Integrated Analysis Demonstrates Alpha(1)-Augmentation Therapy Significantly
Reduces Loss of Lung Tissue in Patients With AAT-Deficiency-Related Emphysema

    


    
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<p>RESEARCH TRIANGLE PARK, N.C., <span class="xn-chron">Nov. 15, 2010</span> /CNW/ -- Talecris Biotherapeutics announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to alpha(1)-antitrypsin (AAT) deficiency.  Results of the studies, published as an integrated analysis of the raw data from two similar pilot trials, were published in the journal Respiratory Research on <span class="xn-chron">October 5, 2010</span> (<a href="http://respiratory-research.com/content/11/1/136">http://respiratory-research.com/content/11/1/136</a>).</p>
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<p>AAT deficiency is a rare, genetic disease in which low levels of AAT protein circulating in the lungs of susceptible individuals can increase their risk of developing emphysema. Treatment with A1PI therapy augments or increases the levels of AAT protein in the lungs.</p>
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<p>Two randomized, double-blind, placebo-controlled clinical trials investigated the effect of A1PI therapy on emphysema progression using change in lung density as a measure. Lung density is a validated and specific measure of emphysema that relates well to physiological and clinical features of the disease. Lung density has also been shown to be the best independent predictor of mortality from emphysema.</p>
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<p>An analysis of the data from both studies was conducted by <span class="xn-person">Professor Robert A Stockley</span>, <span class="xn-location">Birmingham</span>, UK, and <span class="xn-person">Professor Asger Dirksen</span>, Hellerup, <span class="xn-location">Denmark</span>. The two studies were comparable in design, treatment duration, patient characteristics and the use of computed tomography (CT) to study lung density.  The similar characteristics of the studies allowed the pooling of the individual patient data, increasing the number of patients and the statistical power of the analysis.</p>
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<p>The results of the integrated analysis demonstrated a mean change in lung density from baseline to the final CT scan of -4.082 g/L for the AAT treatment group and  -6.379g/L for the placebo group, a statistically significant difference of 2.297 (95% CI, 0.669 to 3.926; p = 0.006).</p>
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<p>"The mean data demonstrate a deceleration of lung tissue loss with AAT augmentation therapy with a high degree of statistical significance," said Stockley. "This indicates that AAT augmentation therapy reduces decline in lung density and may therefore reduce the future risk of mortality in patients with AAT-deficiency-related emphysema."</p>
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<p>The two clinical trials included in the integrated analysis were a 3-year Danish-Dutch study of 56 patients (<a href="http://ajrccm.atsjournals.org/cgi/content/full/160/5/1468">http://ajrccm.atsjournals.org/cgi/content/full/160/5/1468</a>) and the EXAcerbations and CT scan as Lung Endpoints (EXACTLE) trial of 77 patients over 24 to 30 months (<a href="http://erj.ersjournals.com/content/33/6/1345.full">http://erj.ersjournals.com/content/33/6/1345.full</a>).  In both trials patients were randomized to receive infusions of A1PI or a placebo.  The results suggested a trend toward reduction in emphysema progression with A1PI therapy, as measured by CT densitometry. The trials were not powered to show efficacy; thus neither trial reached statistical significance on its own. Pooling the data increased the number of patients and the statistical power of the analysis.</p>
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<p>Talecris Biotherapeutics, manufacturer of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]), funded the integrated analysis and the EXACTLE trial included in the analysis.</p>
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<p>Prolastin-C is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha1-PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema.</p>
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<p>Therapeutic administration of Prolastin-C 60 mg/kg weekly, has been demonstrated to be well-tolerated.  In two clinical studies with Prolastin-C, the most common drug related adverse event was chills, which occurred in 3.2% of Prolastin-C patients (n=2). The following drug related adverse events were reported in 1.6% of patients (one subject each) treated with Prolastin-C: malaise, headache, rash (severe), hot flush, and pruritus.</p>
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<p>Prolastin-C should not be given to patients who are hypersensitive to alpha1-proteinase inhibitor (human) or to any ingredient in the formulation or component of the container, or to individuals with selective immunoglobulin A (IgA) deficiencies, as these patients may experience severe reactions, including anaphylaxis, to IgA which may be present. As with all plasma-derived therapeutics, the potential to transmit infectious agents (e.g., viruses and, theoretically, the Creutzfeldt-Jakob Disease (CJT) agent or its variants (vCJD)) cannot be totally eliminated.</p>
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    About Alpha(1)-Antitrypsin Deficiency
    
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<p>Alpha(1)-antitrypsin deficiency, also known as AAT deficiency or Alpha-1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha(1)-proteinase inhibitor. It is most common in the Caucasian population of northern <span class="xn-location">Europe</span> and <span class="xn-location">North America</span>. 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 chronic obstructive pulmonary disease (COPD) causing disability and premature death. AAT deficiency is estimated to affect 200,000 people in <span class="xn-location">North America</span> and <span class="xn-location">Europe</span> combined, although greater than 90% remain undiagnosed.</p>
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    About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
    
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<p>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. (<a href="http://www.talecris.com">www.talecris.com</a>)</p>
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    Cautionary statement regarding forward-looking statements
    
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<p>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.</p>
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<p>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 <span class="xn-chron">October 1, 2009</span>. Talecris undertakes no duty to update any forward-looking statement.</p>
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For further information: Becky Levine of Talecris Biotherapeutics, [phone], Fax: [phone], [email protected] Web Site: http://www.talecris.com