MorphoSys AG Announces That Its Licensee Janssen R&D Has Submitted A Marketing Authorization Application For Guselkumab In Europe
11/28/2016 9:27:51 AM
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Research & Development, LLC (Janssen) through one of its affiliates, has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a fully human anti-IL-23 monoclonal antibody discovered by Janssen utilizing the HuCAL antibody library technology licensed from MorphoSys.
"The submission for marketing authorization of guselkumab with the EMA by our licensee comes shortly after its filing in the U.S. and is another important step towards making this therapy available to patients with moderate to severe plaque psoriasis," said Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "If approved, guselkumab could become the first marketed antibody based on MorphoSys's proprietary antibody technology."
According to a press release issued by Janssen, data from four studies evaluating the efficacy and safety of guselkumab when administered by subcutaneous injection in the treatment of adults living with moderate to severe plaque psoriasis served as the basis for the submission: the VOYAGE 1, VOYAGE 2 and NAVIGATE phase 3 studies, and the X-PLORE phase 2 study.
Further information can be found in the press release issued by Janssen on November 25, 2016 and on www.janssen.com.
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, including 14 million Europeans, and approximately 20% of people affected have cases that are considered moderate to severe.
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.
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