Sanofi-Aventis' TB Drug Rifapentine Receives Orphan Drug Status In EU - Update
(RTTNews) - French drug maker Sanofi-Aventis SA (SNY) said Thursday that the European Commission has granted Orphan Drug status for rifapentine for the treatment of tuberculosis or TB.
Rifapentine is a member of the rifamycin class of antibiotics. It is a rifamycin derivative with a higher inhibitory activity against M. tuberculosis and a longer half-life than rifampin. These properties are expected to improve drug exposure and potentially lead to a better efficacy.
Rifapentine's Orphan Drug designation confers several benefits to drug development, including protocol assistance provided by the EMA throughout the drug development process, direct access to the European centralized procedure to register the medicinal product in Europe, reduced fees for filing drug approval and marketing exclusivity in the approved orphan indication for a period of 10 years in the European market.
The EU grants Orphan Drug status to medicines intended for treatment of life-threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people in the European community.
Tuberculosis describes a broad range of clinical illnesses caused by the bacteria Mycobacterium tuberculosis. World's 30% population is infected with M. tuberculosis, and around 9.8 million people develop active disease annually. Of these, 1.7 million die each year.
The Orphan drug status was based on the recommendation that rifapentine-based combination regimen may be of significant clinical benefit for drug-susceptible TB patients by shortening their tuberculosis treatment. This positive opinion was released by the Committee for Orphan Medicinal Products or COMP of the European Medicines Agency or EMA.
Rifapentine is currently marketed in the U.S., commercially known as Priftin, for the treatment of pulmonary and drug-susceptible TB in combination with other anti-TB drugs, within a standard 6-month course. In 2008, 12,904 TB cases, which correspond to a rate of 4.2 cases per 100,000 persons, were reported in the United States.
Sanofi-aventis noted that it is revisiting the development of rifapentine to be given daily, in combination with standard daily companion drugs. This aims to significantly shorten the duration of drug-susceptible TB treatment. This should lead to less premature cessations of treatment, and thus to a reduction of treatment failures, a lesser risk of development of drug-resistance, as well as a reduction of costs, all of which are expected to bring significant benefits to patients and public health systems.
SNY finished Wednesday's regular trade at $30.06, on the NYSE.