Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms

NovartisThroughout 2018, Novartis took strong action to focus the company and its capital towards the Innovative Medicines Division, resulting in an industry leading pipeline. Today Novartis holds an R&D and investor update in London which will provide deeper insights into the pipeline including the below.

Progressing cell, gene and radioligand therapy platforms with 13 therapies in clinical development, and 9 more expected to enter the clinic in 2019. The potentially foundational gene therapy AVXS101 delivers rapid, transformational and durable benefit in SMA Type 1, with regulatory approvals expected in US, EU and Japan in H1 2019. In Radioligand therapy, Novartis acquired AAA and successfully launched Lutathera in NET and has projects in development for indications beyond NET. Novartis announced the planned acquisition of Endocyte, which would expand the radioligand platform. Novartis also highlights one of the most comprehensive CAR-T development programs across multiple indications.

Novartis is advancing a pipeline of medicines with potential to change the standard of care in high burden disease areas. In multiple sclerosis, Mayzent (siponimod, formerly BAF312) is expected to launch in Q1 2019 as the first and only drug proven to delay progression for typical patients living with SPMS. Also in MS, OMB157 (ofatumumab) is a next generation B-cell depletor with a potentially favorable safety profile from faster b-cell repletion and preserved immunity, and with a convenient monthly sub-cutaneous dosing. In moderate to severe asthma, QAW039 (fevipiprant) is targeting a unique profile of biologic efficacy with oral simplicity. In nAMD, RTH258 (brolucizumab) has the potential to reduce treatment burden by drying the retina better with fewer injections. In sickle cell disease, SEG101 (crizanlizumab) is a promising treatment with data from a pivotal trial showing patients have more Vaso-occlusive Crisis-free days and regulatory filings are expected in 2019. In lung cancer, ACZ885 (canikinumab) has three phase lll trials in adjuvant NSCLC, 1st line NSCLC, and 2nd line NSCLC with an opportunity to become the standard of care in these settings.

Maximizing the potential of in-line brands with new data is a key development priority. Novartis is pursuing new indications and building out the data profile for Cosentyx, Entresto and Gilenya. Cosentyx is expected to be Novartis' largest drug next year, with robust growth in all three approved indications, PSO, PSA and AS. Confidence in Cosentyx comes from 100 studies and an extensive phase III clinical trial program, including PREVENT in non-radiographic axial spondyloarthropathy, a potential fourth indication. Entresto's position in HFrEF is being strengthened by new data that could increase initiation of therapy in hospitals. Entresto also has the potential to be the first approved treatment for HFpEF with the PARAGON-HF trial, with results expected in 2019. Gilenya continues to benefit from a wealth of data flow, including the recent approval for pediatric use as well as the ASSESS trial which showed superiority to Copaxone®.

Additional Information and Where to Find It

This presentation may be deemed to be solicitation material in respect of the proposed acquisition of Endocyte by Novartis AG. In connection with the proposed acquisition, Endocyte filed a preliminary proxy statement with the SEC on October 31, 2018, and intends to file other relevant materials with the SEC, including Endocyte's proxy statement in definitive form. Stockholders of Endocyte are urged to read these materials (including any amendments or supplements thereto) and all other relevant documents filed with the SEC when such documents become available, including Endocyte's definitive proxy statement, because they will contain important information about the proposed acquisition. Investors and security holders are able to obtain the documents (once available) free of charge at the SEC's web site, http://www.sec.gov, or from Endocyte by going to its investor relations web site at http://investor.endocyte.com/investor-relations.

Participants in Solicitation

Novartis AG and its directors and executive officers, and Endocyte and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the holders of Endocyte shares of common stock in respect of the proposed acquisition. Information about the directors and executive officers of Novartis AG is set forth in the excerpts of Novartis AG's Annual Report for 2017, which was furnished to the SEC on Form 6-K on January 24, 2018 and incorporated by reference into Novartis AG's Annual Report on Form 20-F for the fiscal year ended December 31, 2017. Information about the directors and executive officers of Endocyte is set forth in the proxy statement for Endocyte's 2018 Annual Meeting of Stockholders, which was filed with the SEC on March 23, 2018. Information regarding interests of Endocyte's participants in the solicitation is set forth in Endocyte's preliminary proxy statement relating to the proposed acquisition, and will be set forth in other materials to be filed with the SEC relating to the proposed acquisition, including Endocyte's definitive proxy statement.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125,000 people of more than 140 nationalities work at Novartis around the world.

Most Popular Now

Cancer cells are quick-change artists adapting to …

Until now, researchers have assumed that the growth of solid tumors originates from cancer stem cells characterized by specific surface markers, which develop in a fixed...

Nucala (mepolizumab) gains FDA approval for two ne…

GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjec...

Cannabis use among older adults rising rapidly

Cannabis use among older adults is growing faster than any other age group but many report barriers to getting medical marijuana, a lack of communication with their docto...

Jeff Settleman, Ph.D., joins Pfizer to lead Oncolo…

Pfizer Inc. (NYSE: PFE) announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading al...

Cleveland researchers test novel gene therapy for …

A novel gene therapy clinical trial at University Hospitals Seidman Cancer Center and the Case Comprehensive Cancer Center is showing promising results, garnering funding...

Merck pioneers new effort to see MS from the insid…

Merck, a leading science and technology company, joins the global multiple sclerosis (MS) community in recognition of World MS Day, an initiative created by the Multiple ...

Full data from CAROLINA® outcome trial support lon…

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA® trial demonstrating that Trajenta® (linagliptin) did not increase cardio...

Bristol-Myers Squibb announces post-closing leader…

Bristol-Myers Squibb Company (NYSE:BMY) today announced the future leadership team of the combined company effective upon completion of the company’s pending merger with ...

Novartis Kisqali significantly extends life in wom…

Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated K...

Amgen joins with community oncology networks for n…

Amgen (NASDAQ: AMGN), along with leading community oncology networks, today announced the launch of Amgen Community Oncology Research Collaborators (ACORC), a new initiat...

Bayer receives U.S. FDA breakthrough therapy desig…

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for copanlisib (Aliqopa™) for the treatment of adult patie...

Prescription drug costs steadily soar, yet price t…

After reviewing tens of millions of insurance claims for the country’s 49 most popular brand-name prescription drugs, a team from Scripps Research Translational Institute...