FDA accepts Takeda and Lundbeck’s filing for review of Brintellix (vortioxetine) for the treatment of major depression
12/12/2012 2:00 PM EST
H. Lundbeck A/S
Company Announcement
FDA accepts Takeda and Lundbeck’s filing for review of Brintellix
(vortioxetine) for the treatment of major depression
-- FDA has determined that the New Drug Application filed in October 2012 is
sufficiently complete to permit a substantive review
-- Upon the acceptance of the filing by the FDA, Lundbeck is to receive a
milestone of USD 50 million (approximately DKK 285 million) from Takeda
H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug
Administration (FDA) has accepted the submission of a New Drug Application
(NDA) for Brintellix(TM) (vortioxetine) for the treatment of major depressive
disorder (MDD) in adult patients. Brintellix (pronounced “brin'-tel-ix”) is the
proposed global trade name for vortioxetine.
According to the timelines established by the Prescription Drug User Fee Act
(PDUFA), the review of the NDA is targeted for completion by 2 October, 2013.
The NDA includes positive data from six short-term studies and one long-term
maintenance study. The vortioxetine global clinical development program
included more than 7,500 individuals aged 18 to 88 years old exposed to the
drug. Major depression, often referred to as depression, is a common,
debilitating illness affecting around 15 million Americans and 121 million
people worldwide. Depression was the third leading contributor to the global
burden of disease in 2004 and is projected to be the leading contributor to the
worldwide burden of disease by 2030.
About Brintellix
Brintellix (vortioxetine) is under investigation as an antidepressant with
multimodal activity that is thought to work through a combination of two
mechanisms of action: receptor activity modulations and reuptake inhibition.
In vitro studies indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D
receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist
and inhibitor of the serotonin (5-HT) transporter (SERT). In vivo non-clinical
studies have demonstrated that vortioxetine enhances levels of the
neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and
histamine in specific areas of the brain.
Across the doses of 5-20mg, the most commonly observed adverse reactions in MDD
patients treated with vortioxetine in placebo-controlled studies (incidence =5%
and at least twice the rate of placebo) were: nausea, constipation and
vomiting. Overall, 6.5% of the patients who received vortioxetine discontinued
treatment due to an adverse reaction, compared with 3.8% of placebo-treated
patients in these studies. Nausea was the most common adverse reaction reported
as a reason for discontinuation and considered to be drug-related.
About Takeda and Lundbeck alliance
In September 2007, Lundbeck and Takeda formed a strategic alliance for the
exclusive co-development and co-commercialization in the United States and
Japan of several compounds in Lundbeck's pipeline for mood and anxiety
disorders. The partnership initially focuses on co-development and
co-commercialization of the two most advanced compounds in Lundbeck's pipeline
for mood and anxiety disorders, Brintellix and tedatioxetine (Lu AA24530). If
approved, the companies plan to co-promote the products in the United States
and Japan.
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.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Simon Mehl Augustesen
Chief Specialist, Head of Investor Relations International Media Specialist
+45 36 43 24 26 +45 36 43 49 80
Magnus Thorstholm Jensen
Investor Relations Officer
+45 36 43 38 16
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.