Although investors’ fury at Elan’s management is understandable and legitimate, the management’s mistakes should not blind them to fairly assessing this firm, which has contributed to science and drug development more than most other drug developers, small and large. There is reason to believe that this contribution to science is the main reason behind the firm’s financial debacle. Nevertheless, Elan’s science, scientists, their discovered disease pathways, and the technologies they created have advanced the understanding of neurological diseases and made possible the management of diseases yet to find treatments. While drug companies design, discover and develop drugs that target validated pathways of diseases, Elan, itself, discovered the pathways of diseases for the drugs it designed and developed. In neuropathology, Elan’s research and findings have enriched the medical libraries with breakthrough knowledge about the pathophysiology of diseases such as Alzheimer’s disease, Parkinson’s disease and multiple sclerosis.
The firm developed several products for Alzheimer’s disease based on its understanding of the disease pathways. In addition to its small molecule inhibitors of beta secretase and gamma secretase, the firm developed small molecule drugs that target neurotrophic receptors that could protect vulnerable people’s neurons. It identified unusual forms of alpha-synuclein, a major component of Lewy bodies, which is a signature characteristic in the brain tissue of Parkinson’s disease patients. This finding has led to therapeutic targets that are the focus of Elan’s new drug discovery efforts.
It was Elan’s scientists who discovered the role of the selective adhesion molecule, alpha 4 integrin protein, in the etiology of multiple sclerosis and other autoimmune diseases, including Crohn’s disease. Alpha 4 integrin has a role in the movement of immune cells from the bloodstream into the tissues in response to inflammation. Elan’s breakthrough selective adhesion molecule inhibitor Tysabri® (natalizumab) is approved for the treatment multiple sclerosis and Crohn’s disease. Yet, Elan’s scientists continue to investigate new small molecule inhibitors that block alpha 4 integrin and may selectively block immune cell traficking. The firm’s scientists are also studying signaling molecules that may be involved in the brain inflammation characteristic of secondary progressive MS. The firm aims at disrupting the pathway of chronic inflammation-neurodegeneration that causes permanent disability in advanced MS.
In addition to illuminating the molecular pathological pathways, selecting therapeutic targets, and designing evidence-based drugs, Elan created state-of-the-art technologies that enhance the safety and efficacy of products and, even better, make possible the development of products that lacked the physicochemical requirements of therapeutics. Elan’s two important technologies, NanoCrystal technology and drug delivery technology have contributed to improving the actions, effects and side effects of several drugs.
That said, the question remains: does the resentment of the management’s mistakes prevent us from trying to determine a fair value for this firm at the current stage?
Final word: Again, we prefer to be objective and do our homework, including taking into consideration the harm that resulted from the management’s miscalculations. This harm, which has been financial, has reached a stage where it had to slow, if not halt, the firm’s scientific ambitions, which, together with other unexpected circumstances, like the unexpected risk of progressive multifocal leukoencephalopathy (PML) as a side effect of Tysabri, caused the accumulation of large dept. Elan had to downsize. It did. It had to reform. It did. Still finding itself in a disagreeable territory, it had no option left but to relinquish most of its Alzheimer’s disease programs. It did. It then thought to dispose of its drug delivery technology to get rid of the rest of its dept. It did not.
This surprising hesitation of Elan to execute its own plan has probably been the firm’s belief that Tysabri’s sales could do the financial miracle now that the firm has already filed to include the anti-JC Virus antibody status test in Tysabri’s product labeling. The decrease, or elimination of the risk of PML, which has prevented the breakthrough drug from becoming a blockbuster drug, will, indeed, produce the miracle that would resurrect this firm.
Elan has marketed products that bring to its coffers over $1.1 billion. Around 60% of this revenues comes from Tysabri, which it partnered 50-50 with Biogen Idec (BIIB). The firm is still offering its services for other firms through its technologies, and will continue to cash in royalties on products that have been approved and marketed for other firms. The latest apparent blockbuster drug Ampyra for MS leg walking difficulties was developed for Acorda (ACOR) Therapeutics with Elan’s technology; it had an excellent market penetration.
Tysabri is still the most effective MS drug on the market. Further diminishing the risk of developing PML would lead to sales that would generate between $2.5-$3.0 billion a year. The drug is approved in more than 45 countries; for relapsing forms of multiple sclerosis (MS) in the U.S. and for relapsing-remitting MS in Europe. It is not unrealisted to expect that both the U.S. and EU would expand their approval of the drug to both indications. Elan’s current revenue increase was driven by the growth of Tysabri and the launch of Ampyra.
To make the story short, Elan is insured by Tysabri. We believe Elan will either be resurrected by Tysabri, or be taken over because of Tysabri. Either way would be rewarding to the shareholders.
Disclosure: Long XOMA, ELN