Talecris Biotherapeutics Study Demonstrates PROLASTIN®-C is as Effective as PROLASTIN®
The pharmacokinetic comparability study showed that PROLASTIN-C is as effective as PROLASTIN in raising levels of alpha-1 protein
RESEARCH TRIANGLE PARK, N.C., Oct. 21 /PRNewswire/ -- Talecris Biotherapeutics (Nasdaq: TLCR) today announced the publication of results from a study showing that PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as PROLASTIN® (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency. Results of the pharmacokinetic study are published in BMC Clinical Pharmacology, a peer-reviewed medical journal (http://www.biomedcentral.com/1472-6904/10/13).
PROLASTIN-C is a more purified and concentrated formulation of A1PI than PROLASTIN and is currently approved in the U.S. and Canada for the treatment of panacinar emphysema in patients with AAT deficiency. AAT deficiency is a genetic condition in which low levels of the alpha-1 protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" alpha-1 protein levels in AAT deficient patients. PROLASTIN-C delivers twice the active protein per milliliter as PROLASTIN, cutting the infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min.
The pharmacokinetic (PK) study enrolled twenty-four subjects in a 24-week, multicenter, randomized, double-blind crossover trial that also included an open-label treatment phase with PROLASTIN-C only. The primary end point of the study was a measure of overall exposure to A1PI, known as area under the plasma concentration versus time curve (AUC), measured over seven days post infusion at steady state.
Study results demonstrate that PROLASTIN and PROLASTIN-C have comparable AUC measures with a 90 percent confidence interval of 0.97 to 1.09 (geometric LS mean ratio = 1.03). Four additional PK measures (Cmax, Tmax, T 1/2 and mean Ctrough) provide further support that the PK profiles of PROLASTIN and PROLASTIN-C are essentially superimposable.
This study also shows that the adverse events were similar for both treatments and occurred at a rate of 0.117 and 0.078 per infusion for PROLASTIN-C and PROLASTIN, respectively, with comparable severity of AEs.
During this PK study and a separate safety study with PROLASTIN-C, 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 most serious adverse reaction observed during these clinical studies with PROLASTIN-C was a rash on the abdomen and extremities in one subject.
"We're committed to advancing the care of the alpha-1 patient population and continue to invest in important clinical research in support of that goal," said Steve Petteway, Ph.D., Executive Vice President, Research and Development. "The pharmacokinetic study shows PROLASTIN-C behaves the same way in the body as PROLASTIN, the leading alpha-1 augmentation therapy in North America for over 20 years."
Information about the transition from PROLASTIN to PROLASTIN-C in the U.S. can be obtained through PROLASTIN DIRECT® at 800-305-7881, the product's exclusive distribution program. In Canada, this information is available through PROLASTIN DIRECT™ CANADA at 1-877-3ALPHA1 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.
About PROLASTIN® and PROLASTIN®-C
Like PROLASTIN, PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency in patients with panacinar emphysema. 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 has replaced PROLASTIN in the U.S. In Canada, PROLASTIN-C will also replace PROLASTIN, the only approved augmentation therapy in Canada for more than 20 years.
Important Safety Information for PROLASTIN-C and PROLASTIN
The effect of augmentation therapy with any alpha1-proteinase inhibitor (A1PI) on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
PROLASTIN-C and PROLASTIN may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with antibodies against IgA. 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 most serious adverse reaction observed during clinical studies with PROLASTIN-C was a rash on the abdomen and extremities in 1 subject. In clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common being fever, lightheadedness and dizziness.
Both PROLASTIN-C and PROLASTIN are made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products.
In the US, for additional information on PROLASTIN-C, please see full prescribing information at www.PROLASTIN.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
In Canada, please see PROLASTIN-C Product Monograph for complete prescribing details. To obtain a copy of this Monograph from Talecris, please call 1-866-482-5226 or visit www.talecris.com/ca.
About Alpha1-Antitrypsin Deficiency
Alpha1-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha1-proteinase inhibitor. It is most common in the Caucasian population of northern Europe and North America. AAT deficiency is also the most common cause of genetic liver disease in children, and genetic emphysema (shortness of breath) in adults. Individuals suffering from AAT deficiency often develop severe obstructive pulmonary disease (COPD) causing disability and premature death. AAT deficiency is estimated to affect 200,000 people in North America and Europe.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics (Nasdaq: TLCR) is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis. (www.talecris.com)
Cautionary statement regarding forward-looking statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies. Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.
The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third-party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products. Additional information about factors that could affect the business and financial results of Talecris is contained in its final Prospectus filed pursuant to Rule 424(b)(1) with the Securities and Exchange Commission on October 1, 2009. Talecris undertakes no duty to update any forward-looking statement.
SOURCE Talecris Biotherapeutics, Inc.
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