QDIS Blog

The Chicago Tribune reported last week that Neopharm’s drug IL-13 (cintredekin besudotox) for treatment of brian tumors failed in late stage clinical trials. The drug failed to perform any better than currently approved therapies.

NeoPharm drug fails test | Chicago Tribune

The bulk of the article focuses on how this may impact the biotech industry in the Chicago area.

I should mention that trying to develop treatments for brain tumors, in this case glioblastoma multiforme is quite difficult. The primary difficulty is in getting drugs to cross the blood-brain barrier. They were comparing IL-13 to the Gliadel wafer implant.

This is indeed a setback for Neopharm and after the announcement the stock fell 70%. There other projects are much earlier in development and could take two years or more of development and the company has about 30 million os cash that should get it through 2008 but that may not be long enough.
Neopharm will be an interesting company to keep in eye on for the next few years to see if their other projects proceed. They may become a take-over target if their stock price continues to drop and some company feels there neolipid drug delivery technology is worthwhile. It is estimated that this technology may be worth ~$20 million.

Other Resources

NEOPHARM Announces Efficacy Results for Phase 3 PRECISE Trial

Technorati Tags: cintredekin besudotox, IL-13, Neopharm

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Merck has been in the midst of a year old program to boost revenues and cut costs in order to transform the company into a more competitive company.

Merck Reports Progress on Overhaul:

Merck this year on launched five new vaccines including the first ever cancer vaccine. I’ve posted about Gardasil previously and refer you to those posts if you are interested in that vaccine. I think it will be one of their bigger drivers of revenue in the coming years. Merck has also cut 3,900 jobs on the way to cutting 9,000 jobs world-wide and sold several of their manufacturing plants. They also have a fairly strong pipeline with several products awaiting approval and several more in late stage development. Overall, accept for the long drawn out Vioxx cases, the future looks fairly bright.

I think this may be what needs to happen to Merck but I also feel for those people who are affected by this. I know some folks who work their and it is unnerving until things settle down as to wether or not you may have a job. I also wonder if in the midst of the mega-mergers if Merck can continue o its own. Merck has always had a history of avoiding the M&A mania but given the changing climate in the pharmaceutical I’m not sure how long they can continue on that course.

The main thing hold Merck back right now though is the Vioxx lawsuits. While Merck has come out ahead in the trials so far, continuing to fight each os these individually will be a drag on the company for several years to come.

Technorati Tags: Gardasil, Merck

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I’m late on posting this but still wanted to comment on this. An FDA advisory committee came to the conclusion that drug coated stents are not problematic.

ABC News: FDA Panel Finds Drug-Coated Stents ‘Not Detrimental’:

However, there is concern about the massive use of drug coated stents for indications outside of the approval. As many as 66% of the stents are used “off-label”. This is the category that the panel had great concerns over the use.

Here are the summaries from this meeting.

Summary from the Circulatory System Devices Panel Meeting - December 7 & 8, 2006

Again, I think off-label use is valid however I think that there needs to be some sort of check on this. Too many times the off-label use of a drug or in this case a device, accounts for the vast majority of its use. There was a drug at a company I use to work for where ~80% of the sales were for off-label use.

Many times, pharmaceutical and biotech companies will turn to the easiest indication to get approval and hope to get further sales from these other indications for which it is not yet approved. In some cases, there are actually plans to do more studies and get approval for other indications. This is common practice in oncology but I think in other areas there needs to be some sort of regulation. I would suggest that when the off-label use constitutes a certain percentage, the drug companies should be required to get approval for that indication. Now this could have other consequences and one of the biggest concerns would be how do you determine the percentage of off-label use, that is whose’ data do you use. If you rely on the drug companies there may be under-reporting in order to avoid doing further costly studies. However, I think in non-life threatening situations, this could be justified.

Other Resources
FDA Statement on Coronary Drug-Eluting Stents
FDA Heart Health Online - Questions and Answers on Coronary Drug-Eluting Stents
fda drug-eluting stents - Yahoo! Search Results
fda drug-eluting stents - Google Search

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It appears that Siegfried has agreed to sign over their manufacturing facility at their site in Zofingen, Switzerland to Celgene for $45.7 million USD.

Siegfried signs over capacity to Celgene in €34.9m deal:

This will occur in early 2007 and Celgene will use the site for Revlimid API. This is an interesting development since I’m not aware of other contract manufacturers selling a facility to a main stream pharma or biotech company.

Other Resources

Siegfried Press Release PDF (English)

Technorati Tags: Celgene, Siegfried

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