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	<title>Immune Deficiency Foundation</title>
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	<link>http://primaryimmune.org</link>
	<description>Immune Deficiency Foundation</description>
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		<title>Let Families, Doctors Decide</title>
		<link>http://primaryimmune.org/2012/02/let-families-doctors-decide</link>
		<comments>http://primaryimmune.org/2012/02/let-families-doctors-decide#comments</comments>
		<pubDate>Mon, 06 Feb 2012 15:16:57 +0000</pubDate>
		<dc:creator>afreestone</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4273</guid>
		<description><![CDATA[A mother of two children with PIDD has &#8220;insurers are not doctors&#8221; letter-to-the-editor published in Pennsylvania newspaper. Read More]]></description>
			<content:encoded><![CDATA[<p>A mother of two children with PIDD has &#8220;insurers are not doctors&#8221; letter-to-the-editor published in Pennsylvania newspaper.</p>
<p><a href="http://www.ldnews.com/letterseditor/ci_19885659" target="_blank">Read More</a></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>IDF Article in Pharmaceuticals Policy and Law Journal</title>
		<link>http://primaryimmune.org/2012/02/idf-article-in-pharmaceuticals-policy-and-law-journal</link>
		<comments>http://primaryimmune.org/2012/02/idf-article-in-pharmaceuticals-policy-and-law-journal#comments</comments>
		<pubDate>Wed, 01 Feb 2012 14:39:24 +0000</pubDate>
		<dc:creator>afreestone</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4231</guid>
		<description><![CDATA[An IDF article titled Comparative Effectiveness Research in the United States and Primary Immunodeficiency Diseases was recently published in Pharmaceuticals Policy and Law Read More]]></description>
			<content:encoded><![CDATA[<p>An IDF article titled Comparative Effectiveness Research in the United States and Primary Immunodeficiency Diseases was recently published in <em>Pharmaceuticals Policy and Law</em></p>
<p><a href="http://primaryimmune.org/idf-survey-research-center/idf-surveys?aid=4203&#038;pid=1064&#038;sa=1" target="_blank">Read More</a></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>NIH Scientists Find Cause of Rare Immune Disease</title>
		<link>http://primaryimmune.org/2012/01/nih-scientists-find-cause-of-rare-immune-disease</link>
		<comments>http://primaryimmune.org/2012/01/nih-scientists-find-cause-of-rare-immune-disease#comments</comments>
		<pubDate>Thu, 12 Jan 2012 15:02:14 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4180</guid>
		<description><![CDATA[Investigators at the National Institutes of Health have identified a genetic mutation in three unrelated families that causes a rare immune disorder characterized by excessive and impaired immune function. &#62;&#62;&#62; Read More]]></description>
			<content:encoded><![CDATA[<p>Investigators at the National Institutes of Health have identified a genetic mutation in three unrelated families that causes a rare immune disorder characterized by excessive and impaired immune function.</p>
<p><a href="http://www.niaid.nih.gov/news/newsreleases/2012/Pages/PLAID.aspx" target="_blank">&gt;&gt;&gt; Read More</a></p>
]]></content:encoded>
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		</item>
		<item>
		<title>Man&#8217;s Life Saved After Treatment Reinstated</title>
		<link>http://primaryimmune.org/2012/01/mans-life-saved-after-treatment-reinstated</link>
		<comments>http://primaryimmune.org/2012/01/mans-life-saved-after-treatment-reinstated#comments</comments>
		<pubDate>Thu, 05 Jan 2012 20:51:09 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4166</guid>
		<description><![CDATA[Robert Durkin&#8217;s insurance company had notified him they’d no longer pay for a costly treatment he undergoes every 21 days for a rare immune deficiency disease. “The problem is,” he said. “I need these treatments or I’ll die.” &#62;&#62;&#62; Read More]]></description>
			<content:encoded><![CDATA[<p>Robert Durkin&#8217;s insurance company had notified him they’d no longer pay for a costly treatment he undergoes every 21 days for a rare immune deficiency disease.  “The problem is,” he said. “I need these treatments or I’ll die.”</p>
<p><a href="http://www.ctnow.com/news/ctn-mans-life-saved-after-treatment-reinstated-story-tonight-at-10-and-11-20120104,0,1138127.story" target="_blank">&gt;&gt;&gt; Read More</a></p>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Parents&#8217; Past Worry Will Save Delaware Babies&#8217; Lives</title>
		<link>http://primaryimmune.org/2012/01/parents-past-worry-will-save-delaware-babies-lives</link>
		<comments>http://primaryimmune.org/2012/01/parents-past-worry-will-save-delaware-babies-lives#comments</comments>
		<pubDate>Tue, 03 Jan 2012 17:17:31 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4157</guid>
		<description><![CDATA[After Child&#8217;s Diagnosis, SCID Test is Now a Routine &#62;&#62;&#62; Read More]]></description>
			<content:encoded><![CDATA[<p>After Child&#8217;s Diagnosis, SCID Test is Now a Routine</p>
<p><a href="http://www.delawareonline.com/article/20111230/NEWS/112300335/Parents-past-worry-will-save-Delaware-babies-lives?odyssey=nav|head" target="_blank">&gt;&gt;&gt; Read More</a></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Mother Struggles with Insurance Company to Keep Son&#8217;s Meds, the Ones that Work</title>
		<link>http://primaryimmune.org/2011/12/doctor-visits-the-times-herald-newsroom-to-shed-light-on-healthcare-issues-affecting-some-patients-with-pidd</link>
		<comments>http://primaryimmune.org/2011/12/doctor-visits-the-times-herald-newsroom-to-shed-light-on-healthcare-issues-affecting-some-patients-with-pidd#comments</comments>
		<pubDate>Tue, 20 Dec 2011 17:33:58 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4143</guid>
		<description><![CDATA[In an effort to spur awareness of a health care problem affecting many who suffer from immune deficiencies, a doctor and his patient recently came to The Times Herald newsroom to shed light on some issues. >>> Read More]]></description>
			<content:encoded><![CDATA[<p>In an effort to spur awareness of a health care problem affecting many who suffer from<br />
immune deficiencies, a doctor and his patient recently came to The Times Herald newsroom to shed light<br />
on some issues.</p>
<p><a href="http://primaryimmune.org/wp-content/uploads/2011/12/TimesHerald_IDF.pdf">>>> Read More</a></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Victor Grifols selected as Business Leader of the Year 2011 by the Spain &#8211; US Chamber of Commerce</title>
		<link>http://primaryimmune.org/2011/12/victor-grifols-selected-as-business-leader-of-the-year-2011-by-the-spain-us-chamber-of-commerce</link>
		<comments>http://primaryimmune.org/2011/12/victor-grifols-selected-as-business-leader-of-the-year-2011-by-the-spain-us-chamber-of-commerce#comments</comments>
		<pubDate>Wed, 07 Dec 2011 16:45:18 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4111</guid>
		<description><![CDATA[Angeles Gonzalez Sinde, Minister of Cultural Affairs of the Government of Spain, will present this award that recognizes the professional career of the President and Managing Director of Grifols, whose leadership has driven the transition of Grifols from a family company to the third largest producer of plasma protein therapies worldwide. Grifols maintains a strong ...]]></description>
			<content:encoded><![CDATA[<ul>
<li>Angeles Gonzalez Sinde, Minister of Cultural Affairs of the Government of Spain, will present this award that recognizes the professional career of the President and Managing Director of Grifols, whose leadership has driven the transition of Grifols from a family company to the third largest producer of plasma protein therapies worldwide.</li>
</ul>
<ul>
<li>Grifols maintains a strong relationship with the North American market, investing nearly five billion dollars between 2002 and 2011, and with plans to invest $720 million more by 2015.</li>
</ul>
<p>Barcelona, December 6, 2011 – Victor Grifols Roura, president and managing director of Grifols, has been selected as the “Business Leader of the Year 2011” by the Spain–U.S. Chamber of Commerce, the premier forum fostering commercial, economic and industrial relations between Spain and the United States. This award, given annually, recognizes the professional career of business leaders who stand out in their industries, as well as their contribution to the globalization of the economy. In the case of Victor Grifols, his leadership as sales manager of Grifols since 1979, and as president and managing director since 1987 has driven the transition of Grifols and allowed it to grow from a family company to the third largest producer of plasma protein therapies worldwide.</p>
<p>The award will be presented by Angeles Gonzalez Sinde, Minister of Cultural Affairs of the Government of Spain during the gala dinner that will take place on December 6th, 2011 at the Hotel Pierre in New York, and attendees will include notable political and business figures from both Spain and the United States.</p>
<p>Victor Grifols Roura studied Business Science at the University of Barcelona and joined Grifols in 1973. A man of great strategic and commercial vision, as the Commercial Director he was the architect of the restoration of Grifols’ sales network in Spain. Additionally, as managing director, he was responsible for the in-depth reorganization of the company that allowed it to establish the basis for the multinational group that Grifols is today.</p>
<p>For Victor Grifols, international expansion has always been and continues to be essential to ensure the growth of his organization. In 1988 he opened the company’s first international subsidiary in Portugal, inaugurating the process of progressive expansion of Grifols in other markets, whose first objective was Latin America, though entrance into the United States market was always the long-term goal.</p>
<p>During the 1990´s the international expansion of the group took off, and one of the decisive factors of this was the acquiring of two Food &amp; Drug Administration licenses in 1995: the Establishment License for the production plant in Parets del Vallés (Barcelona, Spain), and the Product License for its product, Albumin.</p>
<p>In 1998, Miami was designated as the site for the first American subsidiary of Grifols, with Central America and the Caribbean as its principal areas of influence, followed by Argentina and Chile in 1991. The disappearance of the Soviet Bloc in 1992 created the opportunity for a new subsidiary in the Czech Republic, and the following year, Mexico was chosen as the next country for expansion.</p>
<p>In 1997, European expansion began through acquisitions. The purchase of subsidiaries of Alpha Therapeutic Corporation in the United Kingdom, Germany and Italy permitted a rapid penetration into those markets and generated enough confidence for the company to leap to the United States, a world leader in the blood derivatives sector. In the years 2002 and 2003, two acquisitions planted the roots of Grifols in the US: the purchase of SeraCare, that ensured the supply of raw materials through the expansion of its plasma acquisition centers, and a large part of the assets of Alpha Therapeutic Corporation, including its plasma division and protein purification plants for the in Los Angeles.</p>
<p>Presently, Grifols maintains a strong presence on the North American market and the internationalization of the group has translated into a global commercial presence including more than 90 countries with direct subsidiaries in 24.</p>
<p>In addition to the process of internationalization, Victor Grifols has been a key player in some of the milestones that have most influenced the success of the company. His broad experience and deep understanding of the plasma protein therapy industry, and strong belief in a job well done has allowed Grifols to adopt some of the decisions that have marked its course. Among these decisions are the company’s choice to go public in 2006 and the recent purchase of Talecris, and the group continues to maintain the support and backing of its shareholders, institutional as well as individual.</p>
<p>With Victor Grifols as president, Grifols has converted into one of the Spanish corporations with the largest presence in the United States, where, after its recent acquisitions, the organization generates around 60% of its revenue and employs over 8,000 workers. Victor Grifols has always maintained a strong relationship with the North American market and a large part of the group’s investments have been focused in this geographic area. Between 2002 and 2011, the company invested approximately five billion dollars, including direct inversions of capital (CAPEX), resources destined for research, development, innovation and other diverse acquisitions. Additionally, Grifols has announced that it will dedicate more than $720 million to direct capital investments in North America by the year 2015.</p>
<p><strong>About the Spain – U.S. Chamber of Commerce</strong><br />
Founded in 1959, the Spain-U.S. Chamber of Commerce, Inc., is the premier forum fostering business and commerce between Spain and the Unite d States. Headquartered in New York City, the Chamber is a private nonprofit membership organization dedicated to serving American and Spanish businesses.</p>
<p>The Spain-U.S. Chamber of Commerce represents some of the most influential companies from the Spanish and American communities with the mission of providing the highest quality services to its members, putting the most effective strategic tools within their reach to increase the competitiveness of their businesses.</p>
<p><strong>About Grifols</strong><br />
Grifols is a world-leading healthcare company. Its commitment to an ongoing research program will improve how patients are cared for, and also benefit society as a whole.<br />
Since its founding in Barcelona (Spain) in 1940, Grifols’ aim has been to produce new healthcare solutions based on the therapeutic properties of plasma-derived proteins. Its capacity to innovate and our strong ethical values place it at the forefront of the international biopharmaceutical industry.</p>
<p>Present in more than 90 countries worldwide and with sales subsidiaries in 24 different countries, it is currently the third largest producer of plasma protein therapies worldwide in terms of capacity and the first European company in the sector, with a diversified and well-balanced range of products.</p>
<p>Since 2006, Grifols ordinary (Class A) shares are quoted on the Spanish Continuous Market, and since 2008 they are listed on the IBEX-35 index (GRF). Additionally, since June 2011, Grifols non-voting (Class B) shares are also listed on the Continuous Market (GRF.P), and in the United States on NASDAQ (GRFS) through ADRs (American Depositary Receipts).</p>
<p>In the years to come, the group will reinforce its leadership in the industry as a vertically integrated company thanks to investments it has already made and those that it is planning to realize. Additionally, Grifols places great importance on its research and development activity, which is focused on discovering solutions and therapies for people affected by plasma protein deficiencies, and on finding new therapeutic indications for plasma derived proteins. An excellent example of this is the new clinical study for the treatment of Alzheimer’s disease.</p>
<p><strong>Grifols Facts</strong></p>
<ul>
<li>Grifols markets and distributes products in more than 90 countries</li>
<li>Grifols’ subsidiaries operate directly in 24 countries</li>
<li>Around 11,500 people are employed by Grifols throughout the world</li>
<li>75% of Grifols workforce is in the United Sates</li>
<li>Production facilities are located in the United States, Spain, Australia and Switzerland</li>
<li>Approximately 2,200 million euros in revenue</li>
<li>Well-balanced and diversified range of products: 53% of all income from the United States, 26% from Europe, 7% from Canada and 14% from the rest of the world</li>
<li>The maximum number of plasma products is obtained from each liter of plasma: Intravenous Immunoglobulin –IVIG- (46%), albumin (10%), factor VIII (9%) alpha-1 antitrypsin (12%) and others (21%)</li>
<li>Grifols operates 147 donation centers for plasma collection in the United States</li>
<li>Between 4% and 5% of Grifols’ revenue is allocated to a significant number of R+D projects</li>
</ul>
<p><strong>DISCLAIMER</strong><br />
The facts and figures contained in this report which do not refer to historical data are “projections and forward-looking statements”. The words and expressions like “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “try to achieve”, “estimate”, “future” and similar expressions, insofar as they are related to Grifols Group, are used to identify projections and forward-looking statements. These expressions reflect the assumptions, hypothesis, expectations and anticipations of the management team at the date of preparation of this report, which are subject to a number of factors that could make the real results differ considerably. The future results of Grifols Group could be affected by events related to its own activity, such as shortages of raw materials for the manufacture of its products, the launch of competitive products or changes in the regulations of markets in which it operates, among others. At the date of preparation of this report Grifols Group has adopted the measures it considers necessary to offset the possible effects of these events. Grifols, S.A. does not assume any obligation to publicly inform, review or update any projections and forward-looking statements to adapt them to facts or circumstances following the preparation of this report, except as specifically required by law. This document does not constitute an offer or invitation to purchase or subscribe shares, in accordance with the provisions of the Spanish Securities Market Law 24/1988, of July 28, the Royal Decree-Law 5/2005, of March 11, and/or Royal Decree 1310/2005, of November 4, and its implementing regulations.</p>
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		<title>Helping make a dream come true for three Billerica brothers</title>
		<link>http://primaryimmune.org/2011/12/helping-make-a-dream-come-true-for-three-billerica-brothers</link>
		<comments>http://primaryimmune.org/2011/12/helping-make-a-dream-come-true-for-three-billerica-brothers#comments</comments>
		<pubDate>Mon, 05 Dec 2011 21:11:15 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4091</guid>
		<description><![CDATA[Benjamin, Jeremy and Matthew Fox all have Primary Immunodeficiency Disease (PIDD). “Primary” indicates that an immune deficiency is an inborn or congenital defect, as opposed to “secondary” which means the damage is caused by an external force&#8230; >>> Read More]]></description>
			<content:encoded><![CDATA[<p>Benjamin, Jeremy and Matthew Fox all have Primary Immunodeficiency Disease (PIDD). “Primary” indicates that an immune deficiency is an inborn or congenital defect, as opposed to “secondary” which means the damage is caused by an external force&#8230;</p>
<p><a href="http://www.wickedlocal.com/billerica/features/x1622884069/Helping-make-a-dream-come-true-for-three-Billerica-brothers#axzz1fhGQMVAO">>>> Read More</a></p>
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		<title>Immune Deficiency Foundation Fears Conventry Health Care Policy Compromises Patient Safety</title>
		<link>http://primaryimmune.org/2011/11/immune-deficiency-foundation-fears-conventry-health-care-policy-compromises-patient-safety</link>
		<comments>http://primaryimmune.org/2011/11/immune-deficiency-foundation-fears-conventry-health-care-policy-compromises-patient-safety#comments</comments>
		<pubDate>Tue, 22 Nov 2011 18:16:47 +0000</pubDate>
		<dc:creator>ehovermale</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4070</guid>
		<description><![CDATA[FOR IMMEDIATE RELEASE November 22, 2011 Restrictive formulary policy for patients with primary immunodeficiency diseases puts safety at risk, removes physician from treatment decisions Pittsburgh, Pennsylvania – (November 22, 2011) – Should patient safety be put at risk as a result of a business decision? Health insurer Coventry Health Care will soon introduce a restrictive ...]]></description>
			<content:encoded><![CDATA[<p>FOR IMMEDIATE RELEASE</p>
<p>November 22, 2011</p>
<p>Restrictive formulary policy for patients with primary immunodeficiency diseases puts safety at risk, removes physician from treatment decisions</p>
<p>Pittsburgh, Pennsylvania – (November 22, 2011) – Should patient safety be put at risk as a result of a business decision?</p>
<p>Health insurer Coventry Health Care will soon introduce a restrictive formulary—a list of drugs preferred by health insurance plans—that could negatively impact patients living with primary immunodeficiency diseases (PIDD), forcing patients to switch therapies on which they are stabilized and unjustifiably exposing them to adverse reactions. The proposed formulary does not account for the fact that immunoglobulin replacement therapies are not clinically interchangeable. The FDA has recognized each brand as unique and with no generic equivalents.</p>
<p>Coventry Health Care’s plan eliminates the important, specialized role physicians have in prescribing the best intravenous immune globulin replacement (IVIG) therapy product for each patient living with PIDD.</p>
<p>For existing patients who have been stabilized on a specific, physician-prescribed IVIG product, the stakes may be very high indeed. Based on the medical literature and according to the IDF Medical Advisory Committee, about one-third of all adverse reactions to immunoglobulin infusions occur in the context of changing products. These physician advisors explained how switching treatments may cause adverse side effects that range from mild headaches to seizures and stroke.</p>
<p>“We understand and support efforts to reduce health care costs and spending,” said Marcia Boyle, President &amp; Founder of IDF, a national patient advocacy organization. “But we can’t support an effort that takes the physician out of the equation and compromises safety for this rare patient population dealing with chronic illness who rely on IVIG as a lifelong and lifesaving therapy.”</p>
<p>The formulary will first affect HealthAmerica members in Pennsylvania beginning December 1, 2011, and Group Health Plan members in Missouri soon thereafter. This week, IDF launched its “Insurers are Not Doctors” initiative. The effort will aim at reversing Coventry Health Care’s restrictive formulary by raising awareness and generating support from health professionals, patients, policymakers and the general public against Coventry’s harmful policy.</p>
<p>Through its initiative, IDF is asking that any Coventry policy:<br />
•	Not determine the specific IVIG therapy a patient must use<br />
•	Ensure that patients already stabilized on an IVIG therapy not be switched to another therapy without medical cause<br />
•	Allow physicians an opportunity to prescribe an alternative if they determine it is in the best interest of the patient<br />
•	Better inform patients and physicians about its policy plans and gain direct feedback on their recommendations</p>
<p>“By requiring all patients to switch to the restrictive formulary’s single preferred product, Coventry is essentially mandating that some of these often-frail patients will need to experience potentially life-threatening adverse reactions with no medical justification for exposing them to such risk,” said Dr. Michael Blaese, Consulting Medical Director of IDF. “Insurers are not doctors, and it is important that we act quickly to stop health insurance plans like Coventry from disempowering patients and physicians.”</p>
<p>For more information about the Coventry Health Care policy and the threat it poses to patient safety, visit www.InsurersAreNotDoctors.com.</p>
<p>About the Immune Deficiency Foundation<br />
The Immune Deficiency Foundation is the national patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education, and research.  www.primaryimmune.org</p>
<p># # #</p>
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		<title>FDA Approves U.S. Market Return for octagam® Following Octapharma’s Implementation of Enhanced Safety Measures</title>
		<link>http://primaryimmune.org/2011/11/fda-approves-u-s-market-return-for-octagam%c2%ae-following-octapharma%e2%80%99s-implementation-of-enhanced-safety-measures</link>
		<comments>http://primaryimmune.org/2011/11/fda-approves-u-s-market-return-for-octagam%c2%ae-following-octapharma%e2%80%99s-implementation-of-enhanced-safety-measures#comments</comments>
		<pubDate>Fri, 04 Nov 2011 13:55:03 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://primaryimmune.org/?p=4047</guid>
		<description><![CDATA[HOBOKEN, N.J. (November 4, 2011) – The U.S. Food and Drug Administration (FDA) yesterday cleared the way for the U.S. market return of octagam® [Immune Globulin Intravenous (human)] 5% Liquid Preparation], the Octapharma USA product used to treat disorders of the immune system. In August 2010, Octapharma initiated a voluntary market withdrawal of selected lots ...]]></description>
			<content:encoded><![CDATA[<p><strong>HOBOKEN, N.J. (November 4, 2011) –</strong> The U.S. Food and Drug Administration (FDA) yesterday cleared the way for the U.S. market return of octagam® [Immune Globulin Intravenous (human)] 5% Liquid Preparation], the Octapharma USA product used to treat disorders of the immune system.</p>
<p>In August 2010, Octapharma initiated a voluntary market withdrawal of selected lots of octagam® 5% in the U.S. in response to an observed increase in thromboembolic events (TEEs) and subsequently expanded the voluntary withdrawal to all lots of octagam®, illustrating the biopharmaceutical company’s preference to exercise the highest level of patient safety. Over the last year, Octapharma has collaborated with the FDA in analyzing the issue of procoagulant activity in industry-wide immune globulin products, which in some cases lead to TEEs in many IVIG products on the market today.</p>
<p>The FDA approval was based on changes Octapharma has made in the octagam® 5% manufacturing process and the company’s decision to implement a quality control test on every batch of the product that is released to the marketplace. Additionally, Octapharma will implement post-marketing studies to ensure product safety.</p>
<p>“We are extremely pleased that the FDA has authorized the market return of octagam® 5%,” said Octapharma USA President Flemming Nielsen. “Our collaboration with the FDA over the last year has enhanced awareness of the industry-wide concerns regarding procoagulant activity and TEEs. Octapharma has always believed that patient safety comes first so the octagam® 5% that we will return to the U.S. market in a few weeks will enjoy the highest level of safety scrutiny available today and the same level of tolerability that our patients have come to expect from Octapharma therapies.”</p>
<p>Thromboembolic events occur due to the formation of a clot or thrombus in an artery or vein that breaks loose and is carried by the blood stream to occlude another vessel. Over the last year, the FDA has identified several immune globulin products on the U.S. market that may have suspect levels of procoagulant activity. Multiple industry research initiatives indicate that TEEs can be caused by a number of different biochemical/physiological factors in susceptible individuals. For those TEE cases involving octagam® 5%, however, the root cause was determined to be associated only with activated Factor XI, one of the many coagulation factors involved in the complex clotting cascade.</p>
<p>Octapharma collaborated with the FDA’s Center for Biologics Evaluation and Research to develop and validate a scientific method to measure the amount of activated Factor XI, the root cause of the TEEs, both during the manufacturing process and at the finished product stage. Although other procoagulant factors, such as kallikrein, have been linked to TEEs in other IVIG products, these were shown not to have contributed to the TEEs seen in association with octagam® 5%. Octapharma now utilizes a commercial absorbent early in the manufacturing process of octagam® 5% that minimizes the presence of Factor XI.</p>
<p>Earlier this year, multiple international regulatory agencies authorized the market return of octagam® 5% and octagam® 10% in worldwide markets.</p>
<p><strong>About octagam® 5%</strong><br />
Immune Globulin Intravenous (Human), octagam® 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. octagam® 5% liquid is a solution for infusion which must be administered intravenously.</p>
<p>octagam® is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.</p>
<p><em><strong>About the Octapharma Group</strong></em><br />
Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 28 years. Octapharma’s core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma’s IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat primary immune deficiencies, and Octapharma’s Albumin (human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma’s wilate® (Von Willebrand Factor/Coagulation Factor VIII Complex [human]) received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of certain types of Von Willebrand Disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J.  Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com or www.wilateusa.com.</p>
<p><em><em>Forward-looking statements</em></em><br />
This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company’s control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.</p>
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