Wednesday, November 7, 2007

MRSA Follow-up

Ahhh, back to our favorite topic-MRSA. As a follow up to the previous post-Andy Behm from Express-Scripts sent a few drugs that are either approved or in the pipeline, as well as a clarification of what "approvable" means in the process.

The most recent drug is Doribax (doripenem) that was approved a few weeks ago for IV use. It falls in the carbapenem class (Remmel is going to get to this soon, so I know nothing on the class as of right now-sorry) but it can be used for complicated intra-abdominal infections and complicated UTI's-so it's effective agains both gram positive and gram negative infections. For further details on what doripenem treats-head here.

The following three drugs that he mentioned are in the "approvable" classification according to the FDA. Andy said that this means that the drug is on the right track towards becoming approvable, and there are a few more things that need to get worked out, like further testing or come up with appropriate labeling. For an interesting discussion on "approvable" letters and how companies respond (and how investors look at the drug development process) head here.

The first drug that falls in this class is the aforementiong televancin-check this one out below. Another drug that is "approvable" is Pfizer's Zeven (dalbavancin). Besides having a sweet brand name-great marketing, Pfizer-dalbavancin works by inhibiting peptidoglycan synthesis and blocking cell wall formation by binding the D-alanyl-D-alanine that is found on precursors of peptidoglycan. For a longer summary of the drug-head here. Also, Pfizer bought the rights to dalbavancin from Vicuron, who first submitted the New Drug Application in 2004.

The third and final drug passed on by Dr. Behm is a drug from Arpida called iclaprim. It works by inhibiting dihydrofolate reductase, and has effectiveness against many different bugs. However, it seems to have met with a critical crowd as evidenced by this article and this one.

As a final note, oh loyal blog-watchers, I wanted to throw this final thought out: When I was looking through these articles, I realized many of the articles didn't discuss the effect and benefit that having more medicines that are effective against resistant strains available and the improvement in treatment this would bring, but on the economic boom that resistant bacteria bring to big PhRMA and their stockholders. As the market share of the treatment of nosocomial infections grows from $10 billion last year to a predicted $40 billion by 2010, it seems that like sharks to blood, drug companies are laboring to bring their drug to market faster and claim a piece of that pie. To see how many companies are looking at this possibility and drooling-look here.

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