GPhA: Banning patent settlements will cost money, not save it
WASHINGTON The main lobbying group for the generic drug industry said federal authorities erred in projecting savings from a proposed ban on patent litigation settlements between branded and generic drug companies.
The Generic Pharmaceutical Association said the Federal Trade Commission and the Congressional Budget Office used faulty assumptions to support legislation against the settlements, based on an analysis led by former Clinton administration official Jonathan Orszag.
“Making drug patent litigation settlements presumptively unlawful will cost, not save, money for the government and consumers,” a statement by the GPhA read. “There are no examples of patent settlements that have delayed generic market entry beyond the date of the patent expiration. But there are many examples of settlements that have proven to be pro-competitive and pro-consumer by making lower-cost generics available months and even years before patents have expired.”
In many such lawsuits, a generic drug company will file for regulatory approval of its version of a branded drug before patent expiration. In response, the branded drug company will file a patent infringement lawsuit, placing a stay on Food and Drug Administration approval of the generic. Often, the two companies will reach a settlement whereby the generic company will agree to hold off launching its version of the drug in exchange for “payment” from the branded drug company, usually in the form of the branded drug company agreeing not to launch an “authorized generic” –– essentially the branded drug marketed under its generic name at a discount –– to compete with the generic.
Critics of the deals have derided them as “pay-for-delay” deals, though by law, the generic drug maker is forbidden from delaying launch beyond patent expiration, and launch often occurs ahead of expiration.
Curemark gets nod to start late-stage trial for ADHD drug
RYE, N.Y. The Food and Drug Administration has approved a late-stage clinical trial of a drug for attention deficit hyperactivity disorder.
Curemark said the FDA cleared its application to run a phase 3 trial of CM-4612 in patients with ADHD. The company is currently conducting a phase 3 trial of CM-AT, a treatment for autism in children.
“We are very excited to have received [clearance] from the FDA so that we can move forward with clinical trials to study CM-4612,” Curemark CEO Joan Fallon said. “Curemark hopes to have the first physiologically based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments.”
FDA approves additional dosage for NovoSeven RT
PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.
The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.
NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.