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The Committee's orphan medicinal products opinions are submitted to theEuropean Commission for orphan designation determination. The orphan drugdesignation will become effective upon adoption of this recommendation by theEuropean Commission. This is expected to occur before the end of the thirdquarter of 2007.
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The EMEA's orphan drug program is designed to promote the development ofdrugs to treat rare life-threatening or very serious conditions that affect nomore than five in every 10,000 people in the European Union (EU). Thedesignation provides EU market exclusivity for up to ten years in the givenindication. Other potential benefits include: a reduction in fees associatedwith various aspects of the regulatory process, including the application formarketing approval, and EMEA guidance in preparing protocols concerningstudies relevant for approval.
PI-88 is part of a new class of multi-targeted cancer therapeuticsinhibiting both angiogenesis (or tumour promoting) factors such as VascularEndothelial Growth Factor (FEGF), Fibroblast Growth Factors (FGF) 1 and 2, andheparanase, a degrading enzyme implicated in metastasis (tumour spread).Progen will this year launch a multi-national two-armed, double-blindedplacebo controlled Phase 3 trial using PI-88, with the primary endpoint ofdisease free survival, in patients with post-operative primary liver cancer.The goals of PI-88 treatment in this population are to reduce diseaserecurrence, prolong the time to recurrence (known as disease-free survivaltime) and improve the overall survival time of patients after tumourresection. Additionally, the Company is currently conducting a Phase 2 trialin patients with melanoma, the other indication in which we have received U.S.FDA orphan drug designation, with results from this trial expected during thesecond half of 2008.
Mr. Justus Homburg, Chief Executive Officer of Progen commented: "Whilethe incidence of primary liver cancer in the European Union is relatively low,with over half a million new cases elsewhere in the world, it is a disease ofsignificant global relevance. We are honored by the Committee's decision andsupport in our efforts to develop PI-88 for liver cancer."
About Progen: Progen Pharmaceuticals Limited is an Australian-basedglobally focused biotechnology company committed to the discovery, developmentand commercialisation of small molecule therapeutics primarily for thetreatment of cancer.
This press release contains forward-looking statements that are based oncurrent management expectations. These statements may differ materially fromactual future events or results due to certain risks and uncertainties,including without limitation, risks associated with drug development andmanufacture, risks inherent in the extensive regulatory approval processmandated by the United States Food and Drug Administration and the AustralianTherapeutic Goods Administration, delays in obtaining the necessary approvalsfor clinical testing, patient recruitment, delays in the conduct of clinicaltrials, market acceptance of PI-88, PI-166 and other drugs, future capitalsneeds, general economic conditions, and other risks and uncertainties detailedfrom time to time in the Company's filings with the Australian Stock Exchangeand the United States Securities and Exchange Commission. Moreover, there canbe no assurance that others will not independently develop similar products orprocesses or design around patents owned or licensed by the Company, or thatpatents owned o
