Replies to post #73877 on Biotech Values

[tinkershaw]

I used yesterday's stock crash to load up on MNTA like I should have done last year when it crashed but was otherwise pre-occupied. Buy this morning, come back after lunch, and dang nab it! Up 13% as I speak! I guess it must be the label expansion for Copaxone.

I do have to say that it is much more comfortable owning an interest in the success of glatiramer acetate then it is in owning an interest in tysabri. I still do not think much of copaxone as a drug, but as a marketing success it lives up to its billing. Clearly those who make a living prescribing it and paying for it do think a lot of it.

I assume from the stock price reaction that this label expansion is materially significant to copaxone's already substantial market.

Tinker

[DewDiligence]

Teva reports Copaxone-in-CIS data from 5-year extension of the PreCISe study:

http://finance.yahoo.com/news/Early-Initiation-of-Treatment-bw-4151190818.html?x=0&.v=1

CIS (Clinically Isolated Syndrome) is considered a precursor of MS and is a modest but not insignificant market for Copaxone. The FDA approved Copaxone in CIS in Mar 2009 (#msg-36015642) based on data from the PreCISe study in which patients were followed for three years; the primary endpoint was time to “conversion” of CIS to full-fledged MS (http://clinicaltrials.gov/ct2/show/NCT00666224 ).

In the pivotal data, the primary-endpoint HR for Copaxone relative to placebo (with crossover after conversion) was 0.55 (p=0.0005); in the 5-year extension, the HR was 0.59 (p=0.0005). In other words, most of the treatment benefit of immediate Copaxone relative to placebo (plus delayed Copaxone) that was observed during the first three years was preserved out to five years.

[DewDiligence]

Rebif delays conversion from CIS to MS in phase-3 study:

http://www.merck.de/en/media/extNewsDetail.html?newsId=BE4AD7B22B3C0C39C12577C600734F7D&newsType=1

The primary endpoint was time to conversion. For patients in the thrice-weekly dosing arm (44mcg per dose), HR=0.49 and p<0.00001. For patients in the once-weekly dosing arm (also 44mcg per dose), HR=0.69 and p=0.008. The full dataset will be presented at an unspecified medical conference.

Copaxone is already approved in this indication based on pivotal data broadly similar to the above data for Rebif (#msg-55641123).