Replies to post #102031 on Biotech Values

[jellybean]

You sure about that?

Here's the official policy statement from one state:

A drug will be considered eligible for P&T Committee review if it meets one of the following criteria:
• A “new brand” drug defined by the FDA as having the new drug application (NDA) approved which indicates that the product may be marketed in the United States
• A “new brand of an established generic” and has met the FDA definition above of “new brand”
• A “First Generic” on the monthly FDA update of “Generic Drug Approvals”. First Generics are those drug products that have not previously been approved as generic drug products and are new to the marketplace.
Drugs that meet these criteria are included on the agenda of the next P&T Committee meeting for review, regardless of whether an annual review is conducted for the respective drug class

Because M-enoxaparin is a first generic, the drug will be reviewed more quickly than Reco, but it will still require review.

[Regulardoc]

Several tardy thoughts on the enox issue. BTW, I am a bull on the company. As a practicing physician, currently on a P&T committee, and having chaired them in the past, the committee does not review each and every generic option. We basically endorse the chemical drug, then leave it to the pharmacy purchasing specialist to get the best deal, brand or generic.

On that subject, for VHA contracts, SNY dropped the price of Lovenox by 40% in July. I believe this is way more aggressive than Sandoz expected and is probably behind the continual drop in the stock, as I believe the legal issues pose minimal risk. This 40% cut prices 40mg Lovenox (which is the most common dose within a hospital) at $17.52 vs the Sandoz price of $28.37. The offered Sandoz price to VHA is actually more than the purchase price at drugstore.com. The 80mg Lovenox dose is priced to VHA at $35.07, while the Sandoz offer was at %56.70. Sandoz may have strategically decided not to go after the VHA consortium.

Finally, something that has not been reported, and probably is not a major issue, except for initial selling of the drug and "first impressions" is that Sandoz has had a few instances in which the prefilled syringe spring mechanism did not work properly. The company sent out a notice to hospitals on 8/16. This may be the nature of the beast, and although I am uncertain, may also occasionally occur with Lovenox itself.

Just reporting what I have heard aorund the hospitals.