Biotech Values

[DewDiligence]

GTCB annual-meeting Q&A:

I just listened to the webcast Q&A and, unfortunately, only Dr. Cox (who was at the podium) is clearly audible. The questions themselves and the answers by the GTCB officers other than Dr. Cox are not audible.

I can fill in most of the blanks. These remarks are paraphrased and not necessarily verbatim accounts:

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Q1 (Dew): What does the EMEA inspection procedure consist of? Is there only one physical inspection of the sites at GTC and its manufacturing partner (Cambrex), or might there be a series of inspections? Does anyone at GTC have experience with these kinds of inspections?

A1: (Gregory Liposky, SVP of Operations): The Europeans generally like to wrap up everything in a single trip; GTCB personnel do indeed have experience with these procedures.

Q2 (Dew): The most recent SEC filing remarks on the shelf life of ATryn. Is this primarily an accounting matter, or is it a bone of contention with the Agency?

A2-1 (Richard Scotland, VP of Regulatory Affairs): [Sorry, I cannot remember the exact answer, but I know that it was reassuring.]
A2-2 (Dr. Cox): [Audible]

Q3 (Dew): In your presentation today, Suzanne (Suzanne Groet, VP of Therapeutic Protein Development) remarked that ATryn may have greater binding affinity to heparin than plasma-based antithrombin. Why is this important, and is this a feature of ATryn that will become part of the product label?

A3 (Dr. Cox): [Audible]

Q4 (Dew): A nomenclature question: is the "antithrombin alfa" name (the newly registered name for the active ingredient in ATryn) the successor to the "antithrombin-III" name?

A4-1 (Richard Scotland): AT-III refers to the plasma-based protein only, while antithrombin alfa refers to GTC’s recombinant protein.
A4-2 (Dr. Cox) [Audible]

Q5 (Dew): On your most recent conference call, I sensed a de-emphasis of GTC’s albumin program and an increased emphasis on the AAT program, Would you please comment on this?

A5 (Dr. Cox): [Audible]

Q6 (Urche): Would you update us on the malaria program?

A6 (Dr. Cox) [Audible]
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