This excerpt taken from the EPCT 8-K filed Aug 4, 2008.
Risks Relating to Ceplene®
If we do not receive final regulatory marketing approval by the European Commission for Ceplene®, our business will be harmed.
Even though the CHMP issued a positive opinion regarding the marketing authorization for Ceplene®, for the remission maintenance and prevention of relapse in patients with AML in first remission, the EMEA has not yet granted marketing authorization for Ceplene®. There is no assurance that we will receive marketing approval in Europe by the EMEA. The formal marketing authorization from the European Commission is usually obtained within 67 days from the date of the CHMPs opinion.
Additionally, the CHMP recommended that Ceplene® be granted a full marketing authorization under the provision of Exceptional Circumstances. As part of granting of the marketing authorization under Exceptional Circumstances, we have agreed to perform two post-approval clinical studies. One of the studies seeks to further elucidate the clinical pharmacology of Ceplene® by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. We can not provide any assurance that these additional studies will be successful. If these studies prove to be unsuccessful, or if we do not make a sufficient effort to complete the studies in a timely manner, our marketing authorization may be suspended or revoked, which will harm our business, financial condition and results of operations.
We may not be able to successfully market and sell Ceplene® or find a collaborative partner to help market and sell Ceplene®.
Even though the CHMP issued a positive opinion regarding the marketing authorization for Ceplene®, for the remission maintenance and prevention of relapse in patients with AML in first remission, we may not be able to effectively market and sell Ceplene®. Our strategy for commercializing Ceplene® currently anticipates that we will enter into collaborative arrangements with one or more pharmaceutical companies that have product development resources and expertise, established distribution systems and direct sales forces to successfully market Ceplene® in the European Union. If so, we will be reliant on one or more of these strategic partners to generate revenue on our behalf.
We expect to incur substantial net losses, in the aggregate and on a per share basis, for the foreseeable future as we attempt to market and sell Ceplene®. We are unable to predict the extent of these future net losses, or when we may attain profitability, if at all. These net losses, among other things, have had and will continue to have an adverse effect on our stockholders equity. We anticipate that for the foreseeable future our ability to generate revenues and achieve profitability will be dependent on the successful commercialization of Ceplene®. There is no assurance that we will be able to obtain or maintain governmental regulatory approvals to market Ceplene® in Europe. If we are unable to generate significant revenue from Ceplene®, or attain profitability, we may not be able to sustain our operations.
We will not be successful in marketing and selling Ceplene® in Europe, or may be delayed in doing so, in which case we would not receive revenue or royalties on the timeframe and to the extent that we currently anticipate.
Ceplene® may fail to achieve market acceptance, which could harm our business.
Even though the CHMP issued a positive opinion regarding the marketing authorization for Ceplene®, for the remission maintenance and prevention of relapse in patients with AML in first remission, physicians may choose not to prescribe this product, and third-party payers may choose not to pay for them. Accordingly, we may be unable to generate significant revenue or become profitable.
Acceptance of Ceplene® will depend on a number of factors including:
If Ceplene® fails to achieve market acceptance, our business, financial condition and results of operations would be materially and adversely affected.
We may be dependent upon collaborative arrangements for the further development and commercialization of Ceplene®. These collaborative arrangements may place the development and commercialization of Ceplene® outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us.
We may enter into collaborations with third parties to further develop and commercialize Ceplene®. We may not be able to enter into collaborative arrangements on attractive terms, on a timely basis or at all. Dependence on collaborators for the development and commercialization of Ceplene® subjects us to a number of risks, including:
If we are not able to enter into collaborative arrangements on commercially attractive terms, on a timely basis or at all, or if any of the risks occur and we are unable to successfully manage such risks, our business, financial condition and results of operations would be materially and adversely affected.