EU regulators launch fresh raids on pharma
pharmafile | December 7, 2010 | News story | Sales and Marketing | AstraZeneca, European Commission, Losec, Nexium, Nycomed, Pantazol, Ratiopharm, antitrust investigation, esomeprazole, pantoprazole
Competition regulators from the EU have raided offices of AstraZeneca and Nycomed in connection with alleged attempts to block generic competitors reaching the market.
The European Commission raided the companies on 30 November, and says it has reason to believe that the companies may have “acted individually or jointly” to delay generic entry for a particular medicine.
The alleged anti-competitive behaviour is understood to relate to Nexium (esomeprazole), AstraZeneca’s heartburn and stomach ulcer treatment, the world’s biggest selling treatment in the market. Nycomed’s pantoprazole (known by various brand names, including Pantazol) is also in the market, and reached its EU patent expiry in May 2009.
A spokesman for AstraZeneca confirmed the company had been subject to inspections relating to alleged practices regarding Nexium in Europe, while Nycomed also confirmed that it was co-operating with the authorities. The companies both individually stressed their commitment to complying with legal and ethical standards.
Nexium was AZ’s biggest-selling drug in 2009, with global sales reaching $5 billion – but its importance is declining for the company.
AstraZeneca’s spokesman pointed out that the Nexium patent did not expire until 2014. However, its protection in Europe was undermined when a “composition of matter” patent was ruled invalid by the European Patent Office in late 2006. Data exclusivity rules protecting Nexium from generics also expired this year.
The drug faces generic rivals in a number of European countries and several generic drug makers have launched cheap copies of Nexium in Germany, Europe’s biggest pharma market.
German generics maker Ratiopharm, now part of Israel-based Teva, said in September it plans to launch a version of the drug in Germany at a discount of more than 60% to the original product.
EU gets tough on pharma
The raids are just the latest in a series carried out by the European Commission, focusing on pharma patent settlements that can delay the introduction of generic rivals.
The Commission has spent more than a year investigating anti-competition issues in the pharma sector within Member States.
Its investigation was first launched in January 2008 in response to concerns that fewer new medicines were being brought to market, amid allegations that generic drugs were being delayed from reaching consumers.
This led to a series of unannounced raids in November of 2008, putting the pharma industry on alert for further incursions from the EU regulators.
Prior to this the EC ruled in 2005 that AstraZeneca had breached European rules by blocking or delaying market access to generic versions of an earlier anti-ulcer drug, Losec, between 1993 and 2000.
The company was fined 60 million euro in the Losec case, although this was later reduced to 52.5 million euro.
Ben Adams
Related Content
European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …
NICE recommends Benralizumab for Rare Form of Vasculitis
The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s benralizumab (Fasenra) as …
NICE approves AstraZeneca’s dual immunotherapy for advanced liver cancer
AstraZeneca has received a positive recommendation from the National Institute for Health and Care Excellence …
