2014

FDA Accepts Takeda and Lundbeck's Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder

DEERFIELD, Ill., Dec. 12, 2012 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by October 2, 2013. Additionally, Takeda and Lundbeck announced Brintellix™ (pronounced "Brin´-tel-ix") as the proposed global trade name for vortioxetine, pending final acceptance by the FDA and other regulatory agencies.

The NDA includes positive data from six short-term studies, one long-term maintenance study, and more than 7,500 total patients aged 18 to 88 years old. MDD, often referred to as major 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 vortioxetine (Lu AA21004)
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 and 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 5-20 mg, the most commonly observed adverse reactions in MDD patients treated with vortioxetine in placebo-controlled studies (incidence greater than or equal to 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.

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, vortioxetine and tedatioxetine (Lu AA24530). If approved, the companies plan to co-promote the products in the United States and Japan.

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) 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's U.S. business is based in Deerfield, Illinois. To learn more about Lundbeck in the U.S., visit www.lundbeckus.com.

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 2.2 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.

About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.  

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.  The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions.  To learn more about these Takeda companies, visit www.takeda.us.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Global Research & Development Center, Inc.; H. Lundbeck A/S



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