King of Prussia, PA — 21 February 2013

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size forPrivigen®, immune globulin intravenous [human]. The new vial size will simplify preparation and administration of the product when high volumes of it are required. Privigen is approved for the treatment of patients with primary immunodeficiency (PID), a group of rare and serious diseases of the immune system, and provides effective protection against infection by assisting the body in maintaining a normal level of immunoglobulin. Privigen is also approved in the United States for chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. With the addition of the 40 g vial, Privigen will be available in four sizes in the United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The first supply of Privigen in this new vial size will be introduced in June.

“CSL Behring strives to bring new innovations to the healthcare marketplace and deliver products that enhance the patient experience,” said Val Romberg, Senior Vice President, Research and Development. “The 40 gram vial size for Privigen continues that commitment by reducing the complexity of administration and increasing time savings for healthcare providers.”

Privigen can be administered through pooled infusion using intravenous (IV) bags or through individual vial infusion – hung separately from the IV line. Patients who are administered Privigen are dosed based on body weight. For patients who require high doses of Privigen, the 40 g vial size of Privigen will reduce the required number of individual vial infusions or the need to pool multiple vials for an IV bag infusion.

About Privigen®
Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. In the US, Privigen is indicated as replacement therapy for patients with primary immunodeficiency (PI) associated with defects in humoralimmunity.Privigen is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).

WARNING: Use of Immune Globulin Intravenous (IVIg) products, particularly those containing sucrose, have been associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. Privigen does not contain sucrose. Administer Privigen at minimum rate practicable in patients at risk of renal dysfunction or acute renal failure. At-risk patients include those with preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; over 65 years of age; or receiving known nephrotoxic drugs. See full prescribing information for complete boxed warning.

Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.

Privigen is derived from human plasma. The risk of virus transmission cannot be completely eliminated.

In clinical studies of patients being treated with Privigen for PI, the most serious adverse reaction was hypersensitivity (one subject) Adverse reactions observed in >5% of subjects with PI were headache, pain, nausea, fatigue, chills, vomiting, joint swelling/effusion, pyrexia, and urticaria.

For more information about Privigen, including full prescribing information, visit http://www.Privigen.com/Privigen-pi-Privigen-prescribing-information.aspx.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. For more information, visit www.cslbehring.com. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.

Biotest Pharmaceuticals announced that its Bivigam [Immune Globulin Intravenous (Human), 10% Liquid] has had its first commercial sales and successful shipments into the pharmaceuticals distribution channel for physicians, pharmacists and hospitals’ use throughout the United States.

The drug is available for patients with Primary Humoral Immunodeficiency (PI). According to the company, significant investments in its infrastructure and its ability to efficiently manufacture and deliver the product have been made in order to best serve the US market and patient population.  The company invested over$50 million to enhance the capacity of its protein purification facility in Boca Raton, Florida. Additionally, the company has developed and set up a comprehensive logistics operation as an added value for its customers.

Bivigam was approved by the US Food and Drug Administration (FDA) on December 19, 2012 and is available in 50 mL and 100 mL vials. It is a sugar-free, glycine stabilized intravenous immune globulin.

“The US Food and Drug Administration’s (FDA) approval and first commercial sales of BIVIGAM are key corporate milestones for Biotest. The expansion and enhancement of our manufacturing capabilities have positioned us strongly to meet current and future patient and market demand,” Jordan Siegel, Chief Executive Officer of Biotest Pharmaceuticals Corporation (BPC) said in a statement. “We are committed to supporting PI patients with BIVIGAM to ensure their uncompromised living.”

According to the Immune Deficiency Foundation (IDF), primary immunodeficiency diseases occur in people who are born with an immune system that is either absent or hampered in its ability to function.  It is a hereditary or genetic disease that can affect anyone, and cause infections, such as the common cold, to cause serious damage.

Biotest provides pharmaceutical and biotherapeutic drugs. The company specializes in the areas of application of clinical immunology, hematology, and intensive medicine.

 

Source: Biotest Pharmaceuticals Corporation; Immune Deficiency Foundation

Last Updated: 2/4/13; 11:40AM EST

The Immune Deficiency Foundation (IDF) announced yesterday that President Obama signed into law the Medicare IVIG Access Act (HR 1845).

HR 1845 provides for a demonstration project to explore benefits of providing coverage and payment for items and services in order for patients with primary immunodeficiency diseases (PIDD) to administer intravenous immunoglobulin (IVIG) in the home. Under a provision in Medicare law, a patient with PIDD is able to receive home infusions of IVIG under Medicare Part B, but prior to enactment of this new law, Medicare is only able to cover the drug and not the costs associated with the infusion of IVIG in a patient at home, eliminating any benefit and effectively denying IVIG home infusions.

“As a leading provider of IVIG to primary immunodeficiency patients nationwide, we are pleased that President Obama signed HR 1845, the Medicare IVIG Access into law. This act will significantly expand access and overage of IVIG for Medicare beneficiaries,” Hetty Lima, RPh, FASHP, Vice President for Specialty Infusion & Rare Diseases at Diplomat Specialty Pharmacy, Flint, Michigan told Specialty Pharma Journal.

Regular treatment is very important to PIDD patients, since common illnesses like the cold can put these individuals at a risk for infection or more serious complications. Before being signed into law by the President, HR 1845 passed in the US House of Representatives by a margin of 401-3, and then passed unanimously by the Senate.

“We are so grateful of the work done by Congress to pass this legislation,” Marcia Boyle, IDF President and Founder said in a news release. “After so many years of working on this issue, finally Medicare beneficiaries with primary immunodeficiency diseases will be able to access IVIG in the home.”

With expressions of enthusiasm came questions and concerns. Amy Clarke, RN, Diplomat’s Clinical Nurse Program Manager indicated that the new act raises some additional issues that require further clarification, such as if the existing diagnosis criteria for coverage of the IVIG will remain the same. IVIG is indicated for several other uses that current Medicare guidelines do not include in the current coverage guidelines.

“IVIG should be infused by a clinician who understands how to appropriately titrate the delivery and manage both adverse reactions as well as potential anaphylaxis. As IVIG is currently provided by specialty infusion pharmacies, many of these do not have Medicare certification under nursing as they address a national scope. The appropriate training and credentialing of nurses infusing IVIG needs to be a major focus. This would help to ensure the safe home infusion of IVIG as more Medicare patients will now have access to IVIG. The Medicare certified agencies do not see IVIG patients as a core part of their patient population. This puts the onus of educating these agencies on the specialty pharmacy if the ability to utilize clinicians who specialize in IgG therapy is not an option,” Clarke commented.

According to IDF, there are approximately 250,000 people diagnosed with PIDD in the US. Patients with primary immunodeficiency patients are born with an immune system that is either absent or poorly functioning.

Source: Immune Deficiency Foundation

Last Updated: 1/11/13; 2:30PM EST

WASHINGTON, Dec. 21, 2012 /PRNewswire-USNewswire/ -- The Immune Deficiency Foundation (IDF), the national patient organization dedicated to improving the lives of persons with primary immunodeficiency diseases (PIDD), is elated to announce that the Medicare IVIG Access Act (HR 1845) has passed in both the U.S. House of Representatives and Senate, allowing the legislation to be signed into law by the President.

In the U.S., there are approximately 250,000 people diagnosed with primary immunodeficiency disease, and thousands more go undetected. Primary immunodeficiency occurs in patients born with an immune system that either is absent or poorly functioning. There are more than 185 different types of PIDD, all caused by hereditary or genetic defects.

Current Medicare law contains a special provision for patients with primary immunodeficiency disease to receive home infusions of intravenous immunoglobulin (IVIG) under Medicare Part B. The Medicare IVIG Access Act, introduced by Representatives Kevin Brady (R-TX) and Doris Matsui (D-CA) in the House with companion legislation introduced by Senators John Kerry (D-MA) and Lamar Alexander (R-TN), responds to a quirk in the law whereby Medicare is only able to pay for the drug but not the costs associated with the infusion of IVIG in a patient at home, thus rendering the benefit useless and effectively denying IVIG home infusions. IDF believes that Medicare patients with PIDD should have the right to access all sites of care, including the right to be infused in the home setting when medically appropriate.

HR 1845 provides for a demonstration project to examine the benefits of providing coverage and payment for items and services necessary to administer IVIG in the home for patients with PIDD. Without treatment, everyday illnesses like the common cold can put these individuals at risk for infection and more serious complications. Fewer than 10,000 Medicare patients with PIDD receive immunoglobulin therapy on a regular basis to replace the antibodies that their bodies do not produce naturally, allowing most to live healthy lives. The Medicare IVIG Access Act was passed by a margin of 401-3 in the U.S. House of Representatives on Wednesday, December 19, 2012. HR 1845 then went to the Senate where it passed on Friday, December 21, 2012.

"We feel very strongly that this legislation is essential to ensure the ability of patients to access their lifesaving treatments in the most appropriate site of care," said Marcia Boyle , IDF President and Founder. "After so many years of working on this issue, finally Medicare beneficiaries with primary immunodeficiency diseases will receive appropriate treatment."

Congressman Brady, a member of House leadership who serves on the House Ways and Means Committee, has been an extraordinary leader in helping patients with PIDD by introducing four IVIG access bills over the past several years and raising the issues of the community throughout the legislative process. Mr. Brady pushed the legislation at the urging of Carole Ann Demaret , the mother of David Vetter , the young Shenandoah, Texas resident who passed away at age 12 after capturing the world's attention while living in a sterile environment at Texas Children's Hospital in Houston, becoming known around the world as the "boy in the bubble."

"I've been inspired by the courage of David Vetter and his mother, Carol Ann Demaret , who as a leader in the Immune Deficiency Foundation helped me understand how dangerous it is to send PIDD patients to hospitals and doctor's offices each month," said Congressman Brady, "For those most at risk, it's important that we continue to make healthcare more affordable and accessible. The bi-partisan support for this bill is a great example of what Congress can accomplish when the needs of patients are our first priority."

Congresswoman Matsui, a member of the House Energy and Commerce Committee, which is one of the key committees with jurisdiction over Medicare legislation, has been a leader on patient access to IVIG in the home for several years.

Senator Kerry holds a senior position in the Senate Finance Committee, the Senate Committee with jurisdiction over the Medicare IVIG Access Act. He has been the lead sponsor of Medicare IVIG Access legislation in the Senate for the past several years, and his leadership in the Senate has been unparalleled.

Senator Alexander is a Member of the Senate Committee on Health, Education, Labor and Pensions and a Ranking Minority Member of the Senate Committee on Rules and Administration. He has been an advocate for the primary immunodeficiency community, introducing several bills to amend the Medicare IVIG Access issue.

For more information, visit http://primaryimmune.org/ivig-reimbursement. To see the video of Congressman Brady's remarks on the House Floor, go to http://primaryimmune.org/2012/12/medicare-ivig-access-act-introduced-on-the-u-s-house-of-representatives-floor

Source: Immune Deficiency Foundation