Sunday, May 15, 2011

Rockwell Medical receives US patent for SFP packaging & method of use

 

Rockwell Medical a fully-integrated biopharmaceutical company offering innovative products and services targeting End-Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), and iron deficiency anaemia, announced that it has received notice from the US Patent and Trademark Office for patent issuance that includes product claims that require ferric pyrophosphate dissolved in a bicarbonate solution held in a polyolefin container, such as an HDPE container; and method claims using the claimed product on its proprietary Soluble Ferric Pyrophosphate (SFP), the company's lead-drug candidate for treating iron deficiency anaemia in ESRD patients.

The patent, “Packaging of Ferric Pyrophosphate for Dialysis,” includes product claims that cover ferric pyrophosphate dissolved in a bicarbonate solution held in a polyolefin container, such as an HDPE container; and method claims using the claimed product. The patent provides protection through 2029. Additionally, the patent may be eligible for an extension under 35 USC 156, which is equal to the period of time from patent issuance to FDA approval. Further patent applications are pending.

Robert L Chioini, chairman, CEO and president of Rockwell Medical, stated, “This is another important patent issuance. It further protects SFP against potential infringement in the marketplace and it enables Rockwell to strengthen its intellectual property portfolio.”

Soluble Ferric Pyrophosphate (SFP) is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency anaemia in ESRD patients. In contrast to intravenous (IV) iron delivery, SFP is a proprietary, water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake.

SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining haemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trial data to date suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs.

Academic studies have shown that more frequent maintenance doses of iron improve therapeutic response to Erythropoiesis-Stimulating Agents (ESA's), thereby decreasing the ESA doses needed to maintain haemoglobin in the target range. Rockwell has licensed exclusive world-wide rights to manufacture and sell SFP and has obtained patent protection for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the US dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $1 billion.

Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting ESRD, CKD, and iron deficiency anaemia. An established manufacturer and leader in delivering high-quality haemodialysis concentrates/dialysates to dialysis providers and distributors in the US and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States. World-wide there are approximately 2 million ESRD patients, growing at an annual rate of 5-6 percent.

 

Source: Pharmabiz

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