FDA approves Caraco’s generic Norvasc
SAN FRANCISO The Food and Drug Administration has granted final approval to Caraco Pharmaceutical Laboratories for its generic version of Pifzer’s hypertension drug Norvasc.
The company has been approved to manufacture all strengths of the drug, which include 2.5 mg, 5 mg and 10mg tablets.
Brand Norvasc had U.S. sales of about $2.7 billion for the year ending Dec. 31, 2006, according to IMS Health.
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.