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Press Release

MorphoSys Announces That Its Licensee Janssen Reports Positive Results From A Phase 3 Study of Guselkumab in Plaque Psoriasis


Posted on: 01 Oct 16

Martinsried / Munich, Germany, Oct. 1, 2016 (GLOBE NEWSWIRE) -- Guselkumab Met Co-Primary Endpoints in Patients with Moderate to Severe Plaque Psoriasis

  • Janssen today presented results from a phase 3 study of guselkumab in 837 patients with moderate to severe plaque psoriasis ("VOYAGE 1" study).
  • Janssen stated in a press release issued today that "new phase 3 data show significant efficacy versus placebo and superiority of guselkumab versus Humira® in treatment of moderate to severe plaque psoriasis" and that guselkumab "demonstrates significant efficacy compared with tumor necrosis factor blocker Humira® across all major study endpoints through 48 weeks of treatment".
  • According to Janssen, the two co-primary endpoints of the study were met: Primary endpoints included improving signs and symptoms of psoriasis, while delivering clear or almost clear skin (IGA 0 or 1 and PASI 90) at week 16, in patients receiving guselkumab compared to placebo. In addition, according to Janssen, all major secondary endpoints achieved statistical significance in comparisons of guselkumab versus Humira®.
  • Guselkumab is a fully human antibody intended to target IL-23 identified from MorphoSys's HuCAL antibody library.

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen Research & Development, LLC (Janssen) has reported positive results from a clinical phase 3 study with 837 patients examining guselkumab, a fully human antibody intended to target IL-23 identified from MorphoSys's HuCAL antibody library, in patients with moderate to severe plaque psoriasis.

Janssen presented the data from its "VOYAGE 1" study today in a late breaking session at the 25th congress of the European Academy of Dermatology and Venereology (EADV) in Vienna, Austria. The randomized, double-blind, placebo- and active-comparator-controlled study evaluated guselkumab, in comparison to placebo and the active comparator adalimumab (Humira®), in the treatment of moderate to severe plaque psoriasis.

"We are excited about the positive results released by our licensee Janssen with respect to guselkumab in the treatment of moderate to severe plaque psoriasis", said Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "We are proud of our long-standing collaboration with Janssen and we are looking forward to the further updates about the development of guselkumab going forward."

Further detailed information about the clinical study results can be found in a press release issued today by Janssen.

About Psoriasis
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.

About MorphoSys:
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.

Humira® is a registered trademarks of AbbVie Inc.

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

For more information, please contact:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR

Jochen Orlowski
Associate Director Corporate Communications & IR

Alexandra Goller
Senior Manager Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com

Media Release (PDF) http://hugin.info/130295/R/2046046/764507.pdf

GlobeNewswire
globenewswire.com

Last updated on: 03/10/2016

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