Octapharma AG

Octapharma Group releases 2011 Annual Report

Fri, 30 Mar 2012 16:25:00 +0200

2011 has been a successful transitional year for the Octapharma Group. Since octagam® 5% and 10% re-entered all important markets profitability experienced a month-by-month continuous improvement. Re-entry combined with the strong demand for our Haematology and Intensive Care products has led to the successful turnaround of the Octapharma Group in 2011.

Octapharma Group today released figures for the year ending December 31, 2011. Net sales stand at €732 million, which is €14 million or 2% above the 2010 figure. The figures for the last months in 2011 indicate a significant improvement in profitability for 2012. Gross profit in 2011 is €205 million, representing 28% of net sales and an increase of €31 million compared to 2010. Operating expenses are €141 million, €8 million or almost 6% less than in 2010. This includes €43 million investments into Research and Development. Earnings Before Interest and Tax (EBIT) can be reported at €64 million. This reflects a 164% increase compared to 2010.

The promising first months of octagam® returning to the markets allow a positive outlook and it is expected that all key figures will further improve during 2012.

To download the full Octapharma AG 2011 Annual Report click here, for the Financial section only click here.

About Octapharma AG

Headquartered in Lachen, Switzerland, Octapharma Group is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for almost 30 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 albumin, immune globulins, coagulation factor and inhibitors. In addition, for more than 20 years Octapharma has manufactured octaplas(LG)® a cell-free pharmaceutical quality therapeutic coagulation-active plasma which has been safeguarded through virus inactivation (S/D treatment) and neutralization of viruses by immune antibodies. Octapharma employs around 4,500 people and has biopharmaceutical experience in more than 80 countries worldwide, including the United States, and operates six state-of-the-art production facilities, of which two sites are licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com

Octapharma USA Submits BLA for octaplasLG®, A Therapy Targeting Adverse Transfusion Events

Tue, 28 Feb 2012 09:08:00 +0100

HOBOKEN, N.J. (February 24, 2012) – Octapharma USA has submitted its Biological License Application (BLA) for octaplasLG^® to the U.S. Food and Drug Administration (FDA) with the goal of expanding its U.S. product portfolio by the fourth quarter of 2012. The FDA will evaluate the octaplasLG^® BLA for an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors. The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP), a blood disorder that causes clot formation in small blood vessels. The product features solvent/detergent inactivation against enveloped viruses and immune neutralization against non-enveloped viruses. “We look forward to bringing octaplasLG^® to the U.S. medical community,” said Octapharma USA President Flemming Nielsen. “This trusted therapy has been successfully used to treat patients for more than 15 years in Europe and over 30 countries worldwide.” Octapharma USA has started to lay the groundwork for the introduction of octaplasLG^®, coordinating a physician advisory board meeting in late 2011 with leading treatment professionals in transfusion medicine, hematology and surgery. About the Octapharma Group 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 nearly 30 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. Forward-looking statements 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.

Octapharma USA appoints David E. Holliday as Vice President of Commercial Development

Thu, 12 Jan 2012 14:31:00 +0100

HOBOKEN, N.J. (January 11, 2012) – Octapharma USA today announced that David E. Holliday has joined the biopharmaceutical company as Vice President of Commercial Development, assuming immediate responsibility for all U.S. product marketing, sales and commercial activities and coordination with global portfolio development initiatives. Holliday is a senior executive with over 24 years of industry leadership experience, most recently serving as Vice President of Global Marketing Operations & Hemophilia with Baxter Bioscience. Holliday has extensive U.S. and international experience with particular expertise in management, commercial, sales, marketing and business development. “We are very excited to have David Holliday, a true global leader in our industry, join our senior management team,” said Octapharma USA President Flemming Nielsen. “David has critical leadership experience with major multinational pharmaceutical and biotech corporations. He joins Octapharma USA at an extremely important time for our company as our product portfolio in the U.S. will be increasing significantly in the next year and we expect David will be integral to our growth.” Holliday also served as Vice President, Global Marketing Operations and United Kingdom Business Unit Director during his eight years with Baxter Bioscience, which included a number of successful product launches. During his 17-year career with Novartis Pharmaceuticals and Ciba-Geigy Pharmaceuticals, Holliday held progressively responsible management positions, including Business Unit Director of the Transplantation and Mature Products Business Units in the UK. About the Octapharma Group 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 nearly 30 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. 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.

Approval of Dedicated Step for Specific Prion Removal and Second Manufacturing Site for octaplas® Through a Mutual Recognition Procedure in Europe

Wed, 23 Nov 2011 08:29:00 +0100

Octapharma AG, Lachen, Switzerland In order to further enhance the safety of octaplas® against the theoretical risk of transmitting the prion disease called variant Creutzfeldt-Jakob disease (vCJD), a chromatographic step to remove the infectious agent of this disease, known as the prion, has been incorporated into the manufacturing process of this product. The prion affinity ligand gel used for this dedicated safeguarding step is manufactured by ProMetic BioSciences Inc. at the Isle of Man and delivered to Octapharma for one-time usage, i.e. disposable gel. This particular amendment to the octaplas® production process was approved by the German drug authorities (Paul-Ehrlich Institut) in 2009 and later by the regulatory bodies in Australia, Switzerland and Portugal. Since the introduction of this new generation solvent/detergent (S/D) virus inactivated plasma in Germany, more than 130,000 bags of the novel product have been sold and used under the trade name octaplasLG® (LG; ligand gel) to treat almost 45,000 patients. The very positive post-marketing feedback regarding the efficacy, safety and tolerability of octaplasLG® mirrors the impeccable record demonstrated by octaplas® over the past 20 years, with 7.2 million bags used to treat approximately 2.4 million patients worldwide. On November the 16th, we were informed that the introduction of this specific prion removal column into the manufacturing process of octaplas® was approved by seven additional countries in Europe through a Mutual Recognition Procedure (MRP). In addition to the United Kingdom (UK) as the Reference Member State for this MRP, the approval was endorsed and is valid for Belgium, Finland, Ireland, Luxemburg, Netherlands and Sweden as well. Today octaplas® is sold in all these countries with an average market share of almost 25% (170,000 bags per year). Based on the approval of the process variation to octaplas®, Octapharma assumes to reach at least a 50% market share in these countries by 2013, with approximately 350,000 bags sold annually. Together with the upcoming launch of octaplas® in Canada and a growing positive interest in this product in other European countries outside the MRP, there is a need for a significant increase in the production capacity of octaplas(LG)® as well. Therefore Octapharma is equally happy to announce that the new octaplas(LG)® manufacturing line in Stockholm (Sweden) was simultaneously approved by the same MRP countries. This means that the long-term planning by the Octapharma Board of Directors and € 15 million investments finally materialised into both an add-on and back-up facility to the Vienna (Austria) plant, which has served as the sole production facility for octaplas(LG)® for almost 20 years. “The approval of the prion safeguarding variation for octaplas® is a major milestone achievement for our company.” says the Chairman Wolfgang Marguerre. “This success results from a planned life-cycle management in line with our company’s long-term commitment to provide plasma-derived products with an utmost safety profile to patients worldwide.” “Due to an increasing demand for octaplas(LG)® worldwide, we needed to strengthen our manufacturing capacity, both in terms of add-on production and back-up to our facility in Vienna,” says the General Manager of Octapharma AB (Stockholm) Tobias Marguerre. “Our substantial investments and efforts into getting the Stockholm octaplas(LG)® plant approved will ensure a steady product supply for our large number of customers – both current and future users of our unique therapeutic plasma.” Octapharma plans to submit a Biological License Application (BLA) for octaplasLG® to the Food and Drug Administration (FDA) before the end of this year, as well as an update of the Canadian license in line with the now approved variation in Europe. “The Canadian and US market accounts for almost 4.4 million bags of fresh-frozen plasma, of which Octapharma will start to supply just above 10% of the 300,000 bags annual market in Canada in February 2012,” says the President of Octapharma’s US Organisation in Hoboken (NJ) Flemming Nielsen. He further emphasises that “The approval of our Stockholm facility by the European drug authorities is both promising and necessary for the North-American activities around octaplasLG®, as long-term routine manufacturing experience is needed before the upcoming FDA inspection and a broad product launch based on the Vienna facility would not be possible in competition with the increasing number of European customers.”

About variant Creutzfeldt-Jakob disease (vCJD) The pathogenic agent causing the prion disease called vCJD, which is the human form of “mad cow disease”, is apparently able to contaminate various blood and plasma components and has allegedly been transmitted to four recipients of non-leukocyte depleted red blood cell concentrates and one haemophilia patient who was treated with an old generation von Willebrand/factor VIII concentrate. All five patients, of which three died from vCJD, were treated with products derived from UK blood and plasma collected during the critical time period of the mad cow disease epidemic, which did affect the UK more than any country in Europe, roughly 20 years ago. The UK and France are the countries which have been affected the most with the human form of vCJD, with 198 cases until October 2011 – of which 173 subjects are from the UK. About octaplasLG® octaplasLG® is the only pharmaceutically licensed cell-free therapeutic coagulation-active plasma available for the treatment of various deficiencies in coagulation factors and other plasma proteins during treatment of trauma with bleeding, major surgical interventions, liver diseases, rare clotting factor deficiencies for which no other concentrates exist, and therapeutic plasma exchanges in patients suffering from e.g. thrombotic thrombocytopenic purpura (TTP). Through its many favourable features – such as proven safeguarding against any transfusion-relevant pathogen known today, abolished risk for transfusion-related acute lung injury (TRALI), and significantly reduced frequency and severity of allergic reactions – octaplasLG® increases the level of efficacy and security in transfusion medicine, both representing the foundation in all medical care, and reduce health costs. About Octapharma AG 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 albumin, immune globulins, coagulation factor and inhibitors. In addition, Octapharma manufactures octaplas(LG)® since 20 years, a cell-free pharmaceutical quality therapeutic coagulation-active plasma which has been safeguarded through virus inactivation (S/D treatment) and neutralisation of viruses by immune antibodies. Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, and operates four state-of-the-art production facilities, of which two sites are licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com.

Octapharma Reports octagam® 5% and octagam® 10% Global Sales Totaled 1.7 Million Grams Through October With No Thromboembolic Events

Mon, 14 Nov 2011 13:44:00 +0100

LACHEN, Switzerland (November 11, 2011) – Octapharma today reported that global sales totaled 1.7 million grams of octagam® 5% and octagam® 10%, [Immune Globulin Intravenous (Human) Liquid Preparation] in the period January 1 through October 30, 2011, an estimated 60,000 treatments, during which there were no reports of thromboembolic events (TEEs). In August 2010, Octapharma implemented a voluntary market withdrawal of octagam® 5% and octagam® 10% in response to an observed increase of TEEs, which occur when a clot or thrombus forms locally in a blood vessel or breaks loose in the blood stream to occlude another vessel. “Octapharma’s 10-month product analysis confirms our commitment to provide patients with an octagam® 5% and octagam® 10% that offers an enhanced level of safety,” said Octapharma Chairman Wolfgang Marguerre. “Industry-wide, immune globulin products can lead to TEEs in approximately 1 individual or less for every 10,000 treatments. But our analysis indicates that octagam® 5% and octagam® 10% outperformed this industry benchmark with no reported TEEs in approximately 60,000 patient treatments.” The U.S. Food and Drug Administration (FDA) last week cleared the way for the U.S. market return of octagam® 5%. The product is expected to again be available in the U.S. within two weeks. Earlier this year, multiple international regulatory agencies authorized the return of octagam® 5% and octagam® 10% in important worldwide markets. The product is presently approved for distribution in the U.S., Austria, Belgium, Bulgaria, Bosnia, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, and the United Kingdom. octagam® 10% is not approved for marketing in the U.S. The marketing approvals are based on changes Octapharma has made in the octagam® 5% and octagam® 10% manufacturing process and the company’s decision to implement a quality control test on every batch of product that is released to the marketplace for the absence of thrombogenic potential. Additionally, Octapharma will implement post-marketing studies to ensure product safety. Octapharma’s estimate of 60,000 octagam® 5% and octagam® 10% patient treatments is based on the reported global sales of 1.7 million grams, not on actual recorded patient treatment sessions. The number of treatments is based on average patient utilization per treatment. The data has not been submitted to the FDA for evaluation. About octagam® 5% octagam® [Immune Globulin Intravenous (Human) 5% Liquid Preparation] 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. octagam® 5% is an immune globulin intravenous (human 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. About octagam® 10% octagam® 10% is a liquid (100 mg/mL) Immune Globulin (Human) solution for intravenous administration (IVIG) which is currently registered mainly in European countries, where it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. About the Octapharma Group 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. Forward-looking statements 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.

Octapharma Chairman receives prestigious award in Vienna

Thu, 10 Nov 2011 16:31:00 +0100

Wolfgang Marguerre has been honored with the Grand Decoration of Honor in Gold (Grosses Goldenes Ehrenzeichen) for Services to the Republic of Austria. Mr Wolfgang Marguerre was selected for this illustrious award by Federal President of Austria Dr Heinz Fischer. This decoration is granted to individuals who have brought outstanding public benefit to the Republic of Austria. Wolfgang Marguerre joins a prestigious group of individuals similarly honored, from fellow business figures, to political leaders and royalty. Fellow Grand Decoration of Honor winners include: former chairman of the Toyota Motor Corporation, Shoichiro Toyoda; former Secretary-General of the United Nations Kofi Annan; the eminent social and political philosopher Karl Popper, who like Mr Marguerre received the Grand Decoration for Services to the Republic of Austria in Gold; celebrated psychoanalyst and daughter of Sigmund, Anna Freud, as well as countless royalty and heads of state. The award was presented by Austrian Minister for Economic Affairs, Family and Youth, Dr. Reinhold Mitterlehner in a ceremony held at the Marble Hall of the ministry. Around 200 people gathered in the great hall to witness the historic ceremony. The Austrian honors system has celebrated and honored distinguished individuals since 1952. Playing at the ceremony was Vienna’s Kamilarov string Quartet “Das Kamilarov Quartett“. It is fitting that Mr Marguerre is being honored by the republic of Austria in Vienna, the home of the first Octapharma-owned production site. On receiving this distinguished award Mr Marguerre said: “I accept this award on behalf of all my staff in Vienna. Vienna was the first Octapharma site. When this plant first opened in 1990 we employed 60 people, 20 years later we employ 670. Vienna is a very important city for Octapharma. In fact, two out of my three children are moving to Vienna this year.” After the ceremony Mr Marguerre and his family travelled to the Vienna plant to share in celebrations with his employees at a special reception. Vienna Plant History
Octapharma’s Vienna plant is one of the most modern fractionation plants in the world. Located on the southern outskirts of Vienna it was the first plant to manufacture a solvent detergent (SD) treated Factor VIII preparation as well as the first virus-inactivated plasma for infusion. About the Octapharma Group
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 AG 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

FDA Approves U.S. Market Return for octagam® Following Octapharma’s Implementation of Enhanced Safety Measures

Fri, 04 Nov 2011 08:08:00 +0100

Product Expected to Be Available for Distribution in a Few Weeks

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 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.

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.

“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.”

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.

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.

Earlier this year, multiple international regulatory agencies authorized the market return of octagam® 5% and octagam® 10% in worldwide markets.

About octagam®5%

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.

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.

About the Octapharma Group

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.

Forward-looking statements

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.

Clinical Trial of wilate® Focuses on Preventing Surgical Bleeding in Type 3 VWD Patients

Tue, 27 Sep 2011 09:26:00 +0200

HOBOKEN, N.J. and LACHEN, Switzerland (September 26, 2011) - Octapharma, one of the largest human protein products manufacturers in the world, has launched an international multi-center clinical study to investigate the efficacy and safety of wilate® (von Willebrand Factor/Factor VIII Concentrate, Human) in preventing excessive intra- and post-operative bleeding in pediatric and adult patients with Type 3 von Willebrand Disease (VWD) who undergo major surgical procedures.

The prospective, open-label, Phase 3 trial is being conducted at study centers in the U.S., Europe, Asia, and South Africa and recently enrolled its first patient. As the most common inherited bleeding disorder in humans, VWD affects one to two percent of the general population or approximately 3 million people in the United States. VWD is a complex congenital bleeding disorder that is divided into subtypes with Type 3 being the most severe form.

"The study will collect valuable information on this rare VWD patient subset," said Coordinating Investigator Craig Kessler, M.D., Georgetown University Hospital, Professor of Medicine and Pathology and Director of the Division of Coagulation. "Sufficient data is not currently available for Type 3 VWD patients. The research will be invaluable in determining the adequacy of dosing and duration of treatment in this group of patients."

Originally approved in Germany in 2005, wilate® is available in 46 countries worldwide. In December 2009, the U.S. Food and Drug Administration (FDA) granted Octapharma orphan drug exclusivity for wilate®, the first replacement therapy developed specifically for VWD.

wilate® is a plasma-derived, stable, highly purified concentrate of freeze-dried human von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of wilate®, specifically a solvent/detergent (S/D) and terminal dry heat treatment.

For more information on the research, entitled "Clinical Study to Investigate the Efficacy and Safety of Human Factor VWF/VIII Concentrate (wilate®) in Subject with Inherited Type 3 Von Willebrand Disease (VWD) who Undergo Major Surgical Procedures (WONDERS)," please visit www.clinicaltrials.gov. U.S. researchers interested in participating in the study should contact Sylvia Werner, Octapharma Associate Director Clinical Operations - Coagulation, at (201) 604-1149 or sylvia.werner@octapharma.com.

About the Octapharma Group
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 27 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 disorders of the immune system, and Octapharma's Albumin (human) is indicated for the restoration and maintenance of circulating blood volume.

Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment 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.

Forward-looking statements
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.

Octapharma is pleased to announce that the Therapeutic Goods Administration in Australia has, on 4 August 2011, approved octagam® (normal immunoglobulin) for resupply in Australia

Tue, 16 Aug 2011 09:07:00 +0200

This is the result of excellent work by various departments within the company. We were able to identify and conclusively show FXIa to be the root cause of the unexpected increase in the occurrence of thromboembolic events observed in our routine pharmacovigilance activities in the 3rd quarter of 2010. Other causes were excluded by extensive R&D work in full cooperation with the regulatory authorities. We were able to eliminate the excess FXIa levels in octagam® by implementing various changes in the manufacturing process.In addition to the manufacturing changes, an additional finished product test has now been introduced that provides further information on the thrombogenic potential of batches. The approved octagam® Product Information has also been updated to include further cautionary information regarding the risk factors for TEEs, the types of TEEs reported with octagam®, advice on monitoring patients and more general information on the types of adverse drug reactions reported during post-marketing.

Please review the Product Information before prescribing.* A prospective study of the tolerability of octagam® will be provided through upcoming non-interventional post-marketing studies.. Octapharma remains committed to providing our patients with the best possible IVIG preparation and consequently intends to manufacture octagam according to the latest state of research in plasma fractionation. Octapharma’s decisive, responsible, and immediate steps which were taken in 2010 to voluntarily withdraw octagam® from the Australian market were taken in the interest of patient safety. Octapharma believes that this is the best way to retain the trust and confidence in our products. Octapharma began supplying octagam® to Australian patients in 2005, when clinical demand for IVIg began to increase and domestic Australian sourced IVIg was insufficient to meet this demand. Since this time, Octapharma has supplied more than 1.5 million grams of octagam® and in so doing, have built up considerable trust and confidence in the product.
Octapharma looks forward to once again working with the National Blood Authority, the Australian Red Cross Blood Service, as well as clinicians and patient groups and all other stakeholders, in supplying octagam®, for the benefit of Australian patients and continuing the long track record which has been established since 2005. About Octapharma Octapharma AG is headquartered in Lachen, Switzerland and is an independent, global provider of pharmaceutical human proteins for life-threatening diseases. Its core business is the development, production and sale of high quality human proteins including plasma derivatives and recombinant products. The company was founded in 1983 and since then has grown to over 4,000 employees. Today it has 38 subsidiaries and representative offices in over 80 countries with state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.
Contact details of Octapharma Australia: Octapharma Australia Pty. Ltd
Jones Bay Wharf
42/26-32 Pirrama Road
Pyrmont NSW 2009
Tel. +61 2 857 25 800
Fax +61 2 857 25 890 * Please note changes in the Product Information

Please click here to find the octagam® Product Information Please click here to find the Consumer Medicine Information

European Commission adopts European Medicines Agency's (EMA) recommendation to lift the suspension of the marketing authorization of octagam® and octagam®10%.

Tue, 31 May 2011 13:25:00 +0200

On 30 May 2011 The European Commission adopted the EMA's recommendation of 14 April 2011 revised on May 12, 2011 to lift the suspension of the marketing authorization of octagam® and octagam®10%, thus allowing both products back on the European markets. On 14 April 2011 revised on May 12, 2011 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended to lift the EU-wide suspension of the marketing authorizations of both octagam® and octagam®10% which has been in place since October 4,2010. This recommendation was based on the safeguards and an action implemented by Octapharma and is subject to certain conditions. In addition to amending the manufacturing process, Octapharma has introduced a new quality control test for Octagam. This thrombin generation assay, able to reveal any thromboembolic potential of a medicinal product, is carried out on every batch to be released for the market. Additionally, post-marketing studies will be conducted in order to confirm the expected tolerability profile of Octagam subsequent to these safety measures.
Octapharma was and is committed to provide their stakeholders with a family of IVIG preparations that offers the best possible value to patients and healthcare professionals and consequently manufactures octagam® and octagam® 10% according to the latest state of research in plasma fractionation. The long term experience with the use of octagam® over 17 years and octagam®10% in over two years in the EU confirms the brand characteristics in terms of quality and tolerability.

About octagam® octagam® is a liquid, 5% (50 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered in about 60 countries, including the USA and the EU. In the EU and other countries it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. About octagam®10%:
octagam®10% is a liquid, 10% (100 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered mainly in European countries, where it is indicated for the use in: primary humoral immunodeficiency (PI); myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; in children with congenital AIDS who have repeated bacterial infections; immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. octagam®10% is the 10% version of octagam® (50 mg/mL) which was first launched in 1995.

About Octapharma Octapharma AG is headquartered in Lachen, Switzerland and is an independent, global provider of pharmaceutical human proteins for life-threatening diseases. Its core business is the development, production and sale of high quality human proteins including plasma derivatives and recombinant products. The company was founded in 1983 and since then has grown to over 4,000 employees. Today it has 38 subsidiaries and representative offices in over 80 countries with state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.