NVS Novartis AG

87.57
-0.28  -0%
Previous Close 87.85
Open 87.46
52 Week Low 69.1801
52 Week High 99.8429
Market Cap $200,419,546,208
Shares 2,288,678,157
Float 2,288,678,157
Enterprise Value $231,801,216,703
Volume 1,101,452
Av. Daily Volume 1,866,252
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Upcoming Catalysts

Drug Stage Catalyst Date
BYL719 + fulvestrant
HR + Metastatic breast cancer (MBC)
Approved
Approved
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Entresto - PARADISE
AMI (acute myocardial infarction)
Phase 3
Phase 3
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Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
Phase 3
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OMB157 (ofatumumab)
Relapsing multiple sclerosis
PDUFA priority review
PDUFA priority review
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LJN452
Non-alcoholic steatohepatitis (NASH)
Phase 2
Phase 2
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PDR001
BRAFV600 mutant metastatic melanoma
Phase 3
Phase 3
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Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)
Phase 3
Phase 3
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Kisqali - MONALEESA-2
Breast cancer
Phase 3
Phase 3
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Beovu (Brolucizumab)
Diabetic macular edema (DME)
Phase 3
Phase 3
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Asciminib (ABL001)
Chronic myeloid leukemia
Phase 3
Phase 3
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Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 3
Phase 3
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Zolgensma AVXS-101 STRONG
Spinal muscular atrophy (SMA) Type 2
BLA Filing
BLA Filing
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Entresto - Panorama
Heart failure
Phase 3
Phase 3
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Zolgensma AVXS-101 SPRINT
Pre-symptomatic patients with spinal muscular atrophy (SMA) Types 1, 2 and 3
Phase 3
Phase 3
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Zolgensma AVXS-101 STR1VE EU
Spinal muscular atrophy (SMA) Type 1
Phase 3
Phase 3
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Entresto - PERSPECTIVE
Heart failure
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
Cosentyx (secukinumab) - PREVENT
Non-radiographic axial spondyloarthritis
Approved
Approved
FDA Approval announced June 16, 2020.
UNR844
Presbyopia
Phase 2
Phase 2
Phase 2 trial has been completed.
Capmatinib
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Hydroxychloroquine
COVID-19 Coronavirus
Phase 3
Phase 3
Phase 3 enrolment to commence within the next few weeks - noted April 20, 2020.
Cosentyx
Psoriatic arthritis
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - October 31, 2019.
Cosentyx (secukinumab) - SURPASS
Ankylosing spondylitis (AS)
Phase 3
Phase 3
Head-to-head trial versus proposed biosimilar adalimumab initiated. Expected completion 2022.
Meropenem-vaborbactam
Complicated urinary tract infections (cUTI)
Approved
Approved
Approved August 29, 2017.
IONSYS
Acute postoperative pain
Approved
Approved
Approved April 30, 2015.
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Phase 3
Phase 3 data met all endpoints - September 25, 2019. Data November 18, 2019 noted LDL-C reductions of 50%.
Oritavancin
ABSSSI
Approved
Approved
Approved August 6 2014 under priority review.
Cangrelor
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
Approved
Approved
CRL April 30 2014. Approved June 22 2015
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
Phase 3
Phase 3 data met all endpoints - September 25, 2019. Detailed data due at AHA noted 58% LDL-C lowering.
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)
Phase 3
Phase 3
Phase 3 trial met all primary and secondary efficacy endpoints. Noted September 2, 2019 a 54% LDL-C lowering after 11 months and 50% over 18 months.
QAW039 (fevipiprant) - LUSTER-1
Asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 16, 2019.
Crizanlizumab
Sickle cell disease
Approved
Approved
FDA Approval announced November 15, 2019.
Biosimilar pegfilgrastim
Pegfilgrastim biosimilar
Approved
Approved
FDA Approval announced November 5, 2019.
QAW039 (fevipiprant) - ZEAL
Asthma
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - noted October 22, 2019.
RTH258 (brolucizumab)
Wet age-related macular degeneration (AMD)
Approved
Approved
FDA Approval announced October 8, 2019.
Kisqali plus fulvestrant: MONALEESA-3
Breast cancer - (post-menopausal)
Phase 3
Phase 3
Phase 3 data presented at ESMO 2019 noted HR=0.724.
QMF149
Asthma
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Zolgensma AVXS-101
Spinal muscular atrophy (SMA) Type 1
Approved
Approved
FDA Approval announced May 24, 2019.
Entresto - PARAGON-HF
HF-pEF (heart failure with preserved ejection fraction)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - July 29, 2019.
LIK066
Obesity
Phase 2
Phase 2
Program discontinued - noted July 18, 2018.
Entresto - PARALLEL-HF
Heart failure
Phase 3
Phase 3
Phase 3 trial completed 1Q 2019.
Mayzent (siponimod/BAF312)
Secondary progressive multiple sclerosis
Approved
Approved
FDA approval announced March 26, 2019.
Egaten
Fascioliasis
Approved
Approved
FDA Approval announced February 13, 2019.
Promacta (eltrombopag)
Severe aplastic anemia (SAA)
Approved
Approved
sNDA approval announced November 16, 2018.
Adalimumab
Rheumatoid Arthritis
Approved
Approved
FDA approval announced October 31, 2018.
ACZ885 (canakinumab)
CV risk reduction
CRL
CRL
CRL announced October 18, 2018.
Erenumab
Migraine
Approved
Approved
Approval announced May 17, 2018.
Fingolimod
Multiple Sclerosis (MS)
Approved
Approved
Approval announced May 11, 2018.
Biosimilar rituximab
Various blood cancers, rheumatoid arthritis.
CRL
CRL
CRL issued May 2, 2018.
Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
Approval announced May 1, 2018.
Tafinlar (dabrafenib) and Mekinist (trametinib)
Melanoma with BRAF V600E or V600K mutations
Approved
Approved
Approval announced April 30, 2018.
Cosentyx
Psoriasis
Approved
Approved
FDA approval announced February 8, 2018.
Lutathera
Inoperable progressive midgut NETs
Approved
Approved
Approved January 26, 2018. Acquired from Advanced Accelerator Applications (NASDAQ: AAAP).
Rydapt (Midostaurin - PKC412)
Acute myeloid leukemia (AML)
Approved
Approved
Priority review granted November 14, 2016. Approval announced April 28, 2017.
LEE011
HR+/HER2- advanced breast cancer
Approved
Approved
Priority review granted November 1, 2016. Approval announced March 13, 2017.
Kymriah (CTL019)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Approved
Approved
Approval announced early - August 30, 2017.
RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
Phase 3
Phase 3 data released March 22, 2017 - primary endpoints not met.
LEE011: MONALEESA-7
Breast cancer - (pre-menopausal)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 8, 2017.
Zykadia
First-line use in patients with ALK+ metastatic NSCLC
Approved
Approved
Priority review granted February 22, 2017. Approval announced May 26, 2017.
Tafinlar (dabrafenib) and Mekinist (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
Approved
FDA Approval announced June 22, 2017.

Latest News

  1. Industry Leader Joins Vasomune's Board of Directors as the Company Transitions to Clinical Development of AV-001 for the Treatment of COVID-19/pathogen-induced ARDS

    Vasomune Therapeutics, Inc., an early stage therapeutic biopharmaceutical company developing a novel first-in-class medicine for the treatment of COVID-19/pathogen-induced ARDS, today announced the appointment of Meenu Chhabra to the Company's Board of Directors. Ms. Chhabra is the President and Chief Executive Officer of Proteostasis Therapeutics, Inc. (NASDAQ:PTI).

    "Ms. Chhabra is an experienced highly regarded leader in the life sciences industry with particular expertise in operations, business development and finance," said Douglas A. Hamilton, President and Chief Executive…

    Industry Leader Joins Vasomune's Board of Directors as the Company Transitions to Clinical Development of AV-001 for the Treatment of COVID-19/pathogen-induced ARDS

    Vasomune Therapeutics, Inc., an early stage therapeutic biopharmaceutical company developing a novel first-in-class medicine for the treatment of COVID-19/pathogen-induced ARDS, today announced the appointment of Meenu Chhabra to the Company's Board of Directors. Ms. Chhabra is the President and Chief Executive Officer of Proteostasis Therapeutics, Inc. (NASDAQ:PTI).

    "Ms. Chhabra is an experienced highly regarded leader in the life sciences industry with particular expertise in operations, business development and finance," said Douglas A. Hamilton, President and Chief Executive Officer, Vasomune. "We are delighted to have Meenu join the Vasomune team as we transition to the clinic with our novel investigational medicine to treat ARDS."

    Ms. Chhabra has been serving as President and Chief Executive Officer and Director of Proteostasis Therapeutics Inc., since May 2014. From August 2007 to May 2014, Ms. Chhabra was President and Chief Executive Officer at Allozyne, Inc., a biopharmaceutical company. From December 2006 to August 2007, she served as Vice President of Business Development and Licensing at the Novartis Pharmaceuticals division of Novartis AG (NYSE:NVS). From July 2003 to November 2006, she served as Chief Business Officer at BioXell SpA, a spin-off from F. Hoffmann-LaRoche Ltd.'s Milan Research Institute (Italy), where she led corporate development and financing activities. Ms. Chhabra has also held management positions with Fresenius Kabi AG, Warner-Lambert Company, LLC, and Bristol-Myers Squibb Company (NYSE:BMY). She obtained her M.B.A. from York University and her B.Sc. from the University of Toronto. Ms. Chhabra is a member of the Biotechnology Industry Organization (BIO) Board and is a member of the Emerging Companies Section.

    "I'm excited to join Vasomune's Board and help build the company during this important transition and contribute to the company's mission of developing innovative medications for critically ill patients with ARDS and COVID-19 pneumonia," stated Ms. Chhabra.

    About AV-001

    AV-001 is an investigational medicine designed to activate the Tie2 receptor and restore normal barrier defense in the vasculature. Following trauma or infection, the body's host vascular response can become unchecked, leading to vascular leak and ultimately organ failure and death. Vasomune is developing AV-001 for the treatment of pathogen-induced moderate-to-severe ARDS. ARDS is a life-threatening condition that can develop after pneumonia, trauma, shock and sepsis, and is also the leading cause of death for patients infected with COVID-19. Prior to the onset of the coronavirus pandemic, the combined annual incidence of ARDS is approximately 370,000 patients per year in the US and EU with an average mortality rate of 40%. At present, there are no effective therapeutics to treat ARDS.

    About Vasomune Therapeutics

    Vasomune Therapeutics is a private early stage biopharmaceutical company developing the next generation of medicines to harness the body's ability to defend against illness by modifying the host vascular response. The company is transitioning in the near term to the clinic with a novel therapeutic approach to ARDS that involves targeting a signaling molecule in the vasculature responsible for regulating barrier defense. Vascular dysfunction is associated with the pathology of several disease states, including COVID-19 pneumonia, acute lung injury, acute kidney injury, hemorrhagic fever, sepsis and diabetic nephropathy. Vasomune's head office and laboratory is located in Toronto, Canada and US offices in San Mateo CA. For more information about the company and its product candidates, please visit www.vasomune.com or email the President and CEO of Vasomune at .

    View Full Article Hide Full Article
  2. Carrols Restaurant Group, Inc. ("Carrols" or the "Company") (NASDAQ:TAST) today announced that it has appointed Markus Hartmann as the Company's Vice President and General Counsel effective February 18, 2020.

    Daniel T. Accordino, Chairman and Chief Executive Officer of Carrols, commented, "Markus is a great addition to the Carrols executive team and we look forward to benefiting from his varied industry experiences and history of effective leadership. We are excited for Markus to be joining us as we strengthen Carrols' foundation of operating two world-class brands with significant scale advantages and execute on growth opportunities across our multiple attractive markets. We look forward to his building on the existing foundation of excellence…

    Carrols Restaurant Group, Inc. ("Carrols" or the "Company") (NASDAQ:TAST) today announced that it has appointed Markus Hartmann as the Company's Vice President and General Counsel effective February 18, 2020.

    Daniel T. Accordino, Chairman and Chief Executive Officer of Carrols, commented, "Markus is a great addition to the Carrols executive team and we look forward to benefiting from his varied industry experiences and history of effective leadership. We are excited for Markus to be joining us as we strengthen Carrols' foundation of operating two world-class brands with significant scale advantages and execute on growth opportunities across our multiple attractive markets. We look forward to his building on the existing foundation of excellence provided by our legal team."

    Accordino concluded, "We would also like to thank Bill Myers for his 19 years at Carrols and for serving as our General Counsel since 2012. Bill will serve in a transitionary role for a period of time after February 18, 2020."

    Mr. Hartmann is a business-oriented legal leader with experience in both public and private companies. He has practiced law in both domestic and international settings. Markus is a driven executive with experience as both a commercial and legal leader, with a distinguished career spanning more than three decades.

    Mr. Hartmann most recently was the Vice President for Technical Compliance at Mercedes-Benz Research & Development North America, Inc. (a Daimler Company) (XETR: DDAIF). During his tenure, he was responsible for establishing the technical compliance function in North America for Daimler's passenger car and vans division. Mr. Hartmann previously served as the North American General Counsel for Sandoz, Inc. (a division of Novartis) (NYSE:NVS), as well as the European and North American General Counsel for Reckitt Benckiser (LSE:RB) while living and working as an expatriate in the Netherlands.

    Earlier in his career, Mr. Hartmann flew CH-46 Helicopters as a Marine pilot during Desert Shield/Storm. After graduating from law school, then Major Hartmann was designated a Judge Advocate in the Marine Corps Reserve and served as the Staff Judge Advocate to the commander of the Combined Joint Task Force – Horn of Africa (Djibouti) in 2005. Mr. Hartmann retired from the Marine Corps Reserve at the rank of Colonel in 2014.

    He holds a JD from Harvard Law School, an MBA from Le Moyne College and a BA from The Colorado College.

    About the Company

    Carrols is one of largest restaurant franchisees in the United States, and currently operates 1,100 restaurants. It is the largest BURGER KING® franchisee in the United States currently operating 1,035 BURGER KING® restaurants and also operating 65 POPEYES® restaurants. It has operated BURGER KING® restaurants since 1976. For more information on Carrols, please visit the company's website at www.carrols.com.

    Forward-Looking Statements

    Except for the historical information contained in this news release, the matters addressed are forward-looking statements. Forward-looking statements, written, oral or otherwise made, represent Carrols' expectation or belief concerning future events. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions, plans or guidance are also forward-looking statements. Such statements reflect management's current views with respect to future events and are subject to risks and uncertainties, both known and unknown. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. Investors are referred to the full discussion of risks and uncertainties as included in Carrols' filings with the Securities and Exchange Commission.

    View Full Article Hide Full Article
    • Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1
       
    • The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA in December 2019
       
    • Comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with excellent safety profile2,3,4
       
    • Adds potentially soon-to-launch, first-in-class investigational product, leveraging significant synergies with existing global cardiovascular commercial capabilities

    Basel, January 6, 2020 Novartis AG (NYSE…

    • Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1
       
    • The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA in December 2019
       
    • Comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with excellent safety profile2,3,4
       
    • Adds potentially soon-to-launch, first-in-class investigational product, leveraging significant synergies with existing global cardiovascular commercial capabilities

    Basel, January 6, 2020 Novartis AG (NYSE:NVS) ("Novartis") today announced that it has completed the acquisition of The Medicines Company (the "Company") through the consummation of a merger of its indirect wholly-owned subsidiary, Medusa Merger Corporation ("Purchaser"), with and into the Company, with the Company surviving the merger, without a vote of the Company's stockholders in accordance with Section 251(h) of the Delaware General Corporation Law. In the merger, each share of the Company's common stock outstanding immediately prior to the effective time of the merger (other than shares owned by Novartis, Purchaser, the Company, any other subsidiary of Novartis or any subsidiary of the Company, or shares that are held in the Company's treasury or shares held by any Company stockholder who has properly demanded and perfected appraisal rights under Delaware law) has been converted into the right to receive USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding. As a result of the merger, the Company became an indirect wholly-owned subsidiary of Novartis and the Company's shares have ceased to be traded on the NASDAQ Global Select Market.

    Vas Narasimhan, CEO of Novartis, said: "Acquiring The Medicines Company and inclisiran gives Novartis a unique opportunity to open up a new chapter on the treatment of the world's leading cause of mortality and disability with a vaccine-like approach. It's a significant step forward on our journey to focus the company, to reimagine medicine, and to bend the curve of life."   

    Marie-France Tschudin, CEO, Novartis Pharmaceuticals said: "I'm looking forward to welcoming associates from The Medicines Company to Novartis. There is a real unmet need for patients living with atherosclerotic cardiovascular disease or familial hypercholesterolemia on current standard of care, who are not achieving LDL cholesterol goals and remain at significant risk of cardiovascular events. With a unique twice yearly, subcutaneous dosing regimen which integrates seamlessly with routine HCP visits, inclisiran has the potential to improve adherence and, potentially, patient outcomes for the millions of people living with ASCVD or FH."

    In December 2019, The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA for use in secondary prevention patients with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH).

    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 "potentially," "first-in-class," "investigational," "remain," "submitted," "soon-to-launch," "leveraging," "synergies," "opportunity," "step forward," "new chapter," "journey," "reimagine," "bend the curve of life," "potential," "looking forward," "will," "expected," "expectations," "expanding," "growing," "pipeline," or similar terms, or by express or implied discussions regarding potential marketing approvals for inclisiran or the other investigational products described in this press release, or new indications or labeling for Entresto or the other 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 Novartis or The Medicines Company's product, inclisiran, will achieve any particular future financial results, or that Novartis will be able to realize any of potential strategic benefits, synergies or opportunities as a result of the acquisition.  Nor can there be any guarantee that inclisiran will be submitted or approved for sale in any market, or at any particular time.  Neither can there be any guarantee that such product will be successfully commercialized even if regulatory approvals are obtained. Nor can there be any guarantee that Entresto will be commercially successful in the future.  In particular, our expectations could be affected by, among other things:  regulatory actions or delays or government regulation generally, as well as potential regulatory actions or delays with respect to the development of inclisiran; the potential that the strategic benefits, synergies or opportunities expected from the acquisition may not be realized or may take longer to realize than expected; the successful integration of The Medicines Company into the Novartis Group subsequent to the closing of the transaction and the timing of such integration; potential adverse reactions to the transaction by customers, suppliers or strategic partners; dependence on key personnel of The Medicines Company; dependence on third parties to fulfill manufacturing and supply obligations; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality, data integrity or manufacturing issues; global trends toward health care cost containment, including government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the acquisition; and other risks and factors referred to in Novartis' current Form 20-F on file with United States 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 in Cardiovascular-Renal-Metabolism
    Bending the curve of life requires addressing some of society's biggest public health concerns. Novartis has an established and expanding presence in diseases covering the heart, kidney and metabolic system. In addition to essential treatment Entresto® (sacubitril/valsartan), Novartis has a growing pipeline of potentially first-in-class molecules addressing cardiovascular, metabolic and renal diseases.

    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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at
    www.novartis.com.

    Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartisnews
    For Novartis multimedia content, please visit www.novartis.com/news/media-library
    For questions about the site or required registration, please contact  
      
    References
    1.   Novartis. Data on file
    2.   Raal FJ et al. Safety and Efficacy of Inclisiran in Patients With Heterozygous Familial Hypercholesterolemia. Data presented at: AHA Scientific Sessions 2019, Nov 16-18; Philadelphia, USA.
    3.   Wright RS et al. Inclisiran for subjects with ASCVD and elevated low-density lipoprotein cholesterol. Data presented at: AHA Scientific Sessions 2019, Nov 16-18; Philadelphia, USA
    4.   Ray K et al. Impact of inclisiran on LDL-C over 18 months in patients with ASCVD or risk-equivalent. Data presented at: European Society of Cardiology Congress, Aug 29 – Sept 2; Paris, France

    # # #

    Novartis Media Relations
    E-mail:

    Anja von Treskow
    Novartis External Communications
    +41 61 324 2279 (direct)
    +41 79 392 8697 (mobile)
     

     

    Eric Althoff
    Novartis US Communications
    +1 646 438 4335 (mobile)
     
    Meghan O'Donnell
    Global Head, Cardio-Renal-Metabolism Communications and Patient Advocacy
    +41 61 324 9136 (direct)
    +41 79 797 9102 (mobile)
     

    Novartis Investor Relations
    Central investor relations line: +41 61 324 7944
    E-mail:  

    Central   North America  
    Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052
    Pierre-Michel Bringer
    Thomas Hungerbuehler 
    Isabella Zinck
    +41 61 324 1065
    +41 61 324 8425
    +41 61 324 7188
    Cory Twining

     
    +1 862 778 3258
           
           

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  3. Basel, January 6, 2020 Novartis AG (NYSE:NVS) ("Novartis") today announced the successful completion of the previously announced tender offer by its indirect wholly-owned subsidiary, Medusa Merger Corporation ("Purchaser"), for all of the outstanding shares of common stock, par value USD 0.001 per share, of The Medicines Company (NASDAQ:MDCO) (the "Company") at a price of USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding.

    American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, has advised Purchaser that, as of 12:00 midnight, New York City time, at the end of the day on Friday, January 3, 2020 (the "Expiration Time"), the expiration of the tender offer, (i) 60,669,325…

    Basel, January 6, 2020 Novartis AG (NYSE:NVS) ("Novartis") today announced the successful completion of the previously announced tender offer by its indirect wholly-owned subsidiary, Medusa Merger Corporation ("Purchaser"), for all of the outstanding shares of common stock, par value USD 0.001 per share, of The Medicines Company (NASDAQ:MDCO) (the "Company") at a price of USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding.

    American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, has advised Purchaser that, as of 12:00 midnight, New York City time, at the end of the day on Friday, January 3, 2020 (the "Expiration Time"), the expiration of the tender offer, (i) 60,669,325 shares were validly tendered and not withdrawn in the tender offer, representing approximately 75.0% of the outstanding shares of the Company's common stock, and (ii) Notices of Guaranteed Delivery had been delivered with respect to 13,655,837 additional shares, representing approximately 16.9% of the outstanding shares of the Company's common stock.  On January 4, 2020, Purchaser accepted for payment all shares validly tendered and not withdrawn and will promptly pay for such shares.

    Novartis will promptly complete its acquisition of the Company through consummation of a merger of Purchaser with and into the Company, with the Company surviving the merger, without a vote of the Company's stockholders in accordance with Section 251(h) of the Delaware General Corporation Law. Following the merger, the Company will be an indirect wholly-owned subsidiary of Novartis, and each share of the Company's common stock outstanding immediately prior to the effective time of the merger (other than shares owned by Novartis, Purchaser, the Company, any other subsidiary of Novartis or any subsidiary of the Company, or shares that are held in the Company's treasury, or shares held by any Company stockholder who has properly demanded and perfected appraisal rights under Delaware law) will be converted into the right to receive USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding, the same consideration received by stockholders who tendered their shares in the tender offer. As a result of the merger, as of January 6, 2020, the Company common stock will cease to be traded on the NASDAQ Global Select Market.

    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 "will," "promptly," "complete," "subject to," "expanding," "growing," "potentially," "first-in-class," "pipeline" or similar terms, or by express or implied discussions regarding the proposed acquisition of the Company by Novartis. 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 proposed acquisition described in this press release will be completed, or that it will be completed as currently proposed, or at any particular time.  Neither can there be any guarantee that Novartis or The Medicines Company's product, inclisiran, will achieve any particular future financial results, or that Novartis will be able to realize any of potential strategic benefits, synergies or opportunities as a result of the proposed acquisition.  Nor can there be any guarantee that inclisiran will be submitted or approved for sale in any market, or at any particular time.  Neither can there be any guarantee that such product will be successfully commercialized even if regulatory approvals are obtained. Nor can there be any guarantee that Entresto will be commercially successful in the future. In particular, our expectations could be affected by, among other things:  regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential acquisition described in this release, as well as potential regulatory actions or delays with respect to the development of inclisiran; potential failures to meet remaining closing conditions; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the successful integration of The Medicines Company into the Novartis Group subsequent to the closing of the transaction and the timing of such integration; potential adverse reactions to the proposed transaction by customers, suppliers or strategic partners; dependence on key personnel of The Medicines Company; dependence on third parties to fulfill manufacturing and supply obligations; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality, data integrity or manufacturing issues; global trends toward health care cost containment, including government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the proposed acquisition; and other risks and factors referred to in Novartis' current Form 20-F on file with United States 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 in Cardiovascular-Renal-Metabolism
    Bending the curve of life requires addressing some of society's biggest public health concerns. Novartis has an established and expanding presence in diseases covering the heart, kidney and metabolic system. In addition to essential treatment Entresto® (sacubitril/valsartan), Novartis has a growing pipeline of potentially first-in-class molecules addressing cardiovascular, metabolic and renal diseases.

    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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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  4. EAST HANOVER, N.J., Dec. 9, 2019 /PRNewswire/ -- Novartis today announced results from two analyses of real-world experience with Kymriah® (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications. These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with evidence of the Kymriah real-world experience in expanded groups of patients. When Kymriah was used in the real-world setting, efficacy and safety were consistent when compared to the pivotal trials, including the 24-month analysis of JULIET in adults with r/r diffuse large B cell lymphoma (DLBCL) and ELIANA in children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL…

    EAST HANOVER, N.J., Dec. 9, 2019 /PRNewswire/ -- Novartis today announced results from two analyses of real-world experience with Kymriah® (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications. These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with evidence of the Kymriah real-world experience in expanded groups of patients. When Kymriah was used in the real-world setting, efficacy and safety were consistent when compared to the pivotal trials, including the 24-month analysis of JULIET in adults with r/r diffuse large B cell lymphoma (DLBCL) and ELIANA in children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL)1-6. The real-world experience data were presented at the 61st American Society of Hematology (ASH) annual meeting.

    "With increased experience supplemented by real world data, physicians like myself have a better understanding of Kymriah and its safety profile," said lead author of this real-world experience analysis, Samantha Jaglowski, MD, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). "This along with the current practice of supportive care for CAR-T therapy provides the ability to routinely use this therapy in the hospital outpatient setting, which can reduce financial burden on patients and hospitals alike1,7."  

    Real-world experience with Kymriah in adults with r/r DLBCL

    Efficacy
    Efficacy outcomes for patients who received Kymriah in the real-world setting were similar to those demonstrated in JULIET. In this analysis of 80 patients with r/r DLBCL for whom three or more months of post-infusion outcomes were available, the overall response rate (ORR) was 58% including 40% who achieved a complete response (CR). Median follow-up was 4.5 months1. In the 24-month analysis of the JULIET trial, ORR was 52% and CR was 38% (N=115) 3.

    Safety
    The anticipation and management of adverse events of CAR-T cell therapy have been crucial to successful administration of this innovative and relatively new type of therapy. In this analysis of real-world experience with Kymriah (safety set, N=83), the rate of grade 3 or higher cytokine release syndrome (CRS) and neurologic events were approximately 4% and 5%, respectively, as compared to 23% and 11% in the JULIET clinical trial (safety set, N=115), suggesting safety outcomes appear more favorable. The real-world analysis used the grading scales ASTCT for CRS and ICANs for neurologic events, whereas the JULIET trial used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic events1,3.

    Further, for patients who had CRS, tocilizumab and corticosteroids were administered in 20% and 4% of patients, respectively, in the real-world setting, and in 27% and 19% of patients, respectively, in the JULIET trial8. Some patients in the real-world setting received tocilizumab earlier than in the clinical trial experience, indicating earlier use of supportive care may mitigate rates of high-grade CRS9. A total of 14 DLBCL patients died after treatment, all due to disease progression, however no deaths were attributed to toxicities from Kymriah1.

    Patient and product characteristics
    More patients in the real-word analysis had a worse performance status, and on average, these patients were older and had received more lines of therapy than those treated in the JULIET trial1-3.

    Cell viability is one of many product release specifications for Kymriah. The commercial specification for the viability specification of Kymriah in the United States is set at greater than or equal to 80%. For all other markets where Kymriah is approved, the cell viability specification is greater than or equal to 70%. In this US real-world analysis, 29 of the 102 patients with evaluable data received product that was below 80% cell viability. Efficacy and safety for patients receiving product with cell viability below the commercial specification was the same as those receiving commercial Kymriah1.

    These data on the use of Kymriah in r/r DLBCL in the real-world setting will be presented in an oral session at the ASH annual meeting (Abstract # 766; Monday, December 9, 3:30 PM EST).

    "As pioneers in bringing CAR-T cell therapy to patients, our dedication to reimagining how CAR-T cell therapy can impact patients in the future remains steadfast," said Susanne Schaffert, PhD, President, Novartis Oncology. "Our efforts include gathering and sharing real-world evidence, expanding and improving our manufacturing capacity and technology and going broader and deeper in our clinical research with Kymriah and other CAR-T cell therapies."

    Real-world experience with Kymriah in children and young adults with r/r ALL
    Efficacy outcomes were similar and safety outcomes appear to be more favorable in the real world setting compared to the ELIANA pivotal trial4-6. Among 146 children and young adult patients with r/r ALL treated in the real world setting for whom three or more months of post-infusion outcomes were available, CR was 85% as compared to 82% in the ELIANA trial (n=79). Median follow-up in the real-world analysis was 6 months. In this analysis (safety set, N=154), the rate of grade 3 or higher CRS and neurologic events were 14% and 8%, respectively, as compared to 48% and 13% in the ELIANA clinical trial. The real-world analysis used the grading scales ASTCT for CRS and ICANs for neurologic events, whereas the ELIANA trial used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic events4-6.

    "It is exciting to see how oncologists are using Kymriah and how patients are responding to it in routine clinical practice," said Stephan A. Grupp, MD, PhD, Director of the Cancer Immunotherapy Program and Section Chief of Cell Therapy and Transplant at Children's Hospital of Philadelphia, and a Professor of Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. "We are seeing broader efficacy data that replicate what we saw in the pivotal trial, and the collection of these data is ensuring that we are getting a clear view of adverse events when administering Kymriah."

    These data on the use of Kymriah in r/r pediatric ALL in the real-world setting will be presented in a poster presentation at the ASH annual meeting (Abstract #2619; Sunday, December 8, 6:00 – 8:00 PM EST).

    The collection of this real-world experience data was made possible by a collaboration between the CIBMTR® (Center for International Blood and Marrow Transplant Research – the research collaboration between the National Marrow Donor Program®/Be The Match® and the Medical College of Wisconsin) and Novartis, developed to capture long-term follow-up of recipients of Kymriah who agree to participate in the registry. For patients whose cell viability was below 80%, product is provided through an established EAP program and long-term follow-up is captured through the CIBMTR. Globally, 90% patients who have been prescribed Kymriah have received the final manufactured product, either commercially, or when out of commercial specification.

    Kymriah® (tisagenlecleucel, formerly CTL019) US Important Safety information
    Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

    Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

    Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

    Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

    Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient's healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

    Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

    After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

    Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.

    Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

    Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

    Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah. 

    Please see the full Prescribing Information for Kymriah, including Boxed WARNING, and Medication Guide at www.Kymriah.com 

    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," "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. 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 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.

    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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Novartis Pharmaceuticals Corporation, a US affiliate of Novartis, is located in East Hanover, NJ. Find out more at www.novartis.com

    Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartisnews and follow @NovartisCancer at https://twitter.com/NovartisCancer

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    References

    1. Jaglowski S., et al. Tisagenlecleucel Chimeric Antigen Receptor (CAR) T-Cell Therapy for Adults with Diffuse Large B-Cell Lymphoma (DLBCL): Real World Experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [abstract]. In: The 61st ASH Annual Meeting.; December 7-10; Orlando, Florida.
    2. Schuster S.., et al. Tisagenlecleucel in Adult Relapsed/Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. December 2018
    3. Bachanova V., et. al. Correlative Analyses of Cytokine Release Syndrome and Neurological Events in Tisagenlecleucel-Treated Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients. ICML 2019 abstract #254
    4. Grupp S., et al. Tisagenlecleucel Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Children and Young Adults with Acute Lymphoblastic Leukemia (ALL): Real World Experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [abstract]. In: The 61st ASH Annual Meeting.; December 7-10; Orlando, Florida.
    5. Maude S., et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439–48
    6. Grupp S., et al. Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #112599.
    7. Broder M., et al. Economic Burden of Neurologic Toxicities Associated with Treating Relapsed or Refractory Diffuse Large B-Cell Lymphoma in the United States [abstract]. In: The 61th ASH Annual Meeting.; December 7-10; Orlando, Florida.
    8. Schuster S.., et al. Consensus Grading of Cytokine Release Syndrome (CRS) in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) Treated with Tisagenlecleucel on the JULIET Study. Poster #4190
    9. Novartis Data on file.

     

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