Novartis Buys Rights to Multiple Sclerosis Drug from GlaxoSmithKline
Novartis is acquiring all the remaining rights to GlaxoSmithKline’s (GSK) multiple sclerosis (MS) drug, Ofatumumab. A fully human monoclonal antibody which targets the CD20 molecule, Ofatumumab is being developed for relapsing remitting multiple sclerosis (RRMS) and other autoimmune conditions.
More than 2.3 million people worldwide are affected by MS, a chronic disorder of the central nervous system that causes progressive loss of both physical and cognitive functions.
Under the terms of the agreement, Novartis will make an initial upfront payment to GSK of $300 million for buying the drug and a further payment of $200 million following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534 million may be made. Novartis will also pay royalties of up to 12% to GSK on future net sales of Ofatumumab in autoimmune conditions.
“Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio. Our vision for patients with MS is to develop treatments that improve on current standards of care, meeting patients’ needs at every stage of their disease with innovative and targeted drugs,” said David Epstein, head of Novartis Pharmaceuticals.
Ofatumumab is now ready to begin phase III pivotal studies.
Meanwhile, Novartis’ skin cancer drug Odomzo has received European approval. Odomzo (sonidegib, formerly LDE225), in the form of 200 mg capsules, can treat adult patients with locally advanced basal cell carconima (laBCC) who are not amenable to surgery or radiation therapy.
BCC consists of abnormal, uncontrolled growths or lesions that arise in the skin’s basal cells which line the outermost layer of the skin and accounts for more than 80% of non-melanoma skin cancers.
“The approval of Odomzo brings new hope in the form of a non-invasive option to help treat this disfiguring and potentially life-threatening disease,” said Reinhard Drummer, professor and vice chairman at the University of Zurich’s department of dermatology.
The approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Outside the EU, Odomzo is approved in the USA, Australia and Switzerland. Additional regulatory submissions are being reviewed worldwide by health authorities.
Odomzo is currently in clinical development in other diseases.
