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News Article | May 5, 2017
Site: globenewswire.com

WIXOM, Mich., May 05, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will hold a conference call to discuss first quarter 2017 financial results on Tuesday, May 9th at 4:30pm Eastern Time.  This call is also being webcast and can be accessed at the Rockwell Medical Investor Relations web page.  You can join this call on: About Rockwell Medical Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.  Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter 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.


Wiseguyreports.Com Adds “Renal Dialysis Equipment -Market Demand, Growth, Opportunities and Analysis of Top Key Player Forecast To 2022” To Its Research Database According to Stratistics MRC, the Global Renal Dialysis Equipment Market was valued at $14.5 billion in 2015 and is projected to reach $22.8 billion by 2022 at a Compound Annual Growth Rate of 6.7%. Growing aged population, a rising prevalence of diabetes and hypertension, End-Stage Renal Disease (ESRD) and lack of kidney donors for transplantation are some of the key factors contributing for the market growth. Furthermore, market has witnessed perceptible growth over the last five years owing to continued efforts made by governments to offer enhanced healthcare for people suffering from renal failure. However, lack of awareness about kidney disease and reimbursement issues in dialysis centers act as major constraints for this market. Peritoneal Dialysis (PD) has gained traction across various countries and now accounts for more than 10% of the dialysis procedures worldwide. By geography, North America and Europe are the largest markets owing to improved healthcare facilities and high frequency of kidney diseases in this region. However, Asia pacific is anticipated to grow at a faster pace due to growing investments in R&D coupled with increasing funding by government. India and China are projected to be the fastest-growing countries for kidney dialysis equipment market in Asia. Some of the key players in the market include Baxter International Inc., Nipro Corporation, Nikkiso, B. Braun Melsungen, Fresenius Medical Care Ag & Co., Asahi Kasei Corporation, Gambro, Allmed Medical, Bellco Societa Unipersonale, Fresenius Medical Care, Davita, Medivators, NXSTAGE Medical, Toray Industries and Rockwell Medical. Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements For more information, please visit https://www.wiseguyreports.com/sample-request/339147-renal-dialysis-equipment-global-market-outlook-2015-2022


WIXOM, Mich., May 22, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) today mailed a letter to its shareholders in connection with the Company’s upcoming 2017 Annual Meeting of Shareholders (“Annual Meeting”) to be held on June 1, 2017. The Rockwell Medical Board of Directors unanimously recommends shareholders vote on the WHITE proxy card today “FOR” David Domzalski, “FOR” each of the proposals listed in the proxy statement and “FOR” holding the “say on pay” advisory vote on executive compensation every THREE years. Shareholders that have already voted the Blue proxy card still have time to change their vote.  Shareholders are encouraged to act quickly by voting today at www.proxyvote.com or by calling 1-800-454-8683. All materials related to the Annual Meeting, including the Company’s proxy statement and shareholder presentation, can be found on the company’s website at www.rockwellmed.com. The full text of the letter follows: ELECTING MARK RAVICH TO ROCKWELL’S BOARD COULD DO LASTING HARM The Rockwell Medical 2017 Annual Meeting of shareholders is fast approaching.  On June 1, 2017, shareholders will have the opportunity to elect David Domzalski to our Board, an individual with the ability to help maximize shareholder value. We encourage you to take advantage of this opportunity to advance our global Triferic commercialization initiative by voting on the WHITE proxy card today. WE BELIEVE ELECTING MARK RAVICH TO THE BOARD WILL HARM THE COMPANY AND COULD PRESENT US WITH SERIOUS SETBACKS: IT’S IMPORTANT FOR SHAREHOLDERS TO KNOW: David Richmond and Mark Ravich each personally own less than 1.0% of Rockwell Medical stock -- significantly less than the 11.8% they have stated they own on behalf of themselves and Richmond Brothers’ clients. We believe they have intentionally misled shareholders by suggesting they have more voting power than they actually have. Despite what Richmond Brothers has said publicly, they have told us they believe Triferic will get add-on reimbursement, and the strategy to secure it before booking sales with bundled reimbursement is the correct one. Furthermore, they have told us directly that they plan to get Mark Ravich elected to the Board this year and then launch another proxy campaign next year to gain control of the Company. PROTECT YOUR INVESTMENT BY VOTING “FOR” DAVID DOMZALSKI ON THE WHITE PROXY CARD TODAY! DAVID DOMZALSKI IS THE RIGHT DIRECTOR FOR OUR BOARD David Domzalski is completely independent of Rockwell’s Board and management.  He was identified as an exceptional candidate by a third-party consulting firm as part of Rockwell’s year-long search for new directors.  David has the right experience that can advance our effort to commercialize Triferic both in the U.S. and globally, to ensure shareholders see maximum returns on their investment.  Mr. Domzalski's relevant and important experience includes: This experience is all directly relevant to growing Rockwell Medical and improving share price. WE ENCOURAGE ALL SHAREHOLDERS TO REVIEW THE FACTS AND VOTE “FOR” DAVID DOMZALSKI ON THE WHITE PROXY CARD If you have already voted the Blue proxy card, you can still change your vote. We encourage you to act quickly by voting today at www.proxyvote.com or by calling 1-800-454-8683. You may also vote by signing and dating the enclosed WHITE proxy card and returning it in the prepaid envelope provided. We need your help in protecting Rockwell and in creating value for all shareholders. Thank you again for your support! If you voted the Blue proxy card you can change your vote using the WHITE proxy card. Many shareholders have changed their votes after getting all the facts and recognizing that Mr. Ravich and Richmond Brothers are out for themselves – not Rockwell shareholders. About Rockwell Medical Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s innovative drug Triferic is the only FDA approved therapy to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.  Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law. Important Additional Information and Where to Find It Rockwell Medical, Inc. (the “Company”), its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from the Company’s shareholders in connection with the matters to be considered at the 2017 Annual Meeting of Shareholders.  Information regarding the names and affiliations of individuals who are participants in the solicitation of proxies of the Company’s shareholders and their respective direct or indirect interests in the Company, by security holdings or otherwise, can be found in the Company’s definitive proxy statement for its 2017 Annual Meeting of Shareholders, including the schedules and appendices thereto, which was filed with the Securities and Exchange Commission (“SEC”) on April 21, 2017.  Investors and shareholders are strongly encouraged to read carefully the definitive proxy statement and the accompanying WHITE proxy card and any other documents filed by Rockwell Medical, Inc. with the SEC when they become available, as they will contain important information.  Shareholders can obtain the definitive proxy statement, any amendments or supplements to the definitive proxy statement, the accompanying WHITE proxy card, and other documents filed by Rockwell Medical, Inc. with the SEC for no charge at the SEC’s website at www.sec.gov.  Copies will also be available at no charge by writing to Rockwell Medical, Inc., Attn: Secretary, 30142 S. Wixom Road, Wixom, Michigan, 48393.  In addition, copies of the Company’s proxy materials may be requested by contacting our proxy solicitor, D.F. King & Co., Inc. 48 Wall Street New York, NY 10005 or by calling toll-free 1-800-884-4725. Triferic® is a registered trademark of Rockwell Medical, Inc.


News Article | April 21, 2017
Site: globenewswire.com

Mails Letter to Shareholders Highlighting Substantial Commercial Progress and Importance of Electing a Director with Relevant Pharmaceutical Expertise Urges Shareholders to Vote “FOR” Rockwell Medical’s Highly-Qualified Director Nominee David Domzalski on the WHITE Proxy Card WIXOM, Mich., April 21, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) today announced that it has filed definitive proxy materials with the U.S. Securities and Exchange Commission (“SEC”) in connection with the company’s upcoming 2017 Annual Meeting of Shareholders (“Annual Meeting”) to be held on June 1, 2017. The proxy statement and other important information related to the Annual Meeting can be found on the company’s website at www.rockwellmed.com. The Rockwell Medical Board of Directors unanimously recommends shareholders vote “FOR” David Domzalski on the WHITE proxy card today. A copy of the letter mailed with Rockwell Medical’s proxy statement follows: THIS YEAR’S ANNUAL MEETING WILL BE MORE IMPORTANT THAN MOST VOTE THE WHITE PROXY CARD TODAY Rockwell Medical’s Annual Meeting of Shareholders will be held on June 1, 2017.  At this year’s meeting, Rockwell Medical’s Board of Directors will nominate David Domzalski for election to the Board.  Mr. Domzalski is a respected industry executive with business experience across multiple healthcare areas, and is currently the President of the U.S. subsidiary of Foamix Pharmaceuticals, Inc. We believe Mr. Domzalski brings significant value to the Rockwell Medical Board and will help facilitate efforts to execute our drug commercialization strategy. In stark contrast, one of our shareholders, Richmond Brothers, has put forth a nominee with real estate experience for election to your Board.  We do not believe adding a Board member with this type of experience will add any value to the Company. Shareholders have an important choice to make: should our Board be strengthened by adding a seasoned pharmaceutical executive, or should we simply fill the vacant board seat with a person whose background is in real estate? We encourage you to vote on the enclosed WHITE proxy card for Mr. Domzalski, to ensure our Board is strengthened with the right knowledge and experience to help facilitate the commercialization of Triferic, Calcitriol and other future drugs. Rockwell Medical is at an important inflection point in the Company’s history.  With the commercial launch of Triferic this past year and our ongoing global partnering efforts, the Company is proactively seeking to improve the Board’s composition with successful pharmaceutical executives to help guide our strategy.  We are fortunate that Mr. Domzalski, a veteran of the healthcare and pharmaceutical industries, is willing to serve on our Board. We encourage you to vote for him on the enclosed card and to discard any proxy ballot sent to you by Richmond Brothers. VOTE TODAY FOR DAVID DOMZALSKI AN EXPERIENCED VETERAN OF THE HEALTHCARE AND PHARMACEUTICAL INDUSTRIES WHITE PROXY CARD Rockwell Medical has made significant progress in its efforts to become a global, fully-integrated commercial biopharmaceutical company.  Among other things, we successfully developed and received FDA approval for the commercialization of Triferic, our innovative iron replacement therapy. Like us, many of our shareholders anticipate Triferic will be the key growth engine for Rockwell Medical. We continue to work on other promising compounds and have a robust pipeline of potential products currently in development while we evaluate other potential drug opportunities for the future. WE HAVE A REFRESHED BOARD OF DIRECTORS WITH RELEVANT EXPERIENCE To maximize our probability of success in these efforts, Rockwell needs the right Board of Directors to help guide the Company’s strategy and operations. We have worked diligently to recruit two new excellent directors with healthcare and pharmaceutical industry experience. In June 2016, Dr. Robin Smith was appointed to the Rockwell Medical Board of Directors. Dr. Smith has extensive strategic, operational and management experience in the biopharmaceutical industry. She is the former CEO of the NeoStem family of companies (currently Caladrius Biosciences, Inc.), which she led as CEO from 2006 to 2015 and established as one of the preeminent healthcare brands focused on the development of cellular therapies. Dr. Smith has an extensive and diversified background in healthcare, sales and marketing, business development and management. In 2008, Dr. Smith founded The Stem For Life Foundation (SFLF), a nonpartisan, 501(c)(3) educational organization devoted to fostering global awareness of the potential for regenerative medicine to treat and cure a range of deadly diseases and debilitating medical conditions. In 2010, Dr. Smith forged a historic, first-of-its-kind partnership with The Vatican to collaborate to create high-profile initiatives that help catalyze interest and development of cellular therapies that could ultimately reduce human suffering on a global scale. At this year’s annual meeting, we are nominating yet another world class healthcare and pharmaceutical executive, David Domzalski, to further strengthen our Board.  Mr. Domzalski is an accomplished pharmaceutical executive with strategic and operational experience across key functional disciplines, including commercial operations, clinical development, manufacturing and product development, corporate financing, and business development. Since 2014 Mr. Domzalski has served as the President of the U.S. subsidiary of Foamix Pharmaceuticals, Inc.  Prior to this, from 2009 through 2013, Mr. Domzalski was the Vice President of Sales and Marketing at Leo Pharma where he led the efforts to design and build-out the U.S. commercial operations, overseeing approximately 200 employees across multiple functional areas.  Earlier in his career, Mr. Domzalski held senior sales and marketing positions at Warner Chilcott, Sanofi-Synthelabo, Pharmacia, Dendrite International and Parke-Davis. Mr. Domzalski has extensive experience in building commercial organizations within multi-cultural environments of “start-up” and established corporations.  He has a record of achievement in new product launches and life-cycle management across multiple therapeutic classes and has been successful in cultivating external partnerships and strategic alliances. We believe he will be extremely helpful as Rockwell Medical works to commercialize Triferic globally. In addition to these distinguished individuals, we will have three more directors, including our founder and CEO Rob Chioini, who together represent the right mix of corporate leadership, operational and financial expertise necessary for Rockwell Medical’s ongoing success. WE HAVE ENHANCED OUR CORPORATE GOVERNANCE AND IMPROVED OUR COMPENSATION PRACTICES Over the past year, Rockwell Medical’s Board has considered and adopted several enhancements to its corporate governance structure and compensation practices in an effort to ensure the Company is appropriately structured, as it evolves, with best-in-class standards.  These include: Rockwell Medical has also adopted several new compensation practices for 2017, including: Further to these changes, the Compensation Committee intends to modify the structure of the Company’s annual bonus program for 2017 to make it more formulaic and more transparent for shareholders. WE HAVE THE RIGHT MIX OF BOARD-LEVEL EXPERTISE CRITICAL TO ROCKWELL MEDICAL’S SUCCESS The ongoing execution of our strategy and the commercialization of Triferic will be the real driving force behind creating significant shareholder value, both today and over the long-term.  To do this effectively, your Board requires a specific set of skills, and importantly, alignment with our purpose. Our nominee, David Domzalski, will bring these skills and alignment to the Board. In contrast to our nominee, Richmond Brothers’ candidate, Mark Ravich, lacks any relevant experience and the vital skills necessary to assist Rockwell Medical or oversee its strategy.  Mr. Ravich’s operating experience is limited to real estate development and discount retailing; he has no executive experience with pharmaceutical commercialization at all. Surprisingly, Richmond Brothers is now seeking the election of a real estate candidate, despite previously suggesting we add pharmaceutical experts to the Board. Mr. Domzalski is precisely the sort of expert Richmond claimed it wanted on our Board. We encourage you to vote for Mr. Domzalski using the WHITE proxy card. RICHMOND BROTHERS AND MR. RAVICH FAILED TO SHARE ITS PLANS AND PROPOSALS WITH ROCKWELL MEDICAL SHAREHOLDERS David Richmond, the Chairman and Co-owner of Richmond Brothers, and Mark Ravich have a long history of working together and failing to inform Rockwell Medical shareholders of their material communications with the Company.  Starting over a year ago, Mr. Richmond and Mr. Ravich, in a series of written communications and phone calls, made specific demands and proposals to management while claiming to control significant blocks of Rockwell Medical stock. Mr. Richmond and Mr. Ravich worked together in an attempt to strong-arm management into a variety of suboptimal strategies, including selling the Company (even suggesting that they themselves may be a buyer) at what would obviously be the wrong time. They did so while misrepresenting to control shares “in excess of 20% of the common stock of the Company” while threatening management that they would “go nuclear” with a costly and distracting “war” if they did not get what they wanted.1 Under the federal securities laws, parties that own in excess of 5% of a company’s stock and who seek to influence the direction of a company are obligated to disclose their plans and proposals to other shareholders. We believe Mr. Richmond and Mr. Ravich clearly did not make these timely and requisite filings so that ALL Rockwell Medical shareholders could know of their intentions. Despite the conduct exhibited by Mr. Richmond and Mr. Ravich, we have repeatedly attempted to engage productively with them. We have met with them many times, exchanged numerous emails and spoken by phone countless times. We are always open to constructive feedback and good suggestions. YOUR VOTE IS IMPORTANT – MAKE YOUR VOICE HEARD Your Board is composed of directors who beneficially own approximately 11% of Rockwell Medical and are fully aligned with the interests of all shareholders.  They are uniquely qualified, independent, and comprised of proven leaders who possess a broad range of commercial, managerial, clinical and operational experience, as well as expertise in the pharmaceutical industry and other areas important to Rockwell Medical. This is a critical time in Rockwell Medical’s history.  The addition of Mr. Domzalski will ensure your board is stronger than ever, providing rigorous oversight of the Company’s progress.  We urge you to vote today by telephone, online or by signing and dating the enclosed WHITE proxy card and returning it in the postage-paid envelope provided. 1 February 4, 2016 and March 24, 2016 letters to Rob Chioini signed by David Richmond and Mark Ravich YOUR BOARD UNANIMOUSLY RECOMMENDS STOCKHOLDERS VOTE FOR DAVID DOMZALSKI ON THE WHITE PROXY CARD TODAY On behalf of the Board of Directors and management team, we appreciate your investment and continued support. Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s innovative drug Triferic is the only FDA approved therapy to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.  Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law. Important Additional Information and Where to Find It Rockwell Medical, Inc. (the “Company”), its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from the Company’s shareholders in connection with the matters to be considered at the 2017 Annual Meeting of Shareholders.  Information regarding the names and affiliations of individuals who are participants in the solicitation of proxies of the Company’s shareholders and their respective direct or indirect interests in the Company, by security holdings or otherwise, can be found in the Company’s definitive proxy statement for its 2017 Annual Meeting of Shareholders, including the schedules and appendices thereto, which was filed with the Securities and Exchange Commission (“SEC”) on April 21, 2017.  Investors and shareholders are strongly encouraged to read carefully the definitive proxy statement and the accompanying WHITE proxy card and any other documents filed by Rockwell Medical, Inc. with the SEC when they become available, as they will contain important information.  Shareholders can obtain the definitive proxy statement, any amendments or supplements to the definitive proxy statement, the accompanying WHITE proxy card, and other documents filed by Rockwell Medical, Inc. with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge by writing to Rockwell Medical, Inc., Attn: Secretary, 30142 S. Wixom Road, Wixom, Michigan, 48393.  In addition, copies of the Company’s proxy materials may be requested by contacting our proxy solicitor, D.F. King & Co., Inc. 48 Wall Street New York, NY 10005 or by calling toll-free 1-800-844-4725. Triferic® is a registered trademark of Rockwell Medical, Inc.


News Article | August 4, 2017
Site: globenewswire.com

WIXOM, Mich., Aug. 04, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will hold a conference call to discuss second quarter 2017 financial results on Wednesday, August 9th at 4:30pm Eastern Time.  This call is also being webcast and can be accessed at the Rockwell Medical Investor Relations web page.  You can join this call on: About Rockwell Medical Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter 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.


ST. LOUIS, Feb. 20, 2017 /PRNewswire/ -- Concordance Healthcare Solutions LLC, one of the largest, independent, healthcare distributors in the U.S., today announced the signing of a definitive agreement to acquire Rockwell Medical Supply. By adding this business, Concordance will now have...


News Article | March 2, 2017
Site: globenewswire.com

WIXOM, Mich., March 02, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that David Domzalski, has been nominated to join the Company’s Board of Directors. Mr. Domzalski is nominated to replace Mr. Ken Holt, whose term is expiring. Mr. Holt has served the Rockwell Board for several years and will remain engaged through the end of his term. “David has a proven track record at a senior level in the pharmaceutical industry,” said Robert L. Chioini, Founder, Chairman and CEO of Rockwell Medical. “He has extensive experience in building commercial organizations and launching products, which will be helpful as we commercialize Triferic globally. We are very pleased to have someone of David’s caliber join our Board of Directors and we look forward to the strategic contributions and insights he will bring.” Mr. Chioini also added, “Ken Holt has been a valuable member of our Board and served the Company loyally for many years and has contributed a great deal during his tenure. We thank Ken for his contributions and wish him the very best.” “I am excited to join the Rockwell Medical Board of Directors at this exciting time for the company,” said David Domzalski. “I look forward to working with the executive team and the Board and contributing to the successful launches of their drug products into the global marketplace.” David Domzalski is an accomplished healthcare and pharmaceutical executive with strategic and operational experience across key functional disciplines, including commercial operations, clinical development, manufacturing and product development, corporate financing, and business development. He has extensive experience in building and restructuring commercial organizations within multi-cultural environments of “start-up” and established corporations. He has a record of achievement in new product launches and life-cycle management across multiple therapeutic classes. He is highly successful in cultivating external partnerships and strategic alliances guided by strong interpersonal and negotiation skills. Mr. Domzalski has more than 20 years of industrial experience. David Domzalski currently serves as President of the U.S. subsidiary of Foamix Pharmaceuticals Inc., a position he has held since April 2014. Prior to his tenure at Foamix, Mr. Domzalski was Vice President of Sales & Marketing at LEO Pharma, Inc. where he led the efforts to design and build-out the U.S. commercial operations, overseeing approximately 200 employees across multiple functional areas. He successfully managed the turnaround of LEO Pharma’s psoriasis franchise from a 2-year prescription decline to an annual growth of 26%. He was responsible for the strategic re-launch of Taclonex® Topical Suspension, which resulted in Taclonex being reestablished as the number one brand in the category. Prior to LEO Pharma, Mr. Domzalski was the Senior Vice President and General Manager of the Women’s Health & Urology division of Azur Pharma, where he had full P&L responsibility for a start-up business unit. Before Azur, Mr. Domzalski spent 5 years from 2003 to 2008 as the Vice President of Sales & Marketing for Warner Chilcott, where he directed all commercial efforts for in-line brands focused on therapeutic areas of dermatology, women’s health and urology. His achievements at Warner Chilcott included the launch of four products within a twelve month period, including Taclonex for psoriasis and Doryx® Tablets for acne. He led the structural design, development and growth of the commercial team at Warner Chilcott from 150 to 500 employees. Earlier in his career, Mr. Domzalski held senior sales and marketing positions at Sanofi-Synthelabo, Pharmacia, Dendrite International and Parke-Davis. He earned a Bachelor of Arts in Economics and Political Science from Muhlenberg College. About Rockwell Medical Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s anemia drug Triferic is the only FDA approved product indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter 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.


JACKSON, Mich. & ST. LOUIS PARK, Minn.--(BUSINESS WIRE)--Richmond Brothers, Inc., a Michigan-based SEC registered investment advisor and wealth management firm that is the largest beneficial owner of Rockwell Medical, Inc. (NASDAQ: RMTI) (“Rockwell” or the “Company”), and Mark H. Ravich, who together with their affiliates beneficially own over 6.1 million shares, or 11.9% of the Company’s outstanding common stock, today announced the nomination of David S. Richmond and Mark H. Ravich for election to the Company’s Board of Directors (the “Board”) at the upcoming 2017 Annual Meeting of Shareholders (the “Annual Meeting”). David S. Richmond, Chairman of Richmond Brothers, Inc., and Mark H. Ravich issued the following statement: “As long-term holders of Rockwell Medical stock, we have been disappointed time and time again by the current Board and management’s repeated strategic failures and the poor corporate governance that we believe have plagued the Company for years. We have made multiple attempts over several years to engage constructively with Rockwell to discuss improvements to the Company’s strategic approach, execution and corporate governance – but we have been repeatedly rebuffed. Management and the Board have proven themselves to be strongly averse to shareholder friendly actions, have failed dismally to communicate with shareholders in a transparent and constructive manner and have been unable to effectively execute on strategies that would drive shareholder value. The fact that the Company’s compensation plan was voted down by shareholders at the 2016 Annual Meeting, coupled with the nearly 11 million votes withheld from the director then running for reelection, demonstrates, in our view, shareholders’ frustration. Unfortunately, management and the Board have failed to heed these signals of shareholder discontent and have persisted in running Rockwell as if it were a private company not accountable to the interests of public shareholders. Furthermore, we believe that with the right strategy and proper execution, Rockwell has the potential to increase significantly in value, especially if its new FDA-approved iron maintenance drug Triferic becomes the standard of care iron maintenance therapy for hemodialysis patients. In our view, the market does not yet understand Triferic’s opportunity worldwide for hemodialysis or the potential to develop Triferic as a platform drug for numerous other indications. Based on a model focused on just the dialysis market in the U.S. alone (i.e. not even the best case scenario), a recent analyst note from Craig-Hallum Capital Group suggests: ‘On a longer term basis, if Triferic advances towards a full commercial launch, we believe that revenue can exceed $300 million given the expected ramp in Triferic and Calcitriol. Applying a 7x revenue multiple would produce a ~$42 stock price.’1 The following represent some of the strategic missteps and corporate governance issues that have plagued Rockwell in recent years: Given this litany of issues, we believe that Rockwell is in desperate need of Board members who have the best interests of ALL of the Company’s shareholders at heart and who will be responsible stewards of shareholder value. We believe fresh, independent voices at the Board level would disrupt the culture of entrenchment and inaction that has characterized the Company’s governance to date and would have the potential to lead to further Board refreshment in the future. As large, long-term holders of Rockwell stock, we believe that we are very well-qualified to bring a truly shareholder-friendly perspective to the Company’s Board and push for the real change that is needed at the Company. We would also note that because the Company did not disclose which class recently-appointed director Robin L. Smith belongs to, it is unclear at this time whether one or two Board seats are up for election at the upcoming Annual Meeting. This ambiguity is yet another example of Rockwell’s failure to communicate transparently with shareholders. Richmond Brothers, Inc. is an SEC registered investment advisor and wealth management firm founded in 1994. Mark Ravich is a private investor and currently serves as President of Tri-Star Management, Inc., a commercial real estate management and syndication company that he co-founded in 1998. CERTAIN INFORMATION CONCERNING THE PARTICIPANTS Richmond Brothers, Inc. (“Richmond Brothers”) and Mark H. Ravich, together with the other participants named herein, intend to file a preliminary proxy statement and accompanying proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of their slate of highly-qualified director nominees at the 2017 annual meeting of shareholders of Rockwell Medical, Inc., a Michigan corporation (the “Company”). RICHMOND BROTHERS STRONGLY ADVISES ALL SHAREHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC’S WEB SITE AT HTTP://WWW.SEC.GOV. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. The participants in the proxy solicitation are Norman J. Ravich Irrevocable Trust (“NJR Trust”), Norman and Sally Ravich Family Trust (“NSR Trust”), Alexander Coleman Ravich 1991 Irrevocable Trust (“ACR Trust”), Alyssa Danielle Ravich 1991 Irrevocable Trust (“ADR Trust”), Mark H. Ravich, Richmond Brothers, RBI Private Investment I, LLC (“RBI PI”), RBI PI Manager, LLC (“RBI Manager”), Richmond Brothers 401(k) Profit Sharing Plan (“RBI Plan”), David S. Richmond and Matthew J. Curfman. As of the date hereof, NJR Trust beneficially owned 44,400 shares of common stock, no par value per share (the “Common Stock”). As of the date hereof, NSR Trust beneficially owned 18,500 shares of Common Stock, consisting of shares underlying certain call options. As of the date hereof, ACR Trust beneficially owned 25,000 shares of Common Stock. As of the date hereof, ADR Trust beneficially owned 25,000 shares of Common Stock. As of the date hereof, Mr. Ravich directly beneficially owned 354,750 shares of Common Stock, including 70,000 shares underlying certain call options. Mr. Ravich, as the trustee of each of NJR Trust, NSR Trust, ACR Trust and ADR Trust, may be deemed to beneficially own the 112,900 shares beneficially owned in the aggregate by such trusts. As of the date hereof, 5,183,152 shares of Common Stock were held in certain accounts managed by Richmond Brothers (the “Separately Managed Accounts”). Richmond Brothers, as the investment advisor to the Separately Managed Accounts, may be deemed to beneficially own the 5,183,152 shares held in the Separately Managed Accounts. As of the date hereof, RBI PI beneficially owned 164,841 shares of Common Stock. RBI Manager, as the manager of RBI PI, may be deemed to beneficially own the 164,841 shares owned by RBI PI. As of the date hereof, RBI Plan beneficially owned 34,087 shares of Common Stock. As of the date hereof, Mr. Richmond beneficially owned directly 176,412 shares of Common Stock. Mr. Richmond, as Chairman of Richmond Brothers, manager of RBI Manager and a trustee of RBI Plan, may also be deemed to beneficially own the 5,183,152 shares held in the Separately Managed Accounts, 164,841 shares owned by RBI PI and 34,087 Shares owned by RBI Plan. Mr. Richmond may also be deemed to beneficially own the 28,096 shares owned directly by his spouse, 147 shares owned directly by his daughter and 7 shares owned directly by his son. As of the date hereof, Mr. Curfman beneficially owned directly 40,684 shares of Common Stock. Mr. Curfman, as President of Richmond Brothers and a trustee of RBI Plan, may also be deemed to beneficially own the 5,183,152 shares held in the Separately Managed Accounts and 34,087 Shares owned by RBI Plan. Mr. Curfman may also be deemed to beneficially own the 34,385 shares owned directly by his spouse.


News Article | February 21, 2017
Site: globenewswire.com

WIXOM, Mich., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today provided an update on the commercial launch progress of Calcitriol, stating that the FDA has requested that the Company resubmit the application for the new contract manufacturer as a Prior Approval Supplement (PAS) and pay a fee for the Agency review. As a result, the Company anticipates Calcitriol to become commercially available in the U.S. market in approximately 4-6 months. Calcitriol is Rockwell’s FDA approved active Vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis. Dr. Raymond Pratt, Chief Medical Officer of Rockwell stated, “Although we believe the initial submission contained all the information FDA required, we are complying with the Agency’s request in an effort to get Calcitriol into the market as fast as possible.” About Rockwell Medical Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis. Rockwell’s anemia drug Triferic is the only FDA approved product indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market and globally. Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis market. Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities. Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to sell and market Calcitriol and Triferic. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter 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.


The invention provides for methods of treating a dialysis patient that is hyporesponsive to erythropoietin stimulating agents (ESA) comprising administering soluble ferric triphosphate (SFP) composition and administering a dose of ESA that is significantly reduced compared to the dose of ESA required by a dialysis patient that is hyporesponsive to ESA that has not received SFP.

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