Replies to post #13713 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

When will Leo pay milestones?

Referring to #msg-12430822, we know that there are $38M in potential clinical/regulatory milestones. Although the amounts have not been disclosed, the triggers have been. They are:

• Completing the phase-2 DIC trial with results sufficient to advance to phase-3
• Enrolling the first patient in a phase-3 DIC trial
• Completing a phase-3 DIC trial that hits its primary endpoint
• Submission of an MAA (similar to a BLA) to the EMEA for the DIC indication
• EU approval for the DIC indication
• Canadian approval for any indication
• Approval in any Middle East country for any indication

Referring again to #msg-12430822, we know that there are $30M of potential sales-based milestones. The $30M is comprised of two one-time milestones (probably about $15M each) that are triggered when annual ATryn sales in all Leo territories exceed undisclosed thresholds.

http://www.sec.gov/Archives/edgar/data/904973/000119312505232480/dex101.htm

[go seek]

Positive opinion from FDA advisory panel / ATryn

If we receive a positive opinion from FDA advisory panel, what is likelihood of approval?

Do you expect an opinion from FDA advisory panel before EOY 2008?


The creation of a thousand forests is in one acorn.

[DewDiligence]

Today’s SEC filing:

http://sec.gov/Archives/edgar/data/904973/999999999708037528/filename1.pdf

The filing means that the SEC has agreed to keep confidential the redacted details of GTC’s contract with Ovation.

[DewDiligence]

When will Ovation pay ATryn milestones?

[Updated for milestones already paid.]

$9M of the $257M total potential milestones pertains to the HD indication:

• $5M already received
• $1M on positive opinion from FDA advisory panel
• $3M* on FDA approval of BLA
[*$4M if FDA overrules a negative panel vote.]

The other $248M consists of undisclosed amounts triggered by three clinical/regulatory milestones for the DIC indication and undisclosed annual sales-based milestones on a nine-tier schedule that apply when sales in the preceding year exceed an undisclosed threshold. There are no clinical/regulatory milestones for the CABG/HR indication.

The three clinical/regulatory milestone triggers for the DIC indication are: i) establishment of a mutually agreeable clinical-development plan (including LFB if the development plan is global); ii) FDA acceptance for review of the sBLA; and iii) FDA approval of the sBLA.

http://sec.gov/Archives/edgar/data/904973/000119312508170051/dex101.htm