Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Feb 17 2010

Talecris Biotherapeutics (Nasdaq: TLCR) announced today that it has received approval from Health Canada for PROLASTIN^®-C (Alpha₁-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN^® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

“Many Canadians with AAT deficiency have been treated with PROLASTIN over the past two decades, and we welcome the introduction of the next-generation product, PROLASTIN-C”

Like PROLASTIN, PROLASTIN-C is indicated for the treatment of panacinar emphysema in patients with alpha₁-antitrypsin (AAT) deficiency. AAT deficiency is a genetic condition in which low levels of the alpha₁ protein can result in emphysema. The active protein in PROLASTIN-C increases or “augments” protein levels in AAT-deficient patients. PROLASTIN-C will replace PROLASTIN, the only approved augmentation therapy in Canada for more than 20 years.

“Many Canadians with AAT deficiency have been treated with PROLASTIN over the past two decades, and we welcome the introduction of the next-generation product, PROLASTIN-C,” said Madelyn McPhedran, president and chairperson of Alpha-1 Canada.

PROLASTIN-C delivers twice the active protein per milliliter as PROLASTIN, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min. Clinical studies have shown that PROLASTIN-C and PROLASTIN are equally effective at raising AAT levels in the blood. In clinical trials, the most common drug-related adverse reactions observed at a rate of ≥1% in subjects receiving PROLASTIN-C were chills, malaise, headache, rash, hot flush and pruritus.

“The modified manufacturing process for PROLASTIN-C incorporates technological advances such as nanofiltration, a virus exclusion technology, and cation exchange chromatography, an additional purification step,” said Steve Petteway, Ph.D., executive vice president, Research and Development. “We are proud of these changes as they result in an improved product that builds on the strong history of PROLASTIN.”

Talecris Biotherapeutics will provide information about the transition from PROLASTIN to PROLASTIN-C through PROLASTIN DIRECT^SM CANADA, the product’s distribution program, and through pharmacies that assist physicians and their patients who currently receive PROLASTIN therapy. Information about the transition to PROLASTIN-C in other countries will be provided as regulatory approvals are granted.