BERKELEY HEIGHTS, NJ, Jan. 17, 2023 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD) is focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. announced today that it is a biopharmaceutical company. The following promotions within your organization:
- SVP Commercial, Erin Mistry, has been promoted to EVP and Chief Commercial Officer. Mr. Mistry will oversee and be responsible for all of DefenCath’s commercial launch strategy and launch infrastructure, including but not limited to market access, commercial operations and field-based sales representatives. Mistry said she joined CorMedix in 2020 and has served as an integral architect of the company’s go-to-market and reimbursement strategies.
- Dr. Tushar Mukherjee, Vice President of Technical Operations, has been promoted to SVP, Head of Technical Operations. Dr. Mukherjee will join CorMedix in early 2022 and is a valuable leader and contributor to the technical team. In his new role, Dr. Mukherjee will report directly to the CEO and will be responsible for all manufacturing, packaging and final validation of analytical testing for DefenCath, as well as all technical reviews of new product opportunities. Dr. Phoebe Maunts, formerly interim overseer of technical affairs, will retain a key role with the organization as general counsel and head of regulatory affairs.
CorMedix CEO Joe Todisco commented: Both Erin and Tushar have been invaluable contributors to the company and have demonstrated the skills, capabilities and drive CorMedix needs to make her DefenCath a commercial success. We would also like to thank Phoebe for taking on these additional responsibilities during the interim period in order to maintain the momentum moving forward towards commercializing Defencas. ”
About Comedyx
CorMedix Inc. is a biopharmaceutical company focused on the development and commercialization of therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company’s flagship product is 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. Focus on developing DefenCath™. DefenCath has been designated as a Fast Track and Qualified Infectious Disease Product (QIDP) by the FDA, and its original New Drug Application (NDA) received priority review for its potential to address unmet medical need. rice field. QIDP will provide an additional 5 years of marketing exclusivity. This is in addition to his five years granted to new chemical entities upon NDA approval. CorMedix is also committed to conducting clinical studies in pediatric patients using central venous catheters for hemodialysis if the NDA is approved. This will add an additional 6 months of marketing exclusivity once the study is complete. We have received a complete response letter (CRL) from the FDA stating that we cannot approve his original NDA until the Contract Manufacturing Organization (CMO) deficiencies are satisfactorily resolved. In its second CRL, the FDA stated that the resubmitted NDA would not be approved until the facility deficiencies identified during the preapproval inspection at the CMO and communicated to the CMO were satisfactorily resolved, and that the CMO did not approve the resubmitted NDA. notified that it will not be approved during testing of an active pharmaceutical ingredient. DefenCath’s heparin supplier manufacturing facility. As CMOs and heparin suppliers work to resolve outstanding deficiencies, CorMedix is concurrently transferring technology to additional his CMOs and working to certify additional heparin suppliers. CorMedix also plans to develop DefenCath as a catheter locking solution for use in other patient populations. The company is also working with leading researchers to develop Taurolidine-based therapies for rare childhood cancers. For more information, please 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 involve risks and uncertainties. All statements, other than statements of historical fact, regarding management’s expectations, beliefs, goals, plans, or CorMedix’s prospects, DefenCath’s plans to resubmit his NDA application, and the timing of such submissions. Description. CorMedix’s future financial condition, financial plans, future earnings, anticipated costs and adequacy of cash and short-term investments to fund our business should be considered prospectively. Please note that actual results may differ materially from projections or estimates due to a variety of important factors, including: Ability of our heparin suppliers to address manufacturing defects identified in non-heparin API warning letters. Resources needed to secure DefenCath’s NDA approval from the FDA. Additional risks and uncertainties in his relationships with CMOs and heparin suppliers. Ability to submit a supplement to CorMedix’s NDA by the end of Q1 2023. Ability to secure final FDA approval or obtain CMS approval for resubmitted NTAP applications before July 1, 2023. Risks and uncertainties associated with CorMedix’s ability to manage limited cash resources, and implications for current, planned, or future research (including continued development of DefenCath and research into additional uses for Taurolidine). include). Additional funding to support CorMedix’s research and development and clinical activities and operations. Preclinical results are not indicative of clinical trial success and may not be replicated in subsequent studies or trials. Ability to retain and employ the personnel necessary to properly place them in our operations. We continue to assess the extent to which the uncertainties surrounding the COVID-19 pandemic may affect our business and operations. These and other risks are described in detail in CorMedix’s filings with the SEC, copies of which are available free of charge on the SEC’s website at www.sec.gov or upon request by CorMedix. . CorMedix may not actually achieve the goals and plans set forth in 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 Ferries
Managing director
Life Science Advisor
(617) 430-7576
