Lundbeck receives approval from Health Canada for Treanda®

H. Lundbeck A/S (Lundbeck) today announced that Health Canada has approved Treanda® (bendamustine hydrochloride for injection) following the success of the brand in both Europe and the US. Treanda was licensed from Cephalon, Inc. (a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. (Teva)) in February 2011, and Lundbeck was granted exclusive commercial rights in Canada.

Treanda is approved in patients with chronic lymphocytic leukemia (CLL) who have received no prior treatment and in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL) who did not respond to treatment with a rituximab regimen or where the disease progressed during or shortly following a rituximab regimen.

Treanda is a novel treatment with a unique chemical structure. Though the exact mechanism of action of Treanda remains unknown, Treanda may act in two distinct ways to kill cancer cells. Pre-clinical studies suggest that Treanda may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway).

“I am very pleased that we are now able to make Treanda available in Canada, thereby offering a new treatment option for patients with untreated chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin’s lymphoma,” says Ole Chrintz, Senior Vice President, International Markets and Europe at Lundbeck, and continues: “Treanda has significant sales potential and is important for the further strengthening of Lundbeck’s already strong position in the Canadian market.”

Lundbeck anticipates that Treanda will be available to physicians and patients in Canada during September 2012.

In a randomized, international, multicenter, open-label pivotal study of 319 treatment-naive patients with CLL, those who received Treanda had better clinical outcomes compared to patients treated with chlorambucil, a commonly used chemotherapy for patients with CLL. Specifically, Treanda patients had a significantly higher overall response (68% of patients responded to Treanda and 33% of patients responded to chlorambucil; p < 0.0001). Patients who received Treanda also had a higher complete response rate than those treated with chlorambucil (9% vs. <1%), which means that after treatment with Treanda some patients had no signs of disease in their blood.

Importantly, Treanda patients also had a significantly longer progression-free survival (21 months vs. 9 months; p < 0.0001), meaning the disease did not get worse for a significant period of time. The response to Treanda lasted longer (duration of response) than in patients who received chlorambucil (23 months vs. 8 months). The most common adverse events in the trial were myelosuppression, fever, nausea, and vomiting.

The approval for iNHL which has progressed during or within six months of treatment with a regimen that included rituximab is also supported by a pivotal study of 100 patients. This study demonstrated that heavily pre-treated patients had a high response rate to treatment with Treanda, and these responses to the treatment were durable. The results from the pivotal study showed that treatment with Treanda as a single agent resulted in an overall response rate of 75%, which means that after treatment, the cancer diminished or disappeared in approximately three out of four patients. Additionally, patient response to treatment in the pivotal study lasted a median of 9.2 months. The most common adverse events in the trial were myelosuppression, nausea, fatigue, diarrhea, vomiting, fever and constipation.