QDIS Blog

Since I use Ambien on occasion it was good to hear Dr. Reddy’s Lab is no approved to sell generic Ambien.

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, zolpidem tartrate, Sanofi-Aventis

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Seems my old company is now paying $10.5 million to resolve claims that they were promoting Trisenox for uses that were not approved.

Cell Therapeutics to pay $10.5 million:

I always thought they were leaving them selves open for this sort of problems back when I was working for them given the huge amount of off-label use. When a huge portion of your drug is being used for diseases it isn’t approved for, you are going to raise some eyebrows.

I should note that “Cell Therapeutics does not admit any wrongdoing in the matter”. And we all know what that really means.

Technorati Tags: CEll THerapeutics

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Express scripts is now reporting that in five eyars, by 2012, biotech drugs will account for 25% of all expenditures on drugs. The market was $54 billion in 2006 and is expected to reach $99 billion by 2010.

SignOnSanDiego.com > News > Business > Biotechnology — Spending on biotech drug prescriptions rising:

I think this shows you why so many big pharma companies are either buying or investing in biotech. Also, since there is currently no biogenerics industry and regulation is only now starting to be worked on it is no wonder.

Technorati Tags: biotech, biogenerics

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This news is somewhat dated now but the M&A activity in the pharmaceutical industry continues. Now AsraZeneca is purchasing Medimmune for $15.6 billion.

AstraZeneca to buy MedImmune for $15.6B - Yahoo! News

The two main products of interest are the children’s respiratory drug Synagis and a refrigerated version of FluMist inhaled influenza vaccine. This follows the current trend of major pharma increasing interest in vaccines. Novartis purchased Chiron and both Sanofi-Aventis and GlaxoSmithKline have sizable vaccine businesses.

MedImmune had until recently, actively resisted any such take-over moves. I’m not sure why they finally relented and went forward with AstraZeneca. Maybe they finally got the price they wanted.

Technorati Tags: AstraZeneca, Medimmune, pharma M&A, pharmaceutical deals

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It isn’t surprising that the FDA rejected Merck’s NDA for Arcoxia, its follow on to Vioxx since an advisory committee already voted 20-1 against its approval. Forbes has an article on it.

FDA Rejects Merck’s Vioxx Successor - Forbes.com:

It is interesting to note though that Arrcoxia is on sale in 63 countries world-wide already. It be be interesting to see what effect if any it has on world-wide sales.

Technorati Tags: Arcoxia, Merck, Vioxx

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Seems the Sanofi BMS merger talks haven’t been without some truth to them. Now the Times Online is reporting that there is a split on the Sanofi side over strategy

Sanofi board split over $54bn deal to acquire Bristol-Myers-Business-Industry Sectors-Health-TimesOnline

The Times has learnt that a disagreement over strategy has emerged between Jean-François Dehecq, the Sanofi chairman, who favours a transformational deal with BMS, and Gérard Le Fur, his younger chief executive, who has emphasised the need to focus on the group’s internal drug research and development programme.

The article goes on to say that the former view of merger with transformation is more probable. I think that it might be the less attractive strategy in the long run. I’m not a big fan of mergers since few ever really show the advantages that are promised.
I think the continuing trend of mega-mergers in the pharmaceutical industry will continue but I also do not think it will solve the long terms problems of the industry.

Technorati Tags: BMS, Bristol-Myers Squibb, pharma M&A, pharmaceutical deals, Sanofi-Aventis

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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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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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