Biotech Values

[srsmgja]

"Copaxone Continues to Clean Tysabri's Clock in the US Market"

Dew's post is long on hyperbole, but short of detailed facts and objective reasoning, IMO. So here is my rebuttal commentary.


1. While it is true that Copaxone's sales increased 12% QoQ in the US, it is also true that Teva increased Copaxone's price by 10% effective January 3. Funny Teva and Dew neglected to mention that little detail. Tysabri saw a 3% price increase, but we don't have to guess on unit growth, because BIIB/ELAN provide the market with EXACT UNIT NUMBERS.

2. If you read the press release and the printed summary in the 1Q conf call and compare it to the year end/ 1Q conference call you will note that TEVA details the sales growth of Copaxone for the 1Q based on price and UNIT GROWTH. Those facts are missing from the recent 2Q report. Gee, I wonder why?

Just a guess ....... they probably would not cast Copaxone unit growth in a very favorable light. Of course, maybe they were just rushed and forgot to mention it.

3. Tysabri's growth rate in the US was flat QoQ. However, if you care to look below the surface and beyond the stated numbers ( a policy often suggested by our moderator), you will find reasons to POTENTIALLY explain this flat growth. Specifically, the first case of confirmed PML in the US occured in the 4Q and the first and ONLY DEATH from PML (again in the US from the same patient) occurred late the 4Q. It is reasonable to suspect that this had a big damper on script growth early in 1Q.

4. Tysabri's drop out rate increased from about 10% pre PML (Aug 2008) to approx 20% into the 4Q and early 1Q. Tysabri must be renewed every 6 months by FDA rules. Hence, neurologists had up till February (6 months from the inital PML cases) to either renew Tysabri or discontinue its use among existing patients.

5. According to BIIB/ELN the month of March saw the largest number of additional ADDS for Tysabri in 5 months and also saw the drop-out rate return to Pre-PML levels. Note that these positive trends occurred even with another confirmed case of PML in February.


6. Overall, the AAN was positive for Tysabri. No new dramatic safety issues, a stated incidence of PML of 1.2/10,000 (about 1/8 the rate stated on the label), new reports of continued efficacy improvements never before seen with other MS medicines, and the first suggestion of evidence of in-vivo remyelination.

7. New and continued safety issues for the 'new competition'. Suggestions by many that the new oral drugs may not be on the market as quickly as many had originally suggested. That leaves less alternatives for all those failing the CRABs.