QDIS Blog

I came across this article in the Washigton Post and found it disturbing.

FDA Consolidation Plan May Close Labs - washingtonpost.com:

The article mentions that the FDA will be forming a transition team to discuss which labs should stay open. Although no sites were mentioned specifically in this FDA email dated Dec 6 talked about in the WP article, they do speculate that it involved facilities in Cincinnati, Denver, Detroit, Kansas City, Philadelphia, San Francisco and Seattle.

There is more information on the Public Employees for Environmental Responsibility (PEER) website. They also had an article on this. They have some more information not in the WP article and say that a similar plan was rejected back in 1996 and that then the General Accounting Office (GAO) found the efficiencies questionable and the plan in general vague.

I must say this caught me completely off guard. I’m still not sure what to think but my initial reaction is this is not a good idea. I have always been in favor of localized offices and while the offices will likely stay, the scientific functions may be what are specific being talked about since it mentions labs. My experience is that having scientific functions consolidated can have a positive effect but that effect is failry small and must be weighed against other factors. In this case, having personal in the area who are more familiar with the localized culture and have the ability to quickly respond to a serious situation should one arise.

The supposed goal is to maximize efficiency but I think it more likely involves cost cutting. Given the food safety situation of late and that these labs are involved in those sorts of situation this is particularly disheartening. The PEER article also point out that the FDA FY 07 budget includes a $20 million increase to “expand the network of laboratories that would rapidly and competently analyze samples in the event of a terrorist attack on our nation’s food supply.” While this increase is minimal at best, the fact that it specifically mentions expanding the network of labs is quite a disparity given the fact that the FDA is wanting to consolidate the labs.

This is especially disturbing in light of the closing of satellite EPA libraries recently.

Technorati Tags: FDA, food safety, FDA labs

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Seems the GlaxoSmithKline business development groups has been very busy lately. Earlier today I posted about GSK acquiring Praecis and before that they acquired Domantis. Now they are concentrating on deals and have entered into a large one with Genmab.

PharmaLive: GlaxoSmithKline and Genmab Enter Global Agreement For HuMax-CD20
GSK sign world’s-biggest licensing deal with Genmab:

This deal is worth $2.7 billion making it the largest deal that I know of (the Erbitux deal between Bristol-Myers Squibb and Imclone was $2 billion).

HuMax-CD20 (ofatumumab) is a human monoclonal antibody in phase III clinical trials for treatment of CD20 positive B-cell chronic lymphocytic leukemia and follicular non-Hodgkin’s lymphoma. Is it also being investigated in phase II trials for rheumatoid arthritis. Analysts (whose numbers I take with a block of salt) say the market for it could be $2-5 billion! GSK hopes to be able to fill an NDA for the compound sometime in 2008.

Technorati Tags: Genmab, GlaxoSmithKline, HuMax-CD20, pharmaceutical deals, ofatumumab

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Mergers are continuing, this time GlaxoSmithKline is acquiring the biotech company Praecis Pharmaceuticals for $5.00 per share for a total of $54.8 million in cash.

PharmaLive: GlaxoSmithKline To Acquire Praecis Pharmaceuticals

It is unclear to me if the products and technologies offered by Praecis (at least that is publicly available) are worth this price. They have one candidate PRI-2458 a small molecule that falls into the anti-angeogenesis or formation of blood vessels. It is being investigated for non-Hodgekins Lymphoma and other There are also two technologies; one called DirectSelect that involves selecting compounds from a library for further study. The other technology is
Rel-Ease a drug delivery technology offering sustained release.

While these technologies are interesting, they both fall into categories that are somewhat crowded and it is very difficult determine which may be the best. Maybe GSK sees some specific uses for this technology and it fits their product portfolio.

Technorati Tags: GlaxoSmithKline, pharma M&A, pharmaceutical deals, Praecis

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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

Technorati Tags: drug coated stents, FDA, stents, tag

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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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I discover this article originally from Mark Senak over at Eye On FDA blog. This FDA proposal would allow for greater access to experimental drugs as reported in the New York Times.

FDA Proposes Broadening Access to Drugs - New York Times

I am a backer of allowing greater access to experimental drugs but feel that the key in this is the word “appropriate”. While no one would object to this with regard to life threatening conditions such as cancer it is unclear how other situations would be dealt with. One of the point in the proposed rule states that:

modernize applicable regulations to include all circumstances under which access to experimental drugs is permitted.

This seems to be a little overly optimistic to me. I find it hard to believe they could define ALL CIRCUMSTANCES in which this may be appropriate. What about someone who has a respiratory ailment that makes breathing difficult and they have tried all approved therapies without positive results? Maybe it keeps them from being mobile and getting out of their home. If there is an experimental drug that could significantly improve their quality of life would this be allowed? The question basically boils down to what is appropriate and this could indeed vary with regard to aliment and even for given patients having a certain condition. I think rather than trying to state all conditions it might be better to define the process allowing for the use of experimental drugs.

One of my other concerns in this involves the fact that our society today seems to be very litigious. Seems anytime something goes wrong, we look for someone else to hold responsible or to sue. I firmly believe that if a company deliberately withholds information concerning dangers or concerns then they should be held liable. However, in the case of an experimental drug, little may be known and opening it to what use to be called compassionate use may be opening a can of words. I firmly believe individuals should be held accountable for their decisions provided it is an informed decision. I’m not sure how this would be worked out, but I’m sure that this will be an item for discussion.

Technorati Tags: drug safety, FDA, experimental drugs

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I’ve reported on the Lilly Icos merger previously and although this news is not unexpected it is interesting.

Lilly Buyout to Cut All Icos Jobs | Chron.com - Houston Chronicle:

Lilly will cut all jobs from Icos meaning they basically just bought Icos to avoid the payment of royalties on Cialis. I have a friend who works for Icos and it looks like they will have to be looking for a new job in the New Year. Some in the manufacturing group will be kept on through 2007 to meet commitments to other companies for making their product.

Technorati Tags: Eli Lilly, Icos, pharma M&A, pharmaceutical deals

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As regular readers know, I’ve been following the developments related to Ketek all year. Now, it seems the FDA advisory committee has recommended that Ketek only be used for certain life-threatening indications.

FDA Panel Hits Antibiotic For Bronchitis, Sinusitis - Forbes.com:

Basically, the committee recommended a black box warning on Ketek for its use in community acquired pneumonia which can be potentially life-threatening. The vote on this aspect was 16 to 3 that for community-acquired infections that Ketek should still be available.

They voted 17 to 2 that the the benefits did not outweigh risks for other indications such as sinusitis and bronchitis. These indications are not as serious and can be treated with other drugs. It will be interesting to see if the FDA rescinds the approval of Ketek for these indications. I think that is very likely to happen. For those out there interested in the chemical structure here it is.

Bottom line was that the drug is effective and can be used in certain indications but that physicians and the patient should be aware of the potential problems. Again, I applauded this recommendation; the risks vs reward must be weighed not for the drug itself but based on the exact indication.

Other Resources

FDA Search Results: ketek (sorted by date with most recent at the top)
Aventis Pharmaceuticals -Ketek - June 2006 prescribing information
Patient Information Sheet: Telithromycin (marketed as Ketek) (from FDA.gov)
ketek - Yahoo! Search Results
ketek - Google Searchimage

Technorati Tags: antibiotics, drug safety, FDA, Ketek, Sanofi-Aventis, telithromycin

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