Replies to post #104628 on Biotech Values

[DewDiligence]

…claiming that they will convert the entire Copaxone market to the 0.5ml by EOY 2011.

Total BS, IMHO.

What is it about Copaxone in a more concentrated form (0.5ml vs 1.0ml) that is patentable?

Any patents that issue on this product probably won’t stand up to scrutiny; however, Teva may be able to get three years of Hatch-Waxman marketing exclusivity for a new formulation.

[rwdm]

A Canadian patent application has been submitted by Teva on the more concentrated Copaxone solution.

http://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2697570/summary.html?type=number_search#Details

[genisi]

I don't think the 0.5ml formulation (indeed it has the same active ingredient) has something that is patentable, it is quite obvious that a lower vol (less sterile water and mannitol) should cause less injection site pain. Teva clearly hopes to delay a generic to the 1ml product. Teva has another formulation - 40mg dose/three times a week for the same purpose.