Posts tagged ‘MDV3100’
The prostate cancer market continues to evolve at a fast pace. Companies with products on the market or in development will need to adapt their marketing strategy to the changing prostate cancer market dynamics. Some of the recent news includes:
MDV3100 shows 4.8 improvement in median overall survival
Sally Church, PhD on Pharma Strategy Blog interviewed David Hung, MD CEO of Medivation and discussed the MDV3100 clinical trial data presented at ASCO GU.
Sally has been following the development of MDV3100 for a while, and previously interviewed Dr Charles Sawyers one of the co-developers.
MDV3100 showed an improvement in median overall survival of 4.8 months in advanced prostate cancer, and offers a number of significant advantages over abiraterone acetate (Zytiga) due to its different mechanism of action on the androgen receptor.
One of the advantages is it’s ability to target splice variants:
You can read more about MDV3100 on Pharma Strategy Blog.
Is ARN-509 more effective than MDV3100?
Another interesting compound in prostate cancer drug development is Aragon’s ARN-509. Recent research published in the AACR journal, “Cancer Research” suggests that ARN-509 may be a more potent androgen-receptor antagonist than MDV3100.
Whether ARN-509 will make it to market remains in question given that Medivation claim the compound was part of the intellectual property it acquired from UCLA along with what became MDV3100.
You can read more about the potential of Aragon’s ARN-509 in prostate cancer on Pharma Strategy Blog.
Radium-223 (Alpharadin) significantly prolongs time to first Skeletal Related Event
Pieter Droppert has written on Biotech Strategy Blog about the radium-223 (Alpharadin) clinical trial data presented by Dr Oliver Sartor at ASCO GU.
Alpharadin is a bone targeted radiopharmaceutical that has shown not only a significant delay in the time to first skeletal related event (SRE) but an increase in overall survival.
Dr Sartor kindly offered some clinical perspective on the data that you can read on Biotech Strategy Blog.
In case you missed it, the video interview with Dr Chris Parker at ECCO/ESMO 2011 in Stockholm offers further information on radium-223 and the ALSYMPCA trial results:
Amgen fails to convince ODAC that Xgeva should have a prostate bone mets indication
If you were following the prostate cancer news this past week, then the ODAC 12:1 vote against granting an indication for denosumab (Xgeva) for the prevention of prostate cancer bone metastases was in the news
Pieter Droppert collated the Xgeva ODAC meeting tweets on Storify if you are interested in what was live tweeted during the meeting.
Once Alpharadin is approved will radiation oncologists now get more involved in the treatment of prostate cancer and how will this impact the market dynamics? Will urologists favor MDV3100 that does not require administration of prednisone at the expense of Zytiga?
Companies will need to adapt their marketing strategy as new prostate cancer new products come to market in 2012.
The fast moving prostate cancer market took another leap forward last week with the announcement of positive phase III data for Medivation’s MDV3100.
As reported by Sally Church on Pharma Strategy Blog, Medivation announced that the interim analysis of the AFFIRM trial showed a 4.8 month increase in overall survival (OS) compared to placebo.
Although this is only interim and not final data, Sally observed:
“the 4.8 month improvement in OS in post-chemo setting is superior to that previously seen reported for abiraterone (Zytiga), which had a 3.9 month advantage over placebo.”
Pieter Droppert on Biotech Strategy Blog noted, MDV3100 and Zytiga have completely different mechanisms of action in advanced prostate cancer.
MDV3100 is an androgen receptor blocker, while Zytiga is an androgen biosynthesis inhibitor. This distinction is key. Zytiga inhibits the CYP17 enzyzme complex required for androgen biosynthesis. However, a consequence of CYP17 inhibition is an increase in mineralocorticoid levels, which can lead to hypokalemia, hypertension, fluid retention.
The result is that Zytiga requires coadministration of a corticosteroid (prednisone) to reduce the incidence and severity of potential mineralocorticoid adverse reactions.
MDV3100 does not require the administration of a steroid, which is a big advantage to patients. Instead it blocks the androgen receptor (AR) that is highly expressed on prostate cancer cells.
Cora Sternberg presents Prostate Cancer Educational Symposia at EMCC 2011 in Stockholm
There are a lot of new products in the pipeline for prostate cancer including TAK-700, Cabozantinib (XL184), radium-223 chloride (Alpharadin), BPX-101, Prostvac-VF, ipilumumab, Custirsen (OGX-011), dasatinib (Sprycel), lenalidomide (Revlimid) and ARN-509 to name a few.
The prostate cancer market is forecast to grow from $1B to $5B by 2015 as new products are approved and new treatment options become available. This is good news for advanced prostate cancer patients.
The prostate cancer market is dynamic, with a lot of news happening. One of the many new treatments in development worth watching is custirsen (OGX-011).
Sally Church on Pharma Strategy Blog recently wrote about Custirsen from OncoGeneX. This drug inhibits the production of clusterin, a protein associated with the development of treatment resistance. As Sally notes it is in essence a “chemo enhancer.”
Photo: OncoGeneX
Phase 3 trials with custirsen are currently underway in castrate resistant prostate cancer patients receiving docetaxel in the first and second line setting.
The potential to improve the efficacy of docetaxel may be of commercial interest as more generic versions become available. According to IMS Health, sales of generic and branded docetaxel were approximately $1.1 billion for the year from June 2010 to June 2011.
This week Sandoz entered the market with their announcement of the FDA approval and launch of their generic version of Taxotere®.
It will be interesting to see whether use of custirsen with docetaxel increases overall survival (OS) in the phase III CRPC trials, and if it does how this compares to other recently approved CRPC treatments such as Zytiga™ (abiraterone acetate).
As Sally noted in her video blog post from the annual meeting of the American Urological Association (AUA), there is also preliminary scientific data to suggest that custirsen may improve the efficacy of androgen receptor antagonists such as MDV3100 from Medivation/Astellas.
We expect there will be new data on prostate cancer new products in development at the ESMO/ECCO European Multidisciplinary Cancer Congress in Stockholm in late September. The possibility of new treatment options is good news for prostate cancer patients. It is a market definitely worth watching.
Sally Church on Pharma Strategy Blog has published a video blog (vlog) post on what’s hot in Prostate Cancer at the 2011 AUA (American Urological Association) annual meeting in Washington DC.
In her post, Sally reviews presentations by Charles Sawyers and Oliver Sartor. She discusses new prostate cancer products in development such as MDV3100 and custirsen (OGX-011), and how our understanding of basic biology may lead to new combinations in the future.
If you missed Sally’s video blog post, then you can watch it on Vimeo below. As Sally would say, “check it out!”
This Friday sees the start of the 2011 annual meeting of the American Urological Association (AUA) in Washington, DC. The meeting runs from May 14-19.
We expect the recent FDA approval of abiraterone acetate (Zytiga®) from Ortho Biotech (JNJ) to be hot news at the meeting as urologists seek to learn more about it’s use.
Icarus Consultants will be in our Nation’s Capital for AUA, so should you be interested in meeting up, please contact us.
Sally Church’s interview with Dr Charles Sawyers rated a “must read” by Forbes Health
May 5th, 2011
Daedalus
Sally Church invests a lot of her personal time in writing for Pharma Strategy Blog. With a focus on the science of new products and treatments in cancer and hematology, Sally willingly shares her passion, knowledge and expertise.
It is always a pleasure to receive endorsement from others. Matthew Herper from Forbes Health kindly highlighted Sally’s interview with Dr Charles Sawyers as a “must read.”
We agree. Dr Sawyers is one of the leading translational scientists in the United States who along with Dr Brian Druker and Dr Nick Lydon received the prestigious Lasker award for their work on imatinib (Gleevec/Glivec) in CML. Dr Sawyers is now working on prostate cancer, and in his interview with Sally, describes his latest work developing MDV3100 and ARN-509.
We unequivocally recommend reading Sally’s post on Pharma Strategy Blog, “Making a difference to the lives of cancer patients: An interview with Dr Charles Sawyers.”
Zytiga (abiraterone acetate) price will impact the Prostate Cancer market following FDA approval
April 29th, 2011
Daedalus
Sally Church on Pharma Strategy Blog has written about the FDA approval yesterday of Ortho Biotech’s ($JNJ) abiraterone acetate, brand name Zytiga for the treatment of castration resistant prostate cancer in patients who have received prior chemotherapy with docetaxel.
The final data showed a 4.6 month increase in overall survival (OS) in these very sick patients in late stage disease. It is to be expected that the response will be significantly better in patients treated earlier.
As Sally states in her post, “it is good to see new treatment options emerge for the treatment of castrate resistant prostate cancer.”
Abiraterone treatment has been priced competitively by JNJ, with a treatment price of around $40K ($5,000 per month for a median treatment cycle of 8 months). As Sally notes “this is very fair.”
The commercial impact for sanofi-aventis is likely to be huge. It’s hard not to see elderly or frail patients preferring 4 pills a day compared to chemotherapy with a side-effect profile that is far from optimal. The price of abiraterone acetate (Zytiga) is lower than cabazitaxel (Jevtana), which was approved early last year. The market opportunity for Jevtana looks less promising now that it has competition.
Sally, in her insightful post on Pharma Strategy Blog, also notes a possible impact on sipuleucel-T (Provenge) from Dendreon, which is $93K for three infusions. It’s hard not to see some off-label usage from urologists given that phase III trials for use of abiraterone in the pre-chemotherapy setting are already enrolled.
The prostate cancer market is currently a very dynamic and competitive one. With more new drugs on the horizon that may potentially be improvements on abiraterone acetate e.g. MDV3100 and ARN-509, it’s an exciting market to watch.
Sally Church has a number of posts on Pharma Strategy Blog that discuss the science and pharma marketing strategy for prostate cancer new products.
As marketing strategy consultants, it’s fascinating to watch the dynamics of a pharmaceutical market in rapid evolution.
With three new therapies for prostate cancer approved last year (cabazitaxel, denosumab, sipuleucel-T) and the approval of abiraterone acetate expected this month, the prostate cancer market is a fast changing one.
This is really good news for patients, and for a disease that effects 1 in 6 men in the United States, and is the most common non-skin cancer.
Pieter Droppert on Biotech Strategy Blog has some commentary from the recent annual meeting of the American Association for Cancer Research (AACR) on additional new products in development that may change the landscape of this disease further.
You can read more about this on Biotech Strategy Blog.
As many of you know, Sally Church attended the recent European Association of Urology Congress in Vienna.
In the first video blog post that she’s ever done on Pharma Strategy Blog, she shares her impressions of the meeting and the changing landscape in advanced prostate cancer. One of the key new product approvals expected this year is for abiraterone.
We love the “BBC News” style graphics of her video blog, and look forward to hearing from Sally throughout the course of the year as she attends other conferences.
You can now watch Sally on her own YouTube channel. Will we see “Sally Church reporting live for Pharma Strategy Blog”?
Many European doctors enjoy a glass of good wine, so Bertrand Tombal’s metaphor that 2010 was a great year for advanced prostate cancer drugs was well received at the recent European Association of Urology Congress in Vienna.
Sally Church attended the meeting, and shared her thoughts on “the changing face of advanced prostate cancer” in a post on Pharma Strategy Blog.
According to Sally, one of the highlights of the meeting was the plenary presentation by Professor Johann de Bono of the Royal Marsden in the UK who discussed the new products that now exist or will soon be available for advanced prostate cancer.
Professor de Bono described how we now know more about Prostate Cancer and the fact that androgen receptor signaling remains active in advanced prostate cancer. Hormone therapy now works after chemotherapy, so the use of the term metastatic hormone refractory mHRPC is no longer valid.
He predicted that the we can expect the prostate cancer field to change in the next few years as we learn more about the molecular aspects of the disease and are better able to stratify patients.
With new products such as abiraterone, MDV3100 on the horizon and recent approvals for cabazitaxel, sipuleucel-T, multiple lines of treatment will be available to patients. The challenge according to Professor de Bono will be how to sequence them.
Further news on new product development in prostate cancer can be expected at AUA, ASCO and ESMO. With approval for abiraterone expected later this year, 2011 may be a Grand Cru year too! You can keep track of the latest developments in this market on Pharma Strategy Blog.