Versatis®, Lidocaine Medicated Plaster Approved by MHRA

Teikoku Pharma annouces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Versatis® in the UK, a novel 5 % lidocaine medicated plaster, for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN), co-developed with the German drug company Grünenthal.

Following this national approval of Versatis^® and its national launch on January, 8th, the UK will become Reference Member State for the registration procedure for other European countries.

Versatis offers a topical and non-systemic approach for the treatment of typically localized neuropathic pain symptoms associated with PHN, often described as burning, shooting or stabbing. It is a combination of lidocaine in a soft hydrogel plaster combining efficacious treatment with proven tolerability, safety and simple handling.

“Nerve pain is personally disastrous for the people who experience it”, said Rob Koremans, MD, Member of the Executive Board of Grünenthal GmbH. “Grünenthal is highly committed to improve the quality of life of those patients. Versatis^® offers a novel treatment option which is effective where it hurts but with a reassuring safety profile. With Versatis^® our company will establish its business in the United Kingdom, a key market for every global pharmaceutical company.”

The lidocaine medicated plaster offers rapid and continuous pain relief 30 minutes after application. Following a once daily 12hours on/12 hours off application schedule, up to three plasters can be used at one time. It is suitable for stand alone therapy or in combination with other medications.

Since 1999, a lidocaine plaster has been marketed in the USA, under the trade name Lidoderm^®, by Endo Pharmaceuticals, where more than one million patients have been treated. In Europe, Grünenthal has developed the lidocaine medicated plaster under the trade name Versatis^®.

Teikoku Pharma USA, Inc. is a world leader in innovative, high-quality drug delivery systems. In addition to its proprietary products, Teikoku has provided the technology and platform for well known branded products including the widely used Lidoderm^®, a lidocaine patch marketed by Endo Pharmaceuticals Inc. in the United States. Total U.S. sales of the Lidoderm patch were $548 million in 2005 and $748 million in 2006, according to IMS. Institut Biochimique S.A. (IBSA) markets the lidocaine patch in Switzerland as Neurodol Tissue Gel. Recently, the patch was approved in the United Kingdom under the Versatis trademark, and it will be distributed by Grunenthal in the European Union, Latin America and the Middle East. Additionally, the patch will be distributed in Korea by SK Chemical under the Lidotop brand. Teikoku Pharma USA is a subsidiary of the Japan based company Teikoku Seiyaku Co., Ltd. More information can be found at www.Teikokuusa.com.

Grünenthal researches, develops and produces high therapeutic value medicines and markets them throughout the world. Grünenthal is an expert in drugs for pain therapy and gynaecology and a leader in the field of intelligent, user-friendly drug delivery technologies. Grünenthal is an independent, family-owned company with a long history of international co-operations. The company was founded in 1946 and has its headquarters in Germany. We supply our markets from seven production sites around the world and have affiliates in 27 countries. Grünenthal employs about 1,900 people in Germany and about 4,700 world-wide. Sales in 2005 amounted to approximately 777 million Euro.