QDIS Blog

I’ve reported on this before but here is an article from Canada about their concerns if the US passes legislation allowing bulk importing of drugs from Canada into the US.

PharmaLive: U.S. Congress Threatens Canada’s Prescription Drug Supply

What is interesting to me is the the Canadian Health Minister has remained silent on this issue although in the past he has said that he doen not expect any impact on the Canadian drug supply. Here are some more articles on this mainly from the UK and Canadian press.

• Open Letter to Minister Clement on Cross Border Drug Trade (pdf)
• Canada pharmacists seek ban on drug exports to U.S.

It is interesting that few if any US based media has reported on this. I think this will be a bigger obstacle to overcome than any other. Between Canadian not allowing exporting of drugs to the US in combination with drug companies potentially limiting the amount of drugs that Canadian pharmacies can purchase, I think drug importing is merely a political ploy.

The article rightly states that this will not solve the problem and will likely create more problems. I think this quote summarizes the issue nicely.

“This is an unsustainable quick-fix for the made-in-America problem of high U.S. drug costs,” said Marc Kealey, CEO of the Ontario Pharmacists’ Association. Kealey added, “Congress is telling Americans it’s okay to cherry-pick the benefits of Canada’s regulated drug system and solve a domestic U.S. problem on the backs of Canadians. Canada cannot afford to become America’s medicine cabinet. That threatens the security of our own drug supply and the health and well-being of Canadians.” Poston noted that Canadians have built a drug supply and pricing mechanism that meets Canadian needs. Buying drugs in Canada as a quick fix to high U.S. drug prices is not a solution. U.S. lawmakers should design a system that responds to the needs of Americans instead of jeopardizing Canada’s drug supply.

I couldn’t agree more! The true issue is affordable health insurance with a drug prescription plan for those Americans who are not covered.

If you would like to track the progress of this US legislation I recommend Govtrack.

• GovTrack: S. 251: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes
• GovTrack: S. 242: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes
• H.R. 380: To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes.

Technorati Tags: drug imports, drug price, Canadian drug imports

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More big deals in the pharmaceutical biotech arena. This time Genetech is fronting $60 million upfront and up to an additional $800 million in milestone payments to develop SGN-40 from Seattle Genetics.

PharmaLive: Genentech and Seattle Genetics Announce Exclusive Global Licensing Agreement for Development and Commercialization of SGN-40 :

Genentech, Seattle Genetics in deal

Genentech must have confidence in Seattle Genetics because they are allowing them to continue with phase I and II trials and will reimburse them the development costs. SGN-40 is a monoclonal antibody and the following is from the National Cancer Institute websit

A monoclonal antibody that binds to cells that have the CD40 antigen on their surface, including cells from multiple myeloma, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. SGN-40 is being studied in the treatment of cancer. It belongs to the family of drugs called monoclonal antibodies.

Seattle Genetics has a web page on SGN-40 with a brief description. I think that Genetech may well have added a great product to their pipeline. However, I do have concern about the amount paid. It may be that milestones are stated such that the drug has to be outstanding before the full payments are made but in my experience, this is rarely the case. I have friends that work for Seattle Genetics so I do wish them the best with this project.

Technorati Tags: Genentech, Seattle Genetics, SGN-40

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Seems the problems with 80 people getting sick at Taco Johns in Iowa and Minnesota were indeed sickened by e. coli and that the strain has been tracked back to a dairy farm near lettuce fields.

Officials track E. coli strain to Calif. - Yahoo! News

Technorati Tags: e coli, Taco Johns

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Well, it didn’t take long for the drug import issue to raise it head again. Seems Senator Grassley (R-Iowa) is pushing for an end to the ban on drug imports from other countries.

Grassley pushes to end drug import ban

While there may be support for this in the both houses of congress, I think it would definitely be vetoed. The question then becomes, are there enough votes to override a veto. I’m uncertain at this point but given how circumstances are unfolding it might be possible depending on the several factors. Interestingly, one of these is Iraq. Whoever thought Iraq would have an impact on drug imports?!

I think if enough Republicans distance themselves from the president first on the war and then on other issues, this may make it possible to pass such legislation and have enough support to override a certain veto.

I do want to say that I don’t think this sort of legislation is good but not for the usual reasons. I think this is treating a symptom and we really need to treat the underlying disease. There are far too many people in the US who do not have any healthcare or who pay a very high price for limited coverage.

I do want to say that I think the most commonly raised compliant of not being able to assure drug safety while certainly a concern, is not insurmountable. This issue could be dealt with if there were the will to do so. It is simply an easy argument to make and doesn’t require any effort. I think the more important concern is the response in other countries. For example, Canada has considered not allowing their pharmacies to sell into the US due to the possibilities of shortages within their own country. Indeed, some pharmaceutical companies have said that they will only sell limited amounts of drugs to Canadian pharmacies. If they choose to sell into the US and not to their own citizens, then that is there prerogative. However, the pharmaceutical companies were not going to increase the amount of drug sold to them.

Another problem is deciding which countries to allow importing and which not. I’m sure Canada will be on the list as well as many European countries. However, many countries should probably not be on the list and maybe even specifically excluded. There is also the problem of misleading websites purporting to be Canadian when they get the drugs from other countries that may be less than reputable.

On another note, not all drugs are cheaper from Canada. This is one of those myths that just won’t die. I talk to many people in my community and almost all believe that ALL drugs are cheaper in Canada. This isn’t the case, in particular with generics. many times, once a drug goes generic, the price drops dramatically and many times the generic from a US pharmacy is cheaper than the same generic from Canada. The FDA put out a white paper entitled Generic Drug Prices in the U.S. Are Lower Than Drug Prices in Canada which point this out.

I think it is interesting to see the reaction to this issue if you change the framing; should the US have the same price controls for drug prices that Canada and other countries do. Many people do not support price controls but do want cheap drugs from Canada?! From my perspective, it is basically the same thing. Why not just have the political will to call it what it is; price controls on drugs. THe reasons is hat moving forward that way would not be acceptable.

The big difference is that in many countries with socialized medicine, there is one buyer, the government. They set the price and as I’ve said before, until now the attitude of most big pharma and biotech is that okay, we’ll make up the difference in the US. That means the US is basically subsidizing development for the rest of the world.

This is an issue that will certainly be front page news this year but I think too many of the aspects of this issue are boiled down to sound bites and simplistic phrases rather than addressing the issue head-on and dealing with the various

Other Resources

Generic Competition and Drug Prices
CNN.com - FDA: U.S. generics better buy than Canada drugs - Jan. 19, 2004
Generic Drug Prices: A Canada US Comparison
GENERIC DRUGS: AN ALTERNATIVE TO DRUG RE-IMPORTATION
U.S. bill aims to import cheaper medications from Canada (CBC News; Canadian source)

Technorati Tags: drug imports, drug price

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Forbes is reporting that AztraZeneca and Bristol-Myers Squibb are teaming up to develop two new type 2 diabetes treatments saxagliptin and dapagliflozin both initially discovered by BMS.

Bristol-Myers, AstraZeneca in Drug Pact - Forbes.com:

Details are that AstraZeneca will pay BMS $100 million upfront and BMS could earn up to another $650 million in development milestones and then another $300 million in sales milestones. This makes the deal worth potentially over $1 billion dollars!!

It is interesting to look at why this deal may have been done. BMS evidently doesn’t feel they could go it alone on this or they would have. They get AstraZeneca to pick up the bulk of the development costs through 2009 and expenses after that being shared. BMS will make the drug and book sales. Also any future compounds discovered by either company would be included under this partnership.

To me this looks like the first step in a possible future merger. If the drugs are blockbusters then it might make sense in the future for them to merge rather than continue the partnership. Only time will tell. Saxagliptin is in late stage clinical trials whereas dapagliflozin is somewhere in the middle of the process, so it will be several years before we’ll know how this plays out. My best guess; if both drugs are approved and are blockbusters then the companies will likely merger sometime after 2010.

Technorati Tags: AstraZeneca, Bristol-Myers Squibb, dapagliflozin, diabetes treatment, drug development, pharmaceutical deals, saxagliptin

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The news stories related to healthcare issues are starting to roll out like a steam engine building up speed. There are many issues now getting press such as the following:

• Stem cells
• Drug imports
• Universal healthcare
• Drug safety
• Medicare drug price negotiation
• Pharmaceutical spending on R&D vs admin and marketing
• Generic biologics

All of these have come across my desk in the last 24 hours. I’m going to try to comment on some of them but certainly am not an expert on all of these and will try to point readers to good resources on these topics. I hope to at least give you my take on many of these but it will take some time.

Technorati Tags: drug cost, drug price, drug safety, stem cell, stem cells

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VaxGen has had problems recently with the US government canceling the anthrax vaccine project.

VaxGen moves to change after anthrax setback / Brisbane company receives $51.3 million in Celltrion sale

They have sold their interest in Celltrion which operates a manufacturing plant in Inchon Korea for $51 million and now have about $96.6 million in the bank which should keep them going for a while depending on their burn rate. However, they are going to be taking a new direction and it will be interesting to see what they become and how they purpose to get there. However, as the article points out VaxGen is now 0 for 2 in their projects (their lead AID drug failed in Nov. 2003) meaning it will be hard to convince investors they have potential and are worth investing in.

Technorati Tags: vaccine, VaxGen

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This article from about a week ago cuaght my eye on Yahoo. It is about the need for collecting long term safety data for two approved diet drugs in the US and another one tat is under review by the FDA. THe three drugs are Xenical (orlistat), Meridia (sibutramine) which are approved and Acomplia (rimonabant) which is under review. The article mentions an article in journal Lancet.

Long-term data needed on anti-obesity drugs - Yahoo! News:

I tend to agree especially since they all seem to have the potential for serious side effects which show up even with just short term use. As I have said here many times, they risk and reward need to be weighed for the use of any drug. There may be cases where the potential benefits outweighs the negative. However, my concern with drugs such as diet drug are the potential for misuse and over-prescribing of such drugs. Given Americans obsession with dieting and weight loss, these drugs have a huge potential for problems and I agree that more long term safety data is needed.

Long term safety data will likely be one of the primary topics for FDA reform this year from the Democrats in Congress especially in the House of Representatives.

Other Resources

XENICAL.com Home
Meridia (Sibutramine HCl)
Accomplia: The New Weight Loss Drug (Rimonabant)

Technorati Tags: Acomplia, Meridia, orlistat, Rimonabant, sibutramine, Xenical

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Just wanted to let readers know that DrugResearcher.com has started a new feature called Drugs Movving Into the Clinic that will cover drugs entering into clinical trials.

Drugs moving into the clinic this week:

Hopefully this will continue and I look forward to browsing it each week to see a consoldiated list of all the company reporting IND filings and phase I clinical trials.

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LIlly has announced they are licensing the compound PSN010 from OSI Pharmaceutical’s subsidiary Prosidion for an upfront payment of $25 million and an additional $360 million in development milestones.

PharmaLive: Lilly and OSI Pharmaceuticals Announce Licensing Agreement :

This is an early stage compound (phase I) for diabetes type 2 and it activates oral glucokinase.

Again, I think it is interesting to see some companies going the mergers and acquisitions (M&A) route while others are making deals for compounds. I’ve stated before I personally think the deal making is the better approach since this doesn’t kill the innovations of the small company. I look at mergers as killing the goose to get the golden eggs.

Other Resources

PSN010 - Yahoo! Search Results

Technorati Tags: Eli Lilly, OSI Pharmaceuticals, Prosidion, PSN010

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