MorphoSys AG announced last week that its licensee Janssen Research & Development, LLC (Janssen) through one of its affiliaties, has submitted a Biologics License Application (BLA), to the U.S. Food and Drug Administration (FDA) for guselkumab, an investigational fully human monoclonal antibody against IL-23 identified from MorphoSys’s HuCAL antibody library.
MorphoSys will receive a milestone payment from Janssen in connection with the BLA filing which seeks approval for the treatment of patients with moderate to severe plaque psoriasis. Financial details were not disclosed.
“We are excited that our licensee has submitted a regulatory filing for guselkumab to the FDA”, said Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. “Plaque psoriasis is a chronic disease affecting millions of patients worldwide. We hope this therapy will be made available for patients living with moderate to severe plaque psoriasis. If the FDA grants approval, guselkumab could become the first marketed antibody based on MorphoSys’s proprietary antibody technology – with more than 100 other MorphoSys compounds currently in development.”
The BLA for guselkumab includes data from the Janssen pivotal phase 3 “VOYAGE 1” study, a randomized, double-blind, placebo- and active-comparator-controlled study which evaluated guselkumab, in comparison to placebo and the active comparator adalimumab (Humira®), in the treatment of 837 patients with moderate to severe plaque psoriasis.
Data from the study were presented on October 1st, 2016, at the 25th congress of the European Academy of Dermatology and Venereology (EADV) in Vienna, Austria.
Further information about the BLA can be found in the press release issued by Janssen on www.janssen.com.
Further information on Janssen Submits Application to EMA
Psoriasis is an autoimmune disease which is characterized by patches of abnormal skin. These skin patches are typically red, itchy, and scaly. They may vary in severity from small and localized to complete body coverage. There are five main types of psoriasis: plaque, guttate, inverse, pustular, and erythrodermic. Plaque psoriasis, also known as psoriasis vulgaris, makes up about 90% of cases. It typically presents with red patches with white scales on top. Psoriasis is usually chronic and has a high morbidity and negative impact on patients’ quality of life. In 2015 prevalence of the disease was 16 million patients in the seven major countries (USA, Japan, France, Germany, Italy, Spain, and Great Britain), as estimated by independent market intelligence experts.
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.