Pseudomonas Vaccine Article

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Berna Biotech's Aerugen® Granted Orphan Drug

Designation in the USA

Berne, Switzerland; May 15, 2002: Berna Biotech Ltd (SWX: BBIN) today

announced that its Aerugen® Pseudomonas aeruginosa vaccine has been granted

orphan drug designation in the USA.

'Orphan drug' is the term applied to pharmaceuticals specially developed to

combat rare diseases for which there is a significant unmet clinical need.

Orphan drug status provides for US marketing exclusivity for seven years upon

marketing approval by the FDA. The status also provides certain tax benefits

for related clinical development costs, the possibility to apply for clinical

research grants, and a potential waiver for marketing application user fees.

It also provides for assistance from the FDA to facilitate the development

and registration of the product.This follows the granting of orphan drug

status for the vaccine in Europe in December 2001, providing for special

incentives, including market exclusivity for up to ten years in

Europe.Vaccination with Aerugen® aims to prevent the progressive destruction

of the lungs in Pseudomonas aeruginosa infection, resulting in a significant

improvement in the quality of life and the extension of life expectancy for

cystic fibrosis sufferers. Pseudomonas aeruginosa infections are frequent and

difficult to treat, and in most cases lead to a fatal outcome. They place a

high financial burden on healthcare providers. Aerugen® should offer the

first effective long-term prophylaxis for Pseudomonas aeruginosa

infections.Aerugen® is the most advanced vaccine for the prevention of

Pseudomonas aeruginosa infections world-wide. An eight-valent conjugate

vaccine, Aerugen® targets strains causing up to 95% of infections. Building

on excellent 10-year observational data on the role of Aerugen® in the

prevention of infection and the preservation of lung function in cystic

fibrosis patients, a phase III clinical study of the vaccine involving 46

centres, in four European countries, is currently ongoing.Market launch in

the USA is scheduled for 2005. Potential US sales are estimated to be between

CHF 30 million and CHF 50 million, similar to those anticipated for Europe.

Berna Biotech Ltd (SWX: BBIN) develops, produces and markets vaccines and

immunotherapeutics. Headquartered in Berne, Switzerland, with affiliates in

Switzerland, Spain and Italy, Berna's range of novel and validated

proprietary technology platforms supports a broad product portfolio. The

fully integrated company markets four core vaccines, and has more than 14

products in development, including four products in or entering phase III

clinical development in 2002. Development is supported through alliances with

academic and commercial partners. In 2001, Berna Biotech, with 650 employees,

generated sales of above CHF 300 million.

Further Information

Press contact

Patrik , General Secretary

Tel: +41 31 980 64 91

Fax: +41 31 980 62 29

Investor Relations

Anya Ramalho, Head of Business Development & Investor relations

Tel: +41 31 980 6410

Fax: +41 31 980 6229

Becki

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