Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 114

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 114
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 epidermis, but also dissolve quickly enough to deliver sufficient doxorubicin to the site during the 30 minute application. Other more traditional parameters of biopharmaceutics also apply, such as consistency of dose between arrays, made more complex than oral or other dosage forms, by the molding and centrifugation process for the arrays. The important biopharmaceutic considerations for the efficacy of the array therefore include the following:

These factors can affect the ability of a dissolvable, tip-loaded microneedle array to perform as expected in human clinical studies. We have taken the following steps to ensure these factors are properly controlled during manufacturing.

Factors Affecting Ability of MNA to Perform Clinically

| Factor                                                                 |     | Measurement                                                                                                                   |
| Fidelity of dose to label claim                                        |     | Quantitative testing of the array samples by a validated HPLC method                                                          |
| Homogeneous distribution of drug throughout the array                  |     | Visual inspection for "hot spots"                                                                                             |
| Consistency of dose between arrays                                     |     | Quantitative testing for content uniformity of the array samples by a validated HPLC method                                   |
| Needle strength/hardness                                               |     | Desiccation measured by loss on drying to approximately 5%.                                                                   |
| Dissolution of the microneedles sufficient to deliver the drug payload |     | Demonstrated in vitro, ex vivo, and in vivo.                                                                                  |
| Doxorubicin stability                                                  |     | pH measurement of the solution prior to carboxymethyl cellulose ("CMC") addition; follow-up analytical testing for impurities |

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CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD.PURSUANT TO 17 C.F.R. SECTION 200.83</div>

MNA = dissolvable microneedle array, HPLC = high power liquid chromatography, UV = ultra-violet, CMC = carboxymethyl cellulose.

Manufacturers of D-MNA Components

| API/Excipient                      |     | Manufacturer/Lot Number                            |
| Doxorubicin HCl                    |     | Gemini PharmChem, Mannheim, GmbH, batch no. 070520 |
| Citric acid anhydrous              |     | Fischer Scientific/185791                          |
| Sodium phosphate dibasic anhydrous |     | Fischer Scientific/175060                          |
| Trehalose dihydrate                |     | Pfanstie