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients,” said Pierre Bourdage, ad interim Global Head of Biopharmaceuticals, Sandoz. “By nature, biosimilars create competition and cost savings, which are proven to make room in healthcare systems to treat more patients. With this agreement, we hope to build on our MS experience with small molecules and complex generics, and ultimately provide patients with expanded access to a DMT that healthcare systems may otherwise not be able to provide.”
Sandoz continues to expand the biosimilars marketplace and is committed to help millions of patients access biologic medicines sustainably and affordably. The addition of proposed biosimilar natalizumab expands the Novartis/Sandoz portfolio across small molecules, complex generics, biosimilars, and innovator medicines enabling broad patient access to patented and off-patent medicines. In addition to entering complex and underserved areas such as MS, Sandoz is already helping patients in the areas of immunology, oncology and endocrinology. The division has a leading global portfolio with eight marketed biosimilars and a further 10+ in development.
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,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential regulatory submissions, marketing approvals, launches, new indications or labeling for biosimilar natalizumab and the other products described in this press release, or regarding potential future revenues from biosimilar natalizumab and such other products, or regarding the proposed commercialization agreement with Polpharma Biologics. 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 biosimilar natalizumab or other Sandoz products will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that biosimilar natalizumab or other Sandoz products will be successfully launched, or at any particular time. Nor can there be any guarantee that, if approved, biosimilar natalizumab or such other Sandoz products will be approved for all indications in the originator product label. Neither can there be any guarantee that biosimilar natalizumab, such other Sandoz products, or the commercialization agreement with Polpharma Biologics will be commercially successful in the future. In particular, our expectations regarding the commercialization agreement with Polpharma Biologics and 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 biosimilar versions of natalizumab; 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 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.
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars, and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
Sandoz is on Twitter. Sign up to follow @SandozGlobal at http://twitter.com/Sandoz_Global.
 Multiple Sclerosis International Federation. The atlas of MS international report. Available from: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf [Last accessed: June 2019].
 Multiple Sclerosis International Federation. Global economic impact of multiple sclerosis, May 2010 [online]. Available from: https://www.msif.org/wp-content/uploads/2014/09/Global_economic_impact_of_MS.pdf [Last accessed: June 2019].
 Brandstadter R, Sand IK. The use of natalizumab for multiple sclerosis. Neuropsychiatr Dis Treat 2017;13:1691–1702.
 D’Amico E, et al. Pharmacoeconomics of synthetic therapies for multiple sclerosis. Expert Opin Pharmacother 2019:1–10.
 McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91(3):405–417 (Figure 7).
Novartis Media Relations
Novartis Global Media Relations
+ 41 61 324 1374 (direct)
Sandoz Global Communications
+49 174 244 9501 (mobile)
Sandoz Global Communications
+1 973 714 8043 (mobile)
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
|Samir Shah||+41 61 324 7944||Sloan Simpson||+1 862 778 3275|
|Pierre-Michel Bringer||+41 61 324 1065||Cory Twining||+1 212 830 2417|
|Thomas Hungerbuehler||+41 61 324 8425|
|Isabella Zinck||+41 61 324 7188|
One Liberty Plaza - 165 Broadway
NY 10006 New York
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
Vestas secures 42 MW order with 27-year service agreement in Sweden 22.11.2019 13:48:00 CET | Press release
News release from Vestas Northern and Central Europe Hamburg, 22 November 2019 Vestas has secured an order from Fu-Gen AG, a Swiss developer for the 42 MW wind project Fjällboheden northwest of Skellefteå in Northern Sweden. To maximise the project’s power production in the site’s cold climate, Vestas provides ten V150-4.2 MW turbines equipped with the Vestas Anti-Icing System, which efficiently minimises ice formation on blades. “This project is a major first milestone for Fu-Gen and its partner Abraxas Capital Management in the Swedish market. We are delighted to have Vestas as the supplier of turbines and of the AOM service agreement and look forward to a fruitful cooperation for the future”, says Matthias Rapp, Chairman of Fu-Gen AG. “With the Fjällboheden project, Vestas once again demonstrates the ability to offer wind energy solutions and services that optimise the cost of energy in a demanding climatic environment, while at the same time create maximum value for our valued cust
JSC Olainfarm continues to improve corporate governance of the Group companies22.11.2019 09:37:00 CET | Press release
JSC Olainfarm continues to improve the activities of its subsidiaries by gradually introducing the principles of corporate governance in all the companies of the Group, thus strengthening the quality of governance of the Olainfarm Group. The expansion of the management board of Silvanols Ltd. and Tonus Elast Ltd. is the first step Olainfarm is taking towards signing the agreement. Improvements to the operations of the Group companies have also led to changes in the articles of association of several Olainfarm subsidiaries, laying down uniform operating and management principles for the Group companies. “Olainfarm is committed to complying with the principles of corporate governance in providing quality control of operations and evaluation and management of the risks associated with operations. Olainfarm is committed to protecting the rights and interests of all its shareholders, and the quality of corporate governance in the Olainfarm Group is constantly being improved. Our goal is to
Scanship Holding ASA : Scanship enters industry decarbonizing contract with unique ETIA pyrolysis technology22.11.2019 09:16:00 CET | Press release
Scanship Holding ASA through its subsidiary ETIA SAS, has been awarded an equipment delivery contract by a major international corporation of consumer goods, who operates multiple production facilities worldwide. The contract is to deliver and install first ETIA Biogreen system in one of their more than 40 production facilities worldwide. The customer is targeting to increase its share of renewable energy used for the activities and the current point of interest for the company is in the substitution of natural gas used on site. As a solution for the challenge, the ETIA customer will use its available waste streams in Biogreen thermochemical conversion system delivered by ETIA, to generate biochar and syngas for generating steam, therefore decreasing the natural gas usage on site. The installation will be done during the fall of 2020. The accumulated order backlog for the Scanship Group, including the order backlog for ETIA, is now at a NOK 770 mill level. For further queries, please c
KALLELSE TILL EXTRA BOLAGSSTÄMMA C-Rad AB (PUBL)22.11.2019 08:30:00 CET | Pressemelding
Pressmeddelande 2019-11-22 Aktieägarna i C-Rad AB (publ), org.nr 556663-9174, kallas härmed till extra bolagsstämma tisdagen den 17 december 2019 klockan 10.00 i bolagets lokaler med adress Bredgränd 18, 753 20 Uppsala. 1. Rätt att delta i bolagsstämman och anmälan Aktieägare som önskar delta i bolagsstämman ska: dels vara registrerad i eget namn (ej förvaltarregistrerad) i den av Euroclear Sweden AB förda aktieboken onsdagen den 11 december 2019, dels anmäla sin avsikt att delta till bolaget senast fredagen den 13 december 2019. Anmälan om deltagande kan via e-post firstname.lastname@example.org eller per brev C-Rad AB (publ), Bredgränd 18, 753 20 Uppsala. Vid anmälan uppges aktieägarens namn, person- eller organisationsnummer (eller motsvarande) och gärna adress, telefonnummer, aktieinnehav, uppgift om eventuella biträden (högst två), samt i förekommande fall uppgift om ställföreträdare eller ombud. 2. Förvaltarregistrerade aktier Förutom att anmäla sig måste aktieägare, som har sina aktier förvalta
Participation Notification by Blackrock Inc.22.11.2019 08:30:00 CET | Press release
Brussels, Friday November 22, 2019 , 08h30 CEST --- According to Belgian transparency legislation (Law of May 2, 2007), BlackRock Inc. (55 East 52nd Street, New York, NY, 10055, U.S.A.) has notified Solvay S.A. that: On November 15, 2019 BlackRock Inc. crossed upwards the 3% statutory threshold for direct voting rights, holding 3.02%. Including equivalent financial instruments, the total voting rights stood at 3.70%. On November 18, 2019 BlackRock Inc. crossed downwards the 3% statutory threshold for direct voting rights, holding 2.98%. Including equivalent financial instruments, the total voting rights stood at 3.67%. On November 19, 2019 BlackRock Inc. crossed upwards the 3% statutory threshold for direct voting rights, holding 3.05%. Including equivalent financial instruments, the total voting rights stood at 3.77%. Declarations by BlackRock Inc. are published in the Investor Relations Section of Solvay's website. Attachments Solvay_2019-11-15_Issuer_signed Solvay_2019-11-18_Issuer_
HOYLU AB PUBLISHES THE INTERIM REPORT FOR JANUARY - SEPTEMBER 201922.11.2019 08:30:00 CET | Press release
Stockholm, Sweden, November 22, 2019 The complete version of the Interim Report for January - September 2019 is attached in this press release and is available on Hoylu's web site (www.hoylu.com). “In Q3 we started to see real growth in the number of users, although it is too early to have a significant impact on our revenues. We completed proof of concepts and security audits with some of our largest customers and started to convert our customer base to a Software as a Service (SaaS) subscription-based business model.” says Hoylu Chief Executive Officer, Stein Revelsby. FIRST NINE MONTHS 2019 - Revenues for the first nine months were SEK 19.0 million (20.4) - Gross margin was 69 percent (69) - Operating loss amounted to SEK 22.7 million (-22.0) * - Profit after tax amounted to SEK -27.5 million (-22.9) - Earnings per share amounted to SEK -1.59 (-1.54) * Excluding the administrative assessment of MSEK 2.1. The amount of the fine appears to be unreasonably large considering the circums