QDIS Blog

Dendreon hit a major snag last week when the FDA declined to approve the drug without further data. THese are somewhat misleadingly called “approvable letters. For more on approvable letters see What Do Approvable Letters Mean? from Mark over at Ee on FDA.

Dendreon will delay Provenge, cuts jobs:

This led to a major drop in stock price and Denreon announcing it will lay off 400 workers mainly those geared towards commercialization of Provenge. If things go well, the company said it could launch the drug as soon as 2008 but it could be as late as 2010.

What is surprising in this case is the the advisory committee unanimously voted (17-0 on safety and 13-4 on efficiency) to approve the drug and it is rare that the agency would then not approve it. Looks like the FDA may be getting more cautious or has access to information that wasn’t know to the committee.

For another look at this see Eye on FDA: Dendreon Gets Complete Response Letter

Technorati Tags: Dendreon, Provenge

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Contract Pharma has an article on Albany Molecular purchasing manufacturing facilities in India.

AMRI Acquires Manufacturing Facilities in India - Contract Pharma

What is surprising to me is how little they paid for it; $11 million for these assets which earned $5 million in revenue last year!

It is interesting that some contract manufacturers are buying facilities in India to get access to cheap labor and that Indian companies are buying European and North American companies for name recognition and established clients.

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I recently upgraded Wordpress and now my old theme for controlling the look of the site no longer works properly. I’m going with the Wordpress default until I can get the usual theme working again. Sorry for the change.

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Avandia, the diabetes drug has been in the news quite a bit recently due to it possibly raising the risk of heart attack.

UPDATE 1-EU agency says already aware of Avandia heart risk
| Reuters

FDA study said to show Avandia risk - Yahoo! News

While I appreciate the information, I think it is interesting to note that the well respected cardiologist Steve Nissen is again involved in this. He was one of the key folks involved in the Vioxx analysis that showed it increased the risk of heart attack.

I can’t help but wonder though if you are a cardiologist and you are looking for cardiac events, if you night not be predisposed to finding such events. I’m not saying that is what happened but it struck me that we all view life through our own experiences and this creates a sort of lens through which we interpret life’s events.

for mre on this story look at some of the links I have listed below. Don’t trust me, read what others are saying and come to your own conclusions.

Other Resources

Yahoo! News Search Results for Avandia
Avandia - Google News
Blog Results

Google Blog Search: Avandia
avandia - IceRocket Tag
Individual Blogs
More Avandia, And More on Marketing. In the Pipeline: (great discussion on that blog on this)
‘Round the Sphere: Health Care Renewal Rebuffed by In the Pipeline on Avandia
Health Care Renewal: Expanded Avandia Story Now Echoes Familiar Themes

Technorati Tags: Avandia, GlaxoSmithKline, Steven Nissen

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Seems three Indian companies have already moved to copy Sanofi’s Acomplia (rimonabant) before it is even for sale in Europe and the US. The companies identified are Sun Pharmaceuticals, Torrent Pharma and Zydus Cadila.

Sanofi’s Acomplia already copied in India - paper:

It should be noted that India patent law does not require them to respect patents on drugs developed prior to 1995. The claim is that these companies are only making it for the Indian market but I find this suspect. Once sold in India, it will be hard to control its sales to other countries. This is likely what these companies are betting on. They are unlikely to go head to head with Sanofi but more likely to throw up their hands and say, we only sold to distributors in India and that they have no control over what happens after that.

Sanofi is exploring legal options but it is not likely to have many from my perspective, provided these companies do only sell in India. If they sell it into other countries they are likely to face legal disputes.

Technorati Tags: Acomplia, Rimonabant, Sanofi-Aventis

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Merck is moving away from a long time approach of internal organic growth to one of strategic acquisitions of small companies.

Merck & Co. keen on small acquisitions: executive - washingtonpost.com:

It will be interesting to keep an eye on this and see how they mange this. THey are getting late into the game and many deals, I’m sure are already in progress s they’ll have their work cut out for them finding those “hidden gems”. So many folks have already done deals I think they are ver many of these hidden gems remaining.

Technorati Tags: Merck, pharma M&A, pharmaceutical deals

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Newsday has an article that illustrates how tough it is to deal with conflicts of interest in this case between advocacy groups and the pharmaceutical companies.

Drug company payments to advocates an issue - Newsday.com:

While the FDA has cracked down on advisory committee members and their ties to drug companies, the same rules do not apply to advocacy groups. This can lead to a variety of problems and could lead to so called “turf groups” that is advocacy groups that are really just lobbying group for the drug companies.

I fully understand that these advocacy groups need money to survive and that they get money form the drug industry. However, it is hard for me to believe when they say there is no conflict of interest if they are unwilling to reveal who is giving how much.

The rules for conflict of interest are not clear and seemingly not very effective in many cases leaving this open for abuses in the future.

Technorati Tags: conlficts of interest

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Forbes has a report on Novartis purchasing the rights to NicQb, an anti-smoking vaccine from Cytos Biotechnology AG up to $500 million. The initial upfront payment is $29 million.

Novartis Buys Right to Experimental Drug - Forbes.com:

It will be interesting to watch and see how NicQb comes along. Currently it is in phase II studies but if successful could be a huge success. To my knowledge, this is the only vaccine being developed to combat nicotine addition.

Technorati Tags: anti-smoking vaccine, Cytos Biotechnology, NicQb, Novartis

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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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