QDIS Blog

A recent report from the Government Accounting Office (GAO) was released a couple of months ago and I’d not yet commented on it.

New Drugs Declining, Research Costs Increasing, GAO Says - washingtonpost.com:

This Washington Post article gives a good overview of the situation but what is interesting ot me is the wide range of opinions on what the underlying data means. Some in congress use this data to prove this the system need to change. I don’t think that is necessarily the case. There could be many reasons why costs increase and why productivity hasn’t increased. I tend to be of the opinion that the low lying fruit has been picked over and that more research is needed to find better ways to get the fruit higher up on the tree. Adding additional regulation that does not directly effect safety would be counter-productive.

Heres the actual report.

GAO Report on New Drug Development

Technorati Tags: drug cost, drug development

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Eli Lilly is acquiring a small company in Mass. called Hypnion that focuses on sleeping disorders. No financial details were released.

Lilly Announces Acquisition of Hypnion

Hypnion lead candidate is HY10275 and has completed phase I and II trials earlier this year. It would likely be a non-schedule sleeping pill and is suppose to be better than those on the market.

More importantly though is the technology Lilly acquires, the SCORE-2004™ platform which is predictive software for a sleep-wake bioassay system. This could be used to make predictions of what compounds would have the best overall profile. Here is the companies quote:

Using SCORE- 2004™, the world’s only predictive sleep-wake bioassay system, we have profiled and evaluated the universe of sleep-wake pathways, screened known marketed CNS drugs which act on those targets, and optimized the sleep or wake-inducing effects of those compounds in order to produce novel, patentable New Chemical Entities (NCE’s) ready for preclinical development.

We are moving ahead with a robust program which includes multiple scaffolds and clinical candidates that have proven themselves to have distinct advantages in efficacy and safety over the market leaders in insomnia and fatigue including Lunesta™, Ambien™ and Provigil™ as well as soon to be marketed drugs including indiplon.

Interesting to note they don’t mention Rozarem (ramelteon).

If it is indeed predictive, it could be a major step forward in terms of being able to test compounds “in silico” without having to make numerous drugs and test them. It remains to be seen and I personally think these “in silico” system are overhyped and still do not take into account side effects or toxicology problems. However, it is a step forward just not as large a ne as many in the industry make it out to be, at least in my opinion.

As an aside, DTC Marketing Blog has an interesting article from back in November about Rozarem, Ambien, and Lunesta in terms of website traffic. They also have an article of Lilly acquiring Hypnion.

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

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More pharm lay-offs. This time it is Bayer Healthcare who will layoff 6,100 people world-wide including 1,500 in Germany. This seems to be mainly due to overlap resulting from the acquisition of Schering AG and the down-sizing is set to be complete by 2009.

PharmaLive: Bayer HealthCare Announces Concrete Plans for the Global Synergy Goals and Job Cuts :

Here is a further breakdown of where the layoffs will occur:

3,150 in Europe
1,000 in the US
750 in Asia and Japan
1,200 in Latin America and Canada.

Here is the breakdown by function:

1,400 in R&D
1,850 in production
2,850 in admin

Technorati Tags: down-sizing, layoffs, Bayer

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Several additional lay-offs have come across my desk recently for the pharmaceutical industry and I thought I would list them.

Pfizer to cut 10,000 jobs in Japan
Dated 1st March it reallt deals with the issues Pfizer announced these back on Jan. 23.
Abbott cuts 200 scientists, hundreds of drug reps | Chicago Tribune
From a Feb 26th article that Abbott will be getting rid of 200 scientists mainly in drug discovery and an unspecified number of sales reps. Tje drug discovery units effected are early discovery, and metabolic research in areas such as obesity and diabetes.
delawareonline ¦ The News Journal ¦ 50 jobs to be cut at plant in Bear (near Newark, Delaware): AstraZeneca to shed 3,000 jobs by 2010.

Let’s hope that these trends don’t translate into much higher employment in the coming year.

Technorati Tags: Abbott Labs, AstraZeneca, down-sizing, layoffs, Pfizer

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LIlly received additional approvals for Cymbalta for treatment of generalized anxiety disorder.

Press Release: FDA Approves Eli Lilly and Company Cymbalta - FierceBiotech:

This brings to three the number of indications for this drug. The others include depression and diabetic neuropathy.

Technorati Tags: drug approval, Eli Lilly, Cymbalta

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Seems they knew what they was doing when Shire purchased New River Pharmaceuticals. Now, the FDA has approved Vyvanse for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

FDA approves Shire’s ADHD drug Vyvanse - Yahoo! News:

Here’s the Shire press release. This is big for them and for anyone suffering from ADHD. This drug seems to be better tolerated and longer lasting than other stimulates used to treat this disorder.

Other Resources

lisdexamfetamine dimesylate - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
Google Blog Search: lisdexamfetamine dimesylate

Technorati Tags: lisdexamfetamine dimesylate, Vyvanse

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Tomorrow, an expert panel of outside advisors will give their recommendation on a Sanofi-Aventis bird flu vaccine.

FDA experts to vote on America’s first bird flu vaccine - Feb. 23, 2007:

It will be interesting to see what comes out of this meeting. I still think that the concerns over bird flu are currently overstated. Many more will die this year from the standard flu than from bird flu.

As the article point out though, it is impossible to develop a precise vaccine against bird flu unless it actually mutates into a pandemic strain. It is a difficult decision to stockpile a vaccine that may likely do no good whatsoever. However, it is also unconscionable to do nothing. I think the best spending of money would be on technologies that get away from using chicken eggs to produce vaccines. The way the pharmaceutical industry produces vaccines has not changes in many, many years. If bird flu should become epidemic within the chicken population and not affect humans directly, it could still have a major impact on humans since ALL vaccines are made using chicken eggs. This would inhibit the ability to produce any other vaccines. These technologies, if they allowed rapid ramp up of production, could easily be used for other vaccines in the future.

Technorati Tags: bird flu, FDA, Sanofi-Aventis, vaccine

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I’ve always said that pharmaceutical companies that are truly looking at improving their image (and heading off further regulations) with the public, should do better at completing agreed upon post-marketing studies. A recent article shows that 71% of agreed upon post-marketing studies (899 studies) have not yet even been started.

Prescription Drugs | Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says - Kaisernetwork.org:

Here is the latest numbers for 2006 from the FDA: Postmarketing Study Commitments 2006 [HTML] [PDF ]

These are studies that pharmaceutical companies agree to as a condition for approval of the drug. The problem is, the FDA has no authority to do anything if companies do not comply. Their only true recourse is to withdrawal approval but that is something they have never done for failure to complete post-marketig studies. It isn’t something I would recommend either as it would hurt too many patients who may truly need a specific drug.

Some in the industry complain that it is hard to recruit patients for some drugs. That may very well be the case, but that doesn’t mean they should not even start trials. It means it may take longer to get them completed. However, that reasoning does not address the extremely high percentage of studies that have not even been started! Also, if there will be a problem getting patients for these studies, then the companies should discuss that with the FDA at the approval and agree to start them but state that it will likely take longer to complete them. It would be interesting to try and determine how many drugs pharmaceutical companies make this sort of claim for and look at how many prescriptions are written for those drugs. One of the problems is, someone in a phase IV study (aka post-marketing studies) will not be generating revenue for the company.

At the heart is the fact that these studies tend to be large and costly and in most cases, the companies will not be achieving anything substantial from them (i.e. a competitive or marketing advantage). They are mainly studies to give the FDA better confidence in the safety of the drug. Therefore, from a strictly business perspective (ignoring safety), it makes sense to put off these trials as long as possible since they are costly and are not likely to bring any benefit for the companies. Also, if there are no consequences than why do them? I would argue that sort of mentality is very shortsighted and not including the potential costs of later legal problems if the drug should have some unintended consequences (i.e. Vioxx).

Also, if this sort of trend continues, there will certainly be more power given to the FDA. I have always found it interesting that the EPA can fine companies in order to protect the environment (and the potential human consequences) but the FDA has no such power to fine companies for failing to complete required pot-marketing studies that have a larger potential to do harm.

Fro another view see Opinion | Delayed FDA Post-Marketing Study Statistics ‘Misrepresented,’ Opinion Piece Says - Kaisernetwork.org

Other Resources (note: some are from 2005)

FDA says too many drug studies delayed - Boston.com
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief® - MedPage Today
FDA To Drug Firms: You Promised, Where Are The Post-Marketing Studies? - CBS News
Postmarketing Study Commitments Database (FDA website)
Postmarketing Study Commitments: Introduction (FDA website)

Technorati Tags: FDA, post-marketing studies, phase IV studies

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There was no love for Advancis from the FDA in this article on Feb 14 when the FDA gave them a refusal to file letter. This is the second one now in the last few weeks.

FDA deny drug application from Advancis - Washington Business Journal: :

What is very interesting to me is that Advancis does not have a press release on this on their website. The last press release they have is dated Jan, 12 2007. This day and age, it is amazing to me that companies don’t react quickly to these sorts of situations. It’s been two weeks since this happened with no word from the company on their website. I understand that time is needed to form a response but something should be immediately announced.

Their Amoxicillin PULSYS once daily dosing is the product concerned and according to the company they were surprised just like Pharmacyclics that I posted about previously at the FDA’s response. The FDA, according to the company, is concerned about how they plan to scale up their manufacturing process to make bulk quantities. Previously, the company had failed some phase III clinical trials which had to be repeated and then had to re-file the NDA in Dec 2006.

I’m wondering if this means the companies are not really listening to the FDA or if the FDA is changing their mind midstream. While this may not seem to be much of difference it could have major implications for other companies getting ready to file NDAs. If the FDA is starting to crack down and not even accept applications, then the industry needs to be much more careful about how they prepare their filings. If on the other hand, these two companies just weren’t really listening and picking up on the nuances from the FDA then it may not have much of an effect on other companies.

I do know from personal experience that you have to be very careful in the questions you ask the FDA. Many times at end of phase x meetings, you submit questions in writing ahead of time and depending on exactly how those questions are worded, you may get different answers. I know of some companies that will only ask yes or no questions and try to word the question so as to get the answer they desire instead of asking questions to really learn what the FDA thinking is on a given set of circumstances. I have always felt this was a mistake. Early on, it is vitally important to ask open ended questions before too much time and money is spent going down a regulatory or development route that may lead to failure at a late stage when it is very costly.

Technorati Tags: Advancis, FDA, amoxicillin pulsys

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Earlier this month, DrugResearcher.com had an article on revamping at major pharmaceutical companies.

Roche revamps R&D for speed:

An import part of the article is in the last paragraph. GlaxoSmithkline reorganized their research into seven Centres of Excellence for Drug Discovery years ago and I don’t know that it has increased their overall productivity. It may gets more drugs into development, but the more important issue of making sure the ones that do go into development have the greatest possible probability of success.

I’ve seen this before and I don’t have much faith in these “reorganizations”. Inevitably, these sorts of moves don’t make major contributions to the bottom line and sometimes actually make matters worse. I personally think that the culture and huge bureaucracies are more to blame for the lack of research results. That isn’t to say re-orgs can’t make thing better, that can be. I just think too many times they don’t pay off.

I’ve also said that just moving the bottlenecks of development from one place to another is not the answer. The bottlenecks need to be removed from the system entirely, rather than just moved from place to place without increasing the overall output.

Technorati Tags: GlaxoSmithKline, Roche

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