BOCA RATON, Fla., Aug. 29 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced that it has obtained the exclusive rights to use a novel hyperimmune immunoglobulin extraction technology from ProMetic Life Sciences Inc., a global biopharmaceutical company based in Montreal, Canada, in the manufacture of certain of Nabi Biopharmaceuticals’ pipeline hyperimmune products. Access to this technology is expected to provide higher yields of Nabi Biopharmaceuticals’ Civacir(R) [Hepatitis C Immune Globulin (Human)] and Altastaph(R) [Staphylococcus aureus Immune Globulin Intravenous (Human)]. Nabi Biopharmaceuticals also has an option to use the technology with its marketed product, Nabi-HB(R) [Hepatitis B Immune Globulin (Human)] and Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous], as well as additional product candidates.
The agreement combines ProMetic’s patented plasma proteins purification technology with Nabi Biopharmaceuticals’ expertise in the large-scale development and manufacture of hyperimmune products. Nabi Biopharmaceuticals expects to achieve a number of benefits through the utilization of ProMetic’s technology, including a more efficient manufacturing process and higher product margins.
“The advantage of the ProMetic technology is that it affords Nabi Biopharmaceuticals the ability to maximize the yield of specific immunoglobulins from a liter of hyperimmune plasma, and, as a result, reduces the cost of manufacturing and increases the capacity for production of some its most promising product candidates,” stated Raafat Fahim, Ph.D., senior vice president research, technical and production operations, Nabi Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, “This agreement exemplifies our commitment to maximizing Nabi Biopharmaceuticals’ core competencies and assets, including our plasma collection centers and manufacturing facility. We look forward to continuing to advance our hyperimmune product candidates, which we believe hold strong commercial promise and for which there is a clear clinical need.”
About the Agreement
Under the terms of the agreement, Nabi Biopharmaceuticals obtains the exclusive worldwide rights to use ProMetic’s plasma fractionation technology in the development of several of Nabi Biopharmaceuticals’ hyperimmune product candidates, including Civacir and Altastaph. In addition, Nabi Biopharmaceuticals obtains an option for the exclusive North American rights to this technology for use with Nabi-HB and in the development of Nabi-HB Intravenous and certain possible product candidates.
Pierre Laurin, ProMetic’s chief executive officer and president, stated, “We are pleased to partner with one of the world’s leaders in the field of blood-derived products. Nabi HB has over 85 percent of the anti-hepatitis B immunoglobulin U.S. market for the prevention of hepatitis B re-infection in hepatitis B-positive liver transplant patients. We are looking forward to helping, through our technology, in the treatment of diseases for which there are few options available. We expect our Mimetic Ligand(TM) technology will allow Nabi Biopharmaceuticals to obtain higher recovery yields of specific hyperimmunes from plasma.”
Nabi Biopharmaceuticals has previously assessed ProMetic’s fractionation technology on a pilot scale, which supports its belief that the licensed technology can be used with larger-scale manufacturing operations. These activities are aligned with the company’s clinical development strategy, which includes conducting “proof-of-concept” studies to best inform and establish optimal Phase III programs.
About Civacir
Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi Biopharmaceuticals announced that Civacir had been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir has also gained Orphan Medicinal Product (OMP) designation in Europe. If a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10-year market exclusivity, thereby preventing a similar drug from receiving authorization for the same indication during this period. Civacir also has Orphan Drug Status in the United States. This provides a seven-year period of market exclusivity in the United States when the product is approved.
About Altastaph
Altastaph is an investigational human antibody-based product containing antigens to S. aureus types 5, 8 and 336 and may provide protection against S. epidermidis. Altastaph is being developed as a treatment for patients with persistent S. aureus and S. epidermidis infections and those who do not optimally respond to an antibiotic; a prophylaxis for patients (e.g. ICU patients; emergency surgery patients; and neonates) who are at risk for S. epidermidis and S. aureus infections; and a combination antibody and vaccine regimen designed to prevent recurrence of these infections in hospital patients.
About Nabi-HB Intravenous
Nabi-HB Intravenous is designed to prevent the re-infection of hepatitis B disease in HBV-positive liver transplant patients. Nabi Biopharmaceuticals filed a BLA with the U.S. Food and Drug Administration (FDA) for this intravenous formulation of their marketed product, Nabi-HB. If approved, this formulation would be the only product available in the U.S. indicated for the protection of the transplanted liver from HBV infection in HBV-positive liver transplant patients. The drug has received Orphan Drug Status in the United States and the BLA has been granted expedited review by the FDA.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in its core business areas: hepatitis and transplant, kidney disease (nephrology), Gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit Nabi’s website: http://www.nabi.com.
About ProMetic Life Sciences
ProMetic Life Sciences Inc. is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) enabling technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of inflammation and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic “drug-like” protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D and manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and MENA countries (Middle East and North Africa).
Forward-Looking Statement
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our products in development, the market for such products, and regulatory approval of our product candidates. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company’s ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended July 1, 2006 filed with the Securities and Exchange Commission.
Nabi Biopharmaceuticals
CONTACT: Thomas E. Rathjen, Vice President, Investor Relations of NabiBiopharmaceuticals, +1-561-989-5800
Web site: http://www.nabi.com//
