Wyeth unveils data from Prevenar 13 vaccine trial
COLLEGEVILLE, Pa. A drug maker developing a vaccine to prevent pneumococcal disease in children said new clinical data could protect against the most common serotypes of the disease.
Wyeth announced Thursday that data from phase 3 trials in Europe showed that Prevenar 13 (pneumococcal polysaccharide conjugate vaccine, 13-valent [adsorbed]) could protect against the 13 most prevalent serotypes associated with the disease, the leading cause of vaccine-preventable death in children younger than 5.
Data from the trials were presented at the 27th annual meeting of the European Society for Pediatric Infectious Diseases. The trials took place in France, Italy, Poland, Spain and the United Kingdom
“Our investigational vaccine, Prevenar 13, builds on the scientific foundation of Prevenar and is designed to provide more comprehensive protection against pneumococcal disease,” Wyeth Pharmaceuticals EVP vaccines research and development Emilio Emini said in a statement. “These new data indicate that Prevenar 13 has the potential to provide direct coverage of the 13 most common disease-causing serotypes, including 3, 6A and 19A, which have been increasing in prevalence in many regions around the world.
The vaccine is designed to protect against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Senate to vote on drug importation measure
WASHINGTON U.S. Sen. Byron Dorgan, D-N.D., has dropped his proposal to add the importation of cheaper medicines from other countries to a tobacco legislation.
Dorgan claims that under the amendment, the Food and Drug Administration would be given the power to oversee packaging, marketing and manufacturing of cigarettes and other tobacco products, Reuters reported. Additionally, U.S.-licensed pharmacies and drug wholesalers would also be allowed to import FDA-approved medicines from Canada, Europe and a few other areas for cheaper prices.
The Senate will consider the drug issue separately, Reuters said.
President Barack Obama has asked Congress for $5 million for the FDA to get started. Despite presidental backing, drugmakers are unhappy with Dorgan’s bill, claiming that with importation comes the risk for counterfeit drugs.
The tobacco bill passed the Senate on Monday with a 61-30 vote and proceeds to legislation later this week.
KV Pharmaceuticals, Purdue Pharma settle OxyContin dispute
ST. LOUIS A generic drug company has settled a dispute with a branded drug company concerning the painkiller OxyContin.
St. Louis-based KV Pharmaceutical Co. announced Tuesday that it had entered a settlement agreement with Stamford, Conn.-based Purdue Pharma in a patent infringement lawsuit that Purdue filed against KV.
Under the terms of the agreement, KV agreed that Purdue’s patents for OxyContin (oxycodone hydrochloride) are valid, enforceable and infringed. In exchange, Purdue granted KV limited rights to sell generic controlled-release oxycodone hydrochloride tablets in the United States for an unspecified period of time.