From NCB Equity Research Morning News & Views
Tysabri Conference Call Highlights
• To clarify some confusion in the market, BiogenIdec stated on the joint CC with Elan that there was nothing in the label that precludes first-line use of Tysabri. When the prescriber and patient agree, the label allows the use of Tysabri in treatment naïve patients (first-line use), as the FDA has recommended but not limited use of Tysabri to patients that have failed other therapies. An estimated c.15K-20K patients are diagnosed with MS annually.
• Tysabri is expected to be available in the US in July 2006. Over the next few weeks the FDA is expected to finalise educational/training materials and BiogenIdec/Elan will validate internal systems based on final FDA requirements. Once internal personnel are trained, infusion centres can be registered. At that point, BIIB/Elan expect that it will take 2-10 weeks before patients are administered Tysabri with reimbursement possibly taking some time although they do not anticipate substantial issues surrounding reimbursement. BIIB/Elan will target the 2000 infusion entres in the US and 2,500 neurologists through the c.220 person sales force. In Europe, a decision on Tysabri's approval by the EMEA is also expected in the July timeframe which will lead to a country-by-country roll-out starting in Germany with roll-out in other European markets in H1 2007.
• The price of Tysabri will be disclosed closer to the launch of the product. With the two year Phase III data now included in the label, it seems likely that Tysabri's price will increase from the $23.5k.
• In terms of the RiskMap there is nothing substantially new incorporated into the risk management program from that discussed at the advisory committee meeting in March 2006. The goals of the RiskMap are to ensure
(i) that patients are fully informed about the risk of PML;
(ii) that early detection of PML can occur and
(iii) that data is continually assessed so that the factors associated with patients developing PML can be made.
The companies anticipate that rumours will surface over the coming quarters about suspected PML cases and they will only comment on fact based cases.
• In the label, no "wash-out" period has been recommended for patients on current MS therapies or for those on immunosuppressants. This could see patients potentially having quicker access to Tysabri than previously thought. Elsewhere, the 70K patient supply capacity at BiogenIdec's North Carolina plant was re-affirmed with the potential to increase this capacity to supply 100K patients. The high-titre process and the facility in Denmark are not anticipated to be in use until 2008. Our peak sales forecasts of $1.8bn assume use of Tysabri in c.65K patients.
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