Indacaterol Acetate/Mometasone Furoate

Lucarista / Shutterstock Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline. Lucarista / Shutterstock Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline. During an R&D Day presentation, the Swiss pharma giant touted that it has the number one most valuable pipeline according to external rankings. The company has more than 500 ongoing clinical trials with 160 different projects in clinical development, 16 of which are advanced platform therapies. Over the course of the next two years, Novartis anticipates more than 80 major submissions to regulatory agencies around the world, the company said during its Thursday presentation in London. Over the course of this past year, the company has seen approvals for multiple sclerosis drug Mayzent, spinal muscular atrophy gene therapy Zolgensma, Piqray for breast cancer, Beovu in wet AMD and Adakveo for sickle cell disease. Each of these drugs has the potential to achieve blockbuster status, annual sales of more than $1 billion. “ Novartis had a year of breakthrough innovation in 2019, with five potential blockbuster NME (new molecular entity) approvals. The near term brings yet another catalyst-rich period with pipeline progress across the portfolio that can sustain long-term growth,” Novartis Chief Executive Officer Vas Narasimhan said in a statement . Since taking over as CEO, Narasimhan has revamped the company with a significantly increased R&D focus on oncology and gene therapies, which are seen as revenue drivers of the future . That reshaping of the company also included the culling of one-fifth of Novartis’ research programs . On Thursday, Narasimhan said the company’s operational focus is “beginning to show results” by including accelerated timelines, reducing costs and improving productivity without “compromising quality.” “We look forward to delivering new transformational treatment options to patients and continuing to reimagine medicine to address some of the world’s greatest unmet healthcare needs,” he added. Data shared at the R&D Day reflect information touted earlier this year at the company’s Meet Novartis Management event. hbspt.cta.load(4413123, '92ebc33d-a4a8-4c10-b41e-a52c39dc69ea', {}); Novartis said it has become a leader in the areas of cell, gene and radioligand therapies. Each of the platform focuses has a deep pipeline of investigational drugs or new indications, with a total of 16 advanced platform therapies now in clinical development, the company said. In those areas, the company has made inroads with the acquisitions of Advanced Accelerator Applications and Endocyte . Novartis plans on seeking new indications for existing drugs in order to maximize their potential. For example, Novartis will seek approval for 10 new indications over the next 10 years for its top-selling drug Cosentyx. Future potential indications include non-radiographic axial SpA, hidradenitis suppurativa, giant cell arteritis and lupus nephritis. For Beovu, which was launched in October in the U.S., Novartis said it will explore its potential in diabetic macular edema and retinal vein occlusion. Piqray, which was approved this year for breast cancer patients with a PIK3CA mutation, the company plans to seek approval for five new indications, including PIK3CA-relative overgrowth syndrome, for which it has already received Breakthrough Therapy and Orphan Drug designations from the FDA. Through 2021, Novartis also expects to launch a minimum of 10 Phase III trials each year. Also, Novartis said its late-stage pipeline has Phase III readouts and launches on the horizon that are expected to drive near- to mid-term growth. Launch preparations are underway for ofatumumab, a B-cell depleting treatment for relapsing multiple sclerosis. Fevipiprant, an oral therapy for asthma and Lu-PSMA-617 a radioligand therapy for prostate cancer, have upcoming Phase III readouts and the potential to change standard of care, the company said. By the end of 2021, the company is eying a potential filing for ligelizumab, a treatment for chronic spontaneous urticarial. Additionally, the company’s recruitment is ahead of schedule for clinical studies of canakinumab, an IL-1 beta mAb for non-small cell lung cancer. Following the R&D Day, Novartis announced positive data from its Phase III asthma drug, QMF149 . Data from the pivotal 52-week readout showed QMF149 met the primary endpoint of lung function improvement and key secondary endpoint of asthma control improvement versus mometasone furoate. Not unexpected, Novartis did see the FDA approve a generic version of its multiple sclerosis drug, Gilenya. The FDA’s decision marks the first generic for that medication.

lucarista/Shutterstock Novartis’s QMF149 met its primary and key secondary endpoints in the Phase III QUARTZ clinical trial for asthma. QMF149 is a once-daily, fixed-dose combination therapy containing indacaterol acetate, a long-acting beta agonist, and mometasone furoate, an anti-inflammatory. lucarista / Shutterstock Novartis ’ QMF149 met its primary and key secondary endpoints in the Phase III QUARTZ clinical trial for asthma. QMF149 is a once-daily, fixed-dose combination therapy containing indacaterol acetate (IND), a long-acting beta agonist, and mometasone furoate (MF), an anti-inflammatory. It is being developed to treat inadequately controlled asthma. It has been accepted for review by the European Medicines Agency (EMA). The second ingredient, mometasone furoate is exclusively licensed to Novartis from Merck & Co. for use in QMF149. The combination drug showed statistically significant improvements in lung faction. The lung function was measured by trough FEV 1 , which is the volume of air that can be forced out in one second after taking a deep breath. The combination drug was compared to mometasone furoate (MF) alone after 12 weeks of treatment in adults and adolescents. “Despite the number of available treatments, many patients’ lives remain impacted by their asthma,” stated Linda Armstrong, Novartis’ Respiratory Development Unit Head. “The QMF149 results of the QUARTZ study complement the recently presented Phase II data of QVM149 at the 2019 American Thoracic Society Congress, showing superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.” In addition to improved trough FEV 1 , the combination therapy showed lung function benefit by improvements in PEF compared to the MF. IND/MF showed statistically significant improvements in other measures of lung function over MF alone as well, such as by ACQ-7 after 12 weeks. Both IND/MF and MF alone were generally well tolerated. The overall number of adverse events was lower in the IND/MF group compared to the MF group. Most adverse events in both groups were mild to moderate in severity and were comparable between both cohorts. “I am very pleased with the results of the QUARTZ study looking at the efficacy and safety of the fixed-dose combination of indacaterol and mometasone furoate,” stated Oliver Kornmann, Pulmonary Department, Internal Medicine, University Hospital Mainz, Germany. “Fixed-dose combination inhalers may offer advantages to people with asthma by simplifying complex inhaler regimens, especially when they can be dosed once daily which can therefore further reduce the burden of the disease.” The PLATINUM clinical development program is developing both QMF149, which is what is being reported on today, and a triple formulation, QVM149. QVM149 is a combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF). This combination has also been accepted for review by the EMA. Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. Glycopyrronium bromide has been exclusively licensed to Novartis since April 2005 by Sosei Heptares and Vectura. There are four clinical trials that are part of the PLATINUM clinical development program. QUARTZ, which is being reported here, compares IND/MF to MF. The PALLADIUM trial compares IND/MF to MF and salmeterol/fluticasone. The IRIDIUM trial compares IND/GLY/MF to IND/MF and salmeterol/fluticasone. And the ARGON trial compares IND/GLY/MF to a combination of salmeterol/fluticasone and tiotropium. Salmterol/fluticasone is marketed under the Advair brand name by GlaxoSmithKline. Tiotropium bromide is marketed as Spiriva Respimat by Boehringer Ingelheim.