RESEARCH TRIANGLE PARK, N.C., Oct. 19 Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.
Like PROLASTIN, the market leader for over 20 years, PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic condition in which low levels of this essential protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT-deficient patients at risk for developing emphysema.
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, and that the adverse event profile of PROLASTIN-C is consistent with that of PROLASTIN. 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 introduction of PROLASTIN revolutionized care for thousands of individuals with Alpha-1," said John Walsh, president and CEO of the Alpha-1 Foundation. "We welcome PROLASTIN-C as an example of the ongoing commitment Talecris has made to the Alpha-1 community."
The manufacturing process for PROLASTIN-C incorporates technological advances such as nanofiltration, a virus exclusion technology, and cation exchange chromatography, an additional purification step.
"PROLASTIN-C is an example of the significant investments Talecris is making in research and development and manufacturing," said Steve Petteway, Ph.D., executive vice president, Research and Development. "Our single-minded goal is advancing the care of patients who rely on our products."
PROLASTIN DIRECT, the exclusive distribution and health management program for PROLASTIN, will provide more information to patients in the U.S. about the transition to PROLASTIN-C. Information about the transition to PROLASTIN-C in other countries will be provided as regulatory approvals are granted.
About PROLASTIN® and PROLASTIN®-C
PROLASTIN and PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human), are derived from human plasma and are administered intravenously to raise the levels of AAT in the blood and lungs. PROLASTIN and PROLASTIN-C are indicated for chronic augmentation and maintenance therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. PROLASTIN was the first plasma-derived AAT augmentation therapy to receive approval from the U.S. Food and Drug Administration (FDA) and was approved in December 1987 and launched in February 1988.
Important Safety Information
In clinical studies comparing PROLASTIN-C and PROLASTIN, adverse events (AEs) were reported at a rate of 0.117 and 0.078 per infusion for PROLASTIN-C and PROLASTIN, respectively, with comparable severity of AEs between treatments. The most common drug related adverse reactions during clinical trials in greater than or equal to 1% of subjects treated with PROLASTIN-C were chills, malaise, headache, rash, hot flush and pruritus. The most serious adverse reaction observed during clinical studies with PROLASTIN-C was an abdominal and extremity rash in one subject. In previous clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%).
PROLASTIN and PROLASTIN-C are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and, theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, and cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products. Individuals with selective IgA deficiencies who have the known antibody against IgA (anti-IgA antibody) should not receive PROLASTIN or PROLASTIN-C, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present. For additional information on PROLASTIN, 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.
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 AAT. 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 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. For more information, please visit: 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
The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking 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. 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.
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