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    Business Development - Trenton, United States - Medimetriks

    Medimetriks
    Medimetriks Trenton, United States

    3 weeks ago

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    Description
    Innovative Dermatology and Podiatry Brands

    Medimetriks Pharmaceuticals, Inc. Submits a New Drug Application to FDA for Ozenoxacin Cream, 1%, a Novel Impetigo Treatment
    FAIRFIELD, NJ – June 27, 2016

    – Medimetriks Pharmaceuticals, Inc.

    announced today that it has submitted a New Drug Application (NDA) to the U.S.

    Food and Drug Administration (FDA) seeking approval of ozenoxacin cream, 1%, a novel, non-fluorinated quinolone for the treatment of impetigo.

    Medimetriks licensed exclusive U.S.

    commercialization rights to ozenoxacin from Ferrer, a leading, privately held Spanish pharmaceutical company, in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015.

    Both Phase 3 pivotal studies demonstrated the superiority of ozenoxacin cream, 1%, applied topically twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints.

    In the studies, ozenoxacin demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4), and showed excellent antibacterial activity against a broad range of bacteria.

    The studies demonstrated that ozenoxacin was safe and well tolerated in both the adult and pediatric populations aged 2 months and older.

    Read More
    MONTREAL and FAIRFIELD, N.J., Feb. 17, 2016



    Knight Therapeutics Inc

    (TSX:

    GUD) (Knight) and Medimetriks Pharmaceuticals, Inc.

    (Medimetriks) announced today that Knight has issued a secured loan of up to US$20 million to support Medimetriks' acquisition of the exclusive U.S.

    development and commercialization rights for OPA-15406 from Otsuka Pharmaceutical Co., Ltd., a global healthcare company headquartered in Tokyo, Japan. Read More
    Otsuka Licenses Pre-Phase 3 Topical Atopic Dermatitis Treatment to Medimetriks
    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, Japan and Fairfield, New Jersey – February 8, 2016

    – 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. Read More
    Overview
    Medimetriks Pharmaceuticals, Inc.

    is building a portfolio of innovative Dermatology and Podiatry brands that meet a variety of unmet needs in the marketplace.

    We seek licensing agreements with companies that are looking to broaden their specialty reach or achieve full-scale commercialization.

    Our team has experience in planning and achieving NDA approvals, and a history of interaction with a wide range of regulatory agencies, including FDA.

    Commercialization Capabilities

    We have a proven track record of successfully commercializing brands through strong Marketing and Sales expertise and by building relationships with physicians in both the Dermatology and Podiatry specialties.

    Product Focus

    We seek to build a pipeline of prescription drug products with strong patent protection by licensing earlier stage products and acquiring commercialized products with remaining patent life.

    Medimetriks Pharmaceuticals, Inc. website may contain information related to various health and medical conditions and their treatment.

    This information is not intended to be a substitute for the advice, treatment or recommendations of a health care professional.

    You should always consult a physician for diagnosing and treating a health or medical problem, and before using any drug product discussed on this site.

    Medimetriks Pharmaceuticals, Inc. is not engaged in rendering medical advice or services.
    This site is intended for U.S. residents only.

    #J-18808-Ljbffr


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