Possible / Probable News Flow in 2008-2009
[Updated for latest guidance.]
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. GTC has guided for an announcement during the first calendar quarter of 2008.
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. I would expect that partnership discussions will be accelerated now that the phase-3 ATryn trial in the US is known to be a success.
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 decides at that time whether to conduct a Priority Review, which shortens the review time from 10 months to 6 months.
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.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
