CorMedix Inc. Announces Promotions in Commercial and Tech Ops

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) has announced significant organizational changes aimed at enhancing its commercial strategy. Erin Mistry has been promoted to Executive Vice President and Chief Commercial Officer, overseeing the launch strategy for DefenCath, the company’s lead product designed to prevent infections in hemodialysis patients. Dr. Tushar Mukherjee is now Senior Vice President, Head of Technical Operations, responsible for final validation processes. These promotions are seen as key steps towards transitioning CorMedix from development to commercialization, reinforcing the leadership team as they move closer to launching DefenCath, which has FDA Fast Track and QIDP designations.

Positive

• Promotions of Erin Mistry and Dr. Tushar Mukherjee strengthen the leadership team.
• Erin Mistry's role as Chief Commercial Officer focuses on the commercial success of DefenCath.
• FDA Fast Track and QIDP designations for DefenCath provide additional marketing exclusivity.

Negative

• Deficiencies identified at contract manufacturing organization may delay NDA approval for DefenCath.
• Second Complete Response Letter from FDA indicates ongoing challenges with CMO and heparin supplier.

BERKELEY HEIGHTS, N.J., Jan. 17, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced the following promotions within the organization:

• Erin Mistry, SVP Commercial, has been promoted to EVP and Chief Commercial Officer. Ms. Mistry will have oversight and responsibility for all commercial launch strategy for DefenCath and the build out of launch infrastructure, including but not limited to market access, commercial operations and field-based sales personnel. Ms. Mistry joined CorMedix in 2020 and has been an integral architect of the company’s go to market and reimbursement strategy.
  
  
• Dr. Tushar Mukherjee, VP of Technical Operations has been promoted to SVP, Head of Technical Operations. Dr. Mukherjee joined CorMedix in early 2022 and has been a valuable leader and contributor for the technical team. In his new role, Dr. Mukherjee will report directly to the CEO and will assume responsibility for the final validation of all manufacturing, packaging and analytical testing of DefenCath, as well as all technical reviews of new product opportunities. Dr. Phoebe Mounts who had previously assumed interim oversight of technical operations will remain with the organization in her critical role as General Counsel and Head of Regulatory Affairs.
  

Joe Todisco, CorMedix CEO, commented, “These organizational changes are critical steps toward preparing CorMedix for the transition from a development stage company into a commercial organization, further bolstering our leadership team. Both Erin and Tushar have been invaluable contributors to the company and have demonstrated the skill, capability and drive that CorMedix needs to make DefenCath a commercial success.  The organization is also grateful to Phoebe for taking on these additional responsibilities during the interim period to maintain our momentum as we drive towards commercializing DefenCath.”

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. 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.  The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, CorMedix’s plans to submit a resubmission of its NDA application for DefenCath and the timing of such submission; CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability of the CMO to address the deficiencies identified by the FDA; the ability of the Company’s heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API; the resources needed to secure approval of the NDA for DefenCath from the FDA; the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix’s NDA by the end of the first quarter of 2023; the ability to secure final FDA approval prior to July 1, 2023 or obtain CMS approval of a resubmitted NTAP application; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

FAQ

What recent leadership changes were announced by CorMedix on January 17, 2023?

CorMedix announced the promotions of Erin Mistry to EVP and Chief Commercial Officer, and Dr. Tushar Mukherjee to SVP, Head of Technical Operations.

How do the recent promotions at CorMedix affect its commercial strategy?

The promotions aim to bolster the leadership team as CorMedix prepares for the commercialization of its product, DefenCath.

What is the current status of DefenCath's New Drug Application?

DefenCath's NDA has received multiple Complete Response Letters from the FDA due to manufacturing deficiencies that need resolution.

What designations has DefenCath received from the FDA?

DefenCath has been designated as Fast Track and as a Qualified Infectious Disease Product, which provides additional marketing exclusivity.

What challenges is CorMedix facing with DefenCath's manufacturing?

CorMedix is dealing with unresolved deficiencies at the contract manufacturing organization and issues with its heparin supplier.