Novartis has acquired Chinook Therapeutics for more than $3.2bn in a move to bolster its portfolio of drugs targeting kidney disease. With reported sales of $13.62bn in Q2 2023, Novartis is looking to expand its drug portfolio. Just last month, the company acquired DTx Pharma for $1bn for its small interfering RNA (siRNA) treatment portfolio for rare diseases. As part of Chinook’s acquisition, its shareholders would receive $40 per share, totalling $3.2bn. The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. The acquisition comes at a significant inflection point with two high-profile drugs, atrasentan and zigakibart, in Phase III development for the treatment of IgA nephropathy (IgAN). A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023. IgAN is a chronic kidney disease, in which immunoglobulin A (IgA) is trapped in the glomeruli of the ...
Novartis has shared positive top-line results from two late-stage studies evaluating its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. Affecting 40 million people worldwide, CSU is a debilitating and unpredictable condition characterised by the occurrence of itchy hives and/or deep tissue swelling that lasts for six weeks or longer. H1-antihistamines are the first-line treatment for the condition; however, approximately 60% of patients are inadequately controlled by these alone and continue to live with the distressing symptoms of CSU. Novartis’ remibrutinib works by blocking the cascade of BTK, an enzyme central to the release of histamine and, when spontaneously activated, plays a critical role in the symptoms associated with CSU. The ongoing phase 3 REMIX-1 and REMIX-2 trials met their primary endpoint of absolute change from baseline in weekly urticaria activity score (UAS7) at week 12, demonstrating clinically ...
By Kate Goodwin Pictured: Novartis Building/iStock, JHVE Photo With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year. In two late-stage studies, remibrutinib met the primary endpoint of change from baseline in a weekly urticaria activity score at week 12. While studies will continue for a full year, the BTK inhibitor demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks. Patients with chronic spontaneous urticaria (CSU) deal with chronic hives that can last for six weeks or longer. The trigger is internal, as opposed to allergen exposure. While antihistamines are the first line of treatment, around 60% of patients’ symptoms are inadequately controlled with antihistamines alone. ...
Novartis has announced its acquisition of DTx Pharma, a preclinical stage biotech focused on developing siRNA therapies for neuroscience indications, in a deal worth up to $1bn. The transaction gives Novartis access to DTx’s fatty acid ligand-conjugated oligonucleotide (FALCON) platform as well as its lead preclinical therapy for Charcot-Marie-Tooth disease type 1A (CMT1A). Approximately 150,000 people in the US and Europe are affected by CMT1A, a slow-progressing and degenerative disease of the peripheral nervous system. There are currently no approved treatments to address the underlying genetic cause of the condition: the over-expression of PMP22, a protein that causes the myelin sheath that supports and insulates nerves in the peripheral nervous system to function abnormally. DTx-1252, which was recently granted Orphan Drug Designation by the US Food and Drug Administration, decreases the expression of this protein. “The FALCON platform facilitates this targeted approach by conjugating siRNAs to naturally occurring fatty acids ...
Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appeal. The combination patent, which includes an extension thanks to a pediatric exclusivity award, is set to expire in July of 2025. Other patents on the drug run until 2026, 2027 and 2036. Now, Novartis will head to the U.S. Court of Appeals for the Federal Circuit (CAFC) in an effort to reverse the decision, the company said in a recent statement. The company will “continue to defend” its Entresto patents “vigorously” and warned that any generics that launch before the outcome of the appeal “may be at risk” of litigation. Currently, there are no Entresto copycats with tentative or official FDA approvals, the company noted. Just last week, the company chalked up a win against Mylan when a West Virginia court ruled that the ...
Just days after sewing up a pair of $897 million deals with Pfizer, Samsung Biologics has added a few hundred million dollars more to its partnership cash pile—this time courtesy of an expanded pact with Novartis. Monday, Samsung Bio said in a regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier Samsung-Novartis tie-up worth $81 million in June 2022. Last week, meanwhile, Samsung Bio said Pfizer had added $486 million to two biosimilar production accords the companies made in early 2023. In June, the partners signed a contract for the Korean CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies linked up on a deal worth $193 million, according to a regulatory filing. Samsung’s Novartis deal comes in below that Pfizer deal from June. Still, the Novartis tie-up now represents ...
More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
Novartis has entered into an agreement to acquire Chinook Therapeutics for approximately $3.5bn, marking a notable expansion to the Swiss drugmaker’s renal pipeline. The deal grants Novartis access to the US biopharma’s two late-stage candidates in development for Immunoglobulin A Nephropathy (IgAN), a rare and progressive kidney disease that mostly affects young adults. IgAN, which Novartis says currently lacks targeted treatment options, affects up to 21 people per million per year in the US, with a higher rate among Asian populations. The most advanced of the two assets is atrasentan, an oral endothelin A receptor antagonist that Chinook bought from AbbVie at the beginning of 2020. The candidate is currently in phase 3 development for IgAN, with a readout from the study expected in the fourth quarter of this year. The second candidate, zigakibart (BION-1301), is a subcutaneously administered anti-APRIL monoclonal antibody that is expected to enter phase 3 development ...
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