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<p align="center"><b>PLIVA Receives a License from BAYER AG for a New Chemical |
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Entity for the Treatment of Fungal Infections</b></p> |
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<p> PLIVA d.d. ('PLIVA') announced today that it has received a license for a |
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new chemical entity for the treatment of fungal infections from BAYER AG, Germany, |
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a compound in its final stage of pre-clinical trials.</p> |
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<p> The compound BAY 10-8888, part of the family of beta-amino acids, was identified |
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at Bayer during an effort to find novel treatment options for fungal infections |
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caused by the Candida yeast. Candida infections are prevalent in patients suffering |
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from AIDS or those undergoing cancer chemotherapy and/or immunosuppressive therapy |
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treatment e.g. for organ transplantation and vaginal mycosis. Furthermore, Candida |
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has been identified as the fourth most common pathogen in nosocomial infections |
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in hospitalized patients. </p> |
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<p>The total market size for anti-fungals amounted to USD 2.6 billion in 1999. |
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Only the azole compound class, which was developed in the early 80s and now |
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dominates over 60% of the market, is currently available for oral treatment |
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of the aforementioned diseases,. Due to the increasing prevalence of Candida |
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infections and the frequent use of azoles in treatment, however, severe resistance |
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problems have arisen in recent years.</p> |
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<p> The compound BAY 10-8888 displays high activity both in vitro and in vivo |
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against Candida infections. Due to its novel mode of action, the compound additionally |
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combats azole resistant pathogens. According to the data generated in various |
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species, the compound exerts highly favorable pharmacokinetic behavior, indicating |
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a single daily dose for patients. The compound would be the first novel class |
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for the oral treatment of yeast infections following the introduction of azoles |
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in the 70s. </p> |
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<p>Due to a shift in its business strategy, BAYER decided to leave the anti-fungal |
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segment and make the compound available for licensing. In its licensing agreement |
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with BAYER, PLIVA received worldwide development and marketing rights to the |
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product under non-disclosed terms.</p> |
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<p> "PLIVA continues to undertake strong steps in an effort to further expand |
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its position in the anti-infective business area," comments Mr. Radan Spaventi, |
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Chief Scientific Officer of PLIVA. "In addition to our successful in-house research |
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efforts in anti-bacterials, BAY 10-8888 will allow us to further broaden our |
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product portfolio in anti-infectives. We believe that this product will represent |
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a significant contribution to the anti-fungal market, given its activity against |
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strains resistant to existing drugs." </p> |
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<p>PLIVA has renamed the compound PLD-118, according to its classification scheme, |
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and plans to start clinical development this year. In line with its R&D strategy, |
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PLIVA intends to establish a relationship with a global partner for the development |
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and marketing of the product after completion of Phase I and/or Phase II clinical |
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trials. PLIVA's total R&D expenditures in 2000 are expected to reach about HRK |
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330 million. </p> |
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<p>For further information, please contact: </p> |
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<p>Erika Kaspar<br> |
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Vice President, Communications and Corporate Affairs <br> |
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Tel: 385 1 6120 755<br> |
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Fax: 385 1 6114 413<br> |
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E-mail: <a href="mailto:erika.kaspar@pliva.hr">Erika.Kaspar@pliva.hr</a></p> |
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<p> Marija Mandic <br> |
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Financial Analyst<br> |
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Tel: 385 1 6160 355 <br> |
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Fax: 385 1 6120 634<br> |
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E-mail: <a href="mailto:marija.mandic@pliva.hr">Marija.Mandic@pliva.hr</a> </p> |
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