- Pharmaceuticals Division growth over the next 5 years expected to bedriven by portfolio of recently launched products
- Division had 7 blockbusters in portfolio in 2011 and expects to achieve 14 or more blockbusters by 2017
- Industry-leading Pharmaceuticals pipeline with 73 new compounds presented:
- 9 key regulatory milestones achieved so far in 2012
- Over the next 12 months, data read out of 13 late-stage pipeline projects, 9 filings and up to 7 regulatory decisions expected
- Oncology pipeline, AIN457 and heart failure (LCZ696 and RLX030) expected to provide significant newsflow; filing of RLX030 planned to commence in early 2013 in US and EU
- LAMA/LABAs, including QVA149 have potential to become new standard of care for COPD
- Oncology business aims to grow through Glivec patent expiry
- Robust late stage pipeline including 13 new chemical entities and 19 new indications
- Oncology late-stage pipeline products expected to contribute more than USD 1 billion in sales by 2017
- Afinitor now expected to contribute USD 2 billion sales in advanced breast cancer alone by 2017
- Start of broad scale clinical development program announced for leading PI3K inhibitor BKM120 across multiple indications (PRISM)
Basel, 10-11-2012 — /europawire.eu/ — Novartis today will provide an update on its leading Research and Development (R&D) pipeline and plans for turning these assets into commercial success to provide the basis for continued growth of the Group through 2017. Continuing R&D productivity in the Pharmaceuticals Division has fueled an industry-leading pipeline with 139 projects in clinical development with more than 73 New Molecular Entities (NMEs) across a multitude of disease areas. Highlights include RLX030 and LCZ696 in heart failure as well as AIN457 in psoriasis and multiple sclerosis. In addition, the company will showcase a comprehensive early and late-stage pipeline of novel oncology compounds.
“As a science-driven company, Novartis is focused on innovation to address unmet medical needs for patients around the world.” said Joseph Jimenez, CEO of Novartis. “As a result, our leading pipeline in all phases of development positions us well for continued future growth.”
Leading pipeline positions Pharmaceuticals for sustained future growth
Novartis Group continues to lead the industry with 56 new approvals in the US, Europe, Japan and China since 2007. In 2012 alone, the Pharmaceuticals division has received 9 approvals or positive recommendations to date.
Novartis Pharmaceuticals has established a strong foundation for the company’s ongoing growth based on currently marketed products. In addition for the next 12 months, Pharmaceuticals expects data read-out on 13 pivotal studies, 9 filings and 7 regulatory decisions. For the following 13 to 24 months, strong pipeline newsflow is expected to continue with a further 11 pivotal trials read-out, 11 filings and 10 regulatory decisions.
As evidenced by the recent launches of Afinitor, Seebri Breezhaler, Jakavi andSignifor, Novartis has a proven track record of bringing innovative products to market. With the current marketed portfolio, Pharmaceuticals is expected to grow from the second half of next year despite loss of exclusivity on mature brands like Diovan,Zometa and Aclasta.
Oncology aims for continued growth through Glivec patent expiry
The Novartis Oncology portfolio has delivered approvals for 6 indications including 2 new molecular entities so far this year and anticipates continued growth over the next five years. One of the major growth drivers, Afinitor, has five indications already approved and has the potential to exceed sales of USD 2 billion in breast cancer alone by 2017. In addition, launches of Jakavi and the planned launches of pipeline projects such as BKM120 for various tumors and LDK378 in lung cancer have the potential to contribute more than USD 1 billion in sales by 2017.
Tasigna: “Path to Cure” – a potential paradigm shift in CML treatment
Novartis has transformed Ph+ chronic myeloid leukemia (CML) to a treatable, chronic condition and is again on the way to redefine what is possible in CML. The new goal is for patients to live free of drug therapy once they have achieved long-term response to treatment. Tasigna, a potent 2nd generation targeted therapy for CML, has demonstrated a reduced risk of progression and deeper and more sustained molecular response than Glivec. Based on these advances, as well as advances in molecular response monitoring, in 2013 the company plans to initiate Tasigna clinical trials to explore the goal of achieving sustained treatment-free remission in patients living with CML. If positive, this could lead to a major paradigm shift in CML treatment.
PRISM: a broad scale program for BKM120, a pan-PI3K inhibitor
Novartis has initiated a broad scale clinical development program named PRISM for its leading PI3K inhibitor BKM120 across multiple indications, both as a single agent and in combination with other therapeutic agents in various breast cancer settings, as well as other indications.
The company also plans to initiate pivotal studies of LDK378, an ALK inhibitor that has shown potent activity in patients with Alk+ non-small cell lung cancer (NSCLC) as well as activity on brain metastases, in December 2012. Additional trials planned for 2013 and regulatory filings expected to begin in 2014 if trials are successful.
Next wave of promising pipeline newsflow
Strong data in heart failure
Recently presented data for RLX030 show that patients receiving a single infusion of RLX030 had both short-term and long-term benefits. In the short term, RLX030 treated patients had improved heart failure symptoms such as dyspnea (shortness of breath) and edema, in addition to having a shorter stay in the hospital. The long term benefits of RLX030 resulted in a statistically significant 37% reduction in cardiovascular mortality and all-cause mortality. Furthermore, fewer patients treated with RLX030 had worsening of heart failure as measured on day 5 and day 14 after treatment. Worsening of heart failure during hospitalization was defined as intensification of intravenous therapy or mechanical ventilator or circulatory support. Based on these findings of the RELAX-AHF study, Novartis plans to initiate regulatory filings for RLX030 in early 2013 in the US and Europe.
Comprehensive clinical program in COPD
Novartis is also progressing its comprehensive clinical program in respiratory to meet the needs of patients with chronic obstructive pulmonary disease (COPD). QVA149 has the potential to establish a new standard of care for patients with COPD, preventing exacerbations and showing improvement in bronchodilation compared to placebo and current standard of care. Across numerous clinical studies, QVA149 enables the limited use of inhaled corticosteroids (ICS) as rescue medications as recommended by the GOLD treatment guidelines for COPD.
IL-17 as promising target in psoriasis and other indications
Clinical data for AIN457, a highly effective novel IL-17 inhibitor, across multiple disease areas including psoriasis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis were presented. In Phase II clinical studies, AIN457 has shown rapid improvement of psoriasis signs and symptoms in patients with moderate to severe psoriasis. Phase III studies for AIN457 in this setting are ongoing with regulatory filings expected to start in late 2013. In addition, the company is investigating AIN457 across multiple indications including multiple sclerosis.
Innovative initiatives showcase how to accelerate development; managing more projects at stable cost level
The discovery process in the Novartis Institute of BioMedical Research (NIBR) focuses on disorders where there is unmet medical need and good mechanistic understanding. This approach has increased the success rate from pre-clinical through Phase 2 trials to more than 20%, three times the industry average. Companion diagnostics and biomarkers, especially in oncology, where most Phase I and II trials have patient selection markers included, have enabled early patient selection for clinical trials, reducing overall development timelines and costs. As a result, Novartis has shown greater than average pipeline return on investment achieving highest average annual peak sales of first launched productsamongst industry.
In addition, Novartis is striving to increase efficiency and productivity to manage more projects while keeping costs at a stable level. Introducing novel technologies and methods reduce recruitment time and trial costs, while improving study quality and patient comfort and safety. These include mobile field monitoring, continuous manufacturing and Telehealth. In addition, through a research initiative with Walgreens in the US, clinical trials will provide more real-world evidence and lower access barriers for participants.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group’s continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Disclaimer
This press release contains forward-looking statements that can be identified by terminology such as “future growth prospects,” “pipeline,” “expects,” “expected,” “planned,” “potential,” “aims,” “will,” “plans,” “recommendations,” “projected,” “promising,” “anticipates,” “could,” “goal,” “can,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such existing or potential new products will achieve any particular revenue levels, or at any particular time. Nor can there be any guarantee that the Group, or any of its divisions, will achieve any particular financial results. In particular, management’s expectations could be affected by, among other things, the inherent difficulties and uncertainties involved in making predictions about events expected to take place in the medium- to long-term future; unexpected clinical trial results, including additional analyses of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; government, industry, and general public pricing pressures; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; competition in general; the Group’s ability to obtain or maintain patent or other proprietary intellectual property protection, including the ultimate extent of the impact on the Group of the loss of patent protection on key products which commenced last year and will continue this year; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, shareholder litigation, government investigations and intellectual property disputes; unexpected product manufacturing and quality issues, including the potential outcomes of the Warning Letter issued to us with respect to three Sandoz manufacturing facilities, and the potential outcome of efforts to restart production of products formerly produced at the Consumer Health manufacturing facility at Lincoln, Nebraska; uncertainties regarding the effects of the ongoing global financial and economic crisis, including the financial troubles in certain Eurozone countries; uncertainties regarding future global exchange rates; the impact that the foregoing factors could have on the values attributed to the Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. 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 as a result of new information, future events or otherwise.
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- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP