8-KRegulation FDExhibits & Filings

BIOGEN INC. 8-K Report, Regulation FD Disclosure (May 30, 2013)

Filed May 30, 2013For Securities:BIIB

Summary

Biogen Idec announced on May 30, 2013, that it had secured a European patent for TECFIDERA™ (BG-12) extending until 2028, covering the expected EU launch dose of 480 mg. This patent, combined with anticipated regulatory data protection, is crucial for the drug's market exclusivity in the European Union. The company also indicated that it is working to clarify the regulatory data protection status, which is expected to cause a delay in the EU launch of TECFIDERA to the second half of 2013.

Key Highlights

  • 1Biogen Idec has obtained a European patent for TECFIDERA, valid until 2028, covering the intended EU launch dose.
  • 2The patent provides significant market exclusivity for TECFIDERA in the European Union.
  • 3Biogen Idec is also pursuing regulatory data protection for TECFIDERA in the EU.
  • 4The company is working to clarify regulatory data protection status with relevant parties.
  • 5The EU launch of TECFIDERA is now projected for the second half of 2013, due to these efforts.
  • 6Investor presentation slides from the Deutsche Bank 38th Annual dbAccess Health Care Conference are included as an exhibit.

Frequently Asked Questions

The European patent grants Biogen Idec market exclusivity for TECFIDERA in the EU until 2028, which is a critical protection for the drug's commercial success and revenue generation in the region.

The EU launch is delayed until the second half of 2013 because Biogen Idec is working to clarify the regulatory data protection status, in addition to securing the patent. This ensures a clearer path to market with guaranteed exclusivity.

While not explicitly detailed in this 8-K, TECFIDERA is known to be a treatment for relapsing forms of multiple sclerosis. Investors should refer to the investor presentation or other company materials for more detailed information on the drug's indication.

The presentation contains forward-looking statements that involve risks and uncertainties. These could cause actual results to differ materially from the company's expectations. Investors should carefully review the cautionary notes provided in the filing and the presentation itself.