Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 30

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 30
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If we are unable to differentiate SkinJectfrom existing therapies for treatment of skin cancer or Teverelix from therapies for high cardiovascular risk advanced prostate cancer patients or from treatment of recurrent AUR ("AURr") episodes, or if the FDA or other applicable regulatory authorities approve generic products that compete with the Products, the ability to successfully commercialize the Products would be adversely affected.

It is possible that we will receive data from additional clinical trials in respect of either or both of SkinJect and Teverelix, or in a post marketing setting from physician and patient experiences with the commercial products, that does not continue to support such interpretations. It is also possible that the FDA, physicians and healthcare payers will not agree with our interpretation of existing and future clinical trial data. If we are unable to demonstrate the value of the Products based on clinical data, patient experience, as well as real world evidence, the opportunity for the Products to maintain premium pricing and be commercialized successfully would be adversely affected.

Additionally, the FDA or other applicable regulatory authorities may approve other generic products that could compete with the Products if we cannot adequately protect it with our patent portfolio. For example, in the US, once an NDA is approved, the product covered thereby becomes a "listed drug" which can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application ("ANDA"). The Federal Food, Drug, and Cosmetic Act (the "FDCA"), FDA regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic substitutes. These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and that the generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Products. These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Products.

A variety of risks associated