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Novartis To Initiate Hydroxychloroquine Study for Coronavirus
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Novartis (NVS - Free Report) announced that it has reached an agreement with the FDA to initiate a phase III study to evaluate efficacy and safety of malaria drug, hydroxychloroquine, in hospitalized COVID-19 patients. The FDA has allowed the use of the generic medicine, which is unapproved for COVID-19, under emergency use authorization for coronavirus infections.
Hydroxychloroquine came into limelight following its promotion by President Donald Trump as a potential treatment for COVID-19. Demand for the drug has been soaring since then. However, there is still uncertainty about its risk-benefit ratio.
Novartis accelerated its research related to hydroxychloroquine to start the late-stage study in a few weeks. Meanwhile, Sandoz, the generic unit if Novartis, has committed to donate up to 130 million tablets of hydroxychloroquine globally, if the drug is proved to be beneficial. The study will complement the company’s commitment to fight the pandemic. We note that Sandoz has already made donations of 30 million tablets to the US Department of Health and Human Services (“HHS”) and is dispatching the drug to other countries on request. Please note that Sandoz markets a generic version of hydroxychloroquine as a treatment for malaria, under the tradename of Plaquenil.
The phase III study will evaluate hydroxychloroquine monotherapy and hydroxychloroquine in combination with antibiotic, azithromycin, compared to placebo in patients. As part of its fight against coronavirus, the company has announced that will make available any of its intellectual property related to hydroxychloroquine as COVID-19 treatment through non-exclusive voluntary licenses and other options for broader development of the drug.
Novartis is also planning to repurpose some of its approved drugs, which are likely to be potent against COVID-19, which include systemic juvenile idiopathic arthritis drug, Ilaris (canakinumab), cancer drug, Gleevec (imatinib mesylate), psoriatic arthritis drug, Cosentyx (secukinumab) and hypertension drug, Diovan (valsartan). The company started evaluating Jakafi (ruxolitinib) in collaboration with its partner Incyte (INCY - Free Report) last week in a phase III study in patients aged 12 years or older with COVID-19 associated cytokine storm.
Novartis’ shares have declined 5.7% so far this year compared with the industry’s decrease of 1.3%.
Meanwhile, in order to accelerate the development of medicines and vaccines for COVID-19, National Institutes of Health (“NIH”) has created a partnership initiative, Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”), to bring several leading biopharmaceutical companies, the HHS, the Centers for Disease Control and Prevention, the FDA and the European Medicines Agency together. There are more than 100 potential preventives and therapeutics for COVID-19 under development and ACTIV is likely to support their accelerated development through a collaborative framework and streamlining clinical studies.
Novartis announced its participation in ACTIV last week. J&J (JNJ - Free Report) and Pfizer (PFE - Free Report) are also closely working with the NIH as part of ACTIV as well as other important consortia for speedier development of COVID-19 medicines.
In a separate press release, Novartis announced that the company has completed the acquisition of a US-based software startup, Amblyotech. The company plans to develop treatment for amblyopia or lazy eye using Amblyotech’s technology in collaboration with Ubisoft and McGill University.
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Novartis To Initiate Hydroxychloroquine Study for Coronavirus
Novartis (NVS - Free Report) announced that it has reached an agreement with the FDA to initiate a phase III study to evaluate efficacy and safety of malaria drug, hydroxychloroquine, in hospitalized COVID-19 patients. The FDA has allowed the use of the generic medicine, which is unapproved for COVID-19, under emergency use authorization for coronavirus infections.
Hydroxychloroquine came into limelight following its promotion by President Donald Trump as a potential treatment for COVID-19. Demand for the drug has been soaring since then. However, there is still uncertainty about its risk-benefit ratio.
Novartis accelerated its research related to hydroxychloroquine to start the late-stage study in a few weeks. Meanwhile, Sandoz, the generic unit if Novartis, has committed to donate up to 130 million tablets of hydroxychloroquine globally, if the drug is proved to be beneficial. The study will complement the company’s commitment to fight the pandemic. We note that Sandoz has already made donations of 30 million tablets to the US Department of Health and Human Services (“HHS”) and is dispatching the drug to other countries on request. Please note that Sandoz markets a generic version of hydroxychloroquine as a treatment for malaria, under the tradename of Plaquenil.
The phase III study will evaluate hydroxychloroquine monotherapy and hydroxychloroquine in combination with antibiotic, azithromycin, compared to placebo in patients. As part of its fight against coronavirus, the company has announced that will make available any of its intellectual property related to hydroxychloroquine as COVID-19 treatment through non-exclusive voluntary licenses and other options for broader development of the drug.
Novartis is also planning to repurpose some of its approved drugs, which are likely to be potent against COVID-19, which include systemic juvenile idiopathic arthritis drug, Ilaris (canakinumab), cancer drug, Gleevec (imatinib mesylate), psoriatic arthritis drug, Cosentyx (secukinumab) and hypertension drug, Diovan (valsartan). The company started evaluating Jakafi (ruxolitinib) in collaboration with its partner Incyte (INCY - Free Report) last week in a phase III study in patients aged 12 years or older with COVID-19 associated cytokine storm.
Novartis’ shares have declined 5.7% so far this year compared with the industry’s decrease of 1.3%.
Meanwhile, in order to accelerate the development of medicines and vaccines for COVID-19, National Institutes of Health (“NIH”) has created a partnership initiative, Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”), to bring several leading biopharmaceutical companies, the HHS, the Centers for Disease Control and Prevention, the FDA and the European Medicines Agency together. There are more than 100 potential preventives and therapeutics for COVID-19 under development and ACTIV is likely to support their accelerated development through a collaborative framework and streamlining clinical studies.
Novartis announced its participation in ACTIV last week. J&J (JNJ - Free Report) and Pfizer (PFE - Free Report) are also closely working with the NIH as part of ACTIV as well as other important consortia for speedier development of COVID-19 medicines.
In a separate press release, Novartis announced that the company has completed the acquisition of a US-based software startup, Amblyotech. The company plans to develop treatment for amblyopia or lazy eye using Amblyotech’s technology in collaboration with Ubisoft and McGill University.
Zacks Rank
Novartis is a Zacks Rank #3 (Hold) stock currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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