Australia’s Biota Holdings has produced new documents to support its claim that UK drugs giant GlaxoSmithKline failed to sufficiently promote its oral flu drug Relenza and implemented an ‘exit strategy’ to end support of the treatment.
The accusations were made by Biota in an amended statement of claim with Australia’s Victorian Supreme Court and the company says that, after a two-year review of more than 200,000 GSK documents, it has evidence that its partner “consistently mismanaged its legal obligation” to develop and market Relenza (zanamivir). The treatment is one of only two drugs recommended by the World Health Organisation for global stockpiling to protect against pandemic influenza, including avian flu, but Relenza is way behind Roche’s competitor Tamiflu (oseltamivir) in terms of orders made by governments.
The statement updates a writ Biota filed in May 2004, which sought damages, thought to be in the region of $350 million, for lost royalties to date as well as future losses through the life of Relenza’s patents and the trial has been set for April 1, 2008. The lawsuit states that Relenza was first in a new class of antiviral flu drugs, and was “not known to have the resistance and side-effect issues” afflicting Tamiflu. However soon after Relenza's worldwide launch in 2000, Biota says that GSK “withdrew its support for the product, adopting and implementing an ‘exit strategy’,” with the result that the drug now holds only a small portion of the estimated $2 billion annual global market for antiviral flu drugs.
Biota is entitled to receive a 7% royalty on GSK's sales of Relenza but as a result of “GSK's alleged consistent failures in marketing and promoting the product,” the Australian drugmaker claims that its drug “has been denied its proper place as a major defence for global populations against the threat of influenza pandemic.”
Biota’s chief executive Peter Cook pulled no punches in his criticism of GSK, saying that the firm is guilty of “systematic failure...in key areas of drug development,” which has had “disastrous consequences from our point of view as a junior biotechnology company. This is especially disappointing given the trust that companies such as us must place in our senior development partners."
Biota goes on to list a whole host of criticisms of GSK which include systematically concealing its decisions to withdraw support for Relenza, “while maintaining the contrary position” with its partner and concludes by saying that “notwithstanding its status as one of the world's largest pharmaceutical companies, GSK's consistent pattern of failures with Relenza cover the full gamut of the drug development process, and include failures of trial design and execution, inappropriate inhaler device selection, poor regulatory approval management, failures of global marketing and promotion, inventory and production too limited to respond to demand
[and] failure to exploit existing and new markets.” GSK denies the allegations.