QDIS Blog

VaxGen is currently on a clinical hold for it’s anthrax vaccine.

Next Clinical Trial of VaxGen’s Anthrax Vaccine Delayed: Financial News - Yahoo! Finance:

seems there may be stability problems with the proposed clinical trial vaccine product. The data VaxGen submitted to the FDA was insufficient to determine if the product is stable enough to resume clinical trials. The FDA expressed concern about the potency of the vaccine declining during the trial and giving results that are not inconclusive.

This is not an uncommon occurrence for vaccines and so really isn’t a negative. I’m sure they will be able to overcome this and get the trials started soon.

Technorati Tags: anthrax, vaccine, VaxGen

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Reuters recently had the following article about pricing pressures on the drug industry.

Pricing threat looms large for global drugmakers | Industry Summits | Reuters.com

One of the major ideas behind this article is that there are many so called “me too” drugs that don’t offer any advantages. Check out the following quote.

“Me-too” medicines, offering no big advantage over the existing products, will be the biggest casualties, according to Novartis AG head of corporate research Paul Herrling.

“Payers are less and less willing to pay, especially in big patient markets, for drugs that do not deliver a very, very distinct new clinical advantage,” he said.

I always hate to see this sort of attitude from major pharmaceutical leaders. I think this ignores the basic fact that each individual responds differently to various medications. I feel more effort should be spent on determining precisely which patients may respond to a given drug. With the advances being made in genetic testing it is possible to see who responds best to certain medications. However this sort of thinking runs counter to most big pharma thinking in that they want to concentrate on the largest possible patient population. I feel this attitude needs to change and the ability to determine precisely who will respond is essential.

I have had strong feelings about the “me too” drug for a long time. Imagine that your health care insurance will only cover one brand name medication for say allergies. There may be three approved drugs but only one is covered by your insurance. You try it and it doesn’t work for you. What then? Your doctor gives you a free sample of another drug that isn’t covered by your insurance and you find out it works great. Now you have a great drug that works for your allergies, but your insurance won’t cover it. This doesn’t make sense to me.

Given the recent advances in being able to determine genetic make-up of individuals I really think it worth while to determine why a given product works for a certain group of individuals and maybe even more importantly, why it doesn’t work in others.

This is what some call individualized medicine. I don’t know that I fully believe there will ever be a time when a drug is tailor made for one single individual. However, determining who, on a genetic basis, may best respond is a step in that direction and is how I see “personalized medicine” playing out.

Technorati Tags: drug cost, drug price

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While not a merger or acquisition this item is interesting from Forbes. Seems 3M is getting out of the pharmaceutical industry and selling those assets to three companies.

3M In Three-Way Deal - Forbes.com

They are selling their US, Canada and Latin America based operations to Graceway Pharmaceuticals for $875 million and then their European division is being purchased by Media AB of Stockholm, Sweden for $857 million. Finally, Private equity firms Ironbridge Capital and Archer Capital will acquire 3M’s operations in the Asia Pacific Region for $349 million.

Not bad, 3M picks up over $2 billion from the sales. It is interesting that I felt 3M never was focused on their pharmaceutical interests. It is probably a good thing for those working in the pharma groups as there should now be more of a focus on what they can provide for their new owners. It is always unsettling though for those involved though not knowing what may come. I can’t really comment on whether or not all or most of the employees will be retained since I know little about the companies purchasing 3M’s assets. Hopefully it works out well for them.

Technorati Tags: 3M, pharma M&A, pharmaceutical deals

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The mergers and acquisitions continue unabated. Genentech is to buy Tanox for almost $1 billion in cash! Tanox is Genentech partner on Xolair (omalizumab) an asthma drug.

Genentech to buy Tanox for $919M in cash

Both of these companies have been working with Novartis for 10 years (since 1996). This will allow Genentech to no long pay royalties to Tanox and also allows it to obtain Novartis’s royalty payments to Tanox.

THis is similar to the Eli lilly purchase of Icos. In that case Lilly felt it was better to purchase Icos than to continue paying royalties on Cialis. This is one of the dangers for a small company that partners with a larger company. If the drug becomes a major seller then it may be easier for the large company to gobble up the smaller one than to continue paying royalties.

Disclosure: I own a few shares of Genentech.

Technorati Tags: Genentech, Novartis, omalizumab, pharma M&A, pharmaceutical deals, Tanox, Xolair

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As if the pharmaceutical industry needed more bad news. Seems Perrigo has recalled their 500 mg acetominophen caplets due to traces of metal in the product. Only the 500 mg caplets are affected, but that is still 11 million bottles.

Perrigo recalls 11 mln bottles of acetaminophen | News One | Reuters.com

At least Perrigo have made the announcement of the recall right on their home page. It should be pointed that no illness or injuries have resulted from this. It appears the metal came from a tabletting machine that the company noted was wearing prematurely.

The FDA has issued a statement on the matter and here is the list of recalled lots from the FDA website as well a list of places where the product is sold.

Technorati Tags: acetominophen, FDA, Perrigo, recall

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I always like to see it when a chemist actually gets to lead a major project. Now, Ralf Kaiser a physical chemist at the University of Hawaii will lead a NASA project to study the atmosphere of Titan, one of the moons of Saturn.

Chemist to lead study of Titan’s moon - Yahoo! News

This five year $2.5 million dollar grant from the National Science Foundation will use the NASA infrared telescope located on Mauna Kea on the big island of Hawaii. The hope is that by studying the atmosphere of Titan insight may be gather about earth’s early atmosphere. One of the major issue to be investigated is to see how hydrocarbons in the atmosphere absorb damaging ultraviolet radiation from the sun and preserve some compounds that are may play a role in the early development of molecules essential to life.

The first workshop is scheduled for February of 2007.

Other Resources

• Reaction Dynamics, University of Hawaii at Manoa
• Titanworkshop 2007
• SPACE.com — Titan: A World that Never Grew Up

Technorati Tags: chemist, NASA, space, Titan

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This is old news by now but I did want to post about it. Chinese scientists are believed to have located a gene in the H5N1 virus that makes it virulent in poultry.

Chinese scientists identify deadly gene in H5N1 - Yahoo! News:

They achieved this by analyzing the difference in two strains, one which caused the disease and another which is harmless. These differences were contained in four genes. They then designed four genetically modified viruses and discovered that only one of these modified viruses caused death in birds. This gene is called NS1.

This should allow for production of better, more efficient vaccines since it is now know what gene to target.

Technorati Tags: avian flu, bird flu

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I just want to recommend that everyone to vote in tomorrows election. I had a post earlier on some sources for information that I recommend you take a look at.

Also, be aware that if there are problems, please report them. First try your local election official and make them aware of the issue. If that doesn’t work, try calling The Election Incident Reporting System (EIRS) at 1-866-OUR-VOTE (687-8683). Also, if there are major problems then let you local media know. Be sure and make the general public aware of any problems that may occur. Many votes will be cast on electronic system for the first time in a national election. The only way these problems will be addressed is for the public to be made aware of the number and extent of the problems.

Make sure that your choices are EXACTLY the way you want it before hitting the final vote button. Always check to make sure your choices are correctly reflected on the confirmation screen. If you have questions, ask a local offical for help. If you have problems getting your vote to be recorded correctly, let the election official know immediately.

Also note that if you are told there is a problem with you voting, ask for a provisional ballot. This allows you to vote and then get any matter cleaer up within a specific period of time which varies from state to state.

Take advantage of your right to vote and make your voice known.

Technorati Tags: election, vote

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Well as I’ve said previously the merger mania continues and now Abbott Labs is in the mix. They are going to purchase Kos Pharmaceuticals for $3.7 billion in cash!

Abbott Labs buys Kos Pharma for $3.7B - Yahoo! News

This is a 56% premium over the Kos stock price on Friday Nov 3. Abbott purchased Kos for basically one produce, Niaspan, which is one of a very few drugs that raise HDL (good) cholesterol. It should be pointed out that this is simply an extended release form of niacin.

There are other niacin forms available over the counter that also increase good cholesterol. I know because my doctor recommended I take it and I have been for over a year now. Niacin use to be used quite a bit before the statin drugs were available and it does a good job but has the side effect of causing flushing. Flushing is a redness of the head and neck and can be itchy and uncomfortable. I know because I purchased some cheaper versions of niacin and had flushing with some of the capsules. I think the quality control on that particular brand wasn’t very good. I switched back to my usual brand of non-flushing formula of niacin and haven’t had any problems. I should say though that I haven’t had my cholesterol checked since being on niacin and so can’t say yet whether or not it is working for me.

Back to the merger. I personally think Abbott may be paying to much for Kos based on their pipeline of currently marketed drugs. The major area for Kos has been cholesterol therapies and that is a very crowded area with many blockbuster statins either now generic or soon to be generic. Kos’s other drug is Advicor and is a combination of Niaspan and lovastatin. I know Abbott wants to get into the cholesterol drug business put I feel this may be too much to pay.

Technorati Tags: Abbott Labs, good cholesterol, Kos Pharmaceuticals, pharma M&A, pharmaceutical deals, HDL cholesterol, puppy

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I recent report from the Harvard Medical School and the National Institute on Aging shows that resveratrol found in red wine can keep fat mice healthy.

Wine extract keeps fat mice healthy - Yahoo! News

Resveratrol is chemically known as 5-[(E)-2-(4-hydroxyphenyl)-ethenyl]benzene-1,3-diol [501-36-0] and the structure is shown below.

It is found mainly in the skins of red grapes as well as peanuts and berries such as blueberries, and cranberries.

The report states that although the mice are fat, their internal organs looked fine and they did not appear to suffer abnormal effects normally associated with obesity. death was down 31% from a control group. It is way too early though to make any conclusions for humans and the does to see this effect were quite high. A person would have to drink ~100 bottles of red wine per day to get the levels of resveratrol they used in these animal studies.. At least Sirtris Pharmaceuticals will be doing trials and intend to file a drug application through the FDA.

It should be pointed out that resveratol is also sold as a non-regulated supplements but that little safety studies have been performed on it to date.

Other Resources

• Therapeutic potential of resveratrol: the in vivo evidence : Nature Reviews Drug Discovery
• A methoxy derivative of resveratrol analogue selectively induced activation of the mitochondrial apoptotic pathway in transformed fibroblasts
• Redistribution of CD95, DR4 and DR5 in rafts accounts for the synergistic toxicity of resveratrol and death receptor ligands in colon carcinoma cells
• resveratrol information from Linus Pauling Institute at Oregon State University (great source of information)

• resveratrol - Yahoo! Search Results
• resveratrol - Google Search

• Resveratrol (from quackwatch.org; lots of references)
• Resveratrol - Wikipedia, the free encyclopedia

Technorati Tags: resveratrol

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