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Favorable Orphan Medicinal Product Status Granted for Altastaph in Europe
OMP designation is reserved for medicines being developed for rare diseases. Orphan medicinal products are used to diagnose, prevent or treat life-threatening or very serious conditions that generally affect no more than five people out of every 10,000 people in the European Union.
The OMP designation will result in reduced Marketing Authorization Application (MAA) fees, free access to scientific advice from the European Medicines Agency (EMEA) and other potential research and development incentives. Further, if a product with an OMP designation is first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10-year market exclusivity, barring a similar drug from receiving authorization for the same indication during this period.
"The OMP designation marks another important step in advancing our comprehensive combination approach to treating and preventing S. aureus infections with Altastaph and StaphVAX," said Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.
Dr. Rasmussen continued, "We are particularly pleased about getting this designation because it acknowledges the persistent increase of staph infections on the European continent. Together with Altastaph's Fast Track designation in the U.S., the OMP status promises to accelerate the drug's development and reduce our development costs."
This is the second recent positive opinion regarding OMP designation for Nabi Biopharmaceuticals product candidates. On June 22, 2005, Nabi Biopharmaceuticals announced that it received the OMP designation for Civacir(TM) [Hepatitis C Immune Globulin (Human)], the company's product candidate for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients.
About S. aureus Infections and Resistance Issues
Worldwide, over 95 percent of patients with S. aureus infections no longer respond to first-line antibiotics, such as penicillin or ampicillin. Methicillin resistance typically symbolizes broad-spectrum resistance to a multitude of antibiotics. In early 2005, a study in The Lancet revealed that the overuse of antibiotics in Spain, Greece, Italy, Portugal and France is causing high rates of antibiotic resistance.
In the U.K., for example, where hospital-acquired infection rates are among the worst in Europe, bloodstream infections resulting from S. aureus are increasing with a 44 percent resistance to methicillin, according to 2004 statistics. Each year, approximately 300,000 people in the U.K., or nine out of every 100 people, who go into hospital, will pick up an infection there. Of these, about 5,000 will die.
Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)] is an investigational human antibody-based product containing high levels of antibodies to capsular polysaccharides (protective outer sugar coatings on S. aureus bacteria) from S. aureus types 5 and 8, which together account for approximately 85% of all S. aureus infections. Altastaph is produced by immunizing healthy volunteers with StaphVAX® [Staphylococcus aureus Polysaccharide Conjugate Vaccine], Nabi Biopharmaceuticals' vaccine being investigated for the prevention of S. aureus infections.
In January 2005, Nabi Biopharmaceuticals announced positive results of its U.S. Phase I/II clinical trial using Altastaph to treat adult in-hospital patients with persistent S. aureus bloodstream infections (bacteremia). This study found a 36% reduction in median time from administration of the study drug to hospital discharge in the Altastaph-treated patients, as compared to the placebo-treated patients (nine days in the Altastaph group versus 14 days in the placebo group). The Altastaph patients were sicker than the placebo group, according to well-accepted and objective clinical parameters. The most frequent study-drug related adverse events were generally mild to moderate fever and chills, which are well-documented adverse events associated with intravenous immune globulin products.
This substantial reduction in the length of hospital stay for the Altastaph-treated group indicates that S. aureus antibodies provided by Altastaph could be associated with considerable medical benefit in the treatment of persistent S. aureus infections.
Altastaph has been designated an orphan drug in the U.S. and has received Fast Track Designation for providing immediate protection against S. aureus infections in low-birth-weight infants. Altastaph is also being developed for prophylactic use to provide short-term, immediate protection to patients who either cannot wait for the vaccine effect to occur or whose immune systems are too compromised to mount an adequate response to a vaccine. Patients in intensive care units and burn units may also benefit from Altastaph in conjunction with standard-of-care therapy, including antibiotic treatment.
Source: Nabi Biopharmaceuticals