CorMedix Signs Sales and Marketing Agreement with MKM Co-Pharma, Bolsters Commercial Management Team to Ready Neutrolin® Catheter Lock Solution for European Market
CorMedix
Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on
developing and commercializing therapeutic products for the prevention
and treatment of cardiorenal disease, announced today that it has signed
a commercial agreement with MKM
Co-Pharma GmbH (http://mkm-europe.com/en/),
a European sales, marketing and advertising company with extensive
experience in the launch of cardiorenal products. CorMedix entered into
this agreement while awaiting the outcome of its application in the
European Union (EU) for a CE mark for Neutrolin®, a catheter lock
solution (CLS). If approved for use in the EU, Neutrolin will be used
for the prevention of catheter related bloodstream infection (CRBI) and
maintenance of catheter patency in hemodialysis (HD) patients.
To help prepare for a successful launch of the Neutrolin solution, which
is planned initially in Germany, MKM hired as a national sales manager
Joachim Petrak, who led the German and Central European launch of
Renagel (sevelamer), a phosphate binder used to control phosphorus
levels in people with chronic kidney disease who are on dialysis. Mr.
Petrak has extensive experience with therapeutics (devices and drugs) in
the renal dialysis market and strong relationships with European key
opinion leaders (KOLs) in this segment.
"We believe our new relationship with MKM, including the addition of
Joachim Petrak, will help drive successful sales and marketing efforts
for the Neutrolin catheter lock solution in Germany at first, and later
in the European Union, in anticipation of product approval,” said Randy
D. Milby, CorMedix Chief Executive Officer. “Together, we will aim
to ensure that Neutrolin becomes widely available in Europe for patients
with central venous catheters on hemodialysis secondary to advanced
chronic kidney disease.”
“These activities reflect the recent business and management progress
we’ve made at CorMedix,” Milby added. “After obtaining the CE mark, we
plan to further our efforts for a U.S. FDA regulatory program for
Neutrolin and to advance our company and pipeline programs.”
Recently, CorMedix reorganized the company bringing in a
new management team to enhance its transformation into a commercial
organization. Pharmaceutical industry executive Randy Milby was named
Chief Executive Officer of CorMedix, supported by Richard Cohen, Chief
Financial Officer, and Arthur Morelli, Vice President of Commercial
Operations. Morelli brings 30 years of pharmaceutical experience at Du
Pont Pharma, Du Pont Merck Pharma, Cardinal Health, Elan
Biopharmaceuticals and Solstice Neurosciences. Throughout his career,
Morelli has held positions from sales representative to Executive Vice
President of Commercial Operations. The new management is focused on
efficient execution, and will be the key link between CorMedix's
operations in Germany and its Bridgewater, NJ headquarters.
Antony
E. Pfaffle, M.D., a CorMedix founder and Chief Scientific Officer,
remarked, "The test of a great new product is whether it can raise the
standard of care for patients. We believe that, if approved, Neutrolin
will reduce potentially life-threatening infections and prevent catheter
loss. We are pleased to have achieved this important milestone that we
believe will strengthen our ability to launch Neutrolin, once approved
in the EU."
About CorMedix
CorMedix Inc. is a development-stage pharmaceutical company that seeks
to in-license, develop and commercialize therapeutic products for the
prevention and treatment of cardiac, renal and infectious diseases.
CorMedix is currently pursuing the CE marking approval process in
Europe, for Neutrolin® catheter lock solution for the prevention of
catheter related bloodstream infections and maintenance of catheter
patency in tunneled, cuffed, central venous catheters used for vascular
access in hemodialysis patients. Please see http://www.cormedix.com
for additional information.
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, 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: obtaining regulatory approvals to conduct clinical
trials and to commercialize CorMedix's product candidates, including CE
Marking for Neutrolin ® in Europe; the outcome of clinical trials of
CorMedix's product candidates and whether they demonstrate these
candidates' safety and effectiveness; the risks and uncertainties
associated with CorMedix’s ability to manage its limited cash resources,
obtaining additional financing to support CorMedix's research and
development and clinical activities and operations; CorMedix's ability
to enter into and maintain collaborations with third parties for its
development programs; CorMedix's dependence on its collaborations and
its license relationships; achieving milestones under CorMedix's
collaborations; CorMedix's dependence on preclinical and clinical
investigators, preclinical and clinical research organizations,
manufacturers and consultants; protecting the intellectual property
developed by or licensed to CorMedix; and CorMedix's ability to maintain
its listing on the NYSE MKT. 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.
