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July 04, 2015 4:10 PM ET

Pharmaceuticals

Company Overview of Novartis International AG

Company Overview

Novartis International AG offers research, development, manufacture, and marketing of pharmaceuticals. The company manufactures drugs such as clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate and (Gleevec / Glivec). Additional agents include ciclosporin (Neoral / Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others. Novartis International AG is based in Basel, Switzerland. Novartis International AG operates as a subsidiary of Novartis AG.

Lichtstrasse 35

Basel,  4056

Switzerland

Phone:

41 61 324 11 11

Fax:

41 61 324 80 01

Key Executives for Novartis International AG

Chief Executive Officer
Age: 55
Division Head of Alcon
Age: 41
Division Head of Sandoz
Senior Vice President and Head of Corporate Strategy
Compensation as of Fiscal Year 2015.

Novartis International AG Key Developments

Novartis International AG Announces Long-Term Safety and Efficacy Results from Pivotal Phase III RESPONSE Study Evaluating Jakavi(R) (ruxolitinib) for Treatment of Patients with Polycythemia Vera (PV)

Novartis International AG announced long-term safety and efficacy results from the pivotal Phase III RESPONSE study evaluating Jakavi(R) (ruxolitinib) for the treatment of patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. A preplanned analysis of the study at 18 months demonstrated that 80% of patients with inadequately controlled PV treated with Jakavi experienced a durable response of sustaining hematocrit less than 45% without the use of phlebotomy and reducing spleen size, two key measures of disease control, for at least one year. In the Phase III study, 83% of patients with PV randomized to Jakavi were still receiving treatment at 18 months compared to 0 patients on the best available treatment arm. Results also show that Jakavi-treated patients who achieved hematocrit control without phlebotomy had an 89% probability of maintaining their response for 18 months from the time of their initial response and all patients who had an initial spleen response maintained their reduction in spleen size. Of the patients on the Jakavi arm at week 32, 90% of patients did not have a phlebotomy between weeks 32 and 80. In addition, patients treated with Jakavi who achieved complete hematologic remission at week 32 had a 69% probability of maintaining their response for at least 18 months from the time of their initial response. A separate analysis of the study at 18 months demonstrated treatment with Jakavi also led to sustained control of white blood cell and platelet levels, important PV hematologic parameters, with the reductions for patients with the most elevated values at baseline. Overall, Jakavi was well tolerated. In the Jakavi-treatment arm, the rate for Grade 3 or 4 anemia and thrombocytopenia was 0.9 and 2.6 events per 100 patient-year exposure, respectively, and did not increase from the week 48 analysis. The most common non-hematologic adverse events (AEs) in the Jakavi arm were headache, diarrhea, pruritus and fatigue, which were mainly Grade 1 or 2. Treatment discontinuation due to AEs remained low in the Jakavi arm (4.5%).

Novartis International AG Announces Phase III Study of Arzerra(R) Met Primary Endpoint of Improved Progression-Free Survival in Patients with Relapsed CLL

Novartis International AG announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra(R) (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed chronic lymphocytic leukemia (CLL) (p=0.0036). The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed. CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately 1 in 4 cases of leukemia. COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone. The primary endpoint of the study was PFS was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines. Secondary endpoints included overall response, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life. Arzerra is not approved for this indication and the company will further analyze the data from the COMPLEMENT 2 study and plans to share the results with regulatory agencies to evaluate the potential for future regulatory filings.

Novartis International AG Signs Collaboration and Licensing Agreements with Intellia Therapeutics and Caribou Biosciences

Novartis International AG announced that it has signed collaboration and licensing agreements with Intellia Therapeutics for the discovery and development of new medicines using CRISPR genome editing technology and Caribou Biosciences for the development of drug discovery tools. The alliance with Intellia combines the resources, research expertise and cell and gene therapy leadership at the Novartis Institutes for BioMedical Research with Intellia's rapidly growing CRISPR expertise and organization. Research and development activities will focus on using CRISPR ex vivo for engineering chimeric antigen receptor T-cells (CARTs) and hematopoietic stem cells (HSCs). The collaboration and licensing agreement with Caribou is focused on using Caribou's foundational CRISPR platform and intellectual property as a research tool for drug discovery. Under the terms of the agreement with Intellia, Novartis is receiving exclusive rights to develop all collaboration programs focused on engineered CARTs and the right to develop an undisclosed number of targets for ex vivo editing of HSCs. In addition Novartis receives non-exclusive rights for limited in vivo therapeutic applications of CRISPR systems. Novartis is increasing its equity investment in Intellia, is making an upfront payment and will provide technology access fees and funding for R&D programs during the 5-year term of the collaboration. Intellia is also eligible to receive downstream success-based milestones and royalties. Under the terms of the agreement with Caribou, Novartis is receiving non-exclusive rights to Caribou's CRISPR platform for research conducted during the collaboration and is providing funding for the one-year research program. Novartis is also making an equity investment in the company.

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