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New HIV drug will be small player

May 24, 2011

Analysis of:J&J AIDS Pill Approval Heralds $9 Billion in New Sales From Drug Pipeline | www.bloomberg.com

Rilpiverine, which will largely be sold through a minority partnership with Gilead seems unlikely to be much of a player in the HIV market.

Bigger concerns about Abacavir than HLA testing

July 28, 2008

Analysis of:F.D.A. Urges Genetic Test Before Giving AIDS Drug | www.nytimes.com

The HLAB5701 test is inexpensive and uncomplicated to perform It reduces risk of the hypersenitivity reaction. Two recent studies have raised concerns about abacavir. -ACTG 5202 study has indicated that in persons with high viral loads epzicom (the main brand of abacavir) is less effective than truvada in initial therapy -The DAD study (Sabin C et al. Lancet 2008) has suggested an association between abacavir and heart attacks.

Impressive results in competitive environment

March 26, 2008

Analysis of:Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load | www.pipelinereview.com

Impressive 7 day antiviral effects Potential for QD naive and BD experienced approaches Potential for coformulations Revised formulation moving into next phase of testing No critical safety issues in volunteers or patients Metabolit may be anti-gout agent

Small delay for first CCR5 antagonsit

July 5, 2007

Analysis of:Pfizer Receives Approvable Letter From FDA For Maraviroc | www.pipelinereview.com

While ideally Maraviroc would now be approved the requests from the FDA do not require new clinical trials. The main issues relate to the failings of other drugs in this class Aplaviroc (Ono/GSK) discontinued for hepatotoxicity and questions over malignancies with Vicriviroc (Schering-Plough). Data presented with Maraviroc do not suggest or even vaguely insinuate that Maraviroc has these problems. The safety, thus far, looks similar to the placebo arms. The efficacy looks great. The drug looks very likely to be approved very soon. Delays, unfortunately, allow the extent of competitive landscape to increase with further data on etravirine and raltegravir expected at the IAS conference in 2 weeks and approvals for the agents pending.

CCR5 antagonists: New Data

August 23, 2006

Analysis of:AIDS 2006: XVI International AIDS Conference | www.aids2006.org

Activity observed in R5 only but minimal activity in X4/R5 viral populations.
Good safety observed for both Maraviroc and Vicriviroc
Data indicate likely need for routine screening for viral tropism. The assay used for this is owned and operated by Monogram Biosciences.

Darunavir (TMC114, Prezista)

August 21, 2006

Analysis of:AIDS 2006: XVI International AIDS Conference | www.aids2006.org

New Standard of Care PI for PI-experienced Patients
Data may set new bar for approval of new agents in treatment-experienced patients
Likely to squeeze market for Kaletra and Tipranavir in this population

No Benefits to 4 drugs over 3 in Treatment

August 18, 2006

Analysis of:Similar Efficacy for 3- and 4-Drug Anti-HIV Regimens | www.medscape.com

No Efficacy Advantage
Some agents add extra toxicity
Lipids a problem with PI+NNRTI combinations

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