07.20.18
Headquarters: Basel, Switzerland
twitter.com/novartis
www.novartis.com
Headcount: 124,000
Year Established: 1996
Revenues: $49,109 (+1%)
Pharma Revenues: $33,025 (-1%)
Net Income: $7,703 (+15%)
R&D: $8,972 (-1%)
TOP SELLING DRUGS
In 2017 Novartis’ Innovative Medicines division, which includes Novartis Pharmaceuticals and Novartis Oncology, reported sales of $33 billion, down 1% from the year before.
Novartis’ performance in 2017 was driven by the strong growth of psoriasis drug Cosentyx, which grew 84% to $2.1 billion. Novartis also reported positive results for Entresto, Promacta/Revolade, and Tafinlar + Mekinist. These strong performers continued to offset the impact of generic competition for the cancer drug Gleevec/Glivec, which saw sales drop 42% during the year.
The company made strong progress on the R&D front in 2017, receiving 16 major approvals, while also making 16 major submissions. It also received six breakthrough therapy designations from the U.S. FDA.
The highlight of the year occurred when the drug Kymriah was approved to treat children and young adults with a deadly cancer called acute lymphoblastic leukemia. Novartis was the first company to receive approval for this type of novel immunocellular therapy, which reprograms a patient’s own T-cells to fight cancer. Novartis also filed for FDA approval for Kymriah to treat adults with the most common form of non-Hodgkin’s lymphoma.
Several other targeted cancer therapies were also approved. They include Kisqali to treat advanced or metastatic breast cancer, and Rydapt was approved for acute myeloid leukemia and advanced systemic mastocytosis. Novartis also strengthened its cancer product portfolio during the year when it paid nearly $4 billion for Advanced Accelerator Applications (AAA), a nuclear medicine theragnostics company. At the time of the deal, in October 2017, AAA had recently received European approval for marketing authorization for cancer drug Lutathera.
Pumped up pipeline
Novartis bolstered its pipeline during the year through several R&D collaborations. In January 2017 it invested in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders, inking a deal worth potentially $1 billion with Ionis Pharmaceuticals and its affiliate Akcea Therapeutics. Novartis will develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx.
Additionally, Allergan entered into a clinical trial agreement with Novartis to conduct a Phase IIb study using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH). The Phase IIb study will assess the safety, efficacy and tolerability of this multi-therapy treatment approach for NASH.
Novartis and Bristol-Myers Squibb (BMS) entered into a clinical research collaboration to investigate the safety, tolerability, and efficacy of Mekinist in combination with Opdivo and Opdivo + Yervoy regimen as a potential treatment option for metastatic colorectal cancer. BMS will conduct the study, which is expected to establish recommended dose regimens and the preliminary anti-tumor activity of the combination therapies.
Novartis and Amgen expanded their collaboration with Banner Alzheimer’s Institute (BAI) to initiate a new trial—the Alzheimer’s Prevention Initiative (API) Generation Study 2. This trial will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid beta, a protein which accumulates in the brains of individuals with Alzheimer’s disease years before clinical symptoms begin.
Strengthening the core
In a move designed to focus on core capabilities, Novartis sold off its stake in its consumer healthcare joint venture with Glaxo-SmithKline (GSK) for $13 billion in March 2018. The joint venture sells products such as Nicotinell nicotine patches and Panadol headache tablets.
At the same time, Novartis entered an agreement to buy AveXis Inc., a gene therapy company, for $8.7 billion as part of its neuroscience strategy. AveXis is conducting several clinical studies for the treatment of spinal muscular atrophy, or SMA, an inherited neurodegenerative disease caused by a defect in a single gene. Their gene therapy candidate AVXS-101 has the potential to be the first one-time gene replacement therapy for SMA according to Novartis, and it currently has orphan drug designation from the U.S. FDA for the treatment of SMA.
In other restructuring news, Novartis unveiled plans in October 2017 to close a Sandoz generics manufacturing facility in Broomfield, CO that will result in the loss of approximately 450 jobs over the next couple of years. The company plans to discontinue and/or divest several products with limited growth potential, specifically those facing pricing pressures in the U.S. The products include oral generic treatments in cardiology, central nervous system, endocrinology, respiratory and pain. The phased closure and transfer of some operations to a Sandoz facility in North Carolina is scheduled to be completed in late 2019.
Novartis also signed an agreement contracting Cryoport for an initial three-year term for cryogenic logistics support of CTL019/CD19 CAR-T cell therapy. In March 2017, Novartis’ BLA for CTL019 was accepted by the FDA and was also granted priority review.
twitter.com/novartis
www.novartis.com
Headcount: 124,000
Year Established: 1996
Revenues: $49,109 (+1%)
Pharma Revenues: $33,025 (-1%)
Net Income: $7,703 (+15%)
R&D: $8,972 (-1%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Gilenya | autoimmune disease | $3,185 | 2% |
Cosentyx | Psoriasis, ankylosing spondylitis and psoriatic arthritis | $2,071 | 84% |
Gleevec/Glivec | oncology | $1,943 | -42% |
Lucentis | age-related macular degeneration | $1,888 | 3% |
Tasigna | chronic myeloid leukemia | $1,841 | 6% |
Sandostatin | acromegaly | $1,612 | 2% |
Afinitor | oncology | $1,525 | 1% |
Galvus | diabetes | $1,193 | 3% |
Exjade | chronic iron overload | $1,059 | 11% |
Exforge | high blood pressure | $960 | 4% |
In 2017 Novartis’ Innovative Medicines division, which includes Novartis Pharmaceuticals and Novartis Oncology, reported sales of $33 billion, down 1% from the year before.
Novartis’ performance in 2017 was driven by the strong growth of psoriasis drug Cosentyx, which grew 84% to $2.1 billion. Novartis also reported positive results for Entresto, Promacta/Revolade, and Tafinlar + Mekinist. These strong performers continued to offset the impact of generic competition for the cancer drug Gleevec/Glivec, which saw sales drop 42% during the year.
The company made strong progress on the R&D front in 2017, receiving 16 major approvals, while also making 16 major submissions. It also received six breakthrough therapy designations from the U.S. FDA.
The highlight of the year occurred when the drug Kymriah was approved to treat children and young adults with a deadly cancer called acute lymphoblastic leukemia. Novartis was the first company to receive approval for this type of novel immunocellular therapy, which reprograms a patient’s own T-cells to fight cancer. Novartis also filed for FDA approval for Kymriah to treat adults with the most common form of non-Hodgkin’s lymphoma.
Several other targeted cancer therapies were also approved. They include Kisqali to treat advanced or metastatic breast cancer, and Rydapt was approved for acute myeloid leukemia and advanced systemic mastocytosis. Novartis also strengthened its cancer product portfolio during the year when it paid nearly $4 billion for Advanced Accelerator Applications (AAA), a nuclear medicine theragnostics company. At the time of the deal, in October 2017, AAA had recently received European approval for marketing authorization for cancer drug Lutathera.
Pumped up pipeline
Novartis bolstered its pipeline during the year through several R&D collaborations. In January 2017 it invested in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders, inking a deal worth potentially $1 billion with Ionis Pharmaceuticals and its affiliate Akcea Therapeutics. Novartis will develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx.
Additionally, Allergan entered into a clinical trial agreement with Novartis to conduct a Phase IIb study using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH). The Phase IIb study will assess the safety, efficacy and tolerability of this multi-therapy treatment approach for NASH.
Novartis and Bristol-Myers Squibb (BMS) entered into a clinical research collaboration to investigate the safety, tolerability, and efficacy of Mekinist in combination with Opdivo and Opdivo + Yervoy regimen as a potential treatment option for metastatic colorectal cancer. BMS will conduct the study, which is expected to establish recommended dose regimens and the preliminary anti-tumor activity of the combination therapies.
Novartis and Amgen expanded their collaboration with Banner Alzheimer’s Institute (BAI) to initiate a new trial—the Alzheimer’s Prevention Initiative (API) Generation Study 2. This trial will determine whether the BACE1 inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population. BACE1 is an enzyme that plays an important role in the production of Amyloid beta, a protein which accumulates in the brains of individuals with Alzheimer’s disease years before clinical symptoms begin.
Strengthening the core
In a move designed to focus on core capabilities, Novartis sold off its stake in its consumer healthcare joint venture with Glaxo-SmithKline (GSK) for $13 billion in March 2018. The joint venture sells products such as Nicotinell nicotine patches and Panadol headache tablets.
At the same time, Novartis entered an agreement to buy AveXis Inc., a gene therapy company, for $8.7 billion as part of its neuroscience strategy. AveXis is conducting several clinical studies for the treatment of spinal muscular atrophy, or SMA, an inherited neurodegenerative disease caused by a defect in a single gene. Their gene therapy candidate AVXS-101 has the potential to be the first one-time gene replacement therapy for SMA according to Novartis, and it currently has orphan drug designation from the U.S. FDA for the treatment of SMA.
In other restructuring news, Novartis unveiled plans in October 2017 to close a Sandoz generics manufacturing facility in Broomfield, CO that will result in the loss of approximately 450 jobs over the next couple of years. The company plans to discontinue and/or divest several products with limited growth potential, specifically those facing pricing pressures in the U.S. The products include oral generic treatments in cardiology, central nervous system, endocrinology, respiratory and pain. The phased closure and transfer of some operations to a Sandoz facility in North Carolina is scheduled to be completed in late 2019.
Novartis also signed an agreement contracting Cryoport for an initial three-year term for cryogenic logistics support of CTL019/CD19 CAR-T cell therapy. In March 2017, Novartis’ BLA for CTL019 was accepted by the FDA and was also granted priority review.