Lundbeck’s partner Mochida receives approval of Lexapro in Japan

H. Lundbeck A/S announced that our partner Mochida Pharmaceutical Co., Ltd. (Mochida) has obtained approval of Lexapro® 10 mg (escitalopram) from the Japanese Ministry of Health, Labour and Welfare (MHLW).

Lundbeck has partnered with Mochida, which conducted the development of Lexapro® in Japan. Lexapro® will, as a new treatment option, contribute to improving the quality of life (QoL) of patients suffering from depression.

Mochida and Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe) will co-promote the product, and Yoshitomiyakuhin Corporation, a subsidiary of Mitsubishi Tanabe, will participate in the promotion. This means that the launch will be supported by more than 2,000 sales representatives, which is fully competitive in the Japanese market. The schedule for the launch of Lexapro® will be announced after its National Health Insurance price listing.

“We are very pleased that the Japanese authorities have approved Lexapro®, as this will soon make Lexapro® available to the many people suffering from depression in Japan,” says Lundbeck Senior Vice President Ole Chrintz, International Markets. He continues: “As in the rest of the world, we are convinced that Lexapro® will prove to be a valuable treatment option for people with major depression in Japan.”

The Japanese antidepressant market

In 2010, the Japanese antidepressant market had a value of JPY 135 billion (EUR ~1bn), 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 patients 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

In May 2002, Lundbeck entered into a license agreement with Mochida for the development and commercialisation of escitalopram in Japan. In January 2010, Mochida announced that the company had signed an agreement to co-promote escitalopram in Japan with Mitsubishi Tanabe.

The financial terms of the agreement have not been disclosed, but Lundbeck is to 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.