MorphoSys AG
MorphoSys Announces Approval of Tremfya(R) (Guselkumab) in Japan for the Treatment of Patients with Palmoplantar Pustulosis (news with additional features)
DGAP-News: MorphoSys AG / Key word(s): Regulatory Approval Planegg/Munich, Germany, November 26, 2018 MorphoSys Announces Approval of Tremfya(R) (Guselkumab) in Japan for the Treatment of Patients with Palmoplantar Pustulosis MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee’s affiliate, Janssen Pharmaceutical K.K. (Janssen) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Tremfya(R) (guselkumab) for the treatment of patients with palmoplantar pustulosis who are not responding or are refractory to existing treatments. Palmoplantar pustulosis is a debilitating, chronic skin disease that causes pustules and inflammation to appear mainly on the palms of the hands and soles of the feet, greatly affecting patients’ quality of life. According to a press release issued by Janssen on November 21, 2018, Tremfya(R) is the first and only biologic treatment available for the estimated 130,000 patients living with palmoplantar pustulosis in Japan. Tremfya(R) is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys’s proprietary HuCAL antibody technology. Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: “We are very pleased about the Japanese approval of Tremfya(R) for patients suffering from palmoplantar pustulosis, following on from its approval there for the treatment of various forms of psoriasis and psoriatic arthritis. We are glad that Tremfya(R) will be made available to patients in Japan suffering from palmoplantar pustulosis. We will continue to follow Janssen’s development activities of this antibody in a range of inflammatory diseases with close attention”. Further information about the Japanese approval of Tremfya(R) in palmoplantar pustulosis can be found in a press release issued by Janssen on November 21, 2018. Tremfya(R) has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of plaque psoriasis and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and now palmoplantar pustulosis. MorphoSys is eligible to certain milestone payments and receives royalties on sales of Tremfya(R). Tremfya(R) (guselkumab) is currently being investigated in clinical studies, including two phase 3 trials in psoriatic arthritis, a phase 3 study in pediatric psoriasis, a phase 3 trial evaluating the efficacy of guselkumab compared with secukinumab for the treatment of adults with moderate to severe plaque psoriasis as well as a phase 2/3 program in Crohn’s disease. More information about guselkumab clinical studies is available on clinicaltrials.gov. Tremfya(R) was recently named “Most Innovative Product 2018” in dermatology during the German Pharma Trend Image & Innovation Awards ceremony in Munich.
Forward-looking statements For more information, please contact: MorphoSys AG Jochen Orlowski Tel: +49 (0) 89 / 899 27-404 Additional features: Document: http://n.eqs.com/c/fncls.ssp?u=WTJCUWADKT Document title: Media Release
26.11.2018 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English |
Company: | MorphoSys AG |
Semmelweisstr. 7 | |
82152 Planegg | |
Germany | |
Phone: | +49 (0)89 899 27-0 |
Fax: | +49 (0)89 899 27-222 |
E-mail: | investors@morphosys.com |
Internet: | www.morphosys.com |
ISIN: | DE0006632003 |
WKN: | 663200 |
Indices: | MDAX, TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
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