Pfizer is withdrawing its application to market the cardiovascular treatment Caduet (atorvastatin and amlodipine) in 12 European countries, because some regulatory authorities were not convinced that its efficacy had been demonstrated.

Caduet had been held up as an important new product for Pfizer as it tries to defend its lucrative $2.5 billion dollar franchise for Norvasc (amlodipine), a calcium channel blocker that is one of a string of products at the firm scheduled to lose patent protection.

But critics have suggested that Caduet is a marketing rather than medical innovation, and sales uptake has been slow. In the first nine months of the year, Caduet’s worldwide sales reached just $121 million, a tiny fraction of Norvasc’s $3.46 billion turnover and the $8.83 billion achieved by Lipitor, Pfizer’s atorvastatin brand.

Caduet was first approved in the USA in June 2004 [[24/06/04b]], and has also been cleared in a number of European countries, including France, Spain, Portugal, Austria, Iceland, Luxembourg, Cyprus, the Czech Republic, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia.

However, Pfizer has now decided to withdraw its application for Caduet in Belgium, Denmark, Estonia, Ireland, Italy, the Netherlands, Norway, the UK, Sweden, Germany, Finland, and Greece.

The other products facing generic competition include the antifungal agent Diflucan (fluconazole), antibiotic Zithromax (azithromycin) the epilepsy drug Neurontin (gabapentin) and the antidepressant Zoloft (sertraline) [[01/12/04a]]). All told, $14 billion in annual revenues are under threat, according to the company.

Facing US probe

Meanwhile, Pfizer also divulged yesterday that it is under investigation by the US Department of Justice over payments to physicians for prescription drug prescribing, without going into details.

The DoJ is also investigating a contractual relationship between Pharmacia – which merged with Pfizer in 2002 - and an unidentified "health care intermediary," according to a filing with the US Securities and Exchanges Commission.

The DoJ probe into Pfizer is just the latest in a series of investigations into the pharmaceutical industry’s pricing, sales and promotion activities, affecting some of the biggest names in the Industry. The Department is already in the middle of investigating price-fixing allegations [[08/06/05c]], and in recent months subpoenaed Sanofi-Aventis [[13/04/05f]], GlaxoSmithKline [[10/03/05a]] and Merck & Co [[10/08/04d]].