Medimetriks Announces that Otsuka has Submitted MM36 (difamilast) New Drug Application for Approval in Japan

FAIRFIELD, N.J., Sept. 29, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced that Otsuka Pharmaceuticals Co. Ltd., submitted an application for approval of MM36 (difamilast) to the Japanese regulatory authorities.  Positive MM36 results in two Phase 3 Japanese clinical trials in adult and pediatric patients with mild to moderate atopic dermatitis (AD) were previously announced. 

Please find below the Otsuka Pharmaceuticals press release:

"Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that a new drug application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for difamilast (OPA-15406) in patients with atopic dermatitis.

Difamilast is a topical atopic dermatitis drug candidate discovered by Otsuka that has phosphodiesterase 4 (PDE4) inhibitory activity. PDE4 inhibitors are believed to improve the symptoms of atopic dermatitis through suppression of the production of chemical mediators such as pro-inflammatory cytokines and through other anti-inflammatory effects. 

The number of patients in Japan with atopic dermatitis is about 4.34 million, a number which increases year by year. (Source: Datamonitor Healthcare, Treatment: Atopic Dermatitis 2017 | Informa)

Otsuka entered into a licensing agreement with Medimetriks, Inc. in 2016 which granted Medimetriks development, marketing, and manufacturing rights for difamilast in the United States."

"We are pleased that Otsuka has achieved this significant milestone in the development of MM36 for the Japanese market," said Bradley Glassman, Chairman and Chief Executive Officer of Medimetriks.  "Given the positive outcome of our recent U.S. FDA Type C meeting, Medimetriks is preparing to begin one, final Phase 3 Pivotal Trial in the U.S. MM36 has demonstrated potential class-leading efficacy, tolerability and itch relief in Phase 2 and Phase 3 studies, and we believe delivers on the vision of helping children and adults suffering from AD achieve better outcomes."               

About MM36 (difamilast)
Medimetriks has sole, exclusive U.S. rights to develop and commercialize MM36 (difamilast).  Discovered by Otsuka, and referred to as difamilast (OPA-15406) by Otsuka, MM36 is an investigational non-steroidal topical anti-inflammatory PDE4 inhibitor in development for the treatment of mild to moderate atopic dermatitis. MM36 is believed to exert anti-inflammatory action by inhibiting the production of cytokines and chemical mediators thought to cause the signs and symptoms of atopic dermatitis. In particular, MM36 exhibits highly selective inhibitory activity against PDE4 subtype B, which is an enzyme that may play a significant role in inflammation.

About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by red, swollen and cracked skin with intense itching.  The onset of AD occurs most commonly between 3 and 6 months of age, with approximately 60% of patients developing the condition in the first year of life and 90% by 5 years of age. The majority of affected individuals have resolution of disease during childhood, although 10% to 30% of patients maintain the condition throughout their lives.  A small percentage of the population develops first symptoms as adults. It has been estimated that approximately 18 million people are living with AD in the U.S. and this disease accounts for up to 20% of patient visits to dermatology offices.

About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka – people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.

About Medimetriks
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company focused on the development, licensing and commercialization of innovative prescription skincare brands. The Company is dedicated to addressing unmet physician and patient needs with unique therapies that advance patient care. 

For more information, please visit: www.medimetriks.com

Medimetriks Media Contact:
David Addis
Chief Operating Officer
Medimetriks Pharmaceuticals, Inc.
[email protected]  
+1 973 882 7512, extension 569

SOURCE Medimetriks Pharmaceuticals, Inc.

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