QDIS Blog

In get caught up on some reading, I came across this article from Pharmaceutical Manufacturing concerning drug safety.

Drug Safety | The Harmful Side Effect We Never Hear About / Congressional Cures? | Pharmaceutical Manufacturing:

I reported recently about drug safety and establishing database and this article has even more details. I highly recommend these two articles article. They were written by Dr. Henry I. Miller of the Hoover Institution. He is an ex-FDA who worked at the administration from 1979 until 1993 and was one of the founding directors of the Office of Biotechnology at the FDA where he served as head from 1989-1993. The first is about harmful side effects of drugs and the mismanagement at the FDA and the second deals legislation currently before Congress. I highly recommend both of these articles.

Technorati Tags: drug safety, FDA

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I missed posting on this when I first saw it but thought folks might be interested in some new federal guidance for disposing of old or unused prescription medicines.

Proper Disposal of Prescription Drugs

The most important point is that you should NOT flush drugs down the toilet unless the accompanying direction specifically say to do so. Municipal waste water treatment plats are not set up to handle this and it can cause environmental problems. In general, the unused or old medication should be placed in the trash in nondescript containers.

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Seems Representative Henry Waxman (D, CA) wants to hear from the following companies about the following drugs for the following reasons:

Lilly: Zyprexa (bipolar). Inappropriate promotion for off-label use
AstraZeneca: Seroquel (schizophrenia). Inappropriate marketing
Boston Scientific: drug coated stents. Safety and off-label use
Cordis: drug coated stents. Safety and off-label use
Cephalon: Actiq (narcotic lollipop) and Fentora (narcotic lozenge). Inappropriate marketing

PharmaLive: Rep. Waxman Requests Research and Marketing Information from Pharmaceutical and Medical Device Companies :

Here are the letters that were sent.

WaxmanLilly.pdf
WaxmanAZ.pdf
WaxmanBoston.pdf
WaxmanCordis.pdf
WaxmanCephalon.pdf

The longest letter went to Cephalon over their narcotic products . All the letters are asking for a long list of items to be provided covering clinical trials, audits, presentations, training material, communication to healthcare providers and much more. It will be interesting to watch and see which cooperate and which may refuse to turn over the requested documents. For Cephalon and Actiq it is for data from 1997 to the present; almost 10 years of data.

Technorati Tags: Actiq, AstraZeneca, Boston Scientific, Cephalon, Cordis, Eli Lilly, Fentora, drug coated stents, Seroquel, Waxman, Zyprexa

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Lilly last week withdrew its application with the European Medicines Agency (EMEA) for Arxxant (ruboxistaurin)

PharmaLive: Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant

The given reason was that they could not respond to the request for the additional information in the required amount of time. Lilly lost an appeal just a few days earlier than this where the FDA upheld thier decision to require additional clinical trials before it would be considered for approval. Lilly said it would take an additional 3-5 years to complete those studies.

My wife is diabetic and has already had some eye problems related to her disease and so I have been following this drug with a personal interest. It will be interesting to see what Lilly will do. Somewhere right now someone is plugging numbers into a spreadsheet to see if it is worthwhile for Lilly to make an additional investment in this drug. Since I have a personal interest in this, I certainly hope so.

Other Resources
Eli Lilly withdraws its marketing authorisation application for ARXXANT (from EMEA website)
FDA rejects Eli Lilly appeal - Pharmaceutical Business Review
Lilly’s Arxxant Hits FDA Snag - Forbes.com (from back in Aug 2006)
Approvable Letter Issued By FDA For Arxxant(R) (ruboxistaurin Mesylate) For Diabetic Retinopathy

Arxxant - Yahoo! Search Results
Arxxant - Google Search
Google Blog Search: Arxxant

Technorati Tags: Arxxant, ruboxistaurin

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Forbes recently had an article about a vaccine from GlaxoSmithKline (GSK) that may protect against many strains of bird flu.

Vaccine May Treat Many Bird Flu Strains - Forbes.com:

The vaccine measurably increased the levels of antibodies in 400 adults after they were given two shots. THe levels were high enough to give presumed protection against the strain of bird flu it was designed to work against. The more promising result is that it may protect against other strains. Other companies such as Novartis and Sanofi-Aventis has also seen cross-protection in their vaccines. What is interesting is the GSK is using a proprietary adjunct which can increase the number of doses by 10-fold. This would be vital if there were an epidemic.

Technorati Tags: avian flu, bird flu, GlaxoSmithKline, H5N1, Novartis, Sanofi-Aventis, vaccine

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Back in January, Reuters had this article on the mysterious pain condition referred to as fibromyalgia

Drugs nearing approval for mysterious pain condition | Health | Reuters.com:

The condition is controversial because it is not east to diagnose and there is no test for it. The diagnosis is made based on patient complaints and responses to subjective questions during an exam. It is estimated that the condition may affect as many as 12 million Americans mainly females. I’m not qualified to say wether or not it should be a recognized disease but it is interesting to note that several major pharma companies are looking at this as an area ripe for new drugs to target this. Among the companies actively developing drugs for fibromyalgia are Pfizer, Lilly, Forest Labs and Wyeth. There may be more but these are mentioned in the above article.

Why is big pharma interested in this? Because it could be a $1 billion market by 2014; it is currently fairly small. The first drug could be approved as soon as next year for fibromylagia. Already Cymbalta from Lilly and Lyrica from Pfizer are being used off label to treat fibromylagia. If either of these two could get approved for this additional indication it could be another $ 200-400 million in annual sales annually for them..

The first approach is to test drugs that companies already sell for other diseases to try and see if they work. Longer term, I am sure their is research ongoing to develop new chemical entities (NCEs) specifically for this condition. However, given the lack of basic understanding of the disorder, it must be difficult to find an animal model to do testing in.

Other Resources
National Fibromyalgia Association
National Fibromyalgia Research Association
fibromyalgia - Yahoo! Search Results
fibromyalgia - Google Search

Technorati Tags: Cymbalta, fibromyalgia, Lyrica, Wyeth

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I somehow didn’t post on this merger from back in early February. Corautus is going to merge with VIA Pharmaceuticals

Corautus to merge with San Francisco company - Atlanta Business Chronicle: :

I’m not familiar with either of these small companies but since I’ve been trying to keep up with M$A activity in the industry I wanted to include it. Corautus Genetics Inc. is a small private company located in
Atlanta GA (hence the reporting in the Atlanta Business Chronicle) focused on cardiovascular and peripheral vascular disease.

VIA Pharmaceuticals is located in San Francisco, CA and also focuses on vascular disease so they seem to be a good fit. I can’t comment on it more than that.

Other Resources
Corautus Genetics and VIA Pharmaceuticals Announce Merger Agreement (official press release)
Corautus Genetics and VIA Pharmaceuticals Announce Merger Agreement: Financial News - Yahoo! Finance
Google Blog Search: corautus “VIA pharmaceuticals”

Technorati Tags: Coratus, VIA Pharmaceuticals

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This is old news from back in Feb but given the recent announcement of acquisition by Schering-Plough I thought it worth commenting on.

PharmaLive: Organon and Pharmacopeia Enter Into Discovery, Development and Commercialization Alliance :

It will be interesting to see what comes out of this agreement now that Schering-Plough will be making the calls once the merger is approved later this year. I don’t know that Schering-Ploug will want to continue with Pharmacopeia but I could be mistaken. I certainly don’t think SP wants to co-develop and co-commercialize future drugs with Pharmacopeia.

Some times agreements such as these can be impediments to acquisitions but I personally think the deal/agreement route is better than the straight acquisition. However these agreements can also mean that the smaller entity can end up being a target that it might not otherwise be due to the terms of the agreement. Icos is still the best example of that. It made more sense monetarily for Lilly to just purchase Icos than to continue to pay royalties under the terms of their agreement.

Technorati Tags: Organon Biosciences, Pharmacopeia, Schering-Plough

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It use to be that major pharma companies did not want to share safety data from clinical trials because they considered the information proprietary.

PharmaLive: Taking the Wraps Off Drug Safety Data from Clinical Trials :

There has been much talk recently about changing that. Some companies have said they will start their own database however, having many different database with differing information I don’t feel would be productive. I also don’t think a voluntary program run by a pharma group would be the best solution either. I’m not sure what is the best but think that in the next five to six years you will see some sort of database covering multiple companies.

Here are some recommendations from the article in Health Affairs in the March/April 2007 issue. The authors are Dr. Aaron Kesselheim and Michelle Mello.

Placing a heavier burden of proof on companies to show competitive harm if data are released.

Replacing the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.

Getting Congress to pass legislation requiring public disclosure of safety data if the FDA fails to take action.

“Safety data from drug clinical trials have important ramifications for public health,” said Kesselheim. “The government should do as much as it can to ensure full disclosure of the information.”

I personally think it will take action from Congress before anything concrete will happen.

Technorati Tags: clinical trials, drug development, drug safety

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I hadn’t commented on the fact that Replidyne and Forest Labs had ended their agreement for development of Faropenem.

StockHouse.com : Replidyne and Forest End Faropenem Collaboration:Zoom structure

This means Replidyne now has full rights to the drug in the US for adults and pediatric use. However, they must overcome the non-approvable letter they received back in Oct 2006 from the FDA. The FDA wanted to see additional clinical trials of a superiority design for acute bacterial sinusitis (ABS) and acute exacerbation of chronic bronchitis (AECB). There were no safety or chemistry and manufacturing concerns. BTW, this drug has been approved in Japan since 1997.

For those interested, here is the structure.
including

Technorati Tags: antibiotics, Faropenem, Replidyne

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