Posts tagged ‘Pharma Marketing Consulting’
January 5th, 2012
Two Bruton’s Tyrosine Kinase (BTK) inhibitors in clinical development (PCI-32765 & AVL-292) generated a lot of interest at the recent American Society of Hematology (ASH) annual meeting in San Diego.
Sally Church on Pharma Strategy Blog has been following BTK as a novel drug development target, and saw its potential in early data presented at ASH 2010 and ASCO 2011.
Bruton’s Tyrosine Kinase is a critical kinase for lymphoma cell survival and proliferation. It plays an important role in B-lymphocyte development, differentiation and signaling. As Sally noted on Pharma Strategy Blog:
“It is a critical part of the BCL pathway that leads to cell proliferation, so targeting it leads to cell death or apoptosis.”
Sally’s insightful blog post goes into more detail on the Bruton’s Tyrosine Kinase clinical data presented at ASH by Dr Susan O’Brien (MD Anderson Cancer Center).
A number of companies are now taking an interest in BTK inhibition. Johnson & Johnson announced a $1B licensing deal for PCI-32765 just prior to the meeting. Sally’s analysis of this was:
“Based on the data seen over the last two years, I thought they got a steal”
BTK inhibition looks to be a promising target for B-cell malignancies such as non-hodgkin’s lymphoma (NHL), mantle cell lymphoma (MCL) & chronic lymphocytic leukemia (CLL). This is good news for patients.
BTK inhibitors are a new class of targeted therapies that we can expect to hear more about in the future.
August 29th, 2011
Late last friday afternoon, Pfizer received FDA approval for Xalkori® (crizotinib) in non-small cell lung cancer (NSCLC). The companion diagnostic test from Abbott was approved at the same time. Sally Church on Pharma Strategy Blog has written about the Xalkori approval and the “wonderful news” this represents for those affected by this disease.
Sally notes that the Xalkori® story “represents another major advance for targeted therapy in a clearly defined subset of patients.” The cost of treatment is $9,600 per month. In addition there will be the cost of screening the majority of NSCLC patients who do not have an abnormal anaplastic lymphoma kinase (ALK) gene. “ALK aberrations typically occur in the order of 4-7% of NSCLC patients.”
Sally in her informative Pharma Strategy Blog post also shares the story from Dr Jack West in Seattle of one patient who has been on the drug for 2 years and is now coaching soccer!
Post Glivec/Gleevec, which Sally helped bring to market while at Novartis Oncology, it’s good to see two new highly targeted therapies that will have a major impact on the lives of patients.
Not withstanding the excellent results, it remains to be seen whether the high price of recently approved oncology drugs such as Zelboraf, Adcetris and Xalkori represents a sustainable business model in the long-run. Drug companies argue that how society spends its healthcare dollars is a matter of public policy and choice by the taxpayers, rather than an issue of how they choose to price their products.
As Pieter Droppert noted on Biotech Strategy Blog last week while writing about the Google/Department of Justice Settlement, many prescription drugs are cheaper in Canada than in the United States. Is it inevitable that the continued rise in the price of oncology drugs in the United States will eventually force some form of price regulation or costing model based on performance metrics such as Quality-Adjusted Life Years (QALY)?
In the meantime, the Xalkori approval is one that Pfizer can be proud of. Despite all that’s been said about the lack of innovation in the pharmaceutical industry, it’s an example of how knowledge of the underlying biology and mechanism of action of a disease can be leveraged in drug development. The result is a new product brought to market within a relatively short period of time.
In addition to Sally Church’s recent post on Pharma Strategy Blog about the crizotinib FDA approval, she previously posted an excellent interview with Dr Ross Camidge on “crizotinb and ALK rearrangements in lung cancer.“ This is well worth reading if you missed it the first time.
April 29th, 2011
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.
April 28th, 2011
It is always a pleasure to be recognized by others. Pieter Droppert’s writing on Biotech Strategy Blog was recently quoted by the Los Angeles Times, alongside Pharmalot’s Ed Silverman, in a story about the Sorrell v. IMS Health case heard by the United States Supreme Court earlier this week.
Pieter is a 2005 graduate of Rutgers School of Law-Newark and recalls that the constitutional theory class he did was one of the most demanding! His post on Biotech Strategy Blog earlier this year, “US Supreme Court to decide whether Vermont can control the use of prescribing data by IMS Health and Pharma companies” was also linked to by the Cornell University Law School Legal Information Institute.
The attempt by the State of Vermont to regulate the use of pharmacy prescribing data and restrict its use for pharmaceutical marketing and sales is something that Pieter has followed on Biotech Strategy Blog. Earlier this week he wrote a preview on the Supreme Court oral argument in Sorrell v. IMS Health and what he thought the Justices would focus on.
His analysis of Tuesday’s oral argument that focused on First Amendment rights and commercial free speech, is that Vermont appear unlikely to prevail and that the law restricting access by data mining companies such as IMS Health will not be upheld.
This is good news for the U.S. pharmaceutical industry that is facing increasing challenges in obtaining access to physicians for sales and marketing.
April 27th, 2011
The results from the BATTLE (Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer elimination) clinical trial in non-small cell lung cancer (NSCLC) undertaken at MD Anderson Cancer Center were recently published in the new AACR journal Cancer Discovery.
The BATTLE study is a landmark in that tumor biopsies were done in “real time” with adaptive randomization to erlotinib, vandetanib, erlotinib plus bexarotene or sorafenib based on relevant molecular biomarkers from the needle biopsy specimens.
Sally Church who did her doctoral research on the early detection of lung disease, has does an excellent job on Pharma Strategy Blog of reviewing the findings from this landmark clinical trial. She discusses the latest results presented by Dr Waun ki Hong in the plenary session at the recent AACR annual meeting in Orlando.
Using Storify to integrate multimedia about the BATTLE trial, Sally explains why this is a ground breaking study. You can read more on Pharma Strategy Blog.