GlaxoSmithKline Plc (GSK) was sent an antitrust complaint by U.K. regulators who are probing whether it may have paid generic-drug makers Alpharma Ltd., Generics (U.K.) Ltd. and a unit of Teva Pharmaceutical Industries Ltd. (TEVA) to delay market entry of copies of its Seroxat antidepressant.
Glaxo colluded with the generic companies in unlawful accords that included payments in return for delaying the introduction of the copycat drugs, the regulator, the U.K. Office of Fair Trading, said on its website. The U.K.’s biggest drugmaker and the generic companies were sent so-called statements of objections, according to the regulator.
The OFT said its “provisional view is that these agreements included substantial payments from GSK to the generic companies in return for their commitment to delay their plans to supply paroxetine independently.” Paroxetine is the name of the active ingredient in Seroxat, which is also known as Paxil.
Antitrust regulators on both sides of the Atlantic are focusing on how settlements between companies that make branded medicines and generics producers might harm consumers. Les Laboratoires Servier, H. Lundbeck A/S (LUN) and Teva, the world’s largest generic-drug maker, were sent statements of objections last year by the European Union’s antitrust watchdog over possible delays for generic drugs.
Glaxo “supports fair competition and we very strongly believe that we acted within the law, as the holder of valid patents for paroxetine, in entering the agreements under investigation,” David Daley, a spokesman for the London-based company, said by e-mail. “These arrangements actually resulted in generic versions of paroxetine entering the market before GSK’s patents had expired.”
The OFT probe covers matters already examined by the antitrust regulators at the European Commission without subsequent sanctions, Daley said. “As we have just received the statement of objections, we will need time to carefully review it before considering any further action.”
“The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS, to the benefit of patients and, ultimately, taxpayers,” said Ann Pope, a director at the OFT, referring to the U.K.’s publicly funded National Health Service. “No assumption should be made at this stage that there has been an infringement of competition law.”
Glaxo, AstraZeneca Plc (AZN), the U.K.’s second-biggest drugmaker, and Sanofi (SAN) are also among companies the Brussels- based commission has queried as part of its probes into the companies’ tactics to keep copies of their medicines off the market. Drug developers use a variety of techniques to delay generics, the EU said in a 2009 report.
Johnson & Johnson (JNJ) and Novartis AG (NOVN) in January were also sent charge sheets by the EU over a pay-for-delay deal that may have hampered the sale of generic versions of pain killer fentanyl in the Netherlands.
Seroxat is an antidepressant that was one of Glaxo’s best- selling drugs during the period in question, according to the OFT.