Intercell AG

euro adhoc: Intercell AG
Orphan Drug status for Intercell’s Japanese Encephalitis Vaccine granted by the European Commission

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Intercell AG (VSE, "ICLL") announced today that the company’s Japanese Encephalitis vaccine, currently in advanced Phase III trials, has been granted orphan drug status by the European Commission.

The European Commission has followed a recommendation of a designated working party at EMEA (European Medicines Agency), which has reviewed the program from Intercell.

The EMEA's orphan medicinal product designations are based on various criteria that include the seriousness and incidence of the condition and the availability of other effective therapies.

The orphan drug designation leads to several important advantages within the development and especially the marketing of Intercell’s lead product:

¬Ľ With the licensure of Intercell¬ís Japanese Encephalitis vaccine, the company will receive 10-year sole exclusive market rights for its product within the EU25 countries including Norway and Iceland.

¬Ľ The orphan drug designation for Intercell¬ís Japanese Encephalitis vaccine also includes fee reduction and waivers during the pre- and post-approval phases of the product and special participation in EU funded projects and protocol assistance for additional trials, as for instance pediatric trials.

"We are convinced that our modern cell culture based vaccine will increase the market potential for vaccination of travelers against the Japanese Encephalitis Virus. The orphan drug status allows us to generate a maximum commercial benefit for our product in the EU", states Gerd Zettlmeissl, CEO of Intercell.

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ots Originaltext: Intercell AG
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Further inquiry note:
Intercell AG
Mag. Katharina Wieser
Head of Corporate Communications
Tel. +43 1 20620-303

Branche: Biotechnology
ISIN:      AT0000612601
WKN:        A0D8HW
B√∂rsen:  Wiener B√∂rse AG / official market

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