QDIS Blog

Wow! I read today that the EU performed raids on almost all the major drug companies on Wednesday. This includes Pfizer, Sanofi-Aventis, GlaxoSmithhKline, Astrazeneca, Merck, and Johnson & Johnson.

E.U. raids drug companies in broad inquiry

The authorities are looking for evidence of abuse of patents and illegal deals to keep cheaper generics off the market. Here is a quote form the article.

The raids will help establish if companies created barriers to competitors, whether they misused patent rights or engaged in “vexatious litigation” and if some firms abused their dominance of the market.

It will be interesting to see what comes of this if anything. I’ll but we don’t hear anything else about this for months but I’ll certainly be keeping my eyes open for further information.
Technorati Tags: GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Sanofi-Aventis
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I Tivo’ed Frontline’s “The Medicated Child” recently and finally got around to watching it the other night. This is a follow up from an episode they did on this back in 2001. You can watch and read about it online. It was somewhat disturbing at parts especially when they mentioned a young child who was on several atypical anti-psychotics at the age of four! Here are some of the interesting points brought up:

1. There has been a 4,000% increase in diagnosis of psychiatric problems in young children over the last ten years

2. Although doctors do not agree about bipolar in young children many kids are being diagnosed as being bipolar at ages as young as four years old.

3. There is a growing number of strip mall places offering “brain scans” looking at blood flow to the brain to give a diagnosis. The company featured was co-founded by a social worker and she was the one featured giving the family the diagnosis of the problem. To me this edges on the verge of giving medical advice but not being a medical doctor.

4. In one case they highlighted it was teachers who told the parents their child had ADHD. I know teachers and I do not envy their job but I think suggesting an actual diagnosis is inappropriate.

5. Another big problem mentioned only in passing on the program was that many of these children are being treated by family pediatricians and not by child psychiatrists.

I’m not always a fan of highlighting individual cases which may or may not be typical. However, these do pull on our heart strings and it does highlight how desperate these families become when dealing with “the problem child”. I truly feel for these parents who are trying everything to help their child but nothing seems to work. Just take a look at the discussion page and read what some of these folks have gone through. This situation is what leads to some of these snake oil salesmen mentioned in point 3 above.

Part of the problem is the whole quick fix attitude especially in the US and the resulting expectation (re-inforced by the pharmaceutical industry) that a few pills can solve all your problems. I have always believed that in the case of mental issues that medication and therapy together are much more beneficial than drugs along.

I really liked the program and highly recommend it. You can watch it for free online and they also have lot of information and further interviews with experts here. There is also a Parents Guide.

I personally look forward to the day when we can run a blood test or do a brain scan and come up with a definitive diagnosis and be able to confidently prescribe medications that will solve the problem >90% of the time. Unfortunately, I don’t know if this will occur in my lifetime. This is one situation where I truly hope I am wrong.

Technorati Tags: medicated child

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Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

Technorati Tags: dalbavancin, FDA, Pfizer

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Here are a few of the important articles from the last couple of weeks.

Glaxo set to axe staff as crisis hits drug - Telegraph
Generic Biotech Drugs Won’t Be in U.S. Legislation Bloomberg.com: News
The Scientist : New patent rules hurt biotech?
Chemical & Engineering News: Government & Policy - Patent Reform Inches Ahead
AstraZeneca to outsource manufacturing - Times Online
AstraZeneca To Outsource Drug Manufacturing - Contract Pharma
StockHouse.com : Encysive Pharmaceuticals Receives Written Response From FDA On
Cephalon warns over pain drug deaths| Reuters
PharmaLive: Adverse Drug Events Reported to FDA Appear to Have Increased Markedly
Sanofi-Aventis Developing New Drugs: Financial News - Yahoo!
Finance
House Passes Bill to Improve Drug Safety: Financial News - Yahoo!
Finance
Senate OKs FDA drug safety bill - washingtonpost.com
Many drugs slip through regulatory ‘black hole’ - CNN.com
Bristol-Myers to buy partner Adnexus for $430 million”>SignOnSanDiego.com >
Warning issued on Cephalon painkiller | Philadelphia Inquirer | 09/27/2007

My overall observations is that there are many factors influencing the pharma industry today and these are not likely to less anytime in the near future. It would be nice to see more positive articles but those seem to be hard to come by in the current environment.

Technorati Tags: Adnexus, AstraZeneca, Bristol-Myers Squibb, Cephalon, Encysive, FDA, Glaxo, GlaxoSmithKline, Sanofi-Aventis

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Looks like PDL Biophrma after going through some tough times and laying-off people is finally up for sale. Here are just some of the articles recently.

PDL to lay off 250, sell four drugs, shift focus - San Francisco Business Times
PDL BioPharma up for sale - Examiner.com
San Jose Mercury News - PDL for sale; CEO quits
San Jose Mercury News - PDL BioPharma’s investors urge company’s sale, executive ousters

This is case from my perspective of poor management which went on for quite a while until finally the major investors forced the ouster of the top two officers. Now it seems that the company’s only real option is to put themselves up for sale.

This will be interesting to watch and I’m not sure how it will shake out. The latest rumors are that Roche may be interested in PDL, but they have refused to comment.

Roche declines comment on PDL BioPharma deal rumours, analysts see …

Other Resources

News
Yahoo! News Search Results for pdl biopharma
pdl biopharma - Google News

Blogs
Google Blog Search: pdl biopharma
Clusty Blogs » pdl biopharma
pdl - IceRocket Blog Search
pdl biopharma: Blogs, Photos, Videos and more on Technorati

Technorati Tags: PDL Biopharma

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Forbes recently had an article on fighting the FDA.

You Can’t Fight The FDA - Forbes.com

I have been watching this drama play out for sometime now and for me it is like watching a train wreck. You know what’s going to happen, you know it isn’t going to be pretty but there’s nothing you can do to stop it from happening. I’m not sure I understand Encysive’s rational for going through this dispute resolution process as it seemed doomed from the start.

Eye on FDA mentioned this in the Weekly Roundup - 9-7-07 and had a great article on this situation earlier: Eye on FDA: What’s at Stake with Formal Dispute Resolution

Other recent articles on this.

Encysive Pharmaceuticals Investor Relations
FDA: Encysive Drug Not Effective Enough - Forbes.com
PharmaLive: Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium)

Other Sources

fda encysive - Yahoo! Search Results
fda encysive - Google Search
Live Search: fda encysive
Clusty Search » fda encysive

Clusty Blogs » fda encysive
fda encysive - Google Blog Search

Technorati Tags: Encysive, Thelin

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Reuters is reporting that the new FDA legislation is unlikely to have any biogenerics in it.

UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters

I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress on how and when they will implement some kind of program.

Here is the key from my perspective.

The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

I realize that biologics are not like standard drugs in terms of generics but really think that until Congress demands that the FDA come up with some sort of plan, nothing will move forward. It is too bad that Europe will be the one taking the forefront in this movement. As an example, EMEA just approved a follow-on for EPO for Sandoz, Novartis’ generics division.

Sandoz Receives European Commission Approval for biosimilar epoetin alfa

I know there will be a lot of lobbying of Congress on this issue but think that regardless there needs to be some sort of plan put forward. Just trying to delay and avoid the issue is only going to cause more public relations problems for biotech in the future.

Other Recent Stories Related to Biogenerics

Biotech firms will soon lose patent protection - Sep. 5, 2007
Lawmakers Offer U.S. Plan for Generic Biotech Drugs
RED HERRING | Going Generic
Follow-on biologics ‘not substitutable’, says BIO
Biopharmaceuticals | Follow-on Biologics: Friend or Foe? | Pharmaceutical Manufacturing
Patent Baristas » Senate Committee Approves Follow-On Biologics Bill: Fear and Trepidation Follow
Biologics Price Competition and Innovation Act of 2007 (S. 1695)

Technorati Tags: biogenerics, biosimilars, FDA, follow-on biologics

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I’m not going to comment on these other than to say the merger mania continues. Here are some recent headlines.

PharmaLive: Shareholders Approve Peptech-EvoGenix Merger :
PharmaLive: Ametek Acquires Cameca SAS
PharmaLive: GeoPharma Announces Shareholder Approval of Merger with Dynamic Health Products
Meda AB to Buy MedPointe Pharmaceuticals for $800 Million in Cash, Stock - News, Search Jobs, Events

Technorati Tags: pharma M&A, pharmaceutical deals

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Amgen is now cutting jobs too and there have been several articles regarding this.

Amgen cutting costs as key anemia drug sales fall: Financial News - Yahoo!
Finance
Hometown feeling Amgen’s pain - Los Angeles Times
Amgen to Cut Up to 2,600 Jobs - washingtonpost.com
Amgen slows its Bay Area expansion - San Francisco Business Times

I’ve seen numbers up to $1 billion savings total. I’ve said it before and I’ll say it again, I think a lot of this is due to the blockbuster mentality which, while it may be changing slightly in big pharma, hasn’t changed at all for the big biotechs.

I think both big pharma and emerging biotech need to look at multiple products in the hundreds of million rather than swinging for the fences with every single drug.

Technorati Tags: Amgen

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I’ve been talking about this for a while and there is finally an AP story outlining all the big pharma job cuts.

Drug Industry Sees Big Job Cuts: Financial News - Yahoo! Finance
Here is a summary:

Johnson and Johnson 4,800
Pfizer 10,000
Merck 7,000
AstraZeneca 7,600
Schering-Plough 1,100
Bristol-Myers Squibb unspecified but likely several thousand

All of these were announced last year accept for Merck and Schering-Plough.

Here is one of the more interesting quotes from this article.

Analyst Steve Brozak of WBB Securities says Wall Street is partly to blame.

By unrealistically demanding the same double-digit profit growth the industry produced through the 1990s, big investors are forcing pharmaceutical companies to scuttle external research partnerships, then reduce head count and other expenses, Brozak said.

“You’re seeing senior VPs … eliminated at these companies,” replaced by junior people with less savvy but half the salary, he said.

While I do agree with the unrealistic demands of Wall Street, I also think that big pharma did not do a good job of explaining to Wall Street the future and are responsible for allowing these unrealistic expectations to continue.

I don’t agree with the part of seeing senior VP’s losing their jobs. I’ve not actually seen that as most of the people I’ve known or heard about are at most middle management but mainly what I refer to as “workers bees” those that actually are doing the work.

And this isn’t going to improve anytime soon. The years 2010 and 2011 are going to be crucial as many blockbuster drugs come off patent including Liptor, Effexor XR, Pavix, and Zyprexa.

The article goes on to say some firms are still seeing demand but I bet if you look into the demand are from small companies and will not offset the large number of layoffs at big pharma.

Also there have been more small companies having trouble getting their drugs approved and some of them are having layoffs too although not to the same scale as the ones above. Overall it is not going to be a good time for the industry for the next five years at least.
Technorati Tags: AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, layoffs, Merck, Pfizer, job cuts, Schering-Plough

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