Rockwell Medical (RMTI) Appoints Andrea Heslin Smiley to Board

Rockwell Medical, Inc. (NASDAQ: RMTI) today announced the appointment of industry leader and renowned life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors, effective December 11, 2020. Ms. Smiley currently serves as President and Chief Executive Officer of VMS BioMarketing and is a member of the Board of Directors of life science company, Assertio (formerly Zyla Life Sciences).

“We are pleased to welcome Andrea to the Board of Directors,” said John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical. “Andrea brings a wealth of experience in patient adherence and outcomes, clinical educator solutions, nursing networks, and pharmaceutical product launches and marketing. She will be a valuable advisor in maximizing the value of Triferic® in kidney disease and our FPC technology in home infusion and heart failure.”

"I am delighted to join Rockwell Medical’s Board of Directors at this exciting time for the Company, especially as we plan to move into the rapidly growing home infusion market," said Ms. Smiley.

Ms. Smiley brings approximately three decades of commercialization and general management experience in the biopharmaceutical industry in both public and private companies. She joined VMS BioMarketing, a leading provider of patient and healthcare provider support, in 2008, and has served as its President and Chief Executive Officer since 2011. Within her first year as CEO, she spun-off commoditized business units and focused the company on impacting patient adherence and outcomes, all the while establishing VMS BioMarketing as the leading provider and growth leader of clinical nurse educator patient support solutions. Prior to joining VMS BioMarketing, Ms. Smiley spent 18 years at Eli Lilly and Company in various positions of increasing responsibility in finance, business development, corporate affairs, brand management and business unit leadership roles. She was the marketing leader for the launch of Humalog® Mix75/25™, she led sales and marketing for Humatrope®, she was responsible for the development and launch of Forteo® and she was the business unit leader of Lilly’s women’s health business, among other programs. Earlier in her career, Ms. Smiley worked as a management consultant for Putnam Associates, where she led consulting teams and advised brands in the biotechnology, pharmaceutical and managed healthcare fields on product launches and access strategies. She is a regular speaker and panel member on patient adherence, patient services and women’s leadership topics at biopharmaceutical industry conferences. Ms. Smiley serves on the board of numerous nonprofit organizations including the Indiana Alzheimer’s Association, Summer Stock, Indiana Salvation Army and the Lung Force Women’s Cabinet. She received a gubernatorial appointment to the Indiana Commission for Women. Ms. Smiley earned her Bachelor of Arts degree in economics from DePauw University, where she was an Honors Management Fellow.

About Rockwell Medical

Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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 kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. 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.

About Triferic Dialysate and Triferic AVNU

Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.

Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintain hemoglobin without increasing iron stores (ferritin). Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood which 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 ESKD patients.

Important Safety Information

Serious 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%).

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