Status: marketed internationally; FDA filing expected

Organizations involved:

Omrix Biopharmaceuticals Inc. – Manuf.; R&D; Tech.; Intl. mark

FFF Enterprises, Inc. – USA mark.

New York Blood Center – Tech.

Cross ref: See the Immune Globulin Products entry (#743) and the entries for other IGIV products.

Description: Omr-IgG-am is a highly purified IVIG solution containing over 95% IgG and only small traces of IgA. Two virus removal and/or inactivation steps ensure safety - solvent/detergent viral inactivation and nanofiltration at pH 4. Omr-IgG-am does not contain sucrose or human albumin. Omrix claims, “The physiological distribution of the IgG subclass is maintained due to a highly effective production process.” Blood used for manufacture of Omr-IgG-am is collected from donors in Israel.

Internationally, Omr-IgG-am 5% IV is available in 2.5 gr (50 mL), 5 gr (100mL) and 10 gr (200 mL) intravenous solutions, and is a ready-to-use liquid preparation that can be stored at room temperature.

Nomenclature: Immune Globulin (IGIV)/Omr-IgG-am [BIO]; Omr-IgG-am [TR]; Immune Globulin Intravenous (Human) [FDA]; gamma globulin [SY]; immune globulin, intravenous [SY]; intravenous immune globulin (IVIG) [SY]; IGIV [SY]

Companies.: Omr-IgG-am was developed and is manufactured and marketed internationally, primarily in Israel, by Omrix Biopharmaceuticals Inc., CBER/FDA est. est. no. 1603. Omr-IgG-am is manufactured at Omrix facilities in Ramat Gan (Jerusalem), Israel.

FFF Enterprises, Inc. has exclusive rights for U.S. marketing for five years after U.S. approval.

FDA class: Biologics BLA

Indications: [in Israel]

Omr-IgG-am is indicated for use in: primary immune deficiency (PID), idiopathic thrombocytopenic purpura (ITP) and chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infection. [Omrix also notes, “As for other IVIG products, Omr-IgG-am is used (off label use) in the treatment of many immune disorders such as: Kawasaki syndrome; bone marrow transplantation (BMT); pediatric HIV infection; as well as in many autoimmune and neurological autoimmune diseases.”

Status: The product is marketed in Israel, and is also apparently available in many other countries, although it may have only received approval in Israel.

A BLA for U.S. approval for primary immunodeficiency treatment is expected after completion of an ongoing U.S. Phase III trial.

Tech. transfer: Solvent detergent viral inactivation was developed by and nonexclusively licensed from the New York Blood Center, e.g., see U.S. patent 4,820,805. See the entry for Pooled Plasma, Solvent Detergent Treated (SD Plasma) (#799) for further information about solvent detergent viral inactivation, used primarily for inactivation of enveloped viruses (e.g., HIV, hepatitis B and C viruses).

Trials: In fall 2006, FFF Enterprises initiated a U.S. Phase III open label, single arm, multi-center trial with Omr-IgG-am for treatment of primary immune deficiency. The trial will determine, on the basis of historical data, whether the product is equivalent to IGIV products currently approved for primary immune deficiency.

Market: Total sales were about $10 million in 2005 and $9 million in 2004.

Ongoing: The National Institute of Allergy and Infectious Diseases (NIAID), NIH, has been conducting studies with Omr-IgG-am for treatment of West Nile virus (WNV) infection. In Israel, West Nile infections are common enough that a large percentage of residents are exposed in childhood, when they are likely to avoid serious illness and develop antibodies to the virus.