CorMedix (CRMD) Receives CRL From FDA for DefenCath Catheter Lock Solution

March 1, 2021 8:30 AM EST

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CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously.

Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns. If an inspection is required, the FDA is currently facing a backlog due to the pandemic and are actively working to define an approach for scheduling outstanding inspections once safe travel may resume. CorMedix will request a meeting with the FDA, which we estimate will occur by mid-April, to obtain agreement with the Agency on our proposed plan for resolution of the issues at our third-party manufacturing facility.

FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with FDA, the Agency added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent with our request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), which provides for a streamlined clinical development program involving fewer clinical trials. The LPAD pathway is intended to encourage the development of safe and effective products that address unmet medical needs of patients with serious bacterial and fungal infections.

Khoso Baluch, CEO, stated that “CorMedix intends to work closely with the FDA and the manufacturing facility to support the completion of the review of the NDA. We are disappointed that we will be delayed in bringing DefenCath to an underserved community with an unmet medical need. We are gratified that FDA did not identify deficiencies in the safety and efficacy data for DefenCath and CorMedix will work diligently to bring DefenCath to dialysis patients who remain at risk of life-threatening catheter-related blood stream infections.”

DefenCath received designations as Fast Track and Qualified Infectious Disease Product (QIDP), and the NDA received priority review. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed.

CorMedix ended the 4th quarter of 2020 with pro forma cash, cash equivalents and short-term investments of approximately $87.8 million, including capital raised though ATM issuance, which the company estimates is sufficient to fund operations at least into second half of 2022.

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