Notes - Elan @ JPM, January ‘08
Company is very financially disciplined
Maintains high cash balances in order to move forward in R&D
Credit markets have been kind - bonds have actually gone up in value
Company has hired ~200 people in 2007
Have consolidated from 27 locations to 8 worldwide
Everything based on science, based on West Coast, World class, leverage across board, continue both tactically and strategically
Perfection and Execution driven – come in all shapes, small and strat, many behind scenes, want to move everything forward to make major impact on Patients
Finished 2007 after moving:
aab-001 -> phase III
aac-001 -> into phase II (vaccine)
aab-001 -> sub-q to phase I (will -> phase II in '08)
elnd 005 -> phase II
Value drivers
Ty for MS:
Cost - due to efficacy of Ty - it is actually the cheapest med because it results in the least relapses
opportunity for Ty in the market is over 100K in time
Should become leading therapy
Many organizations look how much costs to avoid relapse
Given competitors price increases, T is cheapest Tx out there
That is why we and partner BIIB had succ in EU, particularly UK and Scotland, where quite complicated
Very effective re reimb, all reimb worlwdie very good
Mkt opp, 100-150K patients on drug
Fair amt of turnover and switching and many drop off
We believe MS opp for T is very significant
Completely agree w/100K by 2010YE both ELN and BIIB taregt
W/evolution of drug, T will become leading MS drug efficacy, cost attr, unmet med need
Over 40% on curr Tx decline, some say as high as 60%, high patient need for this drug
Very confident will gain traction going forward
Ty for Crohn's:
Evolving market
Globally 300k patients - 170k severely ill (Ty market)
this market is growing
Positioned for those GIs with biologic experience and for patients who have failed anti TNF meds
Anticipate do more clin work
Seek clinicians feedback
Tysabri logical place to move
GI docs eagerly await opp to use drug and incorporate into practice
PDUFA 14 Jan'08 T in CD, launch in 1H'08
Alz:
3 approaches to removing beta amyloid:
with WYE - good partnership - moving forward
with LLY - still option to move into their program
elnd 005 with TTHI - dosed 1st patient in phase II in 2007
New information regarding the 2 p2 trials regarding elnd005 -
One trial for "mild to moderate" and the other for "early onset" or "mild congitive impairment" (MCI).
So, why move to Ph III while still in phase II with aab-001 ?
Much data reaching back to AN1792.
In Phase 1 there was much data and interim data from phase 2. Showed enough good data (May 2007, knew what looking for and what seen early from BAP) to 4 entities, Elan, WYE and 2 reg agencies (FDA, EMEA) to agree to move forward.
P III protocol:
4 pivotal trial 2 APOE4 non-carriers, 2 APOE4 carriers
Approx 4K across 4 trials
ELN lead US/Canada, WYE EU/ROW
1st patient dosed US in Dec2007
elnd 005 TTHI partner:
Fast rack Apr2007
Plan start early P II in 2008, also dosed 1st in Dec2007
Also elnd 005 in 2H'o8 early AD = MCI
Multiple AD trials in 2008:
* aab-001 (4 in phase III)
* aab-001 subQ P1 then p2
* aab-002 p1
* acc-001 p1
* acc-002 p1
* elnd 005 mild AD
* elnd 005 early AD (= mci)
* gamma e/Lilly p3
* elan's gamma pI
(that adds up to 12 concurrent ALZ clinical trials)
ELN will hold Investor Day in 2nd half of year.
"....on the biotech battle-field, you need some élan...."
