Carl June and the Novartis/Penn team weren't the only players to grab the spotlight at the global gathering of hematology experts at the big American Society of Hematology meeting in New Orleans. Several companies touted new data for their therapies over the weekend, and FierceBiotech focused on a roundup of the news related to some top contenders in the field.
The FDA late Friday approved Sovaldi, a highly anticipated hepatitis C drug from Gilead Sciences that is expected to change the face of treatment for the difficult condition while earning up to $7 billion a year for the company.
The FDA has stamped its approval on sofosbuvir for hepatitis C, perhaps one of the most anticipated new drugs of the year. Gilead's therapy, which will be marketed as Sovaldi, will open the door to a new generation of treatments that don't require interferon--freeing patients from an arduous regimen tied to a host of nasty side effects.
As Gilead nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, most recently Idenix Pharmaceuticals, which claims the blockbuster hopeful infringes on its patents.
Gilead Sciences' new hepatitis C drug sofosbuvir won preliminary backing from European regulators on Friday, with marketing approval expected to follow soon. The FDA is expected to clear the drug for take-off Dec. 8, if not sooner. All good for the California-based drugmaker. But there's a battle over sofosbuvir brewing in India.
Gilead Sciences is sprinting toward FDA approval with the promising idelalisib, a targeted cancer therapy that met all its Phase III endpoints, giving the company another boost in the competitive landscape for chronic lymphocytic leukemia treatments.
Gilead Sciences is preparing to meet demand for its highly anticipated investigational hep C drug sofosbuvir with a $47 million expansion of its plant in Canada that is manufacturing the drug in anticipation of its commercial launch.
Ahead of Friday's advisory panel meeting, the agency's staff highlighted sofosbuvir's all-oral treatment approach, with faster cures and fewer side effects than older meds.
Gilead's sofosbuvir appears headed for a quick if not early approval from the FDA, which would set it firmly on a path to a megablockbuster market, with a wide variety of analysts estimating peak annual sales at $5 billion-plus.
J&J and its partner Medivir earned a positive internal review at the FDA for simeprevir. But a substantial subpopulation of patients infected with a particular polymorphism variant likely won't benefit, leaving that field open to some big rivals contending for near-term approvals.