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Novartis begins $256M Singapore expansion

(Left to right) : Ms Cindy Koh, Executive Vice President, Economic Development Board (EDB); Ms Ana Locatelli, Site Head, Novartis Singapore; ⁠Mr Heng Swee Keat, Deputy Prime Minister and Coordinating Minister for Economic Policies; Mr Steffen Lang, President of Operations at Novartis; Mr Christoph Buerki, Chief Financial Officer Operations, Novartis. [Image courtesy of Novartis]

Novartis announced last week that it broke ground on a biopharmaceutical manufacturing plant in Singapore.

The company put forward a $256 million investment to begin the project, which will lead to the deployment of digital and automation solutions to enhance manufacturing productivity, improve operational efficiency, and upskill the workforce. Novartis said this site will focus on manufacturing therapeutic antibody drugs to deliver breakthrough treatments to patients globally.

“In the next phase of growth for the biopharma sector…

Novartis opens new radioligand therapy manufacturing facility in Indianapolis

Novartis today announced the expansion of its radioligand therapy (RLT) manufacturing capabilities with a new facility in Indianapolis.

The Basil, Switzerland–based pharma giant said it has received FDA approval for commercial manufacturing in Indianapolis of its RLT therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat advanced metastatic prostate cancer.

The new 70,000-square foot facility in Indianapolis is the second of its kind for the company in the U.S. and Novartis’ largest globally.

The Indianapolis site, strategically situated in the U.S., is designed from scratch for RLT production. It promises to substantially increase supply to meet growing demands, especially in the U.S. and potentially Canada, subject to approval. The facility is equipped for future expansion, including fully automated lines — a first for the radiopharmaceutical industry.

“The intricate process of providing RLTs to patients within hours of producti…

Novartis’s Sandoz spin-off and Sanofi’s portfolio slim-down reflect pharma push toward specialization

[Gorodenkoff/Adobe Stock]

Modern pharma: Evolving through specialized strategies

The pharmaceutical trend toward increasing concentration appears to be gaining momentum. On September 15, Novartis shareholders approved the company’s proposed spinoff of Sandoz, the generics and biosimilars unit. The company anticipates the deal to close in early October. Similarly, Sanofi is also taking a scalpel to its operations, offloading a selection of its central nervous system medications to Pharmanovia.

Sanofi, similar to several other of its pharma peers, is aiming to realign its portfolio, emphasizing areas where it can drive innovation and deliver robust growth.

Last week, Johnson & Johnson, for instance, announced a rebrand that traded its historic ‘Janssen’ pharma moniker for ‘Johnson & Johnson Innovative Medicine.’ The move is part of a broader initiative to priorit…

Sanofi, Merck and Novartis top pharma M&A in recent years

Despite a temporary slowdown during the early days of the pandemic, the pharma sector has witnessed a steady rise in M&A activity over the years. The number of deals climbed from 23 in 2018 to 43 in 2022. Major players driving this trend include Sanofi, Merck & Co. and Novartis. Those three players have made significant acquisitions to bolster core assets and capabilities in specialized areas such as immunology, oncology and gene therapy.

For instance, in 2022, Merck acquired Prometheus Biosciences for $11 billion to strengthen its presence in immunology, while Sanofi purchased Provention Bio for roughly $2.9 billion to add a first-in-class therapy for type 1 diabetes. Novartis has also been on the hunt, with approximately $31 billion in deals since 2018 that have strengthened its Innovative Medicines portfolio.

Bar chart showing the top 10 most active pharmaceutical companies in M&A activity fr…

Novartis aims to offload eye care unit to Bausch + Lomb for $2.5 billion

Novartis has agreed to sell ophthalmology assets to Bausch + Lomb for an upfront payment of $1.75 billion, with potential milestone payments of up to $750 million. The total value of the deal could reach $2.5 billion. Novartis expects the deal to improve their focus more on higher-margin drugs.

Under the terms of the deal, Bausch + Lomb will get Novartis’ Xiidra, a treatment for dry eye disease, as well as two experimental products: libvatrep (formerly SAF312), an experimental treatment for chronic ocular surface pain with Phase 2b test results expected later this year. It will also receive AcuStream, a medical device being for delivery of topical eye medications.

Xiidra generated more than $400 million in 2022 revenue.

In addition to Xiidra, Bausch + Lomb already has a presence in the dry eye disease market, bagging FDA-approval for a drug called Meibo in May. The two drugs are expected to complement each other, targeting different aspects of the …

Bausch + Lomb acquires XIIDRA eye drops, delivery system from Novartis in $2.5M deal

Bausch + Lomb (NYSE:BLCO) announced today that it agreed to acquire XIIDRA non-steroid eye drops from Novartis.

The company also acquired an investigational medicine and rights to a delivery device for treating dry eye disease (DED). AcuStream, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye.

XIIDRA (lifitegrast ophthalmic) solution 5% has approval to treat the signs and symptoms of DED. It focuses on inflammation associated with dry eye.

The acquisition complements Bausch + Lomb’s existing dry eye portfolio, which includes eye and contact lens drops. It features the recently approved MIEBO eye drop for DED, which works differently than XIIDRA.

Novartis values the transaction at up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments.

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Novartis to spend up to $3.5 billion to acquire Chinook amid pharma M&A upsurge in 2023

Eyeing the booming renal therapeutics market, Swiss pharmaceutical giant Novartis AG plans to spend up to $3.5 billion on Chinook Therapeutics. The deal marks the latest in a string of high-profile mergers and acquisition (M&A) deals in the pharma sector over the past roughly half year.

Chinook’s kidney disease specialization in the Novartis M&A equation

At the heart of the deal is Chinook’s specialization in precision medicines for kidney disease.

The rising prevalence of chronic kidney disease, which affects roughly 10% of the global population, according to the National Kidney Foundation, underscores the urgency of addressing renal disorders.

The growing prevalence of diabetes, a core contributor to the rise of renal disorders, has stimulated the market for therapies for chronic kidney disease.

This bar chart shows Novartis acquisitions over the past three years. The transaction amou…

One-time gene therapy Zolgensma from Novartis shows lasting benefits for SMA patients

[Zolgensma image from Novartis]

A gene therapy for spinal muscular atrophy (SMA) patients is making waves. Novartis (NYSE:NVS) revealed new long-term data highlighting the durability of Zolgensma (onasemnogene abeparvovec) up to 7.5 years after a single treatment. The data comes from two long-term follow-up studies, LT-001 and LT-002, which examined a range of patient populations and demonstrated a positive overall benefit-risk profile. LT-001 is an ongoing 15-year long-term follow-up study of patients who completed the phase 1 START study. More than 3,000 children have been treated with Zolgensma in clinical trials, managed access programs and commercial settings.

Novartis expects Zolgensma to eventually generate $1.5–2 billion, according to BioPharma Dive. NVS shares were up 1 percent to $83.01 today after announcing the new data.

FDA approved Zolgensma (onasemnogene abeparvovec-xioi) in 2019 for chi…

The next wave: 10 promising investigational antihypertensive drugs to watch

[Image courtesy of Adobe Stock]

Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. This review highlights ten promising antihypertensive drug candidates with the potential to address pulmonary arterial hypertension (PAH), resistant hypertension and uncontrolled hypertension.

Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin receptor antagonist (ERA), it effectively blocks the binding of ET-1 to both ET A and ET B receptors. The drug has a low likelihood of interacting with other medications and its mechanism of action is well-suited for treating resistant hypertension. In clinical trials, aprocitentan demonstrated better blood pressure reduction than placebo, with the effects lasting up to week 40, and was generally well-tolerated by patients. (Text continues beneath th…

Iptacopan from Novartis could become preferred therapy for paroxysmal nocturnal hemoglobinuria

Novartis (NYSE: NVS) recently announced that the pivotal iptacopan Phase 3 APPLY-PNH trial met both its primary and most secondary endpoints in patients with paroxysmal nocturnal hemoglobinuria (PNH). The company recently presented the data at this year’s American Society of Hematology (ASH) meeting.

Almost all iptacopan recipients had blood-transfusion independence and had clinically meaningful patient-reported-fatigue improvements. There were no serious cases of breakthrough hemolysis (BTH). Iptacopan led to an 80% difference to anti-C5 in the estimated proportion of patients achieving 2 g/dL or more hemoglobin-level increases from baseline. The drug candidate also led to a 67% difference to anti-C5 in the estimated proportion of patients achieving 12 g/dL or more hemoglobin levels.

“As an oral monotherapy, iptacopan offers PNH patients the convenience of an at-home or anywhere treatment, freeing them from the need to travel to an infusion center for treat…

Novartis mulls spinning off ophthalmology and respiratory divisions

As part of its ongoing restructuring efforts, Novartis AG (NYSE:NVS) is reportedly considering selling its ophthalmology and respiratory businesses, according to Bloomberg.

Private equity firms are reportedly sizing up the business units.

According to the company’s website, its core therapeutic areas are cardiovascular, hematology, solid tumors, immunology and neuroscience.

Novartis’s ophthalmology division focuses on various therapies for vision problems, including glaucoma, ocular surface disease and age-related macular degeneration.

Its respiratory disease unit focuses on developing therapies for asthma, idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease (COPD).

Earlier this year, the company announced that it would lay off about 8,000 employees, representing 7.4% of its workforce. The company had roughly 108,000 workers.

In 2019, Novartis announced it would spin off its Alcon eye-care division. Th…

Novartis to spin off Sandoz

Novartis announced today that it intends to separate Sandoz into a new, publicly traded standalone company through a 100% spinoff.

The spinoff of the generics and biosimilars division of Novartis aims to maximize shareholder value by creating the top European generics company and a global leader in biosimilars, according to a news release. Such a move would allow Novartis shareholders to participate fully in the potential future upside for both Sandoz and Novartis Innovative Medicines, the company said.

Novartis said that its Innovative Medicines and Sandoz businesses would enable enhanced focus and the ability to pursue independent growth strategies through the spinoff.

The company expects Sandoz — which would be headquartered in Switzerland and listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the U.S. — to deliver its “next wave of growth” based on its existing biosimilar…