Comments

1. Lisa Van Syckel

   • April 14th, 2010
   • 7:20 am
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   One of my family members was diagnosed with glioblastoma, stage 3. He is only 32, and his wife gave birth to their first child three weeks ago. so my question is this, how efficacious is this avastin?

2. Salient point

   • April 14th, 2010
   • 8:13 am
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   Remicade is a J&J product, not Merck, as the list states. Merck does have a claim to Remicade ex-US which is going to arbitration. But in the US, it is & will remain J&J.

3. Ed Silverman

   • April 14th, 2010
   • 8:21 am
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   Hi Salient Point,

   Thanks for the note and the list has been clarified. The Thomson Reuters ranking lists it as Merck/J&J and the J&J was inadvertently dropped. However, as you point out, it should be J&J. Appreciate your attention to detail.

   Regards
   Ed

4. Condor

   • April 14th, 2010
   • 8:27 am
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   Great run-down, Ed –

   I, too, was going to mention that Merck is likely to lose these rights by late September 2010, when the arbitration is likely to be concluded.

   It should be entertaining to watch Merck’s $3 billion to $4 billion share of that franchise — Remicade/Simponi (outside the USA). Will it fall off completely, ex-US, for Whitehouse Station, come November 2010? Or, will CEO Clark cut a deal to keep at least a little of it — with CEO Weldon?

   We’ll see.

   नमस्ते

5. Greg Pawelski

   • April 14th, 2010
   • 8:30 am
   • Link to this comment

   The idea that injectables have been and will dominate the market has one common denominator: intravenous (IV) cancer therapies are more profitable than oral therapies. Case in point. Although oral tyrosine kinase inhibitors, like Tykerb, offer patients a well-tolerated, conveniently administered alternative to intravenous (IV) therapy, Decisions Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, found that oncologists were not yet ready to use Tykerb as a replacement for Herceptin. Ninety-one percent of surveyed oncologists stated that intravenous (IV) cancer therapies are more profitable than oral therapies. And fifty-eight percent of oncologists say they would favor IV Herceptin over oral Tykerb because administration of IV drugs remains an important source of income for their practices.

   Profit is a powerful motivating force. Among medical benefit payors, the profit motive is entirely consistent with the goal of developing molecular tests, which are to identify efficacious therapies irrespective of drug mark-up rates. The FDA finds themselves under increasing pressure to allow new drugs into the marketplace, while at the same time protecting the safety of potential recipients of those drugs and also the financial interests of those who will have to pay for them. The pressure is so great that companion molecular diagnostics approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.

   It should be in the FDA’s interest in saving the healthcare system perhaps billions of dollars a year (and thereby the healthcare system itself) by ensuring that expensive treatments are used appropriately. It should serve their interest not only in discovering new cancer treatments, but also using currently-available cell culture technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.

   When clinically relevant and accepted drugs may have the same efficicay, and a tumor is resistant to one of them, it is within the standard of care to give the drug with the least resistance and/or the drug with the most sensitivity. My personal belief is in having additional support of drug patient-specific activity as determined by extensive laboratory pre-tests, with cell culture technology, to bolster the clinical justification of the drug(s) chosen, with no economic ties to outside healthcare organizations; recommendations made without financial or scientific prejudice.

   Avastin has shown activity in many solid tumor types such as breast, lung, and ovarian cancer. One of the most popular combinations for brain tumors is Camptosar (CPT-11) and Avastin. However, as with most “targeted” therapy drugs, Avastin does not necessarily benefit every patient and it is expensive. Until now, there were no tests that existed to show reliably who would benefit from anti-angiogenic agents. There has been an bio-marker assay developed for microvascular viability to identify potential responders to Avastin and other anti-angiogenic drugs. It was discovered that endothelial cells are present in tumor microclusters and it appears that drug effect upon these cells can be assessed in this new microvascular viability assay.

   Confirmatory activities are ongoing. It is being offered currently to selected clients on a research basis and as an adjunct to a standard assay or a tyrosine kinase assay. Every cancer patient should have his/her own unique chemotherapy trial based on consultation of pathogenic profiles and drug sensitivity testing data. Research and application of these tests are being encouraged by growing patient demands, scientific advances and medical ethics. These tests are not a luxury but an absolute necessity, and a powerful strategy that cannot be overlooked.

6. patrons99

   • April 14th, 2010
   • 9:09 am
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   Great post, Ed.

   Begs the question as to where Reuter’s got the 2014 predictions?

   How many of the marketed products have outcomes data (all cause mortality and survival benefit) supporting their efficacy and safety?

   I would argue that several of the products on BOTH of these lists should never have been approved in the first place, for safety reasons.

   For these predictions to all come true, will provide yet further evidence that FDA is “asleep at the wheel”. One OR MORE of these products should be withdrawn from the marketplace for safety reasons.

7. Lisa Van Syckel

   • April 14th, 2010
   • 10:26 am
   • Link to this comment

   Well Patrons99, I guess, its a damned if you do, and damned if you dont situation. I Lyme Arthritis, and their is no way I would even consider taking those Arthritis Meds….

8. Outside the Box

   • April 14th, 2010
   • 12:25 pm
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   On a slightly different point, can we now please put to bed for the last time the notion that the days of the blockbuster are over? If these numbers are close to correct we have 10 products producing a total of $74 billion in annual revenues, and a continuation of the list would find another 20 products over $1 billion. I think any reasonable person would consider $5 billion a blockbuster.

9. William Roth

   • April 14th, 2010
   • 4:47 pm
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   Great list - thanks. Question and a point.

   The question is Crestor - I thought the patent expired in 2012 - best case is 2013 - was there some type of extension or thought that would delay generic competition that has it as a top player in 14?

   The point is the size of patent cliff that yields this list. We just finished a project that looks at the branded ambient market (non-generic/non-biotech) which was valued at $245 billion at the end of 2009. The size of the 2011-2014 patent cliff appears to be $70 billion - almost a 30% loss in market size?Lipitor alone is almost $13 billion - why aren’t more people talking about the cliff and it’s overarching impacts?

10. Pharmavet

    • April 14th, 2010
    • 6:40 pm
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    OTB is correct. When I started in 1983 in Pharma we were continually chided by our bosses that every day that we failed to get a drug approved meant one million dollars in lost revenue, since $300 million/year was considered a blockbuster. That has now been ratcheded up to $3 million/day in lost sales based on more modern definition of blockbuster as a minimum of $1 billion/year in sales.

    Based on the earlier definition, companies like Pfizer had certain rules for which drugs they pushed. Those rules were:

    1) First in class; or
    2) Best in class; or
    3) minimum $500 million/year in sales.

    Suffice to say that drugs like Lipitor far exceeded these goals, hence the present difficulty in making up lost revenue when Lipitor goes generic.