QDIS Blog

Recently the FDA announced they were changing how they review generic drug applications.

FDA Offers Speedy Approval for Some Drugs

Previously, it was first come first serve and applications were held in a que. They were then reviewed, the oldest to the more recent and the median timeframe was about 16 months.

Now however,while still using the FIFO approach, the FDA will prioritize some applications based on “their public health impact”. This sounds good and will indeed help but I’m somewhat hesitant to give it a rousing endorsement. Until I hear more details on what criteria is used, it seems ripe for abuse and/or manipulation. The days of the generic drug scandal are not that far gone and those lessons learned should not be ignored.

I’m hopeful that this will indeed be an improvement but will keep an eye out to see how it is implemented. It should be noted that this will only apply to approximately 25% of the generic applications.

For those interested the 5240.3R Review Order of Original ANDAs, Amendments, and Supplements (pdf) is available online.

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This article talks about a recent press release from both Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) regarding regulation of foreign active pharmaceutical ingredient (API) manufacturers.

US and EU pharma trade bodies slam poor regulation of foreign APIs

Both have valid point that although regulations require inspections on a regular basis, the reality is that the schedule is rarely up to date. In 1999 there were 242 manufacturers who imported into the US but had not been inspected.

The dramatic rise in the number and amount of API’s sources in India or China means that both US and European regulators, already behind, will likely only get worse before it gets any better. This does indeed mean that the possibility of something adverse occurring is increasing.

My main point here would be that the FDA is underfunded for the work they do. Congress likes to increase their responsibility without increasing their budget to do so. Foreign inspections seem to be one of the first items to be cut and I don’t see that changing anytime soon. I personally think it is going to take a major incident before something changes. Unfortunately it will like involve people dying before action is taken. Historically, almost all major pharmaceutical regulations in the US come after a major incident involving deaths. Until then, nothing happens proactively.

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A recent article from New York Business.com talks about Pfizer cutting costs. This is because although they had increased revenue, profits were flat.

Pfizer announces $4 billion cost-cutting plan

This $4 billion cost saving through 2008 represents 12% of their cost base and if they can do it would be tremendous. However, I think it depends on how they achieve these “savings”. In Pfizer’s case, after many mergers in the last few years they probably have redundancies and duplicate facilities. Closing these seems to make sense. However, the one thing that is always overlooked in these cases is the value of the people who operate these facilities especially scientists and operators. Too many times I’ve seen highly motivated and productive people let go simply because that facilities has been chosen to close for a variety of reasons.

This isn’t always a bad thing. Sometimes, people become motivated and decided to start their own small company to compete and fill the void created by such actions. This is especially true in cases where people do not wish to relocate. Such small companies can afford to take risks that large companies are unwilling to take and are more nimble and able to make quick strategic changes that are impossible in larger companies.

On the down side though this means that sometimes, these small companies, once they have achieved some success, can be looked at as food for the these larger pharmaceutical engines. They then end up getting bought out and sometimes shut down. While this means the principals make money, it often means that many are out of work again.

Such is life in the pharmaceutical industry these days.

Other Resources

• Pfizer Unveils Broad Cost-Cutting Plan - Forbes.com

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The Washington Post has a story today on a bird flu vaccine being tested by Sanofi Pasteur.

Bird Flu Vaccine May Hit Many Strains - washingtonpost.com:

The key point appears to be that the specific strain this vaccine was based on from Vietnam, shows cross protection against other strain of the H5N1 from other countries. While this is interesting, it does not guarantee immunity against all H5N1 strains. Indeed it is good to see and emphasize that the researchers state it is very early and they still don’t know enough to make blanket statements about cross protection.

Another point made in the article is that stockpiling vaccine may be an effective approach. However, it is still risky since it is unknown if the next pandemic will even be H5 based. It might very well end up that we are concentrating on the wrong virus; it is impossible to predict which virus could lead to the next pandemic.

Other Resources

• InteliHealth: Bird Flu Vaccine May Hit Many Strains
• Bird flu vaccine may be more protective than thought; Swiss to stockpile | Markets | Headline News | Canadian Business Online
• Sanofi bird flu vaccine may offer wider protection

Technorati Tags: avian flu, bird flu, pandemic flu, Sanofi-Aventis, Sanofi

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I don’t normally make comments on announcements for clinical trials. I prefer to talk about results rather than plans. However, since this is about the only pharmaceutical company in my neck of the woods (Oregon) I though I’d at least mention it.

AVI BioPharma Initiates NEUGENE Antisense Clinical Program in Coronary Artery Bypass Grafting: Yahoo! Finance

The trial looks at improving outcome for bypass grafts in heart patients. The grafts will be immersed in a saline solution of the antisense compound AVI-5126 to see if that improves the outcome. The study will be double blind, randomized and placebo controlled so it sounds like they are doing everything right.

Here’s the pertinent paragraphs telling how this compound works.

AVI-5126 silences a gene known as c-myc, a key regulatory gene involved in cardiovascular restenosis. C-myc is believed to regulate the many downstream genes that produce the pathology of restenosis, namely cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation, among others.

Preclinical studies have shown that silencing c-myc just at the time of injury may be enough to prevent late-term consequences of intimal hyperplasia, considered the primary cause of vessel obstruction after CABG and intra-coronary artery stent placement.

Since this type of surgery is common in the US with 350,000 such surgeries taking place each year, this could be a major adjunct to the surgery to improve the overall outcome. What I think needs to be kept in mind though is that this is a phase !b/II study; after a safety evaluation of the first 110 patients it will then become a phase III trial and the patients will be followed for one year. I personally think that one year is a little too short. It could will end up that at the end of that time there is no statistically significant difference between the two groups. While I know folks involved are probably better informed than myself about this sort of follow-up, I can’t help but point out that many times folks are overly optimistic in such situations. I’d rather see them err on the side of caution and make the follow up longer; at least three years. He only downside to this approach is that investors see this is involving more time and money

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Schering Plough has said they will remain independent and are not looking for mergers at this time.

Schering’s Hassan Says Company Will Stay Independent

While this may be admirable, I don’t know if they can keep up with all the other larger companies. Bristol-Myers Squibb is another one that will in my opinion be gobbled up by someone else in the not to distant future. The pressure to continue growth and adding new chemical entities to the pipeline is strong and I think investors may overlook those who aren’t on the merging track.

i personally don’t think mergers are the answer to some of the current problems associated with discovering new drug candidates. I take the view that there are other things that can be done to improved the productivity. And moving the bottlenecks from one place to another is not the answer either. Many companies and services are focused on getting more candidates into development. However, having spent over 14 years on the development and manufacturing side of things, this many times only results in more projects of lower quality and spending money and then failing on the development side is much more expensive.

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One of the great products released at the recent Podcast Expo was Levelator from Gigavox Media. This is a very easy to use and runs on any platform since it is Java based (actually it’s in C++ but has a Java wrapper). I’ve used it and it does indeed work well, although I’ve not had a audio file that really pushes it to its limit.

Basically it takes any WAV or aiff file and will level the sound volume. This is particularly useful if you do live interviews or have a situation where the levels are uneven.

And the best part is it’s free. Note though that it is still beta and almost certainly has bugs in it.

Here is Michael Geoghegan CEO of Gigavox, posting about Levelator on his blog.

Technorati Tags: audio software, audio volume, Gigavox Media, podcast, sound volume

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Last week there was an article about a study in the New England Journal of Medicine that basically came to the conclusion that common antipsychotic medications do not particularly help Alzheimer’s patients.

No sign antipsychotics a great help to Alzheimer’s patients: study - Yahoo! News

The drugs they looked at were olanzapine (Zyprexa), quetiapine (Seroquel) and risperidone (Risperdal). While they did have some beneficial effects, the side effects were not worth the small benefit. This is common for central nervous system (CNS) drugs and points to the fact that more targeted molecules are needed. This may stem from our rather poor understanding of the biological systems and mechanisms involved in how these drugs have there affect.

Side effects are the primary reason for not taking CNS drugs. Anyone who has had a loved one or a friend who has been on one of these or other CNS drugs can testify to that. Another problem, once a drug has been found that works and has few or no side effects, is that once they are feeling better, the patient thinks they can do it on their own and don’t need to continue taking their medications. I personally have seen this happen and it results in a roller coaster ride for both the patient and those who care for them. I found this to be particularly true for adolescents and young adults.

All of these are reasons I personally think more work needs to be done in understanding how these rugs work in the body and what can be done to improve the effectiveness of CNS drug by eliminating or reducing these side effects.

Other Resources

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Seemingly the last words on the acquisition of AnorMED has been sounded; Genzyme will acquire them.

TheStar.com - AnorMed agrees to takeover by Genzyme

Genzyme offer of $13.50 per share ($580 million) was better than Millennium’s bid of $12.00 per share ($515 million). I do think that Millennium may have been the smarter of the two by walking away from the deal although they are entitled to a $19.5 million breakup fee. Genzyme had to up there original order of only $380 million.

The Boston Globe then reported that Millennium is still on the prowl for someone to acquire.

Millennium renews hunt after losing AnorMed to Genzyme - The Boston Globe

So it seems the merger activity will continue. It will be interesting to see who Millennium has there eye on next.

Other Resources

• Yahoo! News Search Results for genzyme millennium anormed
• genzyme millennium anormed - Google News
• Google Blog Search: genzyme millennium anormed
• genzyme millennium anormed - Ask.com Blog and Feed Search

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Well, Lester Crawford finally pled guilty to filing false and misleading financial disclosures while head of the FDA.

Ex-FDA chief pleads guilty to charges - MarketWatch:

I have been curious for a long time as to what company he owned and what the conflict was. Seems it is Pepsico and Sysco and this was because Crawford was head of the obesity working group that was working on recommendations regarding food labeling and calorie counting. Both these companies definitely have interests in this so there is a clear conflict of interest.

Lester Crawford could face six months in jail or house arrest and/or $50,000 fine. It will be interesting to see what he actually gets. My guess, 2-3 months house arrest (probably none) and maybe $10,000 fine.

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