Lundbeck receives approval from Health Canada for Treanda® (bendamustine hydrochloride for injection) to treat patients with relapsed indolent B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia

• Canadians diagnosed with two common types of cancer now have a new treatment option available to them
• Treanda has been approved since 2010 in Europe and 2008 in the US in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (iNHL) that has progressed
• Treanda is a new treatment option that offers a delay in disease progression
• It is estimated that there are approximately 2,500 patients diagnosed with iNHL and 1,400 diagnosed with CLL in Canada every year
• Canada is one of Lundbeck’s most important markets and the addition of Treanda will substantially strengthen the growth outlook

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.

Financial guidance
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2012, which was provided on 8 February 2012 in connection with the release of the financial results for 2011, and further specified in connection with the announcement of the restructuring plan on 14 June 2012.

About Treanda^® (bendamustine hydrochloride)
Treanda has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that Treanda can lead to cell death via several pathways. Treanda damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of Treanda remains unknown.

In February 2011, Lundbeck announced that the company had been granted commercial rights to several Cephalon, Inc. products in Canada and Latin America. Cephalon, Inc. is a wholly owned subsidiary of Teva. The agreement include Treanda, Fentora^® (fentanyl buccal tablet) [C-II], Provigil^® (modafinil), Trisenox^® (arsenic trioxide) injection and Nuvigil^® (armodafinil).

Cephalon, Inc. (Teva) holds exclusive rights to market and develop Treanda in the United States and is licensed to them from Astellas Pharma GmbH.

Treanda^® important safety information
Treanda has serious warning and precautions identified in the product monograph. The following are clinically significant adverse events: myelosuppression, infections (including fatalities) and second malignancies. Treanda should not be used in patients with serious infections. Treanda should be administered under the supervision of a qualified health professional who is experienced in oncology. For additional information, please refer to product monograph.

About lymphoma  
Lymphoma is a cancer of the lymphocytes, the white blood cells the body needs to fight infection. Currently more than 32,000 Canadians suffer from non-Hodgkin’s lymphoma (NHL), which accounts for 3.7 per cent of all cancer-related deaths, making it the seventh-highest cause of death from cancer in Canada. Indolent NHL (iNHL), which makes up about 40 to 50 per cent of NHL cases, is a slow-growing form of cancer that may require repeated treatments throughout a patient’s life. It is estimated that in Canada about 2,500 patients are newly diagnosed with iNHL every year.

Chronic lymphocytic leukemia (CLL) is considered to be both leukemia – a blood cancer – and lymphoma – a cancer of the lymphocytes. CLL is the most common type of leukemia in adults, accounting for about one-third of all cases of leukemia. About 1,400 new patients are diagnosed with CLL in Canada every year.
 

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About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington’s, Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world’s leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.

Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.