WIXOM, MI, Jun 27, 2012 (MARKETWIRE via COMTEX) -- Rockwell Medical /quotes/zigman/66259/quotes/nls/rmti RMTI -2.41% , 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 deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has received notice from the Canadian Intellectual Property Office that it has obtained patent issuance for its proprietary drug, Soluble Ferric Pyrophosphate (SFP), the Company's late-stage investigational drug that provides iron replacement to hemodialysis patients with CKD. The Canadian patent grant covers the method and pharmaceutical composition for SFP-iron delivery in hemodialysis and peritoneal dialysis patients.

Mr. Robert L. Chioini, Chairman and CEO of Rockwell stated, "We are pleased to secure patent protection for SFP-iron delivery in an important market such as Canada. In conjunction with the successful completion of our SFP clinical studies, we will continue to evaluate worldwide market opportunities with an established marketing partner for the development and distribution of SFP."

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 deficiency, secondary hyperparathyroidism and hemodialysis. Rockwell's lead, late-stage investigational drug for iron therapy treatment is called SFP. SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. and $1B global market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. 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. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval.

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 SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html .

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 launch Calcitriol and SFP following FDA approval. 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.

        
        Contact:
        Michael Rice
        Investor Relations
        (646) 597-6979
        
        
        

SOURCE: Rockwell Medical Technologies Inc.

Copyright 2012 Marketwire, Inc., All rights reserved.

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Published on Wednesday 27 June 2012 10:03

A display of Art work from the Renal Unit at the Midland Regional Hospital Tullamore will go on display on June 28.

Earlier this year Anam Beo Artists: Tina Gaffey and Kieran Brennan facilitated a Pilot Project in The Renal Unit at the Midland Regional Hospital, Tullamore. This pilot was funded by the Community Foundation of Ireland which enabled Anam Beo to employ two artists for an eight week pilot programme of 16 process and participant-led art sessions with patients from the unit. As well as guidance from staff for the facilitating artists on how best to approach working within the hospital, the Renal unit also provided support funding for art materials and the framing of the artwork. A technique of printing was introduced to patient participants using materials suitable for all ages and abilities. This is a simple and accessible process and after a demonstration, participants took to the project quickly. With great enthusiasm all participants produced excellent results and agreed that their prints could be used as part of a larger group work which will be displayed in the Renal Unit for all to enjoy. The pilot project was a great success which allowed participants to print individual pieces of artwork whilst also producing a large group work.

Outcomes and responses to the project have been great from staff, facilitating artists and participants.

‘Very happy with that one, I’m taking it home’; ‘I didn’t think I’d like it, but I did’; ‘enjoyed it, loved it’; ‘would like to “learn to paint”’; ‘I only joined to encourage someone else, but am very happy with results.’ ‘I surprised myself by doing this. I didn’t think I could. I’m going to miss it next week.’ and ‘he really benefits from this’; ‘the artwork is good for both patients and their families’; ‘happy to work with artists coming in’

The Anam Beo programme is possible because of the consistent support and dedication from Offaly County Council and Dublin Mid-Leinster HSE.

Very special thanks go to Noreen Galvin, all the Nurses and staff at Tullamore Hospital for their dedication and support to the project. On June 28 there will also be an exhibition of artwork from the renal unit displayed in the foyer of the Hospital.

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Audience: Health Professional,Infectious Disease, Nephrology

Issue: There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. The Warnings and Precautions and Adverse Reactions sections of the cefepime label are being revised to highlight this risk.

Background:Cases of nonconvulsive status epilepticus associated with cefepime are documented in the medical literature and have been identified in FDA’s Adverse Event Reporting System (AERS) database. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; however, some cases occurred in patients receiving dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, the seizures were reversible and resolved after discontinuing cefepime and/or after hemodialysis. See the Drug Safety Communication for additional information.

Recommendations: Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with cefepime therapy occur, consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

Caregivers who notice symptoms of nonconvulsive status epilepticus in a patient receiving cefepime should seek medical attention right away. Symptoms of nonconvulsive status epilepticus could include altered mental status, confusion, and decreased responsiveness.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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The Big Red Kidney Bus project, spearheaded by dialysis patient Vince Tripodi who died in February, has steadily gathered momentum, attracting donations and widespread support.

A local team is now committed to seeing Vince's dream of having the dialysis bus on the road by the end of the year, become a reality.

Past weeks have been significant for the team of Latrobe Regional Hospital dialysis patients and staff, Kidney Health Australia staff and Vince's family, who remain devoted to the cause and recently accepted an award on their father's behalf.

Vince's son Marco told The Express the award, presented by KHA and received by himself, his mother and two sisters, was a "fantastic honour".

He said his father was aware he was to be recognised formally for his work in leading the Big Red Kidney Bus campaign but "he wasn't overly impressed because he figured he hadn't done anything yet because it wasn't finished".

"It has been a fantastic achievement though," Marco said, of the project which has so far raised $25,000 towards fitting out a bus which it secured, via donation, from Grenada.

Latrobe Valley Bus Lines has also offered drivers for the bus, while multiple local organisations have donated goods in kind to help equip it.

About $100,000 is required to renovate the bus to hospital standards, which will then be staffed with nurses and positioned in holiday locations across Victoria.

Renal patient and active committee member Suzie Picken, together with dialysis unit nurse Bernardette Lewindon, recently presented a paper on the bus project to the Renal Society Australasian Conference 2012 and predicted "once this is operational it's going to be a world first".

"I believe there are other buses out there now but none are staffed and this would be the first staffed satellite unit of its kind," she said.

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