FDA_CVM (Center for Veterinary Medicine) Claims Status

Much of the effort associated with discovering and bringing new drugs into the marketplace has now shifted to small and medium sized biotech companies with limited financial resources and, in some cases, has shifted to individuals. CYGNOS Biotech fits this model of a small company with limited resources working to commercialize a new proprietary drug.

CYGNOS Biotech has adopted a strategy using a dynamic, decentralized, and low-overhead approach to achieve FDA label approval for a none specific anti-viral drug and a targeted anti-tumor drug for canine stages II & III oral malignant melanoma.

Our regulatory guidance approach began by applying for an FDA_CVM ADUFA (Animal Drug User Fee Act) sponsor fee waiver. To date the FDA_CVM has granted CYGNOS Biotech waivers for all applicable sponsor fees under the “significant barrier to innovation” provision of ADUFA totaling an estimated $1.6M.

Current FDA_CVM Milestones Completed

  • Obtained two Investigational New Animal Drug (INAD) numbers from the FDA_CVM for:
    • An antiviral drug for treating viral (non-specific) diseases in companion animals (dogs, cats, horses and birds). (INAD #011-949)
    • A treatment for canine oral malignant melanoma stages II and III. (INAD# 012-035)
  • Obtained a Minor Use Designation (MUMS) from the FDA_CVM to treat stages II and III oral malignant melanoma in dogs. This designation allows the Company to pursue a Conditional New Animal Drug Application (CNADA), which will permit the Company to market MMX for canine oral melanoma after proving it is safe, but before collecting all the necessary effectiveness data. This designation is similar to “orphan” status for human drugs used to treat rare diseases.
  • Completed first pre-CMC (Chemistry, Manufacturing and Controls) document for FDA to review and comment. The FDA CMC approved our basic manufacturing process and characterization of the peptide. We are now allowed to ‘scale-up’ our process and begin pre-cGMP API (Active Pharmaceutical Ingredient) manufacturing for review.