Wyeth is confident that it will eventually receive approval for two drugs that have recently failed to impress US regulators – bifeprunox, an investigational compound for schizophrenia and Pristiq for the symptoms of menopause.
In an interview with the New Jersey newspaper The Star-Ledger, Bernard Poussot, who will succeed Robert Essner as chief executive on January 1, claimed it is “an overreaction to say 'two delays, problem, problem’ and said that analysts had over-reacted to delays imposed on the treatments by the US Food and Drug Administration. In August, the agency issued an action letter for bifeprunox, while a month earlier Pristiq (desvenlafaxine) only received an approvable letter and both this decisions hit the firm’s share price hard.
"My belief is that we should get these drugs approved in the end," Mr Poussot said, noting that the FDA has in fact approved two other Wyeth drugs this year – its first-in-class renal cancer drug Torisel (temsirolimus) and the oral contraceptive Lybrel (levonorgestrel/ethinyl estradiol). However it is clear that the agency’s approvals policy has got tougher and Mr Essner told The Star-Ledger that “no one at the FDA would dispute the fact that their decision-making has changed a great deal”. The outgoing CEO added that “in the case of Pristiq, we looked at the data package over and over again. In a normal FDA environment, that would have been approved, easily."
Mr Poussot echoed this view saying that Wyeth has learned it will have to provide more information to keep regulators happy, and he noted that the firm is “looking at every single project with a team of executives who can help us anticipate the right answers to [the FDA's] questions".
Prevnar and Enbrel drive growth again
His comments came just after Wyeth had posted flat third-quarter earnings of just under $1.15 billion, or $0.84 per share, having taken a $117 million charge as a result of “productivity initiatives”. Group sales were up 9% to $5.62 billion and pharmaceutical revenues contributed $4.67 billion (+10%) to the total. The most impressive performances came from the pneumococcal disease vaccine Prevnar, which grew 24% to $634 million, and the arthritis therapy Enbrel (etanercept), which jumped 39% to $527 million (excluding the USA and Canada, where it is sold by Amgen).
In terms of its other drugs, revenues from the antidepressant Effexor (venlafaxine), increased 4% to $958 million and it “continues to be the number one selling antidepressant globally”, Wyeth noted, although generic competition is only a couple of years away. However, the lack of patent protection has started to hit sales of the gastrointestinal drug Protonix (pantoprazole), which fell 6% to $425 million.
Mr Essner described the results as “outstanding” and said that “we are on track to achieve annual sales of more than $1 billion in seven product categories”. Analysts were fairly non-plussed, however, and questions are still being asked as to how the firm will cope with the losses of Effexor and Protonix.