Replies to post #8195 on GTC Biotherapeutics (fka GTCB)

[vinmantoo]

Dew,

Now I would be surprised if we saw a US partnership materialize until after the final patient has been treated and the rATIII data from the HD phase III trial is completed. That would bring us to mid-year. In my view this means most likely it will occur close to the time when GTCB submits their BLA to the FDA. I won't speculate about Japan but that would be pretty nice to see something on that front.

Vinny

[kaivamei]

Japan partnership in "Possible / Probable News-Flow"

Dew, Perhaps the news flow post should be revised to reflect Cox's informal guidance that a Japan partnership is more likely to be consummated in 2009 than 2008.

[DewDiligence]

Possible / Probable News Flow in 2008-2009

[Updated for latest guidance from 4Q07 CC.]


1. A partnership for ATryn in the US. Now that the phase-3 ATryn study in the US is known to a success, a partnership announcement could come at any time. On the 3/6/08 CC, Dr. Cox guided for an announcement during the next few weeks.

2. A partnership for ATryn in Japan. Japan has substantial sales of plasma-derived antithrombin, including an approved indication for DIC/sepsis. These plasma-derived sales represent low-hanging fruit for eventual conversion to ATryn. At least one Japanese clinical study (by a GTC partner) will be needed to obtain marketing approval. On the 3/6/08 CC, Dr. Cox said he thought a deal in 2009 was more likely than in 2008.

3. Submission and acceptance of the ATryn BLA for FDA review. Submission is expected in mid 2008 and FDA acceptance of the BLA for review occurs approximately 60 days after submission. The relevance of the acceptance-for-review date is that the FDA often decides at that time whether to conduct a Priority Review (which shortens the review time from 10 months to 6 months). However, on the 3/6/08 CC, Dr. Cox said he thought an FDA decision on Priority Review might come sooner—perhaps before the last BLA module is submitted.

4. Results from the phase-2 ATryn study in DIC. The latest guidance from GTC’s partner, Leo Pharma, is for completion of enrollment by the end of 2008 and reporting of data in 1H09. This study will be closely watched by the investment community because DIC—and other acquired antithrombin deficiencies—address a much larger market than hereditary deficiency.

5. A development partner for the CD137 program. This would be significant because CD137 is the most advanced internal program that is not based on a plasma protein. However, GTC has given no guidance about when a CD137 partnership deal might be struck.

6. Something else. This could be an additional program within the LFB collaboration or something out of the blue.

[pharm]

Donald, or is it Roy, I think the thread 8195, talking about partnering, according to the latest CC has to be updated. A partner for DIC treatment in the USA is forthcoming, wihin weeks. A Japanese partner for the same treatment will be wellcomed only in 2010.
Then GTC initiated discussions with potential partners for rec. plasma-proteins, presumably Factor 7, Factor 9 and antitrypsin. Signing this year?
Cox also mentioned coronary artery bypass surgery, as he did that before in an interview on 2/11/08. A potential market of $ 150-200 mm a year. He did not mention that partnering discussions are taking place already, but introduction into the market could be more quickly than the DIC treatment.