Covance fully complies with FDA revisions to iPLEDGE
WASHINGTON The Food and Drug Administration announced that Covance, the developer of the iPLEDGE risk management program has fully implemented the program revisions approved by the FDA on Oct. 3.
The program is designed to reduce the risk of fetal exposure to isotretinoin, or Accutane, a drug used to treat severe recalcitrant nodular acne. Those changes include eliminating the 23-day lockout period, a period when new prescriptions cannot be filled, for females of childbearing potential, with the exception of the first prescription to be filled. Changes to the iPLEDGE program, which were proposed by the FDA, Covance and the manufacturers of isotretinoin, were subsequently endorsed at a joint meeting of the Dermatologic and Ophthalmic Drugs and the Drug Safety and Risk Management Advisory Committees on Aug. 1.
In October 2006, the 23-day lockout for males and females of non-childbearing potential was removed. Previously, all patients prescribed isotretinoin had to fill their prescription within 7 days of their office visit. Patients who missed this window of opportunity and attempted to fill their prescription after 7 days had elapsed could not receive isotretinoin for another 23 days.
Other changes to the program that were approved include linkage of the 7-day prescription window for females of childbearing potential to the date of pregnancy testing rather than the date of the office visit, and extension of the prescription window from 7 days to 30 days for males and females not of childbearing potential.
Isotretinoin and its generic equivalents are approved by the FDA for the treatment of severe recalcitrant nodular acne. This type of acne does not respond to other drug treatments. The iPLEDGE program was implemented on March 1, 2006, to minimize fetal exposure to the drug while providing a system to closely monitor patients taking the medication and their access to the drug. The monitoring system is further supported by trained prescribers, pharmacists and other health care providers
Wyeth and GSK may see competition in pediatric vaccines
LONDON There may be a clash of the titans underway.
Pharma giants Wyeth and GlaxoSmithKline are set to go head to head with their competing childhood vaccines, but Wyeth dismissed any worries about the newcomer to the vaccine playground.
Wyeth’s Prevnar will remain a key sales driver for the company but would not be hindered by Glaxo’s Synflorix, said Emilio Emini, the U.S. group’s head of vaccine research and development, on Tuesday.
Prevnar, a vaccine for infants and children to prevent certain invasive pneumococcal diseases, is active against seven types of streptococcus pneumonia, which together account for some 80 percent of illnesses, Reuters reported Tuesday.
Glaxo’s Synflorix, which a company spokeswoman said remained on track for submission to European regulators by the end of 2007, targets 10 types, and even prevents inflammation of the middle ear.
But Emini said Synflorix was incomparable to the new version of Prevnar.
“Essentially, it is a direct equivalent of the original Prevnar,” he said in an interview with Reuters on the sidelines of the FT Global Pharmaceutical and Biotechnology Conference. “If you look at the residual 20 percent of disease (not addressed by Prevnar) and ask how much is covered by the GSK 10-valent vaccine, it’s actually a small percentage. How much is covered by Prevnar-13? It’s over 60 percent,” Emini said.
Wyeth intends to submit a new version of Prevnar, active against 13 strains, to both European and U.S. regulators by the beginning of 2009.
The original version of the vaccine was introduced in 2000. Third-quarter sales of Prevnar were up 24 percent from a year earlier at $634 million.
Biomira to make move to U.S. under new name
EDMONTON, Canada Biomira shareholders have approved a plan to move the company to the U.S. and to change its name to Oncothyreon Incorporated. Oncothyreon will be the parent corporation of a successor company of Biomira and its subsidiaries, according to Canada.com.
The biotech company, which focuses on cancer treatment, currently has a few drugs in its pipeline including Stimuvax, which it is developing with Merck to treat non-small cell lung cancer. That drug is currently in a Phase III clinical trial. The next drug that is furthest along in development is a small molecule called PX-12, which is a drug used to treat pancreatic cancer and is currently in a Phase II trial.
“We are very pleased to have received the strong support of our shareholders for our relocation and the revision of our capital structure,” chief executive officer Robert Kirkland said. The shareholders will receive one-sixth of a share of common stock of Oncothyreon in exchange for each Biomira share. The new company will be based in Seattle.