Biogen Idec ($BIIB) has taken steps to provide a strong and durable fortress around intellectual property for its potential blockbuster Tecfidera in the European Union, but the effort is going to require additional time. As a result, Weston, MA-based Biogen plans to delay the highly anticipated launch of the oral multiple sclerosis drug until the second half of 2013.
Biogen is expected to grab EU approval of Tecfidera before the close of the second quarter at the end of next month. Yet rather than pulling the trigger on a commercial debut of the treatment in Europe before the end of the quarter, akin to the rapid launch of the drug in the U.S. on the heels of FDA approval in late March, Biogen needs time to tend to IP protections.
As the company disclosed in a May 30 8-K filing, Biogen has won an EU patent that extends protection for Tecfidera at a 480 mg dose until 2028. However, the company also seeks "regulatory data protection" and "is working to make Tecfidera's regulatory data protection clearer to all parties prior to launch," the company said in an 8-K filing with the SEC. In an investor presentation disclosed in the filing, Biogen argues that the delayed launch of Tecfidera in the EU is a good idea to "preserve value over the long term."
So far the long game has benefited Biogen CEO George Scangos, who has helmed the biotech industry's oldest independent company for nearly three years of growth by reprioritizing commercial and research efforts. Tecfidera, known as BG-12 in clinical trials, is the crown jewel of the company's commercial growth in the coming years. Prior to today's news, analysts expected the drug to garner about $300 million in 2013 sales and exceed $3 billion in peak revenue, eventually leading the oral MS drug category that includes Novartis' ($NVS) Gilenya and Sanofi's ($SNY) Aubagio.
It appears that the bright future for Tecfidera remains intact, and it could look even stronger with additional intellectual property protections. ISI Group analyst Mark Schoenebaum made a sharp guess in a note to investors today that Biogen is taking time to work with European regulators on securing a "new active substance" designation for Tecfidera, which would give the treatment additional protection with the separate patent to ensure a sturdy defense against generic threats.
Schoenebaum expects the European market to account for 40% of Tecfidera sales at their peak. And Biogen seems steadfast in making sure to leave no holes in its protection of the MS drug prior to the EU commercial campaign.
Special Report: George Scangos - Top 10 Biotech CEO Pay Packages of 2012