QDIS Blog

Looks like Neurocrine will continue with its development of Indiplon based on recent news.

Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA

Seems the FDA wasn’t happy with the pharmacokintetic/food effect profile provided in the application. The FDA it seems would like to see additional meal profiles to see what effect various meals may have on the distribution of Indiplon in the body. The press release states that Neuocrine will have a meeting with the FDA in October of this year for further clarification. If indeed this is the only sticking point, then it should be relatively easy for Neurocrine to perform additional studies to resolve this issue.

It would be interesting to know what the nature of the problem was. My guess (and it is only a guess) is that Neurocrine may have looked at food consumed hours before taking the drug and not at taking the drug in conjunction with food just before going to bed. Also, some people with insomnia tend to eat fairly large meals right before attempting to go to sleep and this may contribute to problems with the drug’s half-life. Remember, one of the claims for Indiplon is that it lasts longer than others on the market and this may also be why the larger dose was not approvable whereas the lower dose levels were approval (if further work was done).

Technorati Tags: Indiplon, Neurocrine, sleeping pill

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Merck has released some preliminary data for a large clinical trial regarding Arcoxia (etoricoxib), Merck’s second generation Cox-2 inhibitor. It has generated quite a bit of news recently and here are some of the articles.

• Merck’s Vioxx Heir - Forbes.com
• Merck Sees Successor to Vioxx - New York Times
• Merck Provides Preliminary Analyses of the Completed MEDAL Program for ARCOXIA(TM) (Etoricoxib): • Financial News - Yahoo! Finance

Since it will likely be at least three years before any other studies related to COX-2 inhibitors are released, these results will be examined in great detail. Many people want to understand what it is that may be behind the increased risk of hear attack. There are already some people pointing out that they are comparing Arcoxia to Voltaran (diclofenac) from Novartis. Not everyone thinks Voltaran is the best comparator.

I would say that I think coming up with a new pain relief that is safe and effect is needed. I have talked to several people who would almost rather take the risk of cardiovascular problems than continue to put up with the daily chronic pain. Although the FDA now recommends Aleve (naproxen) as the pain relieveer with the lowest risk of the pain medications for arthritis. Arcoxia is approved in about 62 other countries and it is interesting that now, without releasing all the study details, Merck has decided to push the FDA for approval in the US. It was interesting that one side effect seems to be an increase in blood pressure. Merck has stated they will release the full details before the end of this year including articles in peer reviewed journals.

Technorati Tags: Arcoxia, etoricoxib

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A recent article came across my desk and I thought it misrepresented the facts and wanted to make some comments on it. The article was in the Signs on San Diego site.

SignOnSanDiego.com > News > Health — Study: FDA advisers typically recommend approval for drugs and devices

The article implies that something improper may be occurring with the process of having external experts make recommendations on drugs and devices I would point out that the whole drug development process involves weeding out those candidates that do not preform well at early stages. It is in the best interest of the company developing the drug that they be able to make a go-no go decision as soon as possible. Therefore, only the drug candidates that have a very high potential to be approved make it to the point of filing an new drug application (NDA). It is not surprising to me that the majority of those get approved. It should also be noted that just because an expert panel recommends approval, does NOT necessarily mean it will be approved.

While I do acknowledge that there have been some conflicts of interest that were not made transparent in the past, I think there has been some progress made in this regard. I just hope that reason prevails and this isn’t used as another bullet against the FDA.

Technorati Tags: drug development, FDA

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A recent article on the biogenerics market from a money perspective has appeared on the CNN Money site.

Biogenerics face FDA issues amid biotech barriers. - Aug. 15, 2006:

They predict that the biogeneric market will be $20 billion by 2010, only 4 years away. The question is, how much of that market will the US have vs Europe and the rest of the world.

I personally think there are two areas of concern. One is the process by which biogenerics will be approved in the US. It appears to me that the FDA really isn’t going to do anything about it unless forced by congress. My feeling is they will continue to slowly approve product just as they did with Omnitrope. So instead of having a streamlined well laid out process, the standard full testing of products seems to be the expectation.

Many companies are not waiting to see what the US FDA may decide. As an example, Teva, a large generic manufacturer in Israel has recently purchased biological manufacturers in Mexico and Lithuania. Another example is Barr Labs which is attempting to buy Pliva biologics manufacturers in Croatia. This is too bad, because it means the US may miss out on the job creation that could come from having these operations within the US.

Second without biogeneric or “follow on protein products”, healthcare costs will continue to increase at a rapid rate. Since these biological drugs treat serious indication and they are so costly, they can have a large affect. As more and more big pharmaceutical companies, whose blockbuster drugs are expiring turn to biological drugs, the situation will only get worse.

Technorati Tags: biogenerics, FDA

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In looking at all the AIDS information coming out of Toronto this week, I came across a useful site that show drugs that are in development for AIDS/HIV.

First is thebody which has a list of antiretrovirals in development as of June 30, 2006.

The Body: 2006 Antiretrovirals in Development Pipeline

One of the nice things about this page is that it doesn’t just list the drugs but gives links to online resources such as abstracts from conferences. THere i also a chart of entry inhibitors, integrase inhibitors, maturation inhibitors, and other drugs.

Aidsmeds.com also has a list of both approved and investigational drugs that is fairly extensive.

Alphabetical List of Drugs for HIV & AIDS

Technorati Tags: aids drugs, HIV drugs

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Occasionally my reading material stacks up and I have to set aside some time to go over it and read through all the various trade journals and magazines I get. In the course of that exercise, I came across a good article on HIV/AIDS in Drug Discovery and Development.

A Quarter Century of Battling HIV/AIDS

Since the XVI International AIDS Conference is occurring in Toronto, Canada this week, I though it was a good time to alert folks to this.

Basically 21 drugs have been approved since 1987 or about one per year. And this doesn’t include the recent approval of Atripla, the three drug combo for once a day dosing. I’ll post more about some developments on Atripla later this week.

Technorati Tags: aids drugs, HIV drugs

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Healthworld IT is reporting that Steven Paul, executive vice president at Eli Lilly is stating that the cost to develop drugs could top $2 BILLION by 2010 if changes are not made.

Drug Costs Nearing $2 Billion, Warns Lilly Executive

Other than mentioning the FDA’s Critical Path Initiative there isn’t much else new here. The one point that always seems to get mention is the need to reduce the attrition rate in phase II. Currently only 20% make it to phase III studies (one on five). Biomarkers may help with this but I still think that your are always going to have phase II as the place to make go-no go decisions. This makes sense if you stop and think about it. This is the first place where it is tested in humans for the disease indication and the first time it is tested in more than a few people. It should be expected that this is where potential drugs are going to fail. Until we develop much better animal models, this will continue to be the case.

I do think the talk of allowing the use of biomarkers and possibly allowing drugs to go onto market for those identified with certain biomarkers after a successful phase II study could help. However, I don’t see this happening anytime soon as a lot of processes and procedures would need to be put into place before it could be eliminated.

I do find the following quote from the article to be interesting:

The effective patent life of blockbuster drugs is approaching 10 years, said Paul, who contrasted that short lifespan with the 50 years of copyright protection enjoyed by Mickey Mouse! “We should start the clock when the drug reaches market,” Paul suggested.

I think pharmaceutical executives tend to forget or overlook the current attitudes of consumers. There is already much talk about how expensive drugs are and this seems to play right into the view of some consumers of pharmaceutical companies being greedy. While increasing potential income is one approach, I think there is much more room for improvement with the lead discovery to phase II stages.

Technorati Tags: drug development, drug cost

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In the June issue of R&D Directions magazine they list drugs being developed by indication and I thought it was interesting enough to give some of the numbers.

1. 566 drugs for cancer
2. 242 for CNS disorders
3. 229 for infections
4. 198 for pain/inflamation
5. 195 for cardiovascular disease
6. 122 for respiratory disorders
7. 97 for diabetes
8. 88 for blood disorders
9. 83 for gastrointestinal disorders
10. 62 for dermatology disorders

I’m not surprised that cancer drugs are by far and away the bulk of all the drugs being developed; more than twice as many as the next highest category. The one surprise to me was that there were 229 compounds being investigated for infections. I find this promising and hopeful considering the need for new antibiotics.

The magazine requires a subscript but if you can get a copy, I highly recommend it for a high level overview of what is going on in drug development. They also have a list of drugs approved in 2006 from Jan 1 to May 16, those approved from May to Dec of 2005, those awaiting approval as of May 16, and those in development by stage.

Technorati Tags: drug development

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I find it very different and quite interesting that several AIDS drug manufacturers have said they are actually going to help generic manufacturers in India to make generic versions of some AIDS drugs.

Gilead offers secrets to AIDS drug - Marketplace by Bloomberg - International Herald Tribune:

I’d be interested to hear what the details are as I’m sure they aren’t doing this without some sort of compensation (upfront payment or royalties?).

Hear is a quote from Bristol-Myers Squibb.

Bristol-Myers says it will assist two manufacturers, the India-based Emcure Pharmaceuticals and Aspen Pharmacare in South Africa, in making copies of its AIDS pills. “We didn’t just send them the owner’s manual, but we also sent them our technicians to work in their labs,” said Donne Newbury, director of global HIV access programs at Bristol-Myers.

I think this sort of cooperation should be encouraged for just these sorts of situations. Making affordable medications for the rest of the world is going to be a major challenge in the 21st century.

Technorati Tags: aids drugs, BMS, Bristol-Myers Squibb, drug development, Gilead

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In some recent publications I’ve been reading, I came across a list of some compounds that may become blockbusters (sales of more than $1 billion a year). I found it interesting and wanted to post the list here. These are all already filed or in late phase III trials.

• = Continuous Erythropoiesis Receptor Activator

It is interesting that Roche is the only company with two compounds on this list.

Search results for each drug from Yahoo!

• acomplia
• actemra
• cera “Continuous Erythropoiesis Receptor Activator”
• galvus
• paliperidone
• panitumumab
• prasugrel
• rasilez
• TAK-390MR
• torcetrapib atorvastatin

Technorati Tags: blockbuster drugs

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