Watson, GeneraMedix receive FDA approval for Nulecit to treat iron deficiency anemia

Apr 1 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that it is initiating launch activities of Nulecit™ (sodium ferric gluconate complex in sucrose injection), following FDA approval of GeneraMedix Inc.'s, Abbreviated New Drug Application (ANDA).  Nulecit is the first bioequivalent and therapeutically equivalent alternative to Sanofi-Aventis' Ferrlecit^®.  In July 2009 Watson signed a license agreement with GeneraMedix for the exclusive U.S. marketing rights to the product, which will be marketed by Watson's Global Brands business.

Nulecit is approved for the treatment of iron deficiency anemia in adults and children age six years or older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.  It will offer the convenience and cost savings of administration from a single-dose glass vial, minimizing the need for filter needles or a required test dose.

The branded alternative to Nulecit is currently available only in 5 mL glass ampules that require the tops to be broken off manually before administration, and many protocols require that the product withdrawn with a syringe using a filter needle.

"Watson's Brand sales team is uniquely positioned to effectively maximize the opportunities of this value brand offering, given our experience in marketing injectable iron products," said Fred Wilkinson, Executive Vice President, Global Brands, at Watson.  "Nulecit offers the nephrology community a value brand that is bioequivalent to the innovator product, with the added convenience of packaging in glass vials."

Efficacy with Added Convenience

In the bioequivalence study, which involved 240 healthy volunteers, Nulecit and Ferrlecit showed comparable concentrations of total serum iron and transferrin-bound iron over 36 hours.  Each 5 mL glass vial of Nulecit contains a 62.5-mg single dose (12.5 mg of elemental iron per mL).  Additionally, data supports stability of Nulecit in both syringes and saline bags.

"A vial dosage form of sodium ferric gluconate is an important step forward in the treatment of patients with IV iron vs. the old ampule," said Rajiv Agarwal, a board certified nephrologist and professor of medicine at Indiana University School of Medicine.  "Having the 62.5 mg vial is convenient for ongoing or continuous therapy, which is our standard with dialysis patients today and may help to control costs by optimizing delivery and minimizing waste."

The 62.5-mg vial of Nulecit is convenient when IV iron is administered in regular low doses, as in a continuous dosing regimen.  The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI™) guidelines for the administration of parenteral iron suggest that an average of 22 to 65 mg of iron per week are required to achieve neutral iron balance and maintenance of stable serum ferritin values in hemodialysis patients.