Biotech Values

[mcbio]

ACHN - Notes on 2Q09 Conference Call

There were at least a few interesting notes from this call so I'll just try and note those here without rehashing things touched on previously:

1. The ongoing Phase 1 for the HCV PI ACH-1625 is going quite well executionally and the drug is behaving so far "quite consistent with its pre-clinical profile."

2. The multiple-ascending dose portion of this trial in healthy and HCV-infected patients will consist of 5 days of dosing. ACHN didn't specifically disclose this in the prior release disclosing that the trial had started.

3. The resistance profile for ACH-1625 was asked about during Q&A, in particular what differentiates ACH-1625 from telaprevir and other PIs under development. It was noted that telaprevir shows a mutation at amino acid 156 whereas ACH-1625 apparently shows a mutation at amino acid 168. Also, apparently ACH-1625 is the only open-chain PI whereas most of the others are macrocylic. So, there are structural differences that distinguish ACH-1625 from other PIs under development. Whether this leads to advantages or disadvantages of course needs to be played out in the clinic.

4. Regarding ACH-1095, the NS4A antagonist, ACHN finally disclosed that tox signals were seen in animal studies and this is presumably what led GILD to drop the compound. However, ACHN still intends to bring the compound into the clinic at doses below those that caused toxicity in animals. GILD and ACHN have apparently agreed in principle that ACHN will take the compound into the clinic to show PoC and GILD will have the right to join back in the development of the compound. ACHN expects to meet with the FDA in Sept. or Oct. to discuss the IND.

5. GILD and ACHN continue to work on additional NS4A antagonists beyond ACH-1095.

6. ACH-702 - Of the non-HCV assets, ACHN expects this to be the first partnered compound and also expects this compound to warrant the most lucrative deal among the non-HCV assets. They expect the initial target for this compound to be conjunctivitis.