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MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis

Saturday, April 7, 2018, 14:00 Hrs  [IST]

MorphoSys AG, a late-stage, biopharmaceutical company, announced that its licensee Janssen Pharmaceutical K.K. (Janssen) reported that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Tremfya (guselkumab) for the treatment of three forms of psoriasis (plaque, pustular, and erythrodermic) and psoriatic arthritis in patients with moderate-to-severe disease for whom other existing treatments have failed.

Tremfya is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys's proprietary HuCAL antibody library technology.

MorphoSys is eligible to receive royalties on net sales of Tremfya.

Dr Markus Enzelberger, chief scientifc officer of MorphoSys AG, said: "We are very pleased about yet another Tremfya approval in such a short period of time. In addition to recent approvals in Australia and Brazil as well as the approvals in the US, Canada and the European Union seen last year, Japan is now the first Asian country where Tremfya has been approved. Moreover, Japan is the first country where Tremfya has also been approved for the treatment of psoriatic arthritis. We expect Tremfya will continue to provide an important treatment option for patients living with moderate-to-severe plaque psoriasis."

In addition to psoriasis, Tremfya is in phase 3 development for psoriatic arthritis. Janssen has announced plans to investigate guselkumab in Crohn's disease.

Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching and physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, and approximately 20% of people affected have cases that are considered moderate to severe.

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. An estimated 600,000 Americans-and more than 12 million people worldwide-have PsA. Up to 30 per cent of people with psoriasis are estimated to also develop psoriatic arthritis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease.


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