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Product Development

PRODUCT DEVELOPMENT
PRODUCT STRATEGY

Estracure's product strategy focuses on the development and commercialisation of novel therapeutic products for patients suffering from coronary heart diseases (CHD). The Company is using its expertise with 17-β-Estradiol as its leading core technology and it will develop a line of products in which 17-β-Estradiol (or a derivative) will be a key component. A potentially exciting new method for plaque stabilization, a major cause of sudden cardiac death, will also be developed with the primary intent of primum non nocere (First, Do not Harm; Hippocrates) while improving patient outcome.

Estracure estimates its current cash reserves to be sufficient to complete the entire phase II trials (within the next 18 months), during which period, the company hopes to receive, on the basis of its clinical trials results, a European or US approval for its phase III multi-center clinical trials. Following the results of the current clinical trials (results are expected to be announced in Q3 2005), Estracure will seek to attract and conclude a partnership agreement with a major pharmacological company that will support the R&D costs associated with the phase III trials until the product market entry.

TARGET MARKETS

Restenosis

The restenosis market is the first one to which the Company has dedicated its development efforts. It intends to launch two products into this market: a bolus injection of 17-β-Estradiol in combination with a catheter and, more importantly, a 17-β-Estradiol drug-eluting stent.

Estracure is currently pursuing talks with two polymer companies (MediVas and Hemoteq), that could result in either an in-licensing deal or a joint-development agreement. Estracure expects to conclude the polymer deal in Q2 2005. The sooner a drug-eluting stent for 17-β-Estradiol is in place, the stronger the commercial upside. Current clinical trials are assessing the drug's efficacy alone - with or without a stent, but the actual commercial viability of 17-β-Estradiol will lie in its combination with a drug-eluting stent (DES). The value of the DES market in 2004 was estimated at USD 2.1 billion and is expected grow to USD 6.3 billion by 2008.

Vulnerable plaque

The vulnerable plaque market is the second one in which Estracure believes to have a significant competitive advantage. The vulnerable plaque market represents an unmet medical need and has been approximated to be as large as USD 10 billion annually. While Estracure's current competitors are developing products that could destabilize vulnerable plaques, Dr. Tanguay has demonstrated that 17-β-Estradiol can modulate the ERα and ERβ estrogen receptors and stabilize vulnerable plagues. This provides Estracure with a major differentiation factor and competitive advantage against its competitors.