deal for new nrti with bms

BMS snaps up early stage NRTI for $286M
BMS quote benefit of Festinavir is safety
Festinavir results not a patch on ATC...!


Bristol-Myers buys rights to potential HIV drug
Dec 21, 2010 2:23 AM ET
By The Associated Press

NEW YORK (AP) ? Bristol-Myers Squibb has reached an agreement that could be worth up to $286 million to buy exclusive worldwide rights to develop, make and sell a potential HIV treatment in mid-stage testing by Oncolys BioPharma Inc.

Oncolys, a privately held Japanese company, will receive upfront, development, regulatory and sales milestone payments, Bristol said Monday. It also could receive royalties on worldwide product sales.

The drug, festinavir, is a next-generation nucleoside reverse transcriptase inhibitor. The companies said early studies show festinavir may be safer than previous generations of drugs.

http://www.businesswire.com/news/bms/20101220005444/en/Bristol-Myers-Squibb-Oncolys-BioPharma-Enter-Global-Licensing


Festinavir latest results

Festinavir's chemical cousin, d4T, can cause serious side effects, including mitochondrial toxicity that may manifest as lipoatrophy (fat loss in the face and limbs), peripheral neuropathy, or liver damage. In cell cultures, however, festinavir appears to be less toxic, being a weaker inhibitor of mitochondrial DNA synthesis. The drug was previously found to be safe and well-tolerated up to 900 mg in a single oral dose given to healthy HIV negative volunteers.

In the poster presented at ICAAC, researchers described a double-blind, placebo-controlled, dose-escalating study of festinavir in 32 treatment-experienced HIV positive patients who were currently not taking antiretroviral drugs. At study entry participants had an average viral load of about 4.4 logs and a mean baseline CD4 count of about 400 cells/mm3.

Four cohorts of 8 patients each were sequentially recruited and received festinavir monotherapy at doses of 100, 200, 300, and 600 mg once-daily for 10 days; 2 participants in each cohort were randomly assigned to receive placebo.

HIV RNA, CD4 cell count, and safety and tolerability parameters were assessed at baseline and after receiving therapy. A 24-hour pharmacokinetic analysis was done on days 1 and 10. HIV reverse transcriptase (RT) and protease genotyping were performed at baseline, day 10, and day 17 to look for drug resistance mutations.

Results
HIV viral load decreased by -0.87 log in the 100 mg group, -0.98 log in the 200 mg group, -1.36 log in the 300 mg group, and -1.2 log in the 600 mg group, compared with -0.07 log among placebo recipients.
27 out of 32 patients reported a total of 99 adverse events, of which 62 where considered unrelated to festinavir.
Adverse events showed no clear pattern, being reported by 4, 2, 5, and 1 patients in the respective festinavir dose groups, and by 4 people receiving placebo.
Moderate-to-severe adverse events were reported by 5, 3, 0, and 6 patients, respectively, in the escalating festinavir dose groups, and by 1 placebo recipient.
2 grade 4 adverse events were reported in the 600 mg group, but both were considered unrelated to festinavir.
A dose-dependent correlation was observed between festinavir dose and area under the curve (total drug exposure between doses).
No new RT mutations emerged by day 10 or day 17.