QDIS Blog

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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It use to be that major pharma companies did not want to share safety data from clinical trials because they considered the information proprietary.

PharmaLive: Taking the Wraps Off Drug Safety Data from Clinical Trials :

There has been much talk recently about changing that. Some companies have said they will start their own database however, having many different database with differing information I don’t feel would be productive. I also don’t think a voluntary program run by a pharma group would be the best solution either. I’m not sure what is the best but think that in the next five to six years you will see some sort of database covering multiple companies.

Here are some recommendations from the article in Health Affairs in the March/April 2007 issue. The authors are Dr. Aaron Kesselheim and Michelle Mello.

Placing a heavier burden of proof on companies to show competitive harm if data are released.

Replacing the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.

Getting Congress to pass legislation requiring public disclosure of safety data if the FDA fails to take action.

“Safety data from drug clinical trials have important ramifications for public health,” said Kesselheim. “The government should do as much as it can to ensure full disclosure of the information.”

I personally think it will take action from Congress before anything concrete will happen.

Technorati Tags: clinical trials, drug development, drug safety

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The AP reports that Indonesia is refusing to share bird flu virus samples with the World Health Organization (WHO) unless they sign an agreement saying it WILL NOT be used to develop an “expensive vaccine”.

Indonesia refuses to share bird flu samples with WHO without legally binding agreement - International Herald Tribune

While I understand that Indonesia does not want to have pay high prices for a vaccine that may be developed in the future, this seems short sighted. Indonesia is not the only source of the samples and if a major pharma companies wants to get samples, I’m am sure there are other options and other countries. The only reason Indonesia is important is because they seem to have more cases and those cases need to be tracked to determine how the virus may be mutating.

This is a major change from previous understandings where nations share information for public health purposes. One of the reasons WHO has an interest there is Indonesia is a likely center for any future pandemic since it is heavily populated and many people live in close proximity to birds. THis refusal to share seems to put the Indonesian people at even more risk if something should occur.

Technorati Tags: avian flu, bird flu, Indonesia, WHO

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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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This article occurred over a month ago but I hadn’t gotten around to commenting on it yet.

State OKs Plan Against E. Coli Outbreaks - Forbes.com:

Seems California as instituting a voluntary program for produce shippers and handlers where they agree to only work with other companies who are taking preventative steps to stop e. coli and other contamination. Among the proposals are fencing fields to prevent ingress of wildlife and routine testing of irrigation water for bacteria.

I think these are good ideas but it will be interesting to see how successful it is.

Technorati Tags: e coli, food safety

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