May 28, 2017 3:50 PM ET

Pharmaceuticals

Company Overview of Novartis Pharmaceuticals Corporation

Company Overview

Novartis Pharmaceuticals Corporation researches, develops, manufactures, and markets medicines and treatments for helping patients and improving patient care. It offers prescription drugs to treat various diseases and conditions, including cancer, cardiovascular, central nervous system, endocrine, inflammatory, ophthalmic, infectious, neurological, organ transplantation, psychiatric, respiratory, skin, and infectious diseases and conditions. The company also provides patient assistance programs to manage diseases and conditions. Novartis Pharmaceuticals Corporation was formerly known as Sandoz Pharmaceuticals Corporation and changed its name to Novartis Pharmaceuticals Corporation in March 1...

One Health Plaza

East Hanover, NJ 07936-1080

United States

Founded in 1968

Phone:

973-781-8300

Fax:

973-781-8265

Key Executives for Novartis Pharmaceuticals Corporation

President, US Country Head and President of Novartis Corporation
Chief Financial & Administrative Officer and Vice President
Chief Compliance Officer, Vice President and Us Country Head of Ethics & Compliance
Vice President, General Counsel and US Country Head of Legal
Vice President of Communications and US Country Head of Communications
Compensation as of Fiscal Year 2016.

Novartis Pharmaceuticals Corporation Key Developments

Novartis Pharmaceuticals Corporation's CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with R/r DLBCL

Novartis Pharmaceuticals Corporation announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is the second indication for which CTL019 has received this designation; the first being for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients. CAR-T cell therapy is different from typical small molecule or biologic therapies currently on the market because it is manufactured for each individual patient. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient's cancer cells and other B-cells expressing a particular antigen. CTL019 was first developed by the University of Pennsylvania (Penn). In 2012, Novartis and Penn entered into a global collaboration to further research, develop and then commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Through the collaboration, Novartis holds the worldwide rights to CARs developed with Penn for all cancer indications. In March 2017, Novartis announced that the FDA accepted the company's Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r pediatric and young adult patients with B-cell ALL. The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study (NCT02445248), which is evaluating the efficacy and safety of CTL019 in adult patients with r/r DLBCL. JULIET is the second global CAR-T trial, following the Novartis ELIANA study (NCT02435849) investigating CTL019 in r/r B-cell ALL. Findings from JULIET are expected to be presented at an upcoming medical congress.

Cota Healthcare Announces Major Multi-Year Collaboration with Global Pharmaceutical Leader to Advance Innovative Therapies for Breast Cancer Patients

Cota Healthcare announced the signing of a major, multi-year collaboration with Novartis Pharmaceuticals Corporation to help improve clinical and cost outcomes for breast cancer patients. As part of this agreement, which expands significantly on the previous announced collaboration entered into January 2016, teams from across Novartis Pharmaceuticals Corporation will leverage Cota's research-grade, real-world evidence, web-based analysis and visualization tools, and be supported by Cota's medical, data science, and technology experts. Utilizing the real-world evidence and technology platform supplied by Cota is expected to enable Novartis Pharmaceuticals Corporation to accelerate clinical development of new therapies for breast cancer and identify which patients will benefit most. Cota's platform is powered by the patented Cota Nodal Address™ (CNA) system, a digital classification methodology that stratifies patients based on all the personal and clinical factors that matter to the individual. Each patient with the same CNA can be considered medically identical, and thus should have similar treatments and outcomes.

Novartis Drug Zykadia Receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

Novartis announced that the US Food and Drug Administration (FDA) accepted the company's supplemental New Drug Application (sNDA) for filing, and granted priority review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain. The sNDA submission for first-line use of Zykadia is based on the primary analysis of ASCEND-4, a global Phase III, randomized, open-label, multicenter clinical trial which evaluated safety and efficacy of Zykadia compared to platinum-based chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK+ NSCLC. The study was conducted at 134 clinical trial sites across 28 countries, and randomized across 376 patients. The study found: Patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance. A 45% risk reduction in PFS was obtained in the Zykadia arm compared to the chemotherapy arm (hazard ratio [HR] = 0.55, [95% CI: 0.42, 0.73; one-sided p value <0.001]. In a pre-specified analysis of patients receiving Zykadia without brain metastases at screening, patients experienced a median PFS of 26.3 months (95% CI: 15.4, 27.7), compared with 8.3 months (95% CI: 6.0, 13.7) among patients treated with chemotherapy (HR = 0.48 [95% CI: 0.33, 0.69]. In a pre-specified analysis of patients receiving Zykadia with brain metastases at baseline, the median PFS was 10.7 months (95% CI: 8.1, 16.4) in the Zykadia group versus 6.7 months (95% CI: 4.1, 10.6) in the chemotherapy group (HR = 0.70 [95% CI: 0.44, 1.12]. Intracranial overall response rate (ORR) (72.7%, [95% CI: 49.8, 89.3]) is consistent with whole body ORR (72.5% [95% CI: 65.5, 78.7].

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