Another step in the projected marketing battle: abiraterone vs. MDV3100


We have become aware of what appears to be the next step in the projected marketing battle between MDV3100 and abiraterone acetate for prominence as the “better” form of androgen suppressive agent in men with metastatic, castration-resistant prostate cancer (mCRPC).

Even though — as yet — there is no indication that Medivation has submitted the necessary new drug application (NDA) to the U.S Food & Drug Administration (FDA) or to the European Medicines Agency (EMEA) for marketing of MDV3100 as a treatment for mCRPC in men who have previously received at least one cycle of docetaxel-based chemotherapy, and even though we have no idea what the brand name or the generic name of MDV3100 will actually be, here in the USA Medivation and its marketing partner Astellas have started to run promotional advertisements to urologists (and presumably to medical oncologists) about the importance of “androgen receptor signaling inhibition” in “controlling advanced prostate cancer.” Interested readers can see relevant information on a web site created by the companies at www.TargetAR.com.

As we have noted previously, there is going to be a fierce battle between Johnson & Johnson and the Medivation/Astellas partnership to gain leadership in this large prostate cancer market. This may prove to be one of the fiercest marketing battles in the world of prostate cancer since AstraZeneca introduced goserelin acetate (Zoladex®) in the early 1990s and sought to capture market share from TAP Pharmaceuticals’ leuprolide acetate (Lupron®).

The wise patient will want to focus on real, peer-reviewed and published data that support the relative benefits of these two products as the battle heats up.

As we have indicated in prior comments on this topic, abiraterone currently holds “the high ground”. It is already on the market for the treatment of men with mCRPC who have previously received chemotherapy. Furthermore, Johnson & Johnson have already reported that abiraterone has shown a progression-free survival benefit in men with chemotherapy-naïve mCRPC. By comparison, MDV3100 is still to be approved in the first indication and may not report data from its comparable trial in men with chemotherapy-naïve mCRPC until there is clear evidence of a cancer-specific and an overall survival benefit.

History tends to tell us that it can be hard for the second product on the market to outperform the first unless its clinical benefit is clearly considered to be superior to that of its predecessor. It may be a while before we really know how the prescribing community of medical and urologic oncologists evaluate the relative merits of these two products, but make no mistake that it is “your body” that Johnson & Johnson and Medivation/Astellas will be fighting over if you have advanced prostate cancer!

8 Responses

  1. I wonder how TAK 700 will do compared to these two and when it will enter the market.

    How is TAK’s 700 mechanism of action BTW compared to these two? I’m not that much into the scientific details, at least not to that extent, but it would be interesting to have a general idea.

  2. TAK 700 (a.k.a. orteronel) is still enrolling patients into its trials for men with both chemotherapy-treated and chemotherapy-naive mCRPC. It is therefore hard to know just when there will be data from these two studies. Orteronel is an orally bioavailable, reversible non-steroidal inhibitor of 17,20-lyase, which implies that it works in a manner very simnilar to abiraterone. Like abiraterone, it also has to be given with prednisone.

  3. I don’t understand why these two different drugs, acting against the cancer in two different ways, are viewed as competitors; which implies a choice between them. Why can’t they be used either in series or even simultaneously?

  4. Dear Kevin:

    It is perfectly possible that abiraterone and MDV3100 can be used sequentially and/or in combination … but we don’t know that yet for certain, and we also don’t know which would be the better order if they are to be used sequentially. However, we already know what the cost is to treat a man with abiraterone for a year. The cost to treat him with MDV3100 for a year will undoubtedly be similar. That’s a lot of money. Combination therapy just ain’t gonna happen most of the time.

    If you look at this from the point of view of the two manufacturers, whoever’s drug is perceived to be “better” will get used first and will therefore get used for longer. From a business perspective, this is a highly competitive situation.

  5. Mike:

    Regarding cost of MDV3100 versus abiraterone, similarity may not necessarily be so. It is quite possible in this competition that Astellas will see one strong path to success is to offer MDV3100 (at whatever name of drug chosen) at a significantly lower price. This will steal the hearts of insurers and perhaps patients. The lower price will increase market share and increased market share will raise profit. This will also mark an important distinction between the drugs which might otherwise be seen as roughly equivalent based on Phase III results.

    Similar patient result – Lower price = Preferred Rx.

    This strategy is common in every market area.

  6. Ah … Readers, please do not confuse patient health or well-being with business (making money). In a recent Wall Street Journal article, I recall the author estimated the market size for drugs to treat advanced prostate cancer will grow from approx. $1 billion to $4 billion as a result of the new treatment options coming online for the disease. The stock price for these drug companies is, in part, driven by the size of the markets and the companies’ related market shares for their drugs. Medivation has a reputation for being an aggressive company. They recently had a couple of flops (drugs that did not get approved), so they really need a win (for the shareholders).

    I think they will “up the ante significantly” in order to gain increased market share. I think Mike is correct about the upcoming battle. It can sometimes be difficult for the patient to understand what may be motivating stories they read about new drugs. Patient health is not always (usually?) the objective in media campaigns. OK … that may be a little over the top, but you get the idea. My (former) oncologist recently blew off an appointment with me so he could attend a press outing for Medivation. I only found out because I saw his picture in the paper.

    Bill Manning

  7. So, yet another example of where the “Death Panel” is invisible — but it’s the Board Room. I know, I know, “We develop new drugs to make money, if you can think of a more compelling reason, we would love to hear it.”

  8. TAK 700 (orteronel) and abiraterone (Zytiga) are both inhibitors of the CYP17 enzyme that is responsible for androgen production, but there is a big difference between the two drugs. Orteronel is a reversible inhibitor of CYP17, whereas Zytiga is a much more potent irreversible inhibitor. The problem with a reversible inhibitor such as orteronel is that when you inhibit CYP17 there is a large backlash rise in LHRH and LH to drive the biosythesis of more CYP17 enzyme. If the inhibitor is reversible, the LHRH beedback system will overcome the blockade, allowing continued androgen synthesis. So it is important to have an irreversible inhibitor such as Zytiga in order to achieve total androgen blockade. The role of Zytiga in prostate cancer therapy is therefore last-line hormonal therapy.

    MDV3100 is an antiandrogen that is an analogue of Casodex and I think MDV3100 will find its own place in urology for treating Casodex-relapsed patients.

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