January 26, 2018

SECOND NOTIFICATION: Discontinuation of Frisium® (clobazam) Tablets in Canada

Dear Healthcare Professional and Epilepsy Patient Advocacy Organization,

As communicated first in July 2017, after careful consideration, Lundbeck has made the decision to discontinue the manufacturing of Frisium® (clobazam) Tablets in Canada. This decision was not triggered by a safety issue, but rather is based on the numerous generic clobazam alternatives available in Canada.

Due to an increased demand of Frisium in the second half of 2017, we now expect our current inventory to be depleted in the third quarter of 2018.

As mentioned before, Lundbeck first communicated this change well in advance to give healthcare professionals, patients and families as much notice as possible so that Frisium patients have ample time to successfully shift to an acceptable alternative clobazam therapy. Health Canada also was notified last summer. As well, we have listed our proposed discontinuation date on the drug shortages website in Canada.
As a company with a strong record of supporting the epilepsy community, Lundbeck is aware of the ongoing struggles many physicians and their patients experience in managing seizures. We are deeply committed to the epilepsy community, which is why we are taking several steps to ease this transition, including:

• Providing access to Lundbeck’s Medical Information team at 866 880 4636 to address questions or concerns. We will closely monitor responses from patients, their families and healthcare professionals and address concerns appropriately.

• Distributed two discontinuation letters to a comprehensive list of physicians, pharmacists and patient advocacy organizations throughout Canada in July 2017 and January 2018, providing more than a year’s lead time to enable a carefully thought-through treatment transition plan.
○ A final letter is scheduled for the summer of 2018.
○ Patient advocacy organizations will be encouraged to share all notifications for use in on and offline communications materials, as appropriate.

• Implementing allocation plans to ensure appropriate steady supply of the remaining Frisium tablets to the market based on historical demand.
• Conducting outreach to pharmaceutical wholesalers.

Again, please contact Lundbeck Medical Information at 866 880 4636 if you have any questions.
Sincerely,

Doug Williamson, MD
Chief Medical Officer, VP US Drug Development
Lundbeck