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FDA Approval to Lavipharm's Fentanyl Patch

09 Aug 2006

Lavipharm S.A. announces the approval to market its generic fentanyl transdermal system from the FDA (Food and Drug Administration), the US healthcare regulator. The product has been developed by Lavipharm Laboratories, Inc., the Group's Research and Development arm in the USA.

PEANIA, Grece | Aug 07, 2006 | Lavipharm S.A. announces the approval to market its generic fentanyl transdermal system from

the FDA (Food and Drug Administration), the US healthcare regulator. The product has been developed by Lavipharm Laboratories, Inc., the Group's Research and Development arm in the USA.

Lavipharm's fentanyl transdermal system is a small, thin and easy to adhere patch for the management of chronic pain. It is designed to safely and effectively deliver the analgesic active ingredient fentanyl through the skin. This twice-a-week patch provides continuous relief for up to three days from moderate-to-severe pain, as the one caused by cancer. The file was submitted for approval with the FDA in January 2004. The product has been approved in four dosage forms, 25mg/h, 50mg/h, 75mg/h and 100mg/h.

"The approval of our fentanyl transdermal delivery system from the FDA not only justifies our efforts, but also represents a scientific and business achievement. We remain focused and committed to our ambitious but attainable objectives for expansion in the global market", said Dr. Athanase Lavidas, Chairman and CEO of Lavipharm Group.

Lavipharm's regulatory approval to market its Fentanyl patch in the USA represents a significant milestone not only for the company, but for the Greek pharmaceutical industry as a whole. It is the first time that a pharmaceutical product developed by a company of Greek origin is approved by the FDA. It is also the first time that such a product will be launched in the US market, where in 2005 total sales of transdermal fentanyl exceeded 1 billion US Dollars. With a clear vision and objectives, and implementing a well defined but flexible strategy, Lavipharm now further solidifies its position amongst the global players in the international pharmaceutical arena.

LAVIPHARM's first international product, already marketed in United Europe and in Canada, is a new generation, once-a-day matrix transdermal nitroglycerine delivery system for the treatment of angina pectoris. For marketing its nitroglycerine patch, LAVIPHARM has entered into agreements with some of the most prominent multinational pharmaceutical companies.

Lavipharm will host a press conference in Athens at the end of August.

Lavipharm, founded in 1911, is an integrated Group of companies engaged in the research, development, production, import, marketing, sales and provision of logistics services of pharmaceutical, dermocosmetic and healthcare products in Greece with a strong international presence. Lavipharm S.A., the mother company, is listed on the Athens Stock Exchange (ASE: LAVI) since November 1995. In Greece, it offers products developed in-house and high level services not only to the pharmacist but the consumer as well. Internationally, it cooperates for the marketing and sales of its product portfolio with the largest pharmaceutical and cosmetic companies in the world. In 2005, consolidated turnover under International Financial Reporting Standards (IFRS), exceeded 230 million Euros. With facilities in Greece, Cyprus, France and the USA, Lavipharm engages more than 800 employees worldwide.

SOURCE: Lavipharm S.A.

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