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Replies to #87667 on Biotech Values
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tinkershaw

12/16/09 11:39 PM

#87671 RE: rkrw #87667

http://www.medicalnewstoday.com/articles/169171.php

To my knowledge it has only been compared to exantide BID, not exanitide LAR. The quick look I did only said it did better than BID, but no numbers or details were given.

Again, not unexpected at all. The future is 1x a week, i.e, exanitide LAR, so that is where the real comparisons will be made. Byetta bid is a good drug, but it is being improved upon.

So the answer is there are no such comparisons that I know of, and I have not seen any numbers to support the conclusions given by Roche for Taspoglutide. I would assume if the numbers were ground breaking the top line numbers at least would have been provided. Maybe they were in a more detailed press release, but I don't have the time to look it up at present if that is the case.

Tinker
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p3analyze

12/16/09 11:46 PM

#87672 RE: rkrw #87667

Tasoglutide - news release contains no Hb1A specifics, could you supply a better reference for us to compare? Thx

http://www.roche.com/investors/ir_update/inv-update-2009-10-29.htm
Basel, October 29, 2009
First Phase III clinical trial of Roche's weekly taspoglutide meets primary end-point of change in HbA1c

Significant superiority on HbA1c versus twice-daily exenatide demonstrated in this head-to-head study

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that headline results from its Phase III study, T-emerge 2 (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD), showed that the trial met its primary endpoint of change in HbA1c. Superiority versus exenatide was demonstrated.

"We are pleased that these results from our first head to head Phase III trial reinforce taspoglutide’s profile as a potential best-in-class GLP-1, supporting its use as an important and convenient new future therapy for patients with type 2 diabetes", said Jean-Jacques Garaud, Head of Pharma Development, Roche.

The results showed that taspoglutide demonstrated superior HbA1c reduction versus exenatide following 24 weeks of treatment. The study analysis included 1189 patients, equally randomized into three active arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks, and exenatide 10 mcg twice daily). Taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide and exenatide treated patients were nausea and vomiting.

Data from T-emerge 2 will be submitted for presentation at upcoming international scientific meetings. In addition, seven other phase III trials exploring taspoglutide in patients with diabetes are ongoing.

Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.