Pfizer, Sigma-Tau announce agreement to market malaria drug
NEW YORK Two drug makers—one American and one Italian—announced a license and supply agreement Tuesday under which they will market a new treatment for malaria in Africa.
Pfizer and Sigma-Tau Industrie Farmaceutiche Riunite said that pending regulatory submissions and approvals, they will market the drug, Eurartesim (dihydroartemisinin and piperaquine), which they describe as a novel, fixed-dose artimisinin-based combination therapy. The drug, which Sigma-Tau developed with Medicines for Malaria Venture, is in phase 3 clinical trials, and the companies expect to file for regulatory approval with the Food and Drug Administration next year.
The World Health Organization recommends that all uncomplicated malaria be treated with ACTs to reduce drug resistance. The organization estimates that 881,000 people died of malaria in 2006, with more than 90 percent of those deaths occurring in Africa.
“Pfizer is excited about our collaboration with Sigma-Tau,” Pfizer president and general manager for emerging markets Jean-Michel Halfon said in a statement. “The effective treatment of malaria, a preventable and treatable disease, is an essential need for patients in many countries in Africa and around the world.”
FDA grants orphan drug status to two non-Hodgkin’s lymphoma drugs
AMSTERDAM, Netherlands The Food and Drug Administration has granted orphan drug designations to Kiadis Pharma’s drug Reviroc for two types of non-Hodgkin’s lymphoma, Kiadis announced Monday.
The FDA granted one designation for diffuse large B-cell lymphoma and one for follicular lymphoma. The drug is under development for the elimination of cancer cells from an autologous graft in bone marrow transplants for end-stage blood cancer patients.
“This is an important strategic milestone in the development of Reviroc, and we are very pleased with the orphan drug designations received from the FDA,” Kiadis chief executive officer Manja Bouman said in a statement.
The FDA gives orphan drug designations to drugs developed for treating diseases and conditions affecting fewer than 200,000 people in the United States. The designation allows for accelerated review, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after regulatory approval.
FDA approves Boostrix vaccine for use in adults
NEW YORK The Food and Drug Administration has approved a booster vaccine for use in adults, manufacturer GlaxoSmithKline announced Monday.
GSK developed the vaccine, Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed), for use in patients aged 10 to 18 as a protection against tetanus, diphtheria and whooping cough; the FDA’s new approval allows for its use in patients aged 19 to 64 as well.
The new approval follows two clinical trials of 3,000 adult patients.
Sanofi-Aventis makes a similar vaccine, Adacel, for use in patients aged 11 to 64.