Rockwell Medical, Inc. (Nasdaq:RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, today announced that the Company is expanding its medical
capabilities, with the initial goal of building a leading medical
organization in the field of dialysis. The Company believes that
its Triferic® (ferric pyrophosphate citrate) platform has the
potential to transform the way anemia is treated in end-stage renal
disease (ESRD) patients. As a result, the Company is making
investments in its medical organization, real-world data and
medical educational programs, and clinical development
capabilities.
Through the ongoing development and commercialization of
Dialysate Triferic, and in preparation for the potential approval
of I.V. Triferic in 2020, the Company has identified the following
key medical priorities to establish and position Triferic as the
standard of care in anemia over the next three to five years:
- Development of relationships with Centers of Excellence to
assist the Company with real- world data collection, education of
the dialysis community, and guidance for various aspects of anemia
management and the use of Triferic;
- Collection and analysis of additional retrospective and
prospective data to support the real-world impact of Triferic on
clinical and health-economic outcomes;
- Enhancement of, and investment in, the Company’s medical
affairs capabilities, including engagement with Key Opinion Leaders
(KOLs), increased interaction with patient and physician advocacy
groups, data publications and abstracts to drive expanded awareness
of Triferic;
- Expansion of the Company’s medical education capabilities to
challenge an entrenched standard of care and educate clinicians
about the unique scientific attributes and benefits of Triferic;
and
- Addition of global clinical development expertise to: (1) guide
the development of Triferic in key geographies in collaboration
with current and future partners; and (2) further explore the
clinical and pharmacoeconomic attributes of Triferic to address
anemia in ESRD and other medical indications.
With the establishment of these priorities, Rockwell Medical has
appointed Marc Hoffman, MD as Chief Medical Officer (CMO). Dr.
Hoffman’s skillset will complement the Company’s existing medical
capabilities and enable the Company to drive these key medical
priorities. Dr. Hoffman has extensive experience building and
providing medical affairs and clinical development capabilities for
pharmaceutical companies, through both in-house roles at companies
such as Baxter and Hospira and in senior leadership positions at
various contract research organizations (CROs), including Covance
and, most recently, Celerion Inc. Throughout his distinguished
30-year career, Dr. Hoffman has established medical affairs
capabilities in order to harness the data needed to develop and
commercialize pharmaceutical products worldwide. The Company
believes that Dr. Hoffman’s expertise will further complement and
enable the Company to accelerate the execution of the Company’s key
medical initiatives.
Dr. Raymond Pratt, the Company’s current CMO, will transition to
a new role as Chief Development Officer. In this role, Dr. Pratt
will be responsible for managing the global clinical development
and regulatory approval pathway of Triferic in ESRD. Dr. Pratt has
significant experience in drug development in nephrology, including
leading the development and FDA approval of Dialysate Triferic.
Specifically, Dr. Pratt will continue to work on the New Drug
Application for I.V. Triferic, which is currently under review by
the FDA with a PDUFA date of March 28, 2020, and the development
and regulatory submission for Triferic in various countries across
the globe in coordination with the Company’s partners.
Dr. Ajay Gupta, the Company’s Chief Scientific Officer, will
continue to focus on the scientific foundation and applications of
the Triferic platform. As a nephrologist with deep knowledge of the
physiology of anemia and in the mechanism of action of Triferic,
Dr. Gupta works closely with worldwide KOLs in anemia to advance
clinical approaches to improve patient outcomes.
In addition, Rockwell Medical is adding several leading
nephrologists to its Medical Advisory Board. The members of the
Medical Advisory Board will provide critical advice to the Company
as it seeks to accomplish the goals identified above. The additions
include:
- Steven Fishbane, MD, Chief of Nephrology of Northwell Health
and Professor of Medicine at the Zucker School of Medicine. Dr.
Fishbane is a nephrologist with over 25 years of clinical
experience and over 24 years as a medical researcher with more than
210 peer-reviewed publications. He has received multiple honors and
holds several appointments, including to the National Quality
Forum’s Standing Committee of Admissions and Readmissions. Through
his clinical research, Dr. Fishbane has become renowned for
advancement and innovation in the treatment of chronic kidney
disease patients.
- Jay Wish, MD, Professor of Clinical Medicine at Indiana
University School of Medicine in Indianapolis and Chief Medical
Officer for Dialysis at Indiana University Health. Dr. Wish has a
distinguished career in the field of nephrology and dialysis, which
includes serving on the Board of Directors of Renal Physicians
Association and the American Association of Kidney Patients (AAKP),
where he received AAKP’s Visionary Award in 2005. Dr. Wish is Vice
Chairman of the Editorial Advisory Board for Nephrology News &
Issues and serves on the editorial boards of the Journal of the
American Society of Nephrology and Clinical Journal of the American
Society of Nephrology. At the American Society of Nephrology
Conference on November 8, 2019, Dr. Wish presented on Triferic in a
symposium entitled “Advances in Hemodialysis-Associated Anemia
Management: The Benefits of Physiologic Iron Replacement
Therapy.”
- Anatole Besarab, MD, a nephrologist who has served as the Chair
and Co-Chair of the NKF Workgroup on Vascular Access. Dr. Besarab
has also served on various committees for the FORUM of ESRD
networks, the ASN, NKF, ASAIO, and the NIH. He is the author of
more than 215 peer reviewed papers, 28 chapters, and 17 monographs.
His work has focused primarily on optimizing the management of
anemia, particularly on the proper balance between erythropoiesis
and iron delivery. He has also served as lead investigator on
clinical trials involving HIF-PHI inhibitors.
“To achieve our goal of transforming anemia management for
dialysis patients, we are making specific investments in our
medical expertise, real world and clinical data, as well as medical
education programs,” said Stuart Paul, President and Chief
Executive Officer of Rockwell Medical. “We are thrilled to welcome
Dr. Hoffman to our executive leadership team, and we expect his
proven track record in building, managing and globalizing medical
teams and expertise in data management will be an asset as we
position our Company for growth. In parallel, I am delighted that
we have assembled a Medical Advisory Board of world-renowned
experts in anemia and ESRD who can contribute their significant
experience to help guide the further development and
commercialization of Triferic,” concluded Mr. Paul.
“I am delighted to join the Rockwell Medical team at this
pivotal time and to lead the effort to expand the Company’s
real-world evidence dataset, educate the renal community about the
innovative attributes of Triferic in managing anemia in ESRD
patients, and advance the Company’s medical affairs strategy.
Triferic, in its various formulations, is innovative and offers
both clinical and potential pharmacoeconomic benefits. I look
forward to working with Dr. Pratt and Dr. Gupta, while contributing
to the development of a strong medical and clinical support team
and to advancing adoption of this important therapeutic,” stated
Dr. Hoffman.
About Rockwell Medical Rockwell Medical is a
biopharmaceutical company dedicated to transforming anemia
management in a wide variety of therapeutic areas and across the
globe, improving the lives of very sick patients. The Company’s
initial focus is the treatment of anemia in end-stage renal disease
(ESRD). Rockwell Medical's exclusive renal drug therapy, Triferic,
is the only FDA-approved therapeutic indicated for iron replacement
and maintenance of hemoglobin in hemodialysis patients. The Company
has developed multiple formulations of Triferic (1) FDA-approved
Dialysate Triferic, and (2) I.V. Triferic, for which the Company
filed a New Drug Application in May 2019. Rockwell Medical is also
an established manufacturer, supplier and leader in delivering
high-quality hemodialysis concentrates/dialysates to dialysis
providers and distributors in the U.S. and abroad. Please visit
www.rockwellmed.com for more information.
About Triferic Triferic is the only
FDA-approved therapy in the U.S. indicated to replace iron and
maintain hemoglobin in hemodialysis patients via dialysate during
each dialysis treatment. Triferic has a unique and differentiated
mechanism of action which has the potential to provide significant
benefits to patients and health care economics. Triferic represents
one of the most innovative medical advancements in patient iron
management in the past few decades – with the potential to be the
future standard of care.
Triferic delivers approximately 5-7 mg iron with every
hemodialysis treatment to the bone marrow and maintains hemoglobin
without increasing iron stores (ferritin). Unlike traditional IV
iron products, Triferic donates iron immediately and completely to
transferrin (carrier of iron in the body) upon entry into the blood
and is then transported directly to the bone marrow to be
incorporated into hemoglobin, with no increase in ferritin (stored
iron and inflammation) and no reports of anaphylaxis in over
1,000,000 patient administrations, addressing a significant medical
need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mechanism-of-action (MOA) video and for more information.
Important Safety InformationSerious
hypersensitivity reactions, including anaphylactic-type reactions,
some of which have been life-threatening and fatal, have been
reported in patients receiving parenteral iron products. Patients
may present with shock, clinically significant hypotension, loss of
consciousness, and/or collapse. Monitor patients for signs and
symptoms of hypersensitivity during and after hemodialysis until
clinically stable. Personnel and therapies should be immediately
available for the treatment of serious hypersensitivity reactions.
Hypersensitivity reactions have been reported in 1 (0.3%) of 292
patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples.
Post dialysis serum iron parameters may overestimate serum iron and
transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater
than placebo) in controlled clinical studies include: procedural
hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in
extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back
pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%),
asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula
thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
For more information, including full prescribing information,
visit: http://www.triferic.com.
Notice of Issuance of Inducement GrantsPursuant
to his employment agreement, Dr. Hoffman will be awarded
stock-based compensation representing the right to acquire shares
of common stock (the “Inducement Grants”). The Inducement Grants
will consist of options to purchase up to 250,000 shares of common
stock, subject to time-based vesting conditions. The Inducement
Grants will be issued upon Dr. Hoffman’s commencement of employment
(the “Grant Date”), and all stock options included within the
Inducement Grants will have an exercise price equal to the fair
value of the common stock on the Grant Date. The Inducement Grants
have been approved by the Company’s Board of Directors and the
Compensation Committee of the Board of Directors. The Inducement
Grants will be issued outside of the Company’s shareholder-approved
equity incentive plans as an inducement grant, in accordance with
Nasdaq Listing Rule 5635(c)(4).
Forward-Looking Statements Certain statements
in this press release may constitute "forward-looking statements"
within the meaning of the federal securities laws, including, but
not limited to, Rockwell Medical’s intention to bring to market
Triferic, and I.V. Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "intend" or similar expressions, or statements regarding
intent, belief, or current expectations, are forward-looking
statements. While Rockwell Medical believes these forward-looking
statements are reasonable, undue reliance should not be placed on
any such forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties (including, without
limitation, those set forth in Rockwell Medical's SEC filings),
many of which are beyond our control and subject to change. Actual
results could be materially different. Risks and uncertainties
include: statements about the issuance of a unique J code for our
Triferic Powder Packet; timing and regulatory approval process for
Dialysate Triferic in China; the potential market opportunity and
commercialization of Dialysate Triferic in China upon regulatory
approval; timing and regulatory approval process of our NDA filing
for I.V. Triferic as filed with the FDA; potential market
opportunity for I.V. Triferic, as well as other Rockwell Medical
products; the pricing and reimbursement status for I.V. Triferic
under CMS’ final rule relating to TDAPA as announced by CMS on
October 31, 2019; liquidity and capital resources; expected
duration of Rockwell Medical’s existing working capital; the
success of our commercialization of Dialysate Triferic, which
commenced in May 2019; and timing and success of our efforts to
maintain, grow and improve the profit margin of the Company’s
concentrate business. Rockwell Medical expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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