QDIS Blog

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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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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The vaccine maker Acambis ousted their CEO and a financial director after they failed to get a $1 billion smallpox contract with the US government.

Acambis ousts CEO and finance director

Stockholder had wanted a change in direction and it looks like they will now get it. Acambis had been concentrating on vaccines related to bio-defense.

The new CEO is Ian Garland who was head of Arrow Therapeutics when the deal was put together to be acquired by AstraZeneca. This has fueled rumors that Acambis may try to put itself on the market.

It is likely not the last of layoffs as the company has stated they will shed 20% of their workforce which amounts to about 40 jobs. It will be interesting to keep an eye on what happens to them in the next couple of years.

Technorati Tags: Acambis, down-sizing, layoffs

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Back in Feb an AP story stated that if there were such a thing as generic version of major biologics that it could save over $71 billion over ten years.

Generic Biotech Drugs Could Save $71B

The study evidently assumes a 25% decrease in price off brand name biologics. This figured is based on the price of the human growth hormone now available as a generic in Europe. I’m not sure how well this particular instance is representative of all the other classes of biologicals that would be eligible . The study was sponsored by Express SCripts and they claim it is conservative because it only includes insulin, erythropoietins, growth hormones, and treatments for multiple sclerosis.

While it is interesting to speculate, I personally don’t think this would be representative of how the biogenerics might shake out. It is just too uncertain especially considering there is no pathway for approvals of biogenerics, although there is legislation before the US Congress regarding this. Until there is more information in the regulatory arenas I think it is too soon to speculate on the potential savings.

Technorati Tags: biogenerics

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An another major merger, Schering-Plough is acquiring Organon Biosciences, the animal and human health business of Akzo Nobel for $14.4 Billion.

PharmaLive: Schering-Plough to Acquire Organon BioSciences
Schering think this will be a good addition to their pipeline and the deal is excepted to close before the end of this year. The Organon website is pretty vague on the number and kinds of products in its pipeline so it is hard to judge without further research. They say they have products at various stages including several in pate stage development. They have the plan to fill at least one new major product each year for the next few years. As you can see, it is pretty lacking of details. They do mention two products; asenapine for treatment of bipolar and schizophrenia and sugammadex used to reverse the affects of neuromuscular block

Schering Plough news release:

Schering-Plough to Acquire Organon BioSciences

Other Resources

asenapine - Yahoo! Search Results
asenapine - Google Search
Google Blog Search: asenapine
IceRocket Blog Search: asenapine

sugammadex - Yahoo! Search Results
sugammadex - Google Search
Google Blog Search: sugammadex
IceRocket Blog Search: sugammadex

Technorati Tags: Organon Biosciences, pharma M&A, pharmaceutical deals, Schering-Plough

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Zymogenetics received good news recently when they released information that the FDA would NOT require more clinic studies for a spray to be used during surgery to stop bleeding.

ZymoGenetics spray moves ahead

This could shorten the timeline to approval for a spray by as much as 18 months but there would still need to be paperwork filled in the form of a Prior Approval Supplement. They filed for approval of rhThrombin in Dec 2006 and the spray would be a new formulation.

It should be noted that this would be the first Thrombin product which does not rely on animal or human blood. The currently approved thrombin products are derived cow blood and have potential problems such as concerns over Bovine Spongiform Encephalopathy (BSE) as well as leading to complications in some people who develop antibodies to the cow derived product.

Technorati Tags: Thrombin, Zymogenetics

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The US isn’t the only country that is trying to decide what to do in regard to drug pricing.

British regulator calls for drug pricing overhaul - International Herald Tribune

The Office of Fair Trade in Britain wants to change a 50 year old law that places profit limits on branded prescription drugs. They state it could save the country almost $1 billion each year. The proposed plan would tie pricing to the therapeutic benefit they provide to patients but details of how this would be determined were not mentioned.

Other countries have instituted a similar program and include Australia, Canada, and Sweden.The drub manufacturers in Britain such as GlaxoSmithKline and AstraZeneca are concerned about delays relating to launch as well as discourage future companies from investing in the pharmaceutical industry in Britain.

Technorati Tags: drug cost, drug price

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The Washington Post had an article earlier this week where experts questioned whether or not allowing imported drugs would result in significant saving for US customers.

Expert Questions Import Drug Savings - washingtonpost.com

Stephen Schondelmeyer, a University of Minnesota pharmaceutical economist testified that imports would cut U.S. prices by only 12 percent to 20 percent (emphasis mine). I’m not sure what this economist think is significant but for many people on fixed incomes who are paying hundreds or dollars (or more) each month for prescription drugs this is indeed significant! I think it may again be a case of someone in an ivory tower not being in touch with some of the concerns of normal everyday people.

As regular readers know though, this doesn’t mean I favor drug imports. I also don’t think the safety issue usually raised is insurmountable, but it would be costly and I doubt congress would increase the FDA budget enough to allow it to do this job thoroughly and safely. My disfavor of this approach is simply based on populations of the listed countries. Usually this list includes Canada, New Zealand, Australia and some European countries (but never specifically identified).

Excluding Europe for now (I’ll comment on that below) these other countries are so small in population that the US, if even a small percentage of people imported drugs, it would easily strip them of their supplies. Also, some drug companies have already stated that if this occurs, they will only sell certain amounts of drugs to these countries and they would have to decide whether to sell them to their own people or export them to the US but that the drug companies would not allow the purchase of huge amounts of drugs just so those countries could export them to the US.

It should also be noted that in Europe, drug companies must negotiate prices directly with the government since in most cases they are the sole healthcare provider (this could be looked at as another reason why the US should seriously consider universal healthcare, but that’s another subject for another time). If you ask people on the street here in the US if they favor price controls on drugs, most will say no. However, this is basically what would occur. Importing drugs from Europe would essentially be saying we agree with the price controls of foreign governments. If we truly believe that, then why not just pass legislation with price controls tied to those in Europe?

My larger concern is that Congress has a history of giving the FDA additional responsibility but has not given them an increase in funding to achieve those responsibilities. They are already underfunded by most experts estimates and setting up a new system to deal with drug imports would be costly at least at first. Then there are other issues Congress wants the FDA to deal with such as biogenerics and a drug safety database. This is one of the reasons I favor giving the FDA powers similar to the EPA of fining drug companies for infractions of the rules.

The bill being discussed is S424 (S. 242–110th Congress (2007): Pharmaceutical Market Access and Drug Safety Act of 2007

Technorati Tags: drug cost, drug imports, drug price

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