Novartis took actions that paved the way for future growth as the company increased sales and operating profit, generated good cash flows, and continued to innovate. 

 

 

Novartis

Lichtstrasse 35

CH-4056 Basel, Switzerland

Telephone: +41-61-324-1111 

Website: novartis.com

 

OUTCOMES CREATIVITY INDEX SCORE: 53

Manny Awards — 5

Cannes Lions — 2

Clio Health — 9

Creative Floor Awards — 36

MM+M Awards — 1

One Show — N/A

 

Financial Performance

(All figures are in millions of dollars, except EPS.)

2020  

Revenue $48,659  

Net income $8,071  

Diluted EPS $3.52  

R&D expense $8,980  

1H 2021 

Revenue $25,367  

Net income $4,954 

Diluted EPS $2.20  

R&D expense $4,751  


Best-Selling Products

(All sales are in millions of dollars.)

2020  

Cosentyx $3,995  

Gilenya $3,003  

Entresto $2,497  

An oral tyrosine kinase inhibitor that targets the BCR-ABL protein, the oncology medicine Tasigna (nilotinib) generated first-half 2021 global growth of seven percent, reaching $1.04 billion in sales.

Tasigna $1,958  

Lucentis  $1,933  

Promacta/Revolade $1,738  

Tafinlar + Mekinist $1,542 

Sandostatin $1,439  

Jakavi $1,339   

Xolair $1,251   

Galvus Group $1,199  

Gleevec/Glivec $1,188  

Afinitor/Votubia $1,083  

Diovan Group $1,003  

Exforge Group $980  

Zolgensma $920 

Ilaris $873  

Kisqali $687  

Exjade/Jadenu $653  

Votrient $635   

Ultibro Group $623  

1H 2021 

Cosentyx $2,228 

Entresto $1,675  

The blockbuster medicine Gilenya remains the top-prescribed high-efficacy therapy in 32 countries and the only one approved to treat pediatric relapsing multiple sclerosis (RMS) both in the EU and the United States, according to Novartis.

Gilenya $1,428   

Lucentis  $1,096  

Tasigna $1,038  

Promacta/Revolade $976  

Tafinlar + Mekinist $818  

Jakavi $761  

Sandostatin $717  

Xolair $690  

Zolgensma $634  

Galvus Group $542  

Gleevec/Glivec $535  

Afinitor/Votubia $1,083

Ilaris $503  

Exforge Group $501 

Kisqali $420 

Diovan Group $404  

Exjade/Jadenu $300 

Ultibro Group $299  

Kymriah $298  

Votrient $296  

 

“Novartis delivered a strong second quarter (2021), driven by the momentum of our key growth brands, including Cosentyx, Entresto, Zolgensma, our Oncology portfolio and the launch of Kesimpta which continues to accelerate. Our pipeline of novel medicines continues to progress with key positive readouts in diseases with high unmet need, including iptacopan in a range of immune mediated diseases, 177Lu-PSMA-617 in prostate cancer and Zolgensma in spinal muscular atrophy. We reached a notable milestone in our journey to build trust with society, tackling global health access challenges, by reaching a billion antimalarial courses delivered to patients most in need. Looking ahead, we reconfirm our full-year guidance and our commitment to drive long-term accretive growth.” — Vas Narasimhan, CEO

“2020 was a unique year in the long history of Novartis, as the COVID-19 pandemic challenged the company to deliver on its purpose despite immense challenges to healthcare systems and society, according to Novartis CEO Vas Narasimhan. “We continued to make progress on our strategic priorities. We delivered new innovative medicines for patients, including a treatment for relapsing forms of multiple sclerosis and a first-in-class siRNA cholesterol-lowering treatment. We continued to develop and build out our pipeline, which remains one of the most valuable in the industry. We’re especially optimistic about our mid- to late-stage pipeline, tracking five promising assets in our Oncology pipeline, six in our Pharmaceuticals pipeline, and an additional five medicines that are already approved and that we believe can be further applied to expanded areas of treatment.” 

Narasimhan said he is proud of the ways Novartis contributed to the global pandemic response. “Through Sandoz, Novartis was the first company to commit to keeping the prices of essential generic medicines stable. We launched a first-of-its-kind not-for-profit portfolio of medicines to treat symptoms of COVID-19. And we played our part in the scientific effort to find treatments for the disease. Across the industry, we are sharing our scientific findings and our research and manufacturing capacity while committing to equitable distribution of diagnostics, therapeutics and vaccines.

The COVID-19 situation has continued to evolve during 2021 and is taking differing courses across the multitude of geographies in which Novartis operates, according to company management. “While demand is starting to return to pre-COVID-19 levels in most geographies and therapeutic areas, we still see a slight impact on parts of our business for example in oncology, generics and certain geographies. We are assuming further easing of COVID-19 restrictions in the second half of the year (2021) with a positive impact on business dynamics.”

Financial & Product Performance

Novartis leadership is confident that the progress made on strategic priorities as a focused medicines company will result in top and bottom line growth through 2025. Sales during 2020 grew to $48.66 billion and Novartis advanced the company’s next wave of medicines, achieving various new approvals highlighted by Kesimpta in the United States and Leqvio and Zolgensma in the European Union.

Novartis reported first-half 2021 net sales of $25.4 billion (+7 percent, +3 percent cc). The company said volume contributed 7 percentage points to growth, driven by Entresto, Cosentyx and Zolgensma. Management says volume growth was partly offset by price erosion of two percentage points and negative impact from generic competition of two percentage points. 

Net income for Novartis during the 2021 first half totaled $5.0 billion (+23 percent, +19 percent cc), benefiting mainly from lower financial expenses and higher Roche income (the Novartis Group owns 33.3 percent of the bearer shares of Roche Holding). EPS amounted to $2.20 (+24 percent, +21 percent cc), growing faster than net income, benefiting from lower weighted average amount of shares outstanding. 

Novartis’ core operating income came to 8.3 billion (+6 percent, +2 percent cc) during January-June 2021, mainly driven by higher sales, partly offset by higher spend. Core operating income margin was 32.7 percent of net sales, declining by 0.5 percentage points (-0.4 percentage points cc) year-over-year.

Core net income came in at $7.1 billion (+7 percent, +3 percent cc) mainly fueled by growth in core operating income. Core EPS reached $3.17 (+9 percent, +5 percent cc), growing faster than core net income, benefiting from lower weighted average number of shares outstanding. 

Innovative Medicines net sales amounted to $20.7 billion (+9 percent, +5 percent cc) during first-half 2021. According to management, “Volume contributed 8 percentage points to growth. Generic competition had a negative impact of 3 percentage points. Pricing had a negligible impact on sales growth.”

The US segment of Innovative Medicines generated a strong first-half 2021 performance ($7.3 billion, +3 percent) through Entresto, Cosentyx and Kesimpta. Europe sales ($7.4 billion, +16 percent, +8 percent cc) increased, driven by Zolgensma, Entresto and Lucentis. Sales in Japan totaled $1.1 billion (–5 percent, –5 percent cc) as growth was negatively impacted by the Galvus joint-promotion deal. Emerging Growth Markets sales rose +11 percent (+9 percent cc), driven by double-digit growth in China, including the launches of Cosentyx and Entresto.

Pharmaceuticals BU grew 10 percent (+6 percent cc) led by Entresto ($1.7 billion, +46 percent, +40 percent cc), Cosentyx ($2.2 billion, +19 percent, +16 percent cc), Zolgensma ($0.6 billion, +69 percent, +63 percent cc), Lucentis ($1.1 billion, +23 percent, +15 percent cc) and Kesimpta ($0.1 billion).

Oncology BU in first-half 2021 improved 7 percent (+4 percent cc) driven by Promacta/Revolade ($1.0 billion, +18 percent, +16 percent cc), Kisqali ($0.4 billion, +31 percent, +28 percent cc), Jakavi ($0.8 billion, +21 percent, +14 percent cc), Kymriah ($0.3 billion,+41 percent, +35 percent cc), Tafinlar + Mekinist ($0.8 billion, +11 percent, +7 percent cc) and Adakveo ($0.1 billion, +119 percent, +118 percent cc), partly offset by generic competition for Afinitor, Exjade and Glivec.

The Sandoz business produced net sales of $4.7 billion (0 percent, –5 percent cc) in the 2021 first half with a negative price effect of 9 percentage points. Volume rose by 4 percentage points from growth in Biopharmaceuticals partly offset by the impact of softer retail demand, with a historically weak cough and cold season, management says.

First-half 2021 sales for Sandoz in Europe totaled $2.6 billion (0 percent, –7 percent cc) with a decrease due to the impact of COVID-19 on the Retail Generics business. US sales fell to $904 million (–16 percent), mainly due to the Retail Generics business, especially oral solids including partnership terminations, as well as Biopharmaceuticals impacted by higher off-contract sales in the previous year. Sales in Asia/Africa/Australasia improved to $810 million (+20 percent, +14 percent cc). Sales in Canada and Latin America rose to $433 million (+15 percent, +12 percent cc).

Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) in the first six months of 2021 improved to $1.0 billion (+13 percent, +6 percent cc), despite increased competition, particularly in Europe.

Retail Generics sales declined to $3.5 billion (–3 percent, –7 percent cc) and total Anti-Infectives decreased to $520 million (–11 percent, –15 percent cc), both impacted by softer retail demand as a result of COVID-19 and a historically weak cough and cold season.

Novartis said during July 2021 that barring unforeseen events, full-year net sales are expected to grow by low to mid single digits (cc). Management expects net sales performance (cc) in 2021 for Innovative Medicines will increase by mid single digits and Sandoz will decrease by low to mid single digits. Full-year 2021 core operating income is projected to increase by mid single digits, ahead of sales (cc).

Product Approvals & Pipeline Updates

Novartis has one of the industry’s most competitive pipelines with more than 160 projects in clinical development. The company spent $8.98 billion during full-year 2020 and $4.75 billion in the first half of 2021 on R&D expenditure.

Cosentyx won U.S. regulatory approval near the end of May 2021 for the treatment of children and adolescents with-moderate to-severe plaque psoriasis. According to Novartis, the FDA marketing clearance for moderate-to-severe pediatric patients 6 years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo.

Cosentyx (secukinumab) was the recipient of FDA approval on May 28, 2021, for treating moderate-to-severe plaque psoriasis in pediatric patients 6 years and older. The marketing clearance is based on pivotal study data showing Cosentyx demonstrated superior improvements of skin symptoms versus placebo. 

Novartis also secured a new approval in China for Cosentyx in pediatric psoriasis during August 2021. The marketing clearance in China for pediatric psoriasis combined with recent filings in the United States and Europe for juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA) further supports plans to expand Cosentyx to 10 indications during the next 10 years.

The Phase III JUNIPERA study for Cosentyx met the clinical trial’s primary endpoint, showing significantly longer time to flare (longer time to worsening of symptoms) compared to placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA). Results were unveiled during the 2021 European Congress of Rheumatology (EULAR). Cosentyx has received approvals across four indications, and is supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with more than 400,000 patients treated globally since launch.

Entresto was granted an expanded indication in chronic heart failure by the U.S. FDA during February 2021. Entresto represents the first therapy approved in the United States to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).

Entresto (sacubitril/valsartan) received an expanded indication in chronic heart failure by the FDA during February 2021. Entresto is the first therapy approved in the United States to treat patients diagnosed with guideline-defined heart failure to include those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF). The expanded indication allows for potential treatment of more adults with left ventricular ejection fraction (LVEF) below normal.

The Chinese National Medical Products Administration (NMPA) during June 2021 approved a new indication for Entresto for the treatment of patients with essential hypertension. Entresto became the first new therapy for hypertension in China in more than 10 years.

Novartis was the recipient of EU approval in March 2021 for Kesimpta (ofatumumab) as the first self-administered, targeted B-cell therapy for adults with relapsing multiple sclerosis (RMS). The regulatory approval was based on two Phase III ASCLEPIOS trials that met primary endpoints where Kesimpta demonstrated a reduction of annual relapses by more than 50 percent versus teriflunomide, a first-line treatment in MS, and achieved over 30 percent relative risk reduction of 3-month confirmed disability progression

Novartis disclosed data demonstrating mean IgG and IgM levels remain unchanged in adults with RMS treated with Kesimpta over 3.5 years. The ongoing open label extension of the ALITHIOS trial includes 1,703 people living with MS taking Kesimpta for up to 5 years. The long-term findings were consistent with the Phase III ASCLEPIOS study data.

Novartis announced in July that the company refiled the inclisiran New Drug Application (NDA) with the FDA to address the Complete Response Letter (CRL) that was submitted with an action date of Jan. 1, 2022. Novartis listed the company’s own site in Schaftenau, Austria, as the manufacturing location for the final finished product within the resubmission. The inclisiran Complete Response resubmission addresses the CRL issued during December 2020, stating unresolved facility inspection-related conditions at a third-party manufacturing site.

For tislelizumab, the Phase III RATIONALE 302 study showed a 30 percent reduction in the risk of death and extended median overall survival by 2.3 months versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy. In PD-L1 positive patients, tislelizumab extended median overall survival (OS) by 3.5 months with a 46 percent reduced risk of death. A Biologics License Application (BLA) submission supported by the RATIONALE 302 trial was accepted by U.S. regulators, as reported by Novartis in September.

The Phase II RATIONALE 209 trial for tislelizumab showed durable anti-tumor activity in patients with previously treated, locally advanced, unresectable or metastatic microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) cancers.

In February 2021, Novartis closed the in-licensing of tislelizumab from BeiGene in North America, Europe and Japan. Novartis is jointly developing the uniquely designed anti-PD-1 monoclonal antibody with BeiGene and will expand access to patients in North America, Europe and Japan. Specifically designed to minimize binding to FcγR on macrophages, tislelizumab is regarded as a key asset in the Novartis immuno-oncology combination strategy.

In August 2021, Novartis announced that the FDA accepted and granted Priority Review to the company’s NDA for asciminib (ABL001) in chronic myeloid leukemia (CML). The NDA filing was submitted under the FDA’s Real-Time Oncology Review (RTOR) program. FDA Breakthrough Therapy Designations was announced in February 2021 for asciminib in CML. The novel investigational therapy specifically targets the ABL myristoyl pocket – also known as a STAMP inhibitor – and is in development across multiple treatment lines for CML.

During second-quarter 2021, asciminib was filed for treating adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine-kinase inhibitors (TKIs) and patients with Ph+ CML-CP harboring the T315I mutation.

Novartis has received Orphan Drug, Fast Track and two Breakthrough Therapy Designations for asciminib. Breakthrough Therapy Designations were received for treating adults with Ph+ CML-CP previously treated with two or more TKIs, as well as adults with Ph+ CML-CP harboring the T315I mutation.

Novartis reported in September positive health-related quality of life data from the company’s Phase III VISION trial assessing the investigational targeted radioligand therapy 177Lu-PSMA-617 plus standard of care for metastatic castration-resistant prostate cancer (mCRPC) versus standard of care alone. 

The new drug candidate has been demonstrated to reduce mortality in patients with mCRPC. The VISION study assessing 177Lu-PSMA-617 plus best standard of care in patients with progressive PSMA-positive mCRPC showed a 38 percent reduction in risk of death and a 60 percent reduction in the risk of radiographic disease progression or death compared to best standard of care alone based on results presented at American Society of Clinical Oncology (ASCO) 2021.

177Lu-PSMA617 was granted Breakthrough Therapy Designation in June 2021 by the FDA for treating mCRPC. Submission filings to the FDA and European Medicines Agency remain on track for second-half 2021.

Fast Track Designation was granted by the FDA in May 2021 to sabatolimab (MBG 453) for the treatment of adult patients with myelodysplastic syndromes (MDS) defined with an IPSS-R risk category of high or very high risk in combination with hypomethylating agents. In August 2021, sabatolimab received Orphan Drug Designation from the European Commission for MDS. The product is undergoing development for treating higher-risk MDS and acute myeloid leukemia (AML). 

The investigational, potential first-in-class immuno-myeloid therapy sabatolimab binds to TIM-3, a novel target expressed on immune and leukemic cells. The targeting of TIM-3 reawakens the immune system to selectively attack leukemic stem cells, the source of MDS/AML, and has the potential to safely deliver a durable response.

The NEJM published during July 2021 positive Phase III REACH3 data for Jakavi in chronic graft-versus-host disease (GvHD). The REACH3 data demonstrated Jakavi significantly improved overall response rate (ORR) at week 24 (49.7 percent vs. 25.6 percent) with a higher best ORR (76.4 percent vs. 60.4 percent) compared to best available therapy, among steroid-refractory/dependent chronic GvHD patients. Additional new subgroup analysis showed higher ORR for Jakavi-treated patients regardless of the individual organs involved at baseline. 

Novartis and Incyte jointly sponsor REACH3. Novartis says regulatory submissions outside the United States for acute and chronic GvHD are under way.

Zolgensma (onasemnogene abeparvovec) data reported in June 2021 from the completed to-copy cohort of the Phase III SPR1NT trial demonstrated that all children (100 percent) treated presymptomatically survived without respiratory or nutritional support, and sat independently for ≥30 seconds, most (11/14) within the WHO window of expected normal development.

Final late-stage STR1VE-EU data for Zolgensma showed clinically meaningful efficacy in symptomatic children, even those with severe spinal muscular atrophy (SMA) at baseline. Safety remained consistent with previously reported data. 

The SMART Phase IIIb global trial was initiated in April 2021 to assess the safety and efficacy of Zolgensma in children up to 21 kg, adding to real-world experience and regulatory approvals in Europe and Canada.

A Phase II study for iptacopan (LNP023) in patients with IgA nephropathy (IgAN) met the primary endpoint of reduction in proteinuria, and also demonstrated a trend toward stabilization of kidney function. These results were reported in June 2021, and the drug’s Phase III study APPLAUSE is under way.

Interim analysis from a Phase II trial for iptacopan in patients with C3 glomerulopathy (C3G) showed a trend towards improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function. Novartis says a Phase III clinical study will begin in 2021.

Phase II data for the first-in-class, oral, targeted factor B inhibitor iptacopan in treatment-naïve patients with paroxysmal nocturnal hemoglobinuria showed benefit as monotherapy with substantially reduced intra- and extravascular hemolysis.

Novartis announced during September 2021 a collaboration with Solti Innovative Cancer Research on Harmonia. The international, randomized, Phase III, multicenter, open-label trial is assessing Kisqali (ribociclib) compared to Ibrance (palbociclib), both in combination with endocrine therapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with a HER2-enriched (HER2E) intrinsic subtype. Harmonia represents the first prospective Phase III study to enroll patients selected by RNA-based molecular subtyping of their tumors and the first to directly compare two CDK4/6 inhibitors in patients with HR+/HER2- advanced breast cancer.

Results were unveiled by Novartis in September of the final overall survival (OS) analysis of the Phase III MONALEESA-2 study, which tested Kisqali in combination with letrozole compared to placebo plus letrozole in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer with no prior systemic treatment for advanced disease. Kisqali in combination with letrozole met the clinical trial’s key secondary endpoint of OS, showing a statistically significant and clinically meaningful improvement in survival.

The Phase III MONALEESA-3 study data that was presented at ASCO in June 2021 showed a median OS result of 53.7 months, underscoring that Kisqali offers more life to postmenopausal women with HR+/HER2- metastatic breast cancer (MBC) in addition to the OS benefit demonstrated for premenopausal women as shown in MONALEESA-7.

The Lutathera Phase III NETTER-1 study final analysis demonstrated a clinically relevant prolongation in median OS of 11.7 months [48.0 months (95 percent CI: 37.4-55.2) versus the control arm (36.3 months (95 percent CI: 25.9-51.7)]. Novartis says the final OS analysis did not reach statistical significance, hazard ratio for OS (HR): 0.84 with 95 percent CI: (0.60, 1.17) (p=0.30, two-sided) in favor of the Lutathera arm.

The U.S. FDA granted Fast Track Designation for LNA043 for treating osteoarthritis (OA) of the knee. LNA043 is being developed as a potential first-in-class disease modifying treatment for OA. The ANGPTL3 agonist targets damaged cartilage and modulates several pathways involved in cartilage regeneration.

Separate post hoc analyses reported in August 2021 for Leqvio (inclisiran) demonstrated effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction in two sub-populations of patients with atherosclerotic cardiovascular disease (ASCVD): established cerebrovascular disease (CeVD) and polyvascular disease (PVD). Overall, the medicine was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined Phase III ORION-9, -10 and -11 studies. Leqvio is the only approved small interfering RNA (siRNA) LDL-C-lowering treatment in Europe, and is under review by the U.S. FDA and other health authorities.

Sandoz announced in March 2021 updates to the late-stage clinical development program for the proposed biosimilar aflibercept. MYLIGHT is a Phase III confirmatory efficacy and safety trial. Aflibercept is branded as Eylea and indicated to improve visual acuity in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema secondary to retinal vein occlusion, and other specific neovascular retinal diseases.

Beovu’s Phase III MERLIN trial met the primary endpoint of non-inferiority in change in best corrected visual acuity from baseline and superiority on anatomical secondary endpoints at year one compared to aflibercept when given every four weeks following the loading phase. However, IOI including RV, and RO were reported with a higher frequency in the Beovu arm, Novartis says. Based on benefit to risk ratio, the company decided on early termination of MERLIN, RAPTOR and RAVEN trials that were using the more frequent four-week dosing interval.

Positive results were released in August from two Phase III studies evaluating Beovu (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE study assessed Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER trial tested Beovu dosed every four weeks. Each trial showed an overall well-tolerated safety profile.

The late-stage KESTREL and KITE studies testing the efficacy and safety of Beovu 6mg in DME met the primary endpoints of non-inferiority in change in best corrected visual acuity from baseline compared to aflibercept 2mg. KESTREL, KITE and KINGFISHER are global, randomized, double-masked, Phase III, two-year trials comparing the safety and efficacy of Beovu and aflibercept in treating DME.

Novartis has filed applications for Beovu in treating DME to the FDA and EMA, supported by findings from KESTREL and KITE pivotal studies, and intends to submit applications in other markets in due course.

A partial clinical trial hold for intrathecal OAV-101 was lifted by the FDA, as announced by Novartis in early August 2021. The company plans to initiate a new, pivotal Phase III trial in older patients with SMA. The Phase STEER study will assess efficacy, safety, and tolerability of OAV-101 IT in treatment-naïve patients with SMA Type 2 aged between 2 and 18 years old, the first to study gene therapy in this patient population.

Orphan Drug Designation was granted during July 2021 by the FDA for NIS793 in combination with standard of care chemotherapy for treating pancreatic cancer. The potential first-in-class novel antibody is specific for Transforming Growth Factor Beta (TGFβ), which is known to have a significant role in metastatic pancreatic ductal carcinoma (mPDAC) and other solid tumors. A Phase II trial is under way, and a Phase III study in 1L mPDAC was planned to start enrolling patients during 2021.

In the Phase II ELARA trial for Kymriah (tisagenlecleucel) presented at ASCO in June 2021, primary analysis in patients with relapsed or refractory (r/r) follicular lymphoma showed a 66 percent complete response rate and 86 percent overall response rate with a one-time Kymriah infusion. Novartis says no patients in ELARA experienced grade 3/4 cytokine release syndrome, the most common side effect associated with CAR-T therapy.

The first published mature data of patients with metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14) treated with Tabrecta (capmatini) showed a median OS of 20.8 months in treatment-naïve patients and 13.6 months in previously-treated patients. According to the company, new expansion cohort analysis of additional patients achieved an updated ORR data of 65.6 percent in first-line and 51.6 percent in second-line settings.

Significant findings for the retrospective Real-World Evidence study EPIK-P1 of patients with PIK3CA-related overgrowth spectrum (PROS) who received daily treatment with alpelisib (BYL719) for at least 24 weeks were reported. Results demonstrated alpelisib effectively reduced volume of clinically significant PROS-related lesions and improved signs and symptoms in pediatric and adult patients. Details were presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2021.

Novartis and Molecular Partners announced in May the beginning of EMPATHY, a Phase II and III study to explore the use of the novel DARPin therapeutic candidate ensovibep (MP0420) for treating COVID-19. Novartis is conducting the trial program for ensovibep, and Molecular Partners is sponsoring the studies. During March 2021, Molecular Partners reported positive initial Phase I results in healthy volunteers. Novartis has been granted an option from Molecular Partners to in-license worldwide rights of ensovibep and MP0423.

Ligelizumab (QGE031) received Breakthrough Therapy Designation in January 2021 for chronic spontaneous urticaria (CSU). Ligelizumab is the first treatment to receive Breakthrough Therapy Designation for CSU patients with an inadequate response to H1-antihistamines. A U.S. regulatory submission in CSU is anticipated in 2022.

Acquisitions, Deals & Partnerships

Novartis reached an initial agreement in January 2021 to provide manufacturing capacity for PfizerBioNTech’s COVID-19 vaccine. This represented the first of multiple deals being explored by Novartis to leverage manufacturing capacity and capabilities to address the worldwide pandemic, supporting global supply of COVID-19 vaccine. The initial deal signed with BioNTech is using the Novartis manufacturing plant in Stein, Switzerland, to support production of the mRNA COVID-19 vaccine.

Novartis inked an initial pact in March 2021 with CureVac to manufacture the COVID-19 vaccine candidate, CVnCoV. Novartis signed on to manufacture the mRNA and bulk drug product for CVnCoV. This transaction is one of several deals Novartis was reviewing on a worldwide basis to help support the global supply of COVID-19 vaccines and therapeutics.

During September 2021, Novartis acquired Arctos Medical, expanding the Swiss company’s optogenetics portfolio to bring gene therapies to patients with severe vision loss. Management says the acquisition underscores Novartis’ commitment to using optogenetics-based therapies to restore vision to patients with advanced blindness. 

Sandoz agreed to acquire GlaxoSmithKline’s cephalosporin antibiotics business during February 2021, reinforcing the company’s leading global position in antibiotics. Sandoz acquired three established brands sold in 100-plus markets. The transaction includes the leading global brand Zinnat. The acquisition complements Sandoz’s leadership in generic penicillins with a leading position in cephalosporins.

Novartis and the Bill & Melinda Gates Foundation agreed in February to collaborate on the discovery and development of an accessible in vivo gene therapy for sickle cell disease. 

Sandoz announced in September 2021 a commercialization agreement with Bio-Thera Solutions for bevacizumab (BAT1706). The biosimilar bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments. 

Novartis and Hewlett Packard Enterprise joined forces to advance global health efforts for the Swiss drug company. The collaboration is expected to accelerate the use of data and digital technologies within Novartis’ efforts to reimagine global health and improve access to healthcare and medicines. 

Novartis in March 2021 obtained exclusive global rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents – including FAPI-46 and FAPI-74 – through an assignment deal with iTheranostics, an affiliate of SOFIE Biosciences.