As an expert in infectious diseases, Jennifer Leeds could see the storm brewing. When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking. Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help.

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Basel, August 17, 2020 — Novartis welcomes the decision by the US District Court for the District of Delaware to uphold the validity of the Gilenya^® (fingolimod) dosage regimen patent, as our intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives.

The decision also holds that the generic fingolimod product proposed by HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (“HEC”) in its Abbreviated New Drug Application (ANDA) will infringe the dosage regimen patent (US …

• EC approves Xolair^® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication¹

• Chronic rhinosinusitis with nasal polyps is a debilitating condition for many patients, with symptoms including nasal blockage, difficulty breathing and sleeping, and loss of sense of smell, which reduce quality of life^2–4
   
• Approval builds on well-established efficacy and safety record of Xolair, which has over 1.3 million …

• Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis¹
   
• ASCLEPIOS I and II demonstrated significant reductions in risk of relapses, confirmed disability worsening and profound reduction of active or new brain lesions¹
   
• The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple …

• EU approval is based on two Phase III studies showing Cosentyx^® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile¹
   
• Moderate-to-severe psoriasis affects more than 350,000 children worldwide², with the physical and psychological burden disrupting important formative years³
   
• Cosentyx is a proven brand, supported by long-term five-year sustained efficacy and safety data across psoriasis, psoriatic arthritis ( …