Novartis: Strong Growth Foundation

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With a strategic focus on science-based innovation, Novartis is well-positioned to navigate the challenging healthcare environment and sustainably grow sales, profits and dividends.

 

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Novartis AG

Lichtstrasse 35
4056 Basel, Switzerland
Telephone: +41 61 324 11 11
Website: novartis.com

 

 

Best-Selling Products

Product 2015 Sales 2014 Sales
Gleevec/Glivec $4,658 $4,746
Gilenya $2,776 $2,477
Lucentis $2,060 $2,441
Tasigna $1,632 $1,529
Sandostatin $1,630 $1,650
Afinitor/Votubia $1,607 $1,575
Diovan, Diovan HCT $1,284 $2,345
Galvus, Eucreas $1,140 $1,224
Exforge $1,047 $1,396
Exjade $917 $926
Xolair $755 $777
Exelon, Exelon Patch $728   $1,009
Neoral, Sandimmun $570 $684
Votrient $565
Voltaren Group (excluding OTC) $558 $632

All sales are in millions of dollars.

 

 

Financial Performance

  2015 2014
Revenue $49,414    $52,180
Net income $17,794 $10,280
Diluted EPS $7.29 $4.13
R&D expense $8,935    $9,086
  1H16 1H15
Revenue $24,070 $24,655
Net income $3,817 $14,843
Diluted EPS $1.59 $6.06
R&D expense $4,231 $4,273

 All sales are in millions of dollars except EPS.

 

 

 

Novartis has been busy in 2016 positioning the company to thrive in a changing industry environment. Group leaders plan to establish new breakthrough medicines, leverage productivity to improve profitability, and execute strong capex discipline and free cash flow management. This will enable Novartis to continue to increase the dividend while growing the company in a sustainable way.

Management announced on Jan. 27 plans to further focus its divisions, integrating businesses that share therapeutic areas to better leverage Novartis’ development and marketing capabilities, including a new divisional structure. These plans included the transfer of the Ophthalmic Pharmaceuticals franchise from the Alcon Division to the Innovative Medicines Division, which was formerly known as the Pharmaceuticals Division. Selected mature products were transferred from the Innovative Medicines Division to the Sandoz Division. Operationally, these transfers were completed effective April 1. The centralization of manufacturing and integration of certain drug development functions additionally were completed as of July 1.

Then during mid-May, Novartis announced changes to focus its Pharmaceuticals Division by creating two business units reporting to CEO Joseph Jimenez: Novartis Pharmaceuticals and Novartis Oncology. These two units form the Innovative Medicines Division. The leader of each business joined the Executive Committee of Novartis (ECN) as of July 1.

Paul Hudson was named CEO of Novartis Pharmaceuticals and Bruno Strigini was tapped as CEO of Novartis Oncology. Both executives report directly to Mr. Jimenez. With these changes, David Epstein, former Division Head and CEO of Novartis Pharmaceuticals, decided to leave the company.

According to management, the new structure reflects the importance of oncology to Novartis following the successful integration of the oncology assets acquired from GlaxoSmithKline. Leadership anticipates that this change will help drive the company’s growth and innovation strategy, with an increased concentration and improved execution for the Novartis Oncology and Novartis Pharmaceuticals businesses.

“With this move, as well as the centralization of manufacturing and integration of drug development announced in January, we are building a more focused, more profitable company that is capable of sustainable growth regardless of external changes in the environment,” Jimenez commented.

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Novartis highlighted the company’s strong foundation for long-term, sustainable growth at the third Meet Novartis Management event on May 25. Highlights included outlining actions under way to accelerate the launch of Entresto, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx; a leading pipeline of second-generation immuno-oncology assets; confirmation of Sandoz remaining on track for 10 biosimilar submissions by 2017; and demonstrating progress on implementation of Alcon’s growth acceleration plan.

 

2016 Performance & Outlook

Company leadership laid out five priorities for 2016: produce strong financial results; strengthen innovation; improve Alcon performance; capture cross-divisional synergies; and build a higher-performing organization.

For the first six months of 2016, net sales totaled $24.07 billion, down 2 percent in US dollars but up +1% in constant currencies compared to the one-year-earlier period. Growth Products contributed $8.2 billion or 34 percent of first-half 2016 net sales, up 21 percent (USD) compared to the prior-year’s first six months. For the total Group, net income was reported at $3.82 billion versus $14.84 billion during first-half 2015. Basic earnings per share decreased to $1.60 from $6.15 during the 2015 first half. The decline was due to the income from discontinued operations, which in first-half 2015 included $12.8 billion in exceptional pre-tax divestment gains from the portfolio transformation transactions and $0.5 billion in additional pre-tax transaction related expenses.

Innovative Medicines during the first six months of 2016 generated net sales of $16.12 billion (-3% USD, 0% cc), with volume growth (+7 percentage points) fully offset by the impact of generic competition (-6 percentage points) and pricing (-1 percentage point). For the division, Europe sales of $5.59 billion grew 9 percent (cc), while the US performance declined 7 percent (cc) to $5.39 billion due to generic competition. Japan sales ($1.3 billion, -9% cc) were down compared to first-half 2015, mainly because of generic competition and divestments. Sales for Emerging Growth Markets improved 4 percent (cc) to $3.99 billion during the 2016 first half.

For Sandoz, first-half 2016 net sales amounted to $5.02 billion (+1% USD, +4% cc) as volume growth of 10 percentage points more than offset 6 percentage points of price erosion. All regions for the generics business grew in the first half, led by the US (+3% cc), Western Europe (+3% cc), Latin America (+14% cc), Middle East and Africa (+9% cc) and Asia Pacific (+4% cc). Sales in Central and Eastern Europe rose 3 percent (cc), despite macroeconomic difficulties in the region.

Worldwide Biopharmaceuticals sales increased 27 percent (cc) year-over-year to $462 million, benefitting from the performance of the 2015 US market launches of Glatopa in June and Zarxio in September 2015. Sales for the Anti-Infectives franchise totaled $684 million (-3% cc), reflecting discontinued low-margin products and a weak flu season during the first quarter.

Alcon net sales were reported at $2.93 billion (-4% USD, -2% cc) in the first six months of 2016. Surgical sales fell 2 percent (cc) year-over-year, driven by a slowdown in cataract equipment placements and weaker sales of IOLs, partially offset by continued growth in cataract consumables. Vision Care performance decreased 2 percent in constant currencies, affected by weaker contact lens sales in the United States and a decline in contact lens care.

“Performance in Q2 was solid despite a full quarter of Gleevec loss of exclusivity impact in the US,” stated Novartis CEO Joseph Jimenez. “We have strong innovation momentum from earlier-than-anticipated Class I Entresto guidelines, positive Cosentyx data showing durability of response in AS and PsA, the early stop of the LEE011 trial, and positive FLAME results for Ultibro. We will increase investments behind these growth opportunities, particularly Entresto, in the second half of 2016 for long-term growth.”

Based on the first-half results, full-year 2016 net sales are expected by management to be broadly in line with the prior year in constant currencies. Based on the increased spending for Entresto, and depending on Gleevec erosion curve, core operating income is projected to be broadly in line or decrease by low single digits in constant currencies.

 

Product Approvals/Launches & Pipeline Updates In 2016

R&D spending in 2015 throughout the Novartis Group totaled $8.94 billion, and the expenditure for the first two quarters of 2016 totaled $4.23 billion.

Novartis has broadened its R&D pipeline, especially in the areas of immuno-oncology and neuroscience. Management says experimental compounds in both fields have the potential to change the practice of medicine, and Novartis is striving to be among the leaders in oncology and neurology. A new president of the Novartis Institutes for BioMedical Research (NIBR) started during early 2016, while the company continues to attract leading scientists.

NIBR is a competitive advantage for Novartis, according to executives, with a broad and deep pipeline of 400 assets spanning therapeutic fields with significant unmet needs. Executives say Novartis led the industry with five new drugs approved during 2015, four of which originated at NIBR.

Key pipeline projects in the Pharmaceuticals business include RLX030 (serelaxin) for acute heart failure, AMG 334 for migraine, OMB157 (ofatumumab) in multiple sclerosis, RTH258 (brolucizumab) and OAP030 (Fovista, pegpleranib) in neovascular age-related macular degeneration, and QAW039 (fevipiprant) in asthma.

Novartis Oncology is developing efforts in immuno-oncology (IO), with 15 molecules planned to be in clinic by year-end 2016 (12 of which are potentially first-in-class). According to management, the business unit is well positioned with its established portfolio of targeted therapies and proprietary technologies to understand and overcome the pathways in emergent resistance.

Ilaris (canakinumab) during September became the first FDA-approved biologic treatment for patients with Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF). The three conditions are part of a group of rare autoinflammatory diseases known as Periodic Fever Syndromes, which are additionally referred to as Hereditary Periodic Fevers (HPF).

Ilaris is already marketed in the United States as an effective and well-tolerated treatment for another Periodic Fever Syndrome condition – Cryopyrin-Associated Periodic Syndromes (CAPS) – and another autoinflammatory condition, Systemic Juvenile Idiopathic Arthritis (SJIA). During August 2016, the European Commission approved the biologic for a license extension to additionally treat patients suffering from Adult-Onset Still’s Disease (AOSD).

Ilaris is a selective, high-affinity, human monoclonal antibody that inhibits Interleukin-1 (IL-1) beta, which is a significant part of the body’s immune system defenses. Excessive IL-1 beta production plays a prominent role in certain inflammatory diseases. Ilaris works by blocking the action of IL-1 beta for a sustained period of time, therefore inhibiting inflammation resulting from its over-production.

Positive top-line results were reported in September by Novartis from its Phase III ASCEND-4 clinical trial for Zykadia (ceritinib) in patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). In the trial, Zykadia extended progression-free survival (PFS) when compared with standard chemotherapy, including maintenance. Novartis is moving forward with worldwide regulatory filings for this indication.

Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers such as NSCLC. Zykadia was granted EU conditional approval for treating adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. The medicine has been granted FDA accelerated approval for treating patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. Zykadia is approved in 55-plus countries.

A new post-hoc analysis shows that the decline in health-related quality of life (HRQL) scores associated with a heart failure (HF) hospitalization among patients taking Entresto (sacubitril/valsartan) was lower – 50 percent less of a decline – versus those taking the ACE inhibitor enalapril. A second post-hoc analysis in the overall study population demonstrates an association between decline in HRQL score and increased risk of cardiovascular (CV) death and HF hospitalization. The findings, revealed in September, are based on data from PARADIGM-HF, the largest clinical study ever conducted in HF.

entresto-97-103mg-bottle-w-tablets

Entresto is marketed in the United States for treating heart failure (NYHA class II-IV) in patients with systolic dysfunction. The twice-daily product reduces the strain on the failing heart. The medicine does this by enhancing the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other heart failure drugs only block the harmful effects of the overactive RAAS. Entresto is composed of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.

In June, an analysis published in JAMA Cardiology found that timely and broad adoption of Entresto by all eligible heart failure patients with reduced ejection fraction (HFrEF) could prevent or postpone more than 28,000 deaths annually in the US. The findings were the first to quantify magnitude of potential survival benefits if Entresto were prescribed to all eligible US HFrEF patients (as defined by authors). Separate analysis in JAMA Cardiology demonstrated Entresto to be cost effective compared to ACE inhibitor treatment, and consistent with other high-value cardiovascular interventions.

Entresto was given strong Class I recommendation in both US and EU heart failure guidelines, less than a year after regulatory approvals, according to Novartis in May. US guidelines now recommend Entresto as standard of care for HFrEF as an alternative to an ACE inhibitor or angiotensin II receptor blocker. The guidelines call for physicians to switch patients with mild to moderate symptoms to Entresto. In the EU, the ESC HF guidelines recommend physicians switch HFrEF patients meeting the PARADIGM-HF criteria to Entresto from an ACE or ARB.

Novartis announced positive results of the Phase III EXPAND trial, the largest randomized, controlled study in secondary progressive multiple sclerosis (SPMS). EXPAND demonstrated that oral once-daily BAF312 significantly reduced the risk of disability progression compared with placebo in people with SPMS. Also known as siponimod, BAF312 is a scientifically designed, selective sphingosine-1-phosphate (S1P) receptor modulator.

BAF312 binds to the S1P1 sub-receptor on lymphocytes and promotes their retention in lymphoid tissues, which prevents them from entering the central nervous system of MS patients. This process produces the anti-inflammatory effects of BAF312.

In other September news, analyses from the head-to-head FLAME trial confirmed that Ultibro Breezhaler is a more effective option for patients at risk of chronic obstructive pulmonary disease flare-ups (exacerbations) than Seretide, across different patient sub-groups. Analyses demonstrate that Ultibro Breezhaler 110/50 mcg lowered patients’ necessity for rescue medication and had improved benefit-risk profile compared to Seretide 50/500 mcg, with less evidence of systemic effects.

Ultibro Breezhaler (indacaterol/glycopyrronium bromide) is approved in more than 90 countries, including within the EU and Latin America, Japan, Canada, Switzerland and Australia. Clinical studies have demonstrated that the once-daily LABA/LAMA dual bronchodilator offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium (18 mcg).

LEE011 (ribociclib) in August became the 11th Breakthrough Therapy designation granted to Novartis by US regulators since the program’s initiation in 2013, demonstrating the company’s dedication to developing innovative treatments that address unmet medical need. The FDA designation underscores the continuing unmet need of the HR+/HER2-advanced breast cancer population and the potential of LEE011 as an effective new treatment option. The Breakthrough Therapy designation is based primarily on positive results of the Phase III MONALEESA-2 study of LEE011 in combination with letrozole in postmenopausal women who had received no previous therapy for their advanced disease. The clinical study met the primary endpoint of clinically meaningful improvement in progression free survival at a pre-planned interim analysis.

LEE011 is a selective cyclin dependent kinase inhibitor, a new class of medicines that aid in slowing the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can allow cancer cells to grow and divide too quickly.

US approval was granted in late July to CyPass Micro-Stent, expanding Alcon’s surgical presence to treat glaucoma. The prescription medical device, in conjunction with cataract surgery, is designed to reduce intraocular pressure in patients with mild to moderate primary open-angle glaucoma.

Novartis during June revealed Phase III data from RESPONSE-2 for Jakavi (ruxolitinib). In the study, Jakavi helped patients with polycythemia vera (PV) – who did not have an enlarged spleen and were resistant to or intolerant of hydroxyurea – achieve superior hematocrit control compared to best available therapy (BAT) at 28 weeks. Myelofibrosis data suggest patients on Jakavi lived longer with 5-year survival demonstrating a 31 percent reduced risk of death versus those randomized to placebo. RESPONSE-2 is the first trial of this scale to concentrate on patients with inadequately controlled polycythemia vera in a less advanced phase of the disease.

An oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, Jakavi is approved in more than 95 countries for patients with primary myelofibrosis (MF), including in the European Union, Canada, Japan and countries in Asia, Latin and South America. The drug is also cleared for marketing in at least 60 countries for patients with PV, including countries in the European Union, Japan and Canada. The exact indication for Jakavi varies by each country. Additional worldwide regulatory submissions are under way in MF and PV.

Phase III trial data demonstrated a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar (dabrafenib) + Mekinist (trametinib) versus Tafinlar monotherapy. According to the company, the study is the longest Phase III survival follow-up of BRAF V600E/K mutation-positive melanoma patients who received a targeted combination therapy. Presented at the June ASCO annual meeting in Chicago, data demonstrated an estimated 44 percent of patients are alive after receiving Tafinlar + Mekinist combination therapy. Of those patients still enrolled at three years, 58 percent were receiving the Tafinlar + Mekinist combo.

The European Commission approved Afinitor tablet for treating unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. Announced by Novartis in early June, Afinitor (everolimus) is the first approved therapy in all 28 member states of the European Union, plus Iceland and Norway, for this form of lung NET, and one of very few treatment options available for this type of GI NET. FDA during February 2016 approved Afinitor for adult patients with progressive, well-differentiated nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic.

Afinitor is cleared for marketing in more than 110 countries for locally advanced, metastatic or unresectable progressive NET of pancreatic origin. Afinitor is available in the US and EU for treating adult patients with progressive, well-differentiated (Grade 1 or Grade 2), nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic. The drug is also approved in 120-plus countries, including the US and EU, for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy (in the US, specifically following sunitinib and sorafenib). Afinitor is also approved in more than 110 countries, including the United States and European Union, for advanced HR+/HER2-breast cancer in combination with exemestane after prior endocrine therapy.

Everolimus is available from Novartis for use in certain non-oncology patient populations under the brand names Afinitor or Votubia, Certican and Zortress. The drug is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

In April, Novartis reported that everolimus was the first adjunctive therapy shown in a prospective randomized Phase III trial to achieve clinically significant seizure control in tuberous sclerosis complex patients. TSC is a rare genetic disorder affecting up to 1 million people. Everolimus is the first approved non-surgical option indicated for the treatment of non-cancerous brain and kidney tumors in certain patients with TSC.

Revolade gained European Commission marketing clearance in April for treating pediatric – aged 1 year and older – chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments such as corticosteroids and immunoglobulins. The approval includes the use of tablets as well as a new oral suspension form of Revolade, which is designed for younger children who may be unable to swallow tablets. Revolade was approved by the EC during 2010 for use in adults with the same condition.

The once-daily oral thrombopoietin (TPO) receptor agonist Revolade works by inducing stimulation and differentiation of megakaryocytes (large cells, found especially in bone marrow) from bone marrow stem cells to increase platelet production. FDA during August 2015 approved a new oral suspension form, which expanded use of eltrombopag (marketed as Promacta in the United States) to include children 1 year of age and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Revolade is approved in over 100 countries for treating thrombocytopenia in adult patients with chronic immune ITP who have had an inadequate response or are intolerant to other treatments.

Revolade is also cleared for marketing in more than 45 countries for treating thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to enable them to initiate and maintain interferon-based therapy. During September 2015, the European Commission approved Revolade for treating adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.

Late-breaking data revealed in March from the head-to-head CLEAR trial showed that Cosentyx (secukinumab) remains superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis. The product delivered and sustained skin clearance in nearly 8 out of 10 patients with moderate-to-severe psoriasis. Cosentyx is the first fully human interleukin-17A inhibitor approved for adults for the treatment of moderate-to-severe plaque psoriasis, and is marketed for treating psoriatic arthritis and ankylosing spondylitis in the EU and US.

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Cosentyx selectively neutralizes circulating IL-17A. Research suggests IL-17A may play a significant role in driving the body’s immune response in psoriasis, psoriatic arthritis and ankylosing spondylitis.

Cosentyx is approved in more than 50 countries for treating moderate-to-severe plaque psoriasis, including the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is the first biologic approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients. The monoclonal antibody is FDA-approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

Cosentyx is the first IL-17A inhibitor with positive Phase III results for treating active psoriatic arthritis and active ankylosing spondylitis and is approved in Europe, the US, Ecuador, Bangladesh and the Philippines for those conditions. FDA approval for ankylosing spondylitis and psoriatic arthritis occurred in January. Cosentyx is marketed for psoriatic arthritis and pustular psoriasis in Japan.

 

Biosimilar Progress In 2016

Sandoz has a leading biosimilar pipeline and intends to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. This goal will be enabled by 11 regulatory submissions during a three-year period spanning from 2015 to 2017, with six already filed and the remaining four on schedule. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on the company’s experience and capabilities in development, manufacturing and commercialization.

Erelzi in August became the first biosimilar etanercept (marketed as Enbrel by Amgen and Pfizer) approved by FDA. Erelzi was approved for all indications included in the reference product label: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. This is the second biosimilar from Sandoz to receive FDA approval and only the third one in the industry to be approved for US marketing.

In June, Sandoz announced that its biosimilar rituximab candidate demonstrated pharmacokinetic (PK) bioequivalence and similar pharmacodynamics (PD), safety, efficacy and immunogenicity. Marketed as Rituxan/MabThera by Roche, rituximab is indicated to treat autoimmune diseases such as rheumatoid arthritis and hematological cancers including follicular lymphoma. Biosimilar rituximab candidate is undergoing review by the EMA after being accepted for regulatory review during May 2016.

Sandoz bolstered its biosimilars portfolio during February with the acquisition of Pfizer’s biosimilar infliximab in the 28 countries that form the European Economic Area (EEA). Sandoz obtained from Pfizer the rights for the development and commercialization of PF-06438179/biosimilar infliximab. Sandoz intends to complete the Phase III development program and file for EU registration.

The Pfizer transaction strengthens Novartis’ immunology portfolio, which already consisted of the investigational biosimilars adalimumab, etanercept and rituximab. Infliximab, which is marketed as Remicade by Janssen, is a tumor necrosis factor alpha inhibitor used to treat a variety of autoimmune diseases including rheumatoid arthritis and psoriasis.

The European Medicines Agency accepted Sandoz’s Marketing Authorization Application for its biosimilar version to Amgen’s EU-licensed Neulasta (pegfilgrastim). Sandoz is seeking marketing clearance for the same indication as the reference product Neulasta, a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). As a result, five of 10 planned regulatory filings had been achieved by Sandoz as of February. The prescription medicine pegfilgrastim is used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with certain side effects of their treatment.

 

Deals & Collaborations In 2016

Novartis announced during late June a collaboration and licensing transaction with Xencor for the development of bispecific antibodies for treating cancer. The pact is one of a series of acquisitions and strategic collaborations between Novartis and biotechnology companies that have helped strengthen Novartis’ deep and diverse immuno-oncology pipeline.

Through the deal, Novartis receives the right to develop four additional bispecific antibodies and to use other Xencor proprietary antibody engineering technology for up to 10 other biotherapeutic programs across the Group’s R&D portfolio. The companies are jointly developing Xencor’s two bispecific T-cell engaging antibodies targeting CD3xCD123 and CD3xCD20 for treating acute myeloid leukemia and B-cell malignancies.

Novartis additionally announced in June an expansion of the company’s long-standing partnership with Medicines for Malaria Venture (MMV). Novartis is leading the development of the antimalarial compound KAF156 with scientific and financial support coming from MMV in collaboration with the Bill & Melinda Gates Foundation.

KAF156 is a member of a novel class of antimalarial molecules and one of the first antimalarial drug candidates to enter Phase IIb clinical development in more than two decades. The drug compound acts against the two parasites responsible for the majority of malaria deaths (Plasmodium falciparum and Plasmodium vivax) and against the blood and liver stages of the parasite’s lifecycle. KAF156 has the potential to provide a more convenient dosing regimen and address the multidrug resistance that has emerged in five countries of the Great Mekong Sub-region. KAF156 builds on the heritage of Novartis in antimalarial drug development and the 1999 market introduction of Coartem, the first fixed-dose Artemisinin-based combination therapy. ACT is regarded as the standard of care in malaria treatment.

Worldwide eye-care leader Alcon agreed to acquire Transcend Medical during February. A privately held, US-based company, Transcend Medical is concentrated on developing minimally invasive surgical devices for the treatment of glaucoma. The transaction adds minimally invasive glaucoma surgery (MIGS) device to Alcon’s pipeline, expanding the company’s surgical presence in a new category to treat glaucoma. The goal of MIGS is to reduce or eliminate the need for glaucoma medicines.

Transcend Medical has developed a micro-stent for the treatment of mild-to-moderate glaucoma. The MIGS device is implanted just below the eye surface and is designed to treat less severe glaucoma by enhancing part of the natural drainage pathways of the eye with minimal tissue disruption. This process enables the excess fluid in the eye to drain with the goal of reducing intraocular pressure levels.

Novartis continued to grow its immuno-oncology pipeline during January via a strategic alliance and licensing pact with Surface Oncology. The transaction provided Novartis with access to four pre-clinical programs that target regulatory T-cell populations, inhibitory cytokines, and immunosuppressive metabolites in the tumor microenvironment.