Full Press Release Details
CorMedix Inc. Announces Appointment of Chief Commercial
Thomas Nusbickel to join CorMedix as Chief Commercial
Officer; Brings significant experience in renal product launches and commercialization
Berkeley Heights, NJ - May 13, 2021 - CorMedix
Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today announced the appointment of Thomas Nusbickel to the newly created position of
Chief Commercial Officer. Tom will be responsible for advancing the commercial strategy needed to bring DefenCath to patients in the US
when approved by FDA for commercial distribution.
Khoso Baluch, Chief Executive Officer of CorMedix, commented, "Tom
represents a key addition to our executive team as he brings decades of leadership experience in commercial strategy and highly relevant
experience in the renal disease space. As we are eager to continue planning in preparation for our commercial launch of DefenCath, Tom
will be well positioned to lead and strengthen the commercial effort for CorMedix."
Tom most recently served as Vice President of Market Access and Government
Affairs at Coherus Biosciences, a leader in biosimilars. Previously, Tom served as Chief Commercial Officer at Opko Inc, leading an 80-person
renal disease business unit and overseeing the commercial planning and launch for Rayaldee . Before joining Opko, Tom spent the majority
of his career in the pharmaceutical industry, with significant experience in commercial launches, brand building and market access. Tom
spent more than two decades with Amgen, gaining leadership experience across domestic and international marketing roles, including a decade
involved with the successful global launch of Sensipar , a product for End Stage Renal Disease patients on hemodialysis.
"After reviewing the commercial opportunity for DefenCath, I am excited
to join CorMedix at such a pivotal time in the Company's evolution," commented Tom Nusbickel. "Given the potential advantages
of having the first antimicrobial catheter lock solution in the US when the NDA is approved, I believe that CorMedix will be successful
in the commercial introduction of DefenCath."
Tom received his undergraduate degree from Eckerd College and earned an
MBA degree from Pepperdine University.
CorMedix Inc. is a biopharmaceutical
company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory
diseases. The Company is focused on developing its lead product DefenCath , a novel, antibacterial and antifungal solution designed
to reduce the incidence of catheter-related bloodstream infections (CRBSI) in patients with kidney failure receiving chronic hemodialysis
(HD) through a central venous catheter (CVC). DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious
Disease Product (QIDP), and the 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 CVC for hemodialysis when the NDA
is approved, which will provide an additional six months of marketing exclusivity when the study is completed. The Company received a
Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract
manufacturing facility, including in-process controls for the filling operation. CorMedix also
intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging
its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and
topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric
cancers. Neutrolin is CE Marked and marketed in Europe and other territories as a medical device. 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,
future financial position, financing plans, future revenues and projected costs 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 results
of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval
of the new drug application for DefenCath from the FDA; 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/Neutrolin
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.