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mcbio

10/04/11 11:47 PM

#127800 RE: jq1234 #127799

I think they probably over compensated for injection site comfort, it adversely affected efficacy.

I think you may be spot on here. The tolerability issues are gone but 105 and 107 didn't work as quickly as Linjeta. There was also the tail washout issues with 105 and 107.

As of making existing analog UFI, I don't have any data from them as basis to have an opinion. So I don't know.

They mentioned in the CC that analogs themselves don't have washout issues so that presumably shouldn't be an issue with BIOD's potentially improved analog. The big question is presumably whether or not BIOD's version will work much quicker than the existing analog and whether or not that will end up translating into a meaningful clinical benefit. More near-term the important question is if these theoretical advantages and the pre-clinical data are enough to convince the potential big pharma partner to do a deal with BIOD. Like you say, we should know by the end of this quarter.
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jq1234

10/18/11 7:33 PM

#128729 RE: jq1234 #127799

Halozyme Announces Positive Results from Roche's Subcutaneous Herceptin Phase 3 Trial

SAN DIEGO, Oct. 18, 2011 /PRNewswire via COMTEX/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced that the Phase 3 HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin® (trastuzumab), experienced comparable results to Herceptin given as an intravenous (IV) infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1618101&highlight=