Posts tagged ‘Medivation’
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 $5B by 2015 as new products are approved and new treatment options become available. This is good news for advanced prostate cancer patients.
This Friday sees the start of the 2011 annual meeting of the American Urological Association (AUA) in Washington, DC. The meeting runs from May 14-19.
We expect the recent FDA approval of abiraterone acetate (Zytiga®) from Ortho Biotech (JNJ) to be hot news at the meeting as urologists seek to learn more about it’s use.
Icarus Consultants will be in our Nation’s Capital for AUA, so should you be interested in meeting up, please contact us.
Sally Church’s interview with Dr Charles Sawyers rated a “must read” by Forbes Health
May 5th, 2011
Daedalus
Sally Church invests a lot of her personal time in writing for Pharma Strategy Blog. With a focus on the science of new products and treatments in cancer and hematology, Sally willingly shares her passion, knowledge and expertise.
It is always a pleasure to receive endorsement from others. Matthew Herper from Forbes Health kindly highlighted Sally’s interview with Dr Charles Sawyers as a “must read.”
We agree. Dr Sawyers is one of the leading translational scientists in the United States who along with Dr Brian Druker and Dr Nick Lydon received the prestigious Lasker award for their work on imatinib (Gleevec/Glivec) in CML. Dr Sawyers is now working on prostate cancer, and in his interview with Sally, describes his latest work developing MDV3100 and ARN-509.
We unequivocally recommend reading Sally’s post on Pharma Strategy Blog, “Making a difference to the lives of cancer patients: An interview with Dr Charles Sawyers.”
Zytiga (abiraterone acetate) price will impact the Prostate Cancer market following FDA approval
April 29th, 2011
Daedalus
Sally Church on Pharma Strategy Blog has written about the FDA approval yesterday of Ortho Biotech’s ($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.
Sally Church on Pharma Strategy Blog will be providing live coverage of the annual European Association of Urology (EAU) Congress that starts in Vienna this weekend.
If you can’t join Sally at the meeting for a slice of schwarzwälder kirschtorte, then you can experience the meeting virtually as Sally aggregates all the live tweets, and contributes her own.
There are a lot of new products in the prostate cancer market. With new treatment options such as Dendreon’s sipuleucel-T, sanofi-aventis’ cabizatexel and JNJ’s abiraterone expected in the not too distant future, the meeting is bound to be interesting. We can also expect the latest news about new product development in bladder and renal cancer.
The Cover it Live widget on Sally’s blog will be aggregating all the tweets that use the conference hashtag #EAU11, so if you are unable to be in Vienna, you can follow what’s happening by clicking here.