Nabi Biopharmaceuticals 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 [Hepatitis C Immune Globulin (Human)] and Altastaph [Staphylococcus aureus Immune Globulin Intravenous (Human)]. Nabi Biopharmaceuticals also has an option to use the technology with its marketed product, Nabi-HB [Hepatitis B Immune Globulin (Human)] and Nabi-HB Intravenous [Hepatitis B Immune Globulin (Human) Intravenous], as well as additional product candidates, a Nabi press release stated.
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.
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.
"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."
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 per cent of the anti-hepatitis B immunoglobulin US 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 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.
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.
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.