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| EX-10.1 - EXECUTIVE ELOYMENT AGREEMENT - CorMedix Inc. | crmd_ex101.htm |
| 8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CorMedix Inc. Appoints Khoso Baluch as Chief Executive
Officer
Bedminster, NJ – October 3, 2016
–
CorMedix Inc.
(NYSE MKT: CRMD), a
biopharmaceutical company focused on developing and commercializing
therapeutic products for the prevention and treatment of infectious
and inflammatory diseases, announced today that it has concluded its executive search with the
appointment of Khoso Baluch as Chief Executive Officer. Mr. Baluch
succeeds Randy Milby, who previously announced that he would be
stepping down as CEO. In conjuction with the appointment, Mr.
Baluch will join CorMedix’s Board of Directors, replacing Mr.
Milby. Mr. Baluch has 32 years of combined experience in general
management, commercial, business development and pharmaceutical
development and has a proven track record of success in building
organizations, both in the U.S. and internationally, and
successfully launching new products.
Cora Tellez, Chair of the CorMedix Board of Directors, said,
“In Khoso Baluch, we have found an outsanding leader for
CorMedix as the Company prepares for the next stage in its
development. Khoso’s record demonstrates strong commercial
and operational execution, which we believe is important for the
company’s future as we advance Neutrolin®
through Phase 3 clinical studies and
potentially launch our product in the U.S. if we receive FDA
approval. We offer our sincerest thanks to Randy Milby for his
dedication and immeasurable contribution to the success of
CorMedix, as his leadership brought us to this inflection point. On
behalf of the Board, our best wishes are with him in his next
endeavor.”
Khoso Baluch, Chief Executive Officer of CorMedix, said, "Having
worked for decades with prominent pharmaceutical and biotechnology
companies, I am looking forward to preparing CorMedix for the
potential launch of Neutrolin, a promising anti-microbial.
Infection is a vital issue to the global healthcare system, and in
the U.S. in particular, an aging population could generate greater
use of catheters and attendant risk of bloodstream infections. In
addition, I look forward to continuing to explore additional
product opportunities for CorMedix in diverse areas of infectious
disease, oncology, aesthetics, dermatology, and orthopedics, based
on its taurolidine-based platform.”
Randy Milby, former Chief Executive Officer of CorMedix, said,
“In my time at CorMedix, we have achieved a great deal. We
have completed successful rounds of financing that raised
$60M for CorMedix, gained CE Marking for Neutrolin in
the EU and Middle East, and advanced Neutrolin into late-stage
clinical development in the United States. We have entered into
select, strategic parterships to generate additional potential
up-side with our taurolidine technology. Khoso’s track record
on commercializing products makes him a strong choice as the
Company enters the final stretch towards a potential NDA filing and
commercial launch for Neutrolin. I’m bullish about the
Company’s prospects and intend to make myself available to
assist in the transition and provide consultation as
needed.”
Mr. Baluch has built and led successful U.S. and international
commercial teams in the primary care, specialty and hospital
segments, launching leading products including Cialis, Byetta,
Insulin devices, Cimzia, Vimpat and Neupro. During the 24 years Mr.
Baluch worked for Eli Lilly & Co, he held international
positions in general management, business development, market
access and product leadership, and spanning Europe, the Middle East
and the United States. At Lilly, as Diabetes Worldwide Franchise
head, he had responsibility for guiding pipeline products from
Phase 3 to completion on the market. He oversaw a team of nearly
130 people responsible for the medical, regulatory, legal, supply
chain, marketing, pricing and reimbursement aspects of drug
launches in the U.S. and globally.
Following his tenure at Lilly, Mr. Baluch held multiple positions
at UCB, the global biopharmaceutical company, as Senior Vice
President & Chief Marketing Officer and most recently serving
as Senior Vice President & President European Middle East &
Africa (EMEA) Region. Since 2013, Mr. Baluch has been a board
member of Poxel, a French publically traded Biotech
Company.
About CorMedix Inc.
CorMedix
Inc. is a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease. The Company is
focused on developing its lead product Neutrolin®, a novel,
non-antibiotic antimicrobial solution designed to prevent costly
and dangerous bloodstream infections associated with the use of
central venous catheters. Such infections cost the U.S. healthcare
system approximately $6 billion annually and contribute
significantly to increased morbidity and mortality. Neutrolin is
currently in a Phase 3 clinical study in patients undergoing
chronic hemodialysis via a central venous catheter. The company is
planning to conduct its second Phase 3 study in patients with
cancer receiving IV parenteral nutrition, chemotherapy and
hydration via a chronic central venous catheter, subject to
sufficient resources. If successful, the two pivotal studies may be
submitted to the FDA for potential approval for both patient
populations. Neutrolin has FDA Fast Track status and is designated
as a Qualified Infectious Disease Product, contributing to
potentially accelerated FDA review and up to 10 years of market
exclusivity upon potential U.S. approval. It is already a CE Marked
product in Europe and other territories. CorMedix is also seeking
to unlock additional value for its taurolidine-based technology by
establishing collaborative partnerships in oncology and medical
device applications. For more information visit: www.cormedix.com.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua
Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine
McCargo: jmccargo@tiberend.com; (646) 604-5150
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
cost, timing and results of the ongoing and planned Phase 3 trials
for Neutrolin® in the U.S.;
obtaining regulatory approvals to conduct clinical trials and to
commercialize CorMedix's product candidates, including marketing of
Neutrolin in countries other than Europe; the risks and
uncertainties associated with CorMedix's ability to manage its
limited cash resources; the outcome of clinical trials of
CorMedix's product candidates and whether they demonstrate these
candidates' safety and effectiveness; the risks associated with the
launch of Neutrolin in new markets; CorMedix's ability to
enter into, execute upon and maintain collaborations with third
parties for its development and marketing programs; CorMedix's
ability to maintain its listing on the NYSE MKT; CorMedix’s
ability to identify and enter into strategic transactions;
CorMedix's dependence on its collaborations and its license
relationships; achieving milestones under CorMedix's
collaborations; obtaining additional financing to support
CorMedix's research and development and clinical activities and
operations; CorMedix's dependence on preclinical and clinical
investigators, preclinical and clinical research organizations,
manufacturers, sales and marketing organizations, and consultants;
and protecting the intellectual property developed by or licensed
to CorMedix. 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.