8-KRegulation FD

BIOGEN INC. 8-K Report, Regulation FD Disclosure (Nov 7, 2017)

Filed November 7, 2017For Securities:BIIB

Summary

Biogen Inc. (BIIB) announced on November 7, 2017, updated patient participation data for its spinal muscular atrophy (SMA) therapy, SPINRAZA®. As of September 30, 2017, approximately 200 SMA patients were enrolled in U.S. clinical studies for SPINRAZA®. Furthermore, an additional 1,200 SMA patients in the U.S. had initiated post-marketing therapy with SPINRAZA®. Notably, approximately two-thirds of these post-marketing patients were individuals diagnosed with Type 2 or Type 3 SMA, suggesting a broad uptake across different severities of the disease.

Key Highlights

  • 1As of September 30, 2017, 200 SMA patients were in U.S. clinical studies for SPINRAZA®.
  • 2An additional 1,200 SMA patients in the U.S. have started SPINRAZA® therapy in the post-marketing setting.
  • 3Approximately two-thirds of the 1,200 post-marketing patients have Type 2 or Type 3 SMA.
  • 4This filing provides an update on patient access and market penetration for SPINRAZA®.
  • 5The data indicates significant patient enrollment in both clinical trials and real-world treatment.

Frequently Asked Questions

The primary purpose of this 8-K filing is to provide an update on the number of patients participating in clinical studies and receiving post-marketing therapy for Biogen's drug SPINRAZA®, used to treat Spinal Muscular Atrophy (SMA).

As of September 30, 2017, approximately 200 patients were in U.S. clinical studies and an additional 1,200 patients in the U.S. had started therapy in the post-marketing setting.

The information that approximately two-thirds of the 1,200 post-marketing patients have Type 2 or Type 3 SMA suggests that SPINRAZA® is being utilized by a significant portion of the SMA patient population beyond just the most severe (Type 1) cases, indicating broader market acceptance and application.

No, the information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section.