Generic drug legislation receives criticism from GPhA
ARLINGTON, Va. Legislation introduced in the House last week and given a hearing Tuesday before the House Subcommittee on Commerce, Trade and Consumer Protection to address reverse payment settlements has drawn criticism from the Generic Pharmaceutical Association.
H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009, would prohibit brand-name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.
The GPhA said that the legislation would limit the options available in the settlement of the patent challenge, thus creating a chilling effect on settlements that could delay the entry of generic drugs into the market.
“The generic pharmaceutical industry has consistently argued that patent litigation settlements between brand and generic pharmaceutical companies are pro-consumer and pro-competitive and have generated billions of dollars in savings for consumers,” GPhA president and CEO Kathleen Jaeger said.
FDA approves fast-track designation for Hodgkin lymphoma treatment
BOTHELL, Wash. An investigational drug for treating Hodgkin lymphoma has received fast-track designation from the Food and Drug Administration, the maker of the drug has announced.
Seattle Genetics, based in the Seattle suburb of Bothell, Wash., said it received the designation for SGN-35, for which it hopes to soon start a phase 2 study.
“Receiving fast-track designation is another important component of our regulatory strategy for SGN-35 and a key step for this program,” Seattle Genetics president and CEO Clay Siegall said. “With our pivotal trial underway, we expect data in 2011.”
That year, Siegall said, the company hopes to file for regulatory approval, possibly launching the drug in 2012. So far, the drug has received orphan drug designation in the United States and Europe for Hodgkin lymphoma and anaplastic large cell lymphoma.
GSK submits study results for HPV, cervical cancer vaccination
PHILADELPHIA British drug maker GlaxoSmithKline has submitted data from a phase 3 efficacy study on a vaccine for human papillomavirus and cervical cancer to the Food and Drug Administration, the company announced Monday.
The drug, Cervarix (human papillomavirus vaccine [Types 16, 18] recombinant, adjuvanted, adsorbed), is designed to prevent HPV types 16 and 18. The study, called HPV-008, enrolled more than 18,600 girls and women aged 15 to 25 from 14 countries in North America, Latin America, Europe and the Asia-Pacific region. Cervarix already has approval in more than 90 countries, including the member countries of the European Union, Mexico, Australia, Singapore and the Philippines.
“We are pleased to have reached this significant milestone for Cervarix,” GSK VP and director North American vaccine development Barbara Howe said in a statement. “The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile.”
Merck & Co. already has FDA approval for its vaccine, Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16, 18]).