Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Kymriah (tisagenlecleucel, formerly CTL019) - a novel one-time treatment that uses a patient's own T cells to fight cancer. The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory (r/r) after two or more lines of systemic therapy in adults.
Novartis announced its intention to spinoff Alcon, its eye care division, into a separately traded standalone company. The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies. Completion of the transaction is subject to general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval at the 2019 AGM in line with Swiss corporate law. Novartis also announced that it will initiate a share buyback of up to USD 5 billion to be executed by the end of 2019.
Novartis announced results from a new comparison study showing that Jakavi (ruxolitinib)-treated patients with polycythemia vera (PV), who were resistant or intolerant to hydroxyurea (HU), had a significantly reduced risk of thrombosis (blood clots) and death compared to PV patients who received best available therapy. The study findings are based on a comparison of patients in the Phase III RESPONSE Jakavi clinical trial and the real-world Spanish GEMFIN patient registry. PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack.
Sandoz announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly (infliximab) and biosimilar Erelzi (etanercept). Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi showed that each biosimilar matched its reference biologic in terms of safety, efficacy and quality, reinforcing previously presented findings. The research also indicated that switching from the reference medicine to the biosimilar did not affect safety, efficacy or immunogenicity.
Novartis announced that the Journal of Clinical Oncology has published results of an analysis of the impact of Lutathera (lutetium Lu 177 dotatate) treatment on time to deterioration in HRQoL in the pivotal phase III NETTER-1 trial. The data demonstrate that treatment with Lutathera provides significantly longer time to deterioration of quality of life for patients with progressive midgut Neuroendocrine tumors (NETs) compared to octreotide LAR alone.
Novartis announced positive results from the third Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer. MONALEESA-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. MONALEESA-3 is the largest phase III trial to evaluate efficacy and safety of a CDK4/6 inhibitor plus fulvestrant in multiple advanced breast cancer patient populations - first-line and second-line settings.
Novartis announced the completion of the divestment to GlaxoSmithKline PLC of its 36.5 percent stake in a consumer healthcare joint venture (JV) for a total consideration of USD 13.0 billion. The divestment was completed in accordance with the terms of the transaction announced on March 27, 2018 and brings to an end Novartis' participation in the JV, which was formed in 2015 as part of Novartis' portfolio transformation.
Sandoz announced that the CHMP has adopted a positive opinion for marketing authorization of proposed biosimilar adalimumab. The CHMP opinion recommends the proposed Sandoz biosimilar adalimumab for treatment of all indications of its reference medicine including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.
Novartis announced the CHMP has recommended approval for Aimovig (erenumab) for the prevention of migraine in adults who have at least four migraine days per month.
Novartis announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA).
Sandoz announced that the European Commission (EC) has approved Zessly (infliximab) for use in Europe.
Novartis announced that the US FDA has approved Aimovig (erenumab) for the preventive treatment of migraine in adults.
Novartis announced that Felix R. Ehrat, Group General Counsel of Novartis, decided to retire from the company. Shannon Thyme Klinger, currently Chief Ethics, Risk and Compliance Officer, will be appointed Group General Counsel, effective June 1, 2018.
Novartis announced that it has completed the acquisition of AveXis, Inc. through the consummation of a merger of its indirect wholly owned subsidiary, Novartis AM Merger Corporation, with and into AveXis without a vote of the AveXis stockholders in accordance with Section 251(h) of the Delaware General Corporation Law.
Novartis announced that the US FDA has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients.
Novartis announced the US FDA has approved Kymriah (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Novartis announced that the US FDA has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
Novartis announced new positive brolucizumab (RTH258) data in neovascular age-related macular degeneration (nAMD) from a pre-specified secondary analysis of the Phase III HAWK and HARRIER trials. The findings showed that patients assessed as appropriate for a 12- week treatment frequency during the first 12-week cycle after loading could reliably stay on that quarterly interval through week 48. This is the first time a high level of reliability has been prospectively demonstrated for a pre-specified secondary endpoint of a 12-week dosing interval with an anti-vascular endothelial growth factor (VEGF) therapy in Phase III trials.
Novartis announced new analyses from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). In prespecified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapses. In addition, new post-hoc analyses using more accurate methods to estimate the treatment effect on disability progression, now substantiate that the risk reduction with siponimod is largely disassociated from relapses. Siponimod also showed a significant benefit on cognitive processing speed, the key cognitive function impacted by MS, which frequently deteriorates in people with the disease.
Novartis announced the appointment of John Tsai, M.D., as Head of Global Drug Development (GDD) and Chief Medical Officer. Dr. Tsai joined Novartis on May 1, 2018, and is based in Basel, Switzerland. He reports to Vas Narasimhan, M.D., CEO of Novartis, and is a member of the Executive Committee of Novartis (ECN). He succeeds Dr. Narasimhan who became CEO of Novartis on February 1, 2018. Dr. Rob Kowalski, who led GDD ad interim since February 1, 2018, resumed his responsibilities as Head of Global Regulatory Affairs for GDD.
Novartis delivered a strong first quarter and acted to become a more focused medicines company.
Sandoz announced that it has entered into a collaboration with Pear Therapeutics to commercialize and continued development of novel prescription digital therapeutics designed to effectively treat disease and improve clinical outcomes for patients.
Novartis announced full results from the Phase IIIb LIBERTY trial of Aimovig (erenumab, AMG 334) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or intolerable side effects. The data showed the potential of investigational erenumab as an effective preventive treatment option for these patients, who have tried several treatment options without gaining relief.
Novartis announced a five-year commitment to the fight against malaria in conjunction with the 7th Multilateral Initiative on Malaria Conference and the Malaria Summit of the Commonwealth Heads of Government meeting. Further, the company releases new African research on progress and remaining challenges toward the 2030 malaria elimination targets, together with Elimination 8 and the KEMRI-Wellcome Trust program. Over the next five years, as part of its commitment, Novartis will invest more than USD 100 million to advance research and development of next-generation treatments to combat emerging resistance to artemisinin and other currently used antimalarials. The company will also implement an equitable pricing strategy to maximize patient access in malaria-endemic countries when these new treatments become available. In order to contribute to the WHO's target of reducing malaria-related child mortality by at least 90% by 2030, Novartis will further help expand access to pediatric antimalarials and implement healthcare system strengthening programs in four sub-Saharan countries.
Novartis announced a new post hoc analysis of the pivotal Phase III heart failure study, PARADIGM-HF, demonstrating that treatment with Entresto (sacubitril/valsartan) helped to preserve kidney function, as assessed by estimated glomerular filtration rate (eGFR), in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril. In a sub group of patients who had both HFrEF and diabetes, the magnitude of benefit was twice as high. The findings of the analysis were published in The Lancet Diabetes & Endocrinology.
Novartis announced that it has entered into an agreement and plan of merger with AveXis, Inc. to acquire the US-based Nasdaq-listed clinical stage gene therapy company for USD 218 4 per share or a total of USD 8.7 billion in cash. The transaction was unanimously approved by the Boards of both companies.
Novartis announced that it has entered into an agreement with GlaxoSmithKline plc (GSK) to divest its 36.5 percent stake in its consumer healthcare joint venture (JV) to GSK for USD13.0 billion. The sale will enable Novartis to further focus on the development and growth of its core businesses.
Sandoz announced today that the CHMP has adopted a positive opinion for marketing authorization of infliximab, a proposed biosimilar to reference medicine infliximab.
Novartis announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet. These pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed disability progression with siponimod versus placebo and favorable outcomes in other relevant measures of MS disease activity. If approved, siponimod would be the first disease-modifying therapy to delay disability progression in typical SPMS patients, including many who had reached a non-relapsing stage and high level of disability.
Novartis announced that the US FDA expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Novartis announced changes to its senior leadership team to support the implementation of its strategic priorities. Bertrand Bodson, Chief Digital Officer, Steffen Lang, Global Head Novartis Technical Operations, and Shannon Klinger, Chief Ethics, Risk and Compliance Officer, have been appointed to the Executive Committee of Novartis (ECN). All changes are effective as of April 1, 2018. André Wyss, President Novartis Operations, has decided to step down from the ECN on April 1, 2018, to pursue his career outside of Novartis.
Novartis shareholders agreed to the Board of Directors' recommendations for all proposed resolutions at the Group's Annual General Meeting (AGM). A total of 1,731 shareholders were present at the meeting held in Basel, representing approximately 62.6% of the issued shares of Novartis.
Novartis has entered into a collaboration with Pear Therapeutics to develop novel prescription digital therapeutics, software applications designed to effectively treat disease and improve clinical outcomes for patients. The collaboration brings together Novartis expertise in biomedical research and clinical development with Pear's leading experience in digital therapeutics design and implementation.
Novartis presented new Cosentyx (secukinumab) data from the prospective Phase III SCALP study, which showed significant improvement in skin clearance with Cosentyx in patients with scalp psoriasis. Due to the presence of hair, scalp psoriasis is particularly difficult to treat with common topical and phototherapy options.
Sandoz announced the US FDA approval and launch of Glatopa (glatiramer acetate injection) 40 mg/mL.
Novartis announced that the US FDA has approved a label update for Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-tosevere plaque psoriasis. The updated label includes Cosentyx data in moderate-to-severe 5 scalp psoriasis - one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.
Novartis announced the completion of the subsequent offering period of the tender offer by its subsidiary, Novartis Groupe France S.A., to purchase all of the outstanding ordinary shares, including Ordinary Shares represented by American Depositary Shares, of Advanced Accelerator Applications S.A., for a price of USD 41.00 per Ordinary Share and USD 82.00 per ADS, in each case payable net to the seller in cash, without interest. The subsequent offering period for the Offer, which commenced on January 22, 2018, expired as scheduled at 12:00 midnight, New York City Time, on January 31, 2018.
Novartis announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US FDA approval of its new drug application (NDA) for Lutathera (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
Novartis announced a licensing agreement with Spark Therapeutics covering development, registration and commercialization rights to voretigene neparvovec in markets outside the US.
Novartis announced that Elizabeth (Liz) Barrett, previously Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the Executive Committee of Novartis, effective February 1, 2018. She is based in Basel. Mrs. Barrett succeeded Bruno Strigini who decided to retire from Novartis for personal reasons.
Novartis announced that the US FDA has granted Breakthrough Therapy designation to Promacta (eltrombopag) for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia (SAA) as a first-line therapy. Promacta, which is marketed as Revolade in most countries outside the US, is already approved as a second-line therapy in the refractory setting in SAA. Promacta is also approved for adults and children with chronic immune thrombocytopenia (ITP), for patients who are refractory to other treatments.
Novartis announced that Kisqali(ribociclib) received US FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
Novartis announced that the US FDA approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna (nilotinib) US product label. Tasigna is now the first and only BCRABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale [IS] <= 0.0032%) in its FDA-approved prescribing information.
Novartis announced that Kisqali is the first and only CDK4/6 inhibitor to show superior median PFS compared to oral endocrine therapy as first-line treatment in a prospective, randomized Phase III trial.
Novartis announced Phase III STRIVE data published in the New England Journal of Medicine demonstrating significant and sustained efficacy of erenumab in migraine prevention.
Novartis announced that Tasigna (nilotinib) secured EU approval for first and second-line treatment of Ph+ CML-CP in children.
Novartis announced that canakinumab (ACZ885) reduced cardiovascular risk by 25% in subgroup of CANTOS Phase III trial participants.
Novartis announced further positive results from two Phase III studies of brolucizumab versus aflibercept. Results showed non-inferiority in primary endpoint, superiority in key retinal health outcomes, and long-lasting effect in patients with neovascular age-related macular degeneration (nAMD), a leading cause of blindness.
Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Novartis announced Phase III data demonstrating Cosentyx reduced signs and symptoms of psoriatic arthritis while inhibiting progression of joint structural damage.
Novartis announced an expanded collaboration with Amgen and the Banner Alzheimer's Institute to collaborate on a new Generation Study 2 to assess whether investigational BACE1 inhibitor CNP520 can prevent or delay the symptoms of Alzheimer's disease in a high-risk population.
Novartis announced that Phase III PARADIGMS data showed children and adolescents with MS had an 82% lower relapse rate with Gilenya vs. interferon beta-1a.
Novartis announced that the US FDA has granted Breakthrough Therapy Designation (BTD) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.
Alcon received CE Mark for first-of-its-kind AutonoMe(TM) preloaded intraocular lens (IOL) delivery system with Clareon IOL.
Novartis announced that it has made significant progress in its strategic review of the Alcon Division and has examined all options, ranging from retaining the business to a capital markets solution (e.g., an IPO or a spin-off). As part of this, we updated Alcon’s strategic plan which confirms that it has the potential to grow sales at or above market while delivering profitability at least in line with the industry. Key criteria for a final decision and timing remain continued Alcon sales growth and margin improvement which need to be demonstrated for multiple quarters leading to potential action not likely before the first half of 2019.
Novartis announced that its over-the-counter ophthalmic products and certain surgical diagnostic products will transfer from the Innovative Medicines Division to the Alcon Division effective January 1, 2018.
Novartis announced that Rydapt (midostaurin) received EU approval for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM).
Sandoz announced new data on its proposed biosimilar adalimumab. Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis.
Novartis' Cosentyx (secukinumab) is the first and only fully human IL-17A inhibitor to show sustained skin clearance rates at five years in phase III in psoriasis. The landmark data showed that PASI 90 and PASI 100 response rates were nearly 100% maintained with Cosentyx from Year 1 to Year 5 in patients with moderate-to-severe plaque psoriasis.
Novartis announced that a Phase III study demonstrated adjuvant Tafinlar + Mekinist reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma.
Novartis presented new data confirming Lucentis efficacy and durability versus aflibercept. Interim results from the Phase IV head-to-head RIVAL study confirm strong efficacy and comparable durability versus aflibercept in patients with nAMD. Five-year results from the Lucentis LUMINOUS study, the largest ever in retinal disease, demonstrate real-world efficacy and safety across five retinal diseases.
Novartis announced a collaboration with UC Berkeley to establish the Novartis-Berkeley Center for Proteomics and Chemistry Technologies.
Novartis announced that, effective February 1, 2018, Vasant (Vas) Narasimhan, M.D., will succeed Joseph Jimenez as CEO of Novartis, who had indicated his desire to retire after eight years. Robert Kowalski, Pharm.D., Head of Global Regulatory Affairs, will assume ad-interim leadership of our Global Drug Development organization, effective February 1, 2018.
Novartis received first ever US FDA approval for a CAR-T cell therapy, Kymriah (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.
Novartis revealed primary data from CANTOS, a Phase III study evaluating quarterly injections of ACZ885 (canakinumab) in people with a prior heart attack and inflammatory atherosclerosis as measured by high-sensitivity C-reactive protein (hsCRP) levels of >=2mg/L, a known marker of inflammation. Trial participants received either placebo or one of three doses of ACZ885 in combination with current standard of care therapies, with 91% of them taking lipid-lowering statins. The study showed that ACZ885 led to a statistically significant 15% reduction in the risk of major adverse cardiovascular events (MACE), a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo (pvalue 0.021). This benefit was sustained throughout the duration of the study (median follow up 3.7 years) and was largely consistent across key pre-specified baseline sub groups. The study met the primary endpoint in cardiovascular risk reduction with the 150mg dose of ACZ885; the 300mg dose showed similar benefits and the 50mg dose was less efficacious.
Novartis announced that the EC approved Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis.
Novartis announced that, effective January 1, 2018, Bertrand Bodson has been appointed to the new role of Chief Digital Officer, reporting to the CEO of Novartis. Mr. Bodson is responsible for creating and executing a company-wide digital strategy, led by the ECN. As part of this strategy, we plan to improve the ways we use data in drug discovery and development, engage with patients, doctors and other stakeholders, as well as to automate business processes.
Novartis received positive CHMP opinion for Rydapt (midostaurin) for newly diagnosed FLT3- mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM).
Novartis announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52-week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® (ustekinumab) in psoriasis. The updated label also includes the use of Cosentyx to treat moderate-to-severe scalp psoriasis – one of the most difficult-to-treat forms of psoriasis, which affects approximately 60 million people worldwide. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx.
Novartis announced that the EC approved expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. Approval follows a positive opinion granted in May by the CHMP, and is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.
Sandoz announced that the EC has approved Erelzi (biosimilar etanercept) for use in Europe. Erelzi is approved for use in all indications of the reference medicine, Enbrel® .
Novartis announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. The CHMP recommendation of combining Kisqali with any aromatase inhibitor means that, if approved, oncologists could prescribe Kisqali with letrozole, anastrozole or exemestane, giving them the discretion to select the therapy they believe is most appropriate for each individual patient.
Novartis announced the US FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic NSCLC whose tumors express the BRAF V600E mutation. The US FDA granted Tafinlar + Mekinist Breakthrough Therapy designation in July 2015 for the treatment of patients with advanced or metastatic BRAF V600E mutationpositive NSCLC who received previous treatment with chemotherapy.
Novartis announced topline results from the global Phase III CANTOS study investigating the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in people with a prior heart attack and inflammatory atherosclerosis. With more than 10,000 patients enrolled in the study over the last six years, CANTOS is one of the largest and 9 longest-running clinical trials in Novartis' history. The CANTOS study met the primary endpoint, demonstrating that when used in combination with standard of care ACZ885 reduces the risk of major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in patients with a prior heart attack and inflammatory atherosclerosis. The full data from the study will be submitted for presentation at a medical congress and for peer reviewed publication later this year.
Sandoz announced that the EC has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera® .
Novartis announced that the EC has approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna (nilotinib) Summary of Product Characteristics (SmPC). TFR is the ability to maintain molecular response (MR) after stopping tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP). This is an important milestone for the Ph+ CML community because Tasigna is now the first and only TKI to include information on TFR in the European Union (EU) label.
Novartis announced that it has entered into a clinical research collaboration in which BristolMyers Squibb is to investigate the safety, tolerability, and efficacy of Mekinist (trametinib) in combination with Opdivo® (nivolumab) and Opdivo® + Yervoy® (ipilimumab) regimen as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).
Novartis announced a collaboration with IBM Watson Health to explore development of a cognitive solution that uses real-world data and advanced analytical techniques with the aim to provide better insights on the expected outcomes of breast cancer treatment options.
Novartis announced that the US FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.
Novartis announced that it has notified Conatus Pharmaceuticals Inc. of its exercise of the option to an exclusive license for the global development and commercialization of emricasan, under the option, collaboration and license agreement signed with Conatus on December 19, 2016. The exercise of the option with Conatus, a biotechnology company focused on the development of novel medicines to treat liver disease, and grant of exclusive license to Novartis will be effective upon receipt of all required anti-trust approvals and payment of USD 7 million option exercise fee to Conatus.
Novartis announced the launch of Better Hearts Better Cities, an innovative initiative to address the high rates of high blood pressure in low-income urban communities.
Novartis announced that the US FDA has approved Rydapt (midostaurin) for two indications. The first indication is for the treatment of acute myeloid leukemia (AML) in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with chemotherapy. Rydapt is also approved to treat adults with advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia. This approval follows a prior Breakthrough Therapy designation in FLT3- mutated AML, as well as Orphan Drug designation and Priority Review in both indications by the FDA. Worldwide filings for Rydapt are currently underway.
Novartis delivered sales growth across all divisions (cc) as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued.
Novartis announced an expanded collaboration agreement with Amgen to co-commercialize erenumab (AMG 334) in the US, currently being investigated for the prevention of migraine. This agreement builds on the previously announced 2015 global collaboration between Novartis and Amgen.
Novartis announced data from the Phase IV Multiple Sclerosis and clinical outcome and MRI in the US (MS-MRIUS) study, which confirmed the effectiveness of Gilenya (fingolimod) in the real-world setting, supporting previous findings from Phase III trials. Results show that Gilenya impacted four key measures of MS disease activity (relapses, MRI lesions, disability progression and brain shrinkage), in people with relapsing-remitting multiple sclerosis (RRMS) for up to 16 months. This is also the first time a multicenter study has evaluated and shown that routine magnetic resonance imaging (MRI) scans taken in the every-day clinical setting can reliably be used to measure brain shrinkage, a key measure of disease progression, in people with RRMS.
Novartis announced that the US 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.
Novartis announced that it has exercised an option to in-license ECF843 for ophthalmic indications worldwide (outside Europe). The closing of the deal is subject to customary closing conditions including regulatory approvals. The financial and other terms of this transaction are not disclosed.
Novartis announced the EC has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic NSCLC. The approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the EU, plus Iceland and Norway.
Novartis announced that it has entered into a clinical trial agreement with Allergan plc to conduct a Phase IIb study, involving the combination of a Novartis FXR agonist and Allergan's cenicriviroc for the treatment of non-alcoholic steatohepatitis (NASH). Novartis announced that is has exercised an option to in-license ECF843, a recombinant form of human lubricin from Lubris, LLC, for ophthalmic indications worldwide (outside Europe). This transaction closed and Novartis received its exclusive license on April 21, 2017.
Alcon has received approval from the US FDA for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens (IOL) with ACTIVEFOCUS optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopia at the same time. The unique optical design of the ACTIVEFOCUS toric lens delivers both crisp, clear distance vision and a range of vision for patients who desire less dependence on glasses. The ACTIVEFOCUS toric IOL is the only multifocal toric IOL in which the central portion is 100 percent dedicated to distance vision. Previous presbyopia-correcting IOL designs tend to compromise on distance vision in order to provide patients with a range of vision.
Novartis announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX030 (serelaxin) in patients with acute heart failure (AHF). RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through 11 Day 180 or reduced worsening heart failure through Day five when added to standard therapy in patients with AHF.
The US FDA has approved Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Sandoz presented data for its proposed biosimilar adalimumab (GP2017). The Phase III confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira® . Results were presented at the American Academy of Dermatology (AAD) in Orlando, Florida
Novartis completed euro-denominated bond offerings in an amount equivalent to approximately USD 2 billion.
Novartis shareholders agreed to the Board of Directors' recommendations for all proposed resolutions at the Group's Annual General Meeting (AGM). A total of 1,805 shareholders were present at the meeting held in Basel, representing approximately 60.6% of the issued shares of Novartis.
Novartis completed a USD 3 billion bond offering under its US SEC Registration Statement on Form F-3.
Novartis announced that the EC has approved Votubia (everolimus) dispersible tablets as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). Votubia is now the first approved pharmacologic therapy in all 28 member states of the EU, plus Iceland and Norway, specifically for the treatment of refractory partialonset seizures associated with TSC.
Novartis announced that it is considering options for the Alcon Division. The review will explore all options, ranging from retaining all or part of the business to separation via a capital markets transaction (e.g. IPO or spin-off), in order to determine how to best maximize value for our shareholders. The review will be conducted during the course of 2017 and in a manner such that Alcon Division associates can fully focus on the unit’s return to growth.
Novartis announced that it is initiating a share buyback of up to USD 5.0 billion in 2017 under existing shareholder authority.
Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued.
Novartis announced that it has entered into a collaboration and option agreement with Ionis Pharmaceuticals, Inc. and its affiliate Akcea Therapeutics, Inc., to license two investigational treatments with the potential to significantly reduce cardiovascular risk in patients suffering from high levels of lipoproteins known as Lp(a) and ApoCIII. In addition, Novartis entered into a stock purchase agreement with Ionis and Akcea. This transaction was completed on February 14, 2017.
These materials contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” 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; 12 or regarding the proposed 100% spinoff of the Alcon Division, including express or implied discussions regarding the potential financial or other impact on Novartis, and the potential strategic benefits, synergies or opportunities expected as a result of the proposed spinoff; or regarding the potential impact on Novartis of the completed acquisition of AveXis Inc., including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected from the acquisition; or regarding the potential financial or other impact of the other significant acquisitions and reorganizations of recent years; or regarding the potential impact of the share buyback; or regarding potential future sales or earnings of the Novartis Group or any of its divisions or potential shareholder returns; or by discussions of strategy, plans, expectations or intentions. 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 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 products will achieve any particular revenue levels. Neither can there be any guarantee that the proposed 100% spinoff of the Alcon Division will be approved by our shareholders, or that it will be completed, or completed as currently proposed, or at any particular time. Nor can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the proposed 100% spinoff of the Alcon Division, or that the proposed spinoff will in fact maximize shareholder value. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the significant acquisitions and reorganizations of recent years. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Neither can there be any guarantee that the Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating or financial results. In particular, our expectations could be affected by, among other things: global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in these materials; the potential that the proposed 100% spinoff of the Alcon Division may not be approved by our shareholders, or that it may not be completed, or completed as currently proposed, or at any particular time; the potential that the strategic benefits, synergies or opportunities expected from the proposed 100% spinoff of the Alcon Division may not be realized or may take longer to realize than expected, or that the proposed spinoff may not in fact maximize shareholder value; the potential that the strategic benefits, synergies or opportunities expected from the significant acquisitions and reorganizations of recent years may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns; 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, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; safety, quality or manufacturing issues; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes and government investigations generally; uncertainties involved in the development or adoption of potentially transformational technologies and business models; general political and economic conditions, including uncertainties regarding the effects of ongoing instability in various parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and uncertainties regarding potential significant breaches of data security or data privacy, 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 these materials 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.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group Companies.