This excerpt taken from the ELN 6-K filed Sep 29, 2009.
we will be materially and adversely affected.
While approximately 39% of our 2008 revenue was generated by our Elan Drug Technologies (“EDT”) business unit, we have only four marketed products and several potential products in clinical development. Our future success depends upon the continued successful commercialization of Tysabri, which accounts for 42% of our total revenue for 2008, and the development and the successful commercialization of additional products (including bapineuzumab which is being developed by Johnson & Johnson and Wyeth and in which we retain an approximate 25% interest).
Uncertainty created by the serious adverse events (including cases of PML and death) that have occurred or may occur, with respect to Tysabri, and the restrictive labeling and distribution system for Tysabri mandated by regulatory agencies, may significantly impair the commercial potential for Tysabri. The FDA stated in September 2009 that the risk for developing PML appears to increase with the number of Tysabri infusions received. We cannot assure you that the PML incidence rate will not increase in the future as more patients are treated with Tysabri and/or as the duration of patients treated with Tysabri lengthens. The FDA and other global healthcare regulators monitor the PML incidence rate and there can be no assurance that, as a result of an increase in the overall incidence rate or an increase in the incidence rate for patients receiving longer-duration therapy, one or more of these regulatory authorities will not change either the regulatory requirements for the sale of Tysabri in the future or the determinative factors that influence the labeling requirements mandated by the FDA and other global healthcare regulators. These changes could result in modifications to the labeling, changes to the TOUCH Program or the implementation of additional or more restrictive risk management programs for Tysabri. An increase in the incidence of PML and/or any such changes in the labeling or to the regulation of the administration of Tysabri may have a material adverse affect on sales of Tysabri and may materially affect us.
We commit substantial resources to our R&D activities, including collaborations with third parties such as Biogen with respect to Tysabri, and Transition Therapeutics, Inc. (“Transition”) with respect to a part of our Alzheimer’s disease programs. Our collaborators’ interests may not be aligned with our interests, which may adversely affect the success of our collaborations. We have committed significant resources to the development and the commercialization of Tysabri and to the other potential products in our development pipeline, including ELND 005. These investments may not be successful. If we do not successfully commercialize additional products, we will be materially and adversely affected.
In the pharmaceutical industry, the R&D process is lengthy, expensive and involves a high degree of risk and uncertainty. This process is conducted in various stages and, during each stage, there is a substantial risk that potential products in our R&D pipeline will experience difficulties, delays or failures. In addition, if the Phase 3 clinical trials for bapineuzumab are not successfully completed by Johnson & Johnson and Wyeth, we will be materially and adversely affected.
A number of factors could affect our ability to successfully develop and commercialize products, including our ability to:
Even if we obtain positive results from preclinical or clinical trials, we may not achieve the same success in future trials. Earlier stage trials are generally based on a limited number of patients and may, upon review, be revised or negated by authorities or by later stage clinical results. The results from preclinical testing and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in initial clinical trials, but subsequently failed to establish sufficient safety and effectiveness data to obtain necessary regulatory approvals. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. Clinical trials may not demonstrate statistically sufficient safety and effectiveness to obtain the requisite regulatory approvals for product candidates. In addition, as happened with Tysabri, unexpected serious adverse events can occur in patients taking a product after the product has been commercialized.
Our failure to continue to successfully commercialize Tysabri and develop and commercialize other products would materially adversely affect us.