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
8/28/2012 2:30 AM EST
H. Lundbeck A/S
Company Announcement
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.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Chief Specialist, Head of Investor Relations Media Relations Manager
+45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
+45 36 43 38 16 +45 36 43 49 80
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.