- OPA-15406 is a topical PDE-4 inhibitor being developed for the treatment of atopic dermatitis (AD)
- OPA-15406 represents a potential best-in-class treatment for the management of AD
- Otsuka to receive milestone payments including a $22 million upfront payment and Medimetriks to obtain exclusive development and commercialization rights
- Should OPA-15406 be approved by the U.S. FDA, it will be launched with 250 Medimetriks sales representatives
TOKYO and FAIRFIELD, New Jersey, Feb. 8, 2016 /PRNewswire/ --Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that they have entered into a licensing agreement granting Medimetriks exclusive development and commercialization rights for OPA-15406 in the U.S. and Puerto Rico. The agreement also provides manufacturing rights. OPA-15406 is a topical, non-steroidal phosphodiesterase IV (PDE-4) inhibitor, a new treatment class for atopic dermatitis.
In a Phase II clinical trial, OPA-15406 demonstrated clinically significant results versus placebo and appeared to be safe and well tolerated. Specifically, OPA-15406 achieved a statistically significant effect on the primary endpoint versus vehicle control, thereby identifying a therapeutic benefit of the compound as measured by improvement in IGA score (Investigators Global Assessment) and percentage change in EASI scores (Eczema Area and Severity Index). OPA-15406 was also associated with improvements in patient-reported outcomes, most notably rapid and sustained itch relief. OPA-15406 reduced inflammation in affected skin by inhibiting production of cytokines and chemical mediators that are believed to cause the signs and symptoms of atopic dermatitis.
"Atopic Dermatitis affects millions of children and adults in the United States and has a striking, negative impact on their lives," said Linda Stein Gold, MD, director of clinical research, Department of Dermatology at Henry Ford Hospital. "Our currently approved treatments are limited to topical corticosteroids and topical calcineurin inhibitors that do not provide enough opportunity for safe, effective and well tolerated treatments to control the disease in many patients. OPA-15406 has the potential to offer patients with an efficacious and safe option and could help fulfill an important need in dermatology."
Under the terms of the agreement, Otsuka will receive an upfront payment of $22 million from Medimetriks and additional milestones through NDA approval. In addition, Otsuka will participate in the success of OPA-15406 through sales royalties. Medimetriks will fund and be responsible for Phase III studies for the U.S.
"We are excited that U.S. development and eventual commercialization rights to OPA-15406 are in the very capable hands of Medimetriks," said Tatsuo Higuchi, president and representative director, Otsuka Pharmaceutical. "We believe that OPA-15406, together with Medimetriks' track record in dermatology, offer a significant opportunity to meet the medical needs of patients suffering from atopic dermatitis."
"Medimetriks is honored to work with Otsuka, one of the world's most respected pharmaceutical companies" said Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks. "OPA-15406 represents an exciting potential treatment for atopic dermatitis. Expected to be the 2nd topical PDE-4 inhibitor marketed in the U.S., we believe OPA-15406 has the potential to be a best-in-class treatment for patients suffering from this disease. In addition to executing Phase III studies, we are preparing for a significant commercial effort that includes building our sales force to 250 sales representatives nationally."
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.
Current treatments for atopic dermatitis include topical corticosteroids and topical calcineurin inhibitors. Topical steroids are typically used as first line therapies and are effective anti-inflammatory agents. However, topical steroids may be associated with local and systemic side effects when used for extended periods of time, including skin atrophy, acne and telangiectasias locally, and HPA axis suppression systemically. Topical calcineurin inhibitors (TCIs) are recommended as second-line treatment for people with atopic dermatitis who are at risk of steroid-related side effects. TCIs carry boxed warnings about a possible association with skin malignancies and lymphoma, although studies have not demonstrated a clear link. Their use can be limited by local adverse reactions such as burning and stinging.
About OPA-15406
OPA-15406, discovered by Otsuka, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of atopic dermatitis. OPA-15406 is hypothesized to exert anti-inflammatory action by inhibiting the production of cytokines and chemical mediators thought to cause the signs and symptoms of atopic dermatitis.
About Otsuka
Otsuka Pharmaceutical 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.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical, which employs approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group that is headquartered in Tokyo, Japan. The Otsuka Group has business operations in 26 countries and regions around the world, with consolidated sales of approximately USD 10.2 billion (EUR 7.7 billion)in fiscal year 2014, a nine-month period (4/1/2014-12/31/2014) due to the company's change to a calendar year reporting cycle. 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
Media Contacts:
Otsuka (in Japan)
Jeffrey Gilbert
Leader, Pharmaceutical PR
Otsuka Pharmaceutical Co, Ltd.
gilbert.jeffrey@otsuka.co.jp
+81 3 6361 7379, +81 80 8728 6039
Medimetriks (in U.S.)
David Addis
Senior Vice President, Brand Communication
daddis@medimetriks.com
+1 973 882 7512, extension 569
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