Launch of Lexapro commenced in Japan

Mon Aug 22, 2011 4:00am EDT

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  • Lexapro® - the most prescribed branded antidepressant in the world - now also available to Japanese patients
  • Clinical phase III studies in Japan have confirmed the positive efficacy and tolerability profile of Lexapro®
  • Lexapro® in Japan will contribute to Lundbeck's financial performance from 2012

H. Lundbeck A/S today announced that its partners Mochida Pharmaceutical Co., Ltd. (Mochida) and Mitsubishi Tanabe Pharma Corporation (MTPC) have launched Lexapro® 10mg (escitalopram) in Japan, for which Mochida obtained the marketing approval following the NHI (National Health Insurance) Drug Price listing.

"It is a milestone in our global expansion strategy that Lexapro® is now available in Japan following a fast regulatory process," says Lundbeck Senior Vice President Ole Chrintz, International Markets. He continues: "We are pleased that Lexapro® will now also contribute to improving quality of life for patients in Japan diagnosed with depression."

Lexapro® has been very well-received by the patients and doctors for the treatment of depression in many countries, and is currently the most prescribed branded anti-depressant in the World. 

Mochida and MTPC estimate sales of Lexapro® amounting to JPY 3 billion (DKK ~0.2 billion) for the first year following the launch and JPY 33.8 billion (DKK ~2.3 billion) in its peak year 6 years later.


For reference:

Brand Name: Lexapro® 10mg

Generic name: Escitalopram oxalate

Ingredients and Contents: 12.77mg escitalopram oxalate per tablet (10mg escitalopram per tablet)

Indication: Depression and depressive symptoms

Dosage and Administration: Usually, to adults, 10mg of escitalopram is orally administered once daily after meal in the evening. The dosage may be adjusted according to the patient's age and symptoms; however, the daily dose should not be increased over 20mg.

Package: 28,100,140,500 tablets (PTP), 500 tablets (Bottle)

NHI Drug Price: JPY 212.00 per tablet

Date of Approval: April 22, 2011

Date of NHI Drug Price Listing: July 19, 2011

Date of Launch: August 22, 2011

Distributor: Mochida Pharmaceutical Co., Ltd.


The Japanese antidepressant market
In 2010, the Japanese anti-depressant market had a value of JPY 135 billion (DKK ~9 billion), up 10.7% from 2009 according to IMS Japan. The three most sold antidepressants in Japan were by the end of 2010 paroxetine with a value market share of 37%, sertraline with a share of 20% and fluvoxamine with a share of 15%.

The number of people diagnosed with depression in Japan is increasing every year and is currently estimated to exceed one million. Escitalopram has been very well received by patients and doctors worldwide for the treatment of depression and will offer a new treatment option for patients with depression in Japan.


Mochida and Lundbeck alliance
I
n May 2002, Lundbeck entered into a license agreement with Mochida for the development and commercialization of escitalopram in Japan. In January 2010, Mochida announced that the company had signed an agreement to co-market escitalopram in Japan with MTPC.

The financial terms of the agreement have not been disclosed, but Lundbeck will receive regulatory milestone payments and royalties on sales.

In Japan, Mochida began the development of escitalopram in 2002 and conducted clinical trials in patients with depression. The results of these studies confirmed its efficacy and tolerability, which has led to the filing and subsequent approval of escitalopram.

Financial guidance
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2011 which was provided on 24 February 2011 in connection with the release of the financial results for 2010.


Lundbeck contacts

Investors: Media:
   
Palle Holm Olesen Mads Kronborg
Chief Specialist, Investor Relations Media Relations Manager
palo@lundbeck.com mavk@lundbeck.com
+45 36 43 24 26 +45 36 43 28 51
   
Magnus Thorstholm Jensen Simon Mehl Augustesen
Investor Relations Officer International Media Specialist
matj@lundbeck.com smeh@lundbeck.com
+45 36 43 38 16 +45 36 43 49 80
   
Jacob Tolstrup  
Vice President  
jtl@lundbeck.com  
+1 847 282 5713  

 

 

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 central nervous system (CNS) 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, schizophrenia, insomnia, 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 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2010, the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.




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