Lek Acquires Marketing Rights for a New Form of Drug for the Treatment of Asthma

9. 10. 2001

Ljubljana, 9 October 2001 – Slovenian based pharmaceutical company Lek d.d. (Lek), and Sofotec GmbH & Co. KG (Sofotec), the German pharmaceutical company focussing on inhale technologies, signed a contract that grants Lek exclusive rights to market a drug for the treatment of asthma in a new form of inhalation. Asthma – one of the leading diseases of the modern age – and its treatment are on Lek’s priority list. Patients will find this new form of TafenŽ beneficial and advantageous since it is so much easier to use.

TafenŽ, which ranks third on Lek’s respiratory drugs list, is available in a 200 micrograms spray bottle. Lek’s sales of TafenŽ totalled SIT 156 million in 2000. We anticipate that the new form of TafenŽ will boost our sales, particularly since we have exclusive marketing rights for this drug in Central and Eastern Europe. We already project sales amounting to $5 to 10 million in the first five years of marketing.

We at Lek have tried to come up with a product that would be beneficial to patients and the environment; a product that would allow patients to more easily control the amount of the drug they inhale. Our goal was also to replace the existing form of the product with a more modern one, called the Dry Powder Inhaler (brand NovolizerŽ).

Sofotec, a subsidiary of the German biotech company Zentaris, originated from ASTA Medica, the pharmaceutical unit of Degussa AG, specialises in inhale technologies: developing of innovative drug delivery technologies through the lung. The Zentaris group’s mission is “to combine technological solutions and develop specific capabilities for the purpose of creating beneficial and suitable results for patients."

Lek signed a contract with Sofotec for the asthma treatment drug budesonide delivered by the innovative NovolizerŽ, which is on the market in Germany since mid 2000, where it is marketed by ASTA Medica and Klinge Pharma. Now that Lek has acquired exclusive marketing rights for Central and Eastern Europe, Southeastern Europe and Russian Federation, Lek has access to a significant share of the European market.

As stipulated by the contract, Lek has preferential rights to Sofotec’s newly developed products, creating an extremely important strategic partnership. This partnership combines Lek’s established marketing position in Central and Eastern Europe and Sofotec’s innovative products. Lek will begin the product approval and registration process immediately. As soon as the product obtains marketing authorisation, which is expected next year, Lek will start marketing this asthma treatment drug.

The drug will be presented on the market under the trademark TafenŽ (the property of Lek) NovolizerŽ (the property of Sofotec), further underlining and emphasising the strategic partnership of the two companies. Lek will introduce the drug in Slovenia and the markets of Central and Eastern Europe in 2002, which will coincide with the planned launch of the product on the European Union market.

Lek has already designed a web page “All about asthma" (www.astma-info.com) in collaboration with the University Clinic of Respiratory and Allergic Diseases Golnik and the Pulmonary Patients Association of Slovenia. The page provides information about the disease, its treatment and advice on how to live with asthma.