On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following “moderate-to-severe plaque psoriasis” and “ankylosing spondylitis”. Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient’s physical function and ...
SHANGHAI, Jan. 07, 2024 /PRNewswire/ — Shanghai Argo Biopharmaceutical Co., Ltd. (“Argo”), a biotechnology company focused on the discovery and development of next-generation RNAi therapeutics, today announced that it has entered into two exclusive license and collaboration agreements with Novartis PHARMA AG (“Novartis”). Under the first agreement, Argo has granted Novartis exclusive global licenses to develop and commercialize a Phase 1 stage program. The first agreement also includes a research collaboration and Novartis also receives an option to potentially license compounds directed against up to two additional targets for cardiovascular disease treatment. Under the second agreement, Argo granted Novartis an exclusive ex-Greater China license to develop and commercialize a Phase 1/2a clinical-stage program for cardiovascular disease treatment. Discovered and developed with Argo’s cutting-edge RNAi platform technology, these clinical-stage assets offer industry-leading efficacy and durability therapies. The transactions have a combined potential value of up to $4.165 billion for Argo and ...
San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
Novartis woke up one morning and hired itself a mom, putting Jamie-Lynn Sigler of The Sopranos fame at the center of a new TV spot focused on how Kesimpta empowers multiple sclerosis patients to use their time their way. Sigler, who played Tony Soprano’s daughter Meadow in the show, was diagnosed with MS aged 20 but only discussed her condition publicly almost 15 years later. At that time, the actor was taking Biogen’s Tecfidera, having previously “run the gamut” with MS drugs, but had suffered damage that prevented her from walking for long periods of time without resting and made stairs challenging. Today, Sigler is taking Kesimpta, a targeted B-cell therapy for patients with relapsing multiple sclerosis that received FDA approval shortly before Sigler first spoke about her MS diagnosis publicly. Novartis has made Sigler as the front of push to maintain the momentum of the Kesimpta launch. The ad ...
Novartis drug iptacopan, which won its first FDA approval in early December in a rare blood disorder, has met the main goal of a pivotal test in an ultra-rare kidney disease. The small molecule’s potential to address many diseases has stirred up blockbuster expectations. By FRANK VINLUAN The blockbuster potential for new Novartis drug iptacopan rests on the molecule’s ability to reach many diseases. The drug is on the way to its first one, following a recent FDA approval in a rare blood disorder. Now Novartis has data in a different rare disease with no approved treatment options. The Swiss pharmaceutical giant says these results could support regulatory submissions in 2024. While Novartis has said iptacopan could achieve peak sales topping $3 billion, the company has provided no breakdown of that projection by indication. The results announced Monday are from a Phase 3 test of iptacopan in C3 glomerulopathy (C3G), ...
After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. The case stems back to 2017 and has its roots in Novartis’ Tafinlar, a melanoma therapy that the company acquired from GSK after a 2015 asset swap. Daiichi’s former subsidiary Plexxikon, which makes melanoma treatment Zelboraf, alleged that GSK scientists only gathered the knowledge necessary to develop the rival drug after consulting with Plexxikon for talks about a partnership that never came to fruition. Plexxikon’s patents date back to 2005, while GSK filed its first patent application on the drug in 2008, Plexxikon said. In 2021, a Northern California jury ruled in favor of Plexxikon, determining that Novartis stepped on two of the Daiichi subsidiary’s patents. Novartis was ordered to pay Daiichi’s subsidiary 9% royalty payments on future Tafinlar sales until certain Zelboraf patents expire ...
Novartis’ Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first oral monotherapy for adults with paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disease affecting approximately ten to 20 people per million worldwide. PNH patients have an acquired mutation that causes them to produce red blood cells susceptible to premature destruction by the complement system, which can cause anaemia, thrombosis, fatigue and other symptoms that can impact quality of life. The disease has a significant unmet need, Novartis reports, with a large proportion of patients on anti-C5 treatment remaining anaemic and dependent on blood transfusions. Fabhalta is a factor B inhibitor of the immune system’s complement pathway and offers an alternative to therapies that need to be delivered by infusion or injection. Victor Bultó, president US, Novartis, described the approval as an “extraordinary moment” for the PNH community. “This new, effective oral medicine may ...
Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
By Tyler Patchen Legend Biotech has secured an exclusive global license deal with Novartis giving the Swiss pharma access to Legend’s CAR-T cell therapies. The deal announced on Monday will give Novartis access to CAR-Ts that target the delta-like ligand protein (DLL3) candidate LB2102, which Legend has been investigating to treat adults with certain small cell lung cancers. Novartis will pay Legend $100 million upfront, and the New Jersey–based biotech “will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties,” according to the company’s announcement. The deal has Legend taking the lead on the Phase I trials for LB2102 in the U.S., while Novartis will handle all other development. No hard date has been given as to when the deal will close. For its part, Novartis will receive exclusive worldwide rights to develop, produce and eventually commercialize the therapies. The company ...
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