Posts tagged ‘Pharma Strategy Blog’
November 10th, 2011
November 10, 2011 is the second worldwide neuroendocrine (NET) cancer awareness day. Pancreatic NET is what Steve Jobs sadly succumbed to.
In recognition of NET Cancer Day, Sally Church has written an insightful post on Pharma Strategy Blog about pancreatic neuroendocrine tumors and new treatment options. It is well worth reading!
Sally highlights two new therapies for pNET approved by the FDA this year:
- everolimus (Afinitor) from Novartis that targets mTOR, downstream of the PI3K/AKT pathway
- sunitinib (Sutent) from Pfizer, a multikinase inhibitor
Both showed a benefit over placebo with an increase in progression free survival (PFS). They do, however, have some challenges associated with their side effects.
Sally concludes that “in the future, we may well see sequencing studies emerge as well as other targeted therapies to prolong outcomes for patients with this rare disease.”
We hope that the Neuroendocrine Cancer Awareness day achieves its goal of raising awareness about this disease. You can read more on Pharma Strategy Blog.
November 1st, 2011
The phosophoinositide-3-kinase (PI3K) pathway is a hot area in cancer new product development and is currently attracting a lot of interest in drug development.
Infinity Pharmaceuticals yesterday announced they would begin two Phase 1 trials of their small molecule (IPI-145), previously licensed from Intellikine, that inhibits PI3K delta and PI3K gamma.
A review by Sally Church of the top posts of the past year on Pharma Strategy Blog, showed that the most popular post was, you guessed it on:
Amongst the 640,000 reads of Pharma Strategy Blog this past year and a choice of over 900 posts, that is certainly quite an achievement. Incidentally, No 9 in the list of top 10 posts for the year, was Sally’s Update on PI3K from ASCO.
The PI3-kinase or PI3K pathway is one of Sally’s favorites, and as she notes it “has been shown to play a major role in proliferation and survival in a wide variety of human cancers, thus making it a potential target for therapeutic intervention.”
New data and further insights are expected at the forthcoming AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics in San Francisco.
October 5th, 2011
Making a Difference to the Lives of Cancer Patients
Sally Church has written over 900 blog posts on Pharma Strategy Blog about oncology and hematology new product development.
One series of posts stands out, and that is the “Making a Difference” interviews with thought leaders and business visionaries who are making a difference to the lives of cancer patients.
The latest in the series has just been published – a video interview with Dr Gordon B. Mills MD, PhD of MD Anderson Cancer Center.
Sally interviewed Dr Mills in Stockholm at the European Multidisciplinary Cancer Congress where he gave a keynote presentation on personalized medicine in the presidential, plenary session of the meeting.
Anyone interested in cancer drug development strategy, personalized medicine and how industry and academia can collaborate together in drug development should watch this video.
We look forward to many more in the future.
August 29th, 2011
It is a pleasure to announce that Sally Church, PhD has been invited to be a speaker in the Distinguished Lecturer Student Seminar Series held at the Science Park campus of the University of Texas, MD Anderson Cancer Center.
The Science Park located at Smithville, just outside of Austin, TX is the location of the Victoria Harris Cockrell Cancer Research Center, where basic science research is undertaken in the Department of Molecular Carcinogenesis.
The mission of the center is “to investigate the molecular biology of cancer and to develop means for cancer prevention and detection.”
Sally’s seminar on October 5, 2011 to the graduate students in cancer research is entitled, “On Science, Blogging and Drug Development.”
We look forward to reading more about Sally’s visit and seminar on Pharma Strategy Blog.
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.
August 26th, 2011
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.”
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.
August 24th, 2011
Sally Church on Pharma Strategy Blog has published a thought-provoking piece that discusses why targeted and focused new therapies will lead to higher rather than lower costs of drug development.
Cost drivers include the need to develop biomarkers, undertake more translational medicine and the potential use of combination therapies.
Sally highlights the cost of recently approved drugs such as Yervoy, Adcetris and Zelboraf as examples of how costs are increasing, not decreasing.
Contrary to the opinion of Harpal Kumar, CEO of Cancer Research UK, Sally believes that:
“specialized treatment based on the underlying biology will ultimately cost more, not less, in the long run in terms of research and development, diagnostics/biomarkers and treatment costs of every smaller subsets.”
Is this sustainable in the long-run? Industry, government and payors have yet to tackle this issue. It’s a problem that is not going away.
You should read Sally’s thought provoking op-ed on “the spiraling costs of cancer research and treatment” on Pharma Strategy Blog.
August 5th, 2011
As reported by Sally Church, PhD on Pharma Strategy Blog today, the tumor suppressor gene PTEN has an important role to play in breast cancer. Sally previously wrote about the role PTEN plays in non-melanoma skin cancer.
Researchers looked at genetic changes found in cancer tumor cells and identified the critical genes associated with the growth of specific cancer subtypes, and those that were not. As Sally describes it, “which are drivers and passengers.” This is important if you want to develop a targeted therapy.
This large scale profiling led to the classification of breast cancers into distinct subtypes. In particular the ICR researchers identified possible targets for PTEN-mutated and oestrogen-receptor positive breast cancers.
As Sally notes this approach if successful “could be replicated in other tumor types.”
You can read more on Pharma Strategy Blog about PTEN as a target, and inhibitors in development such as Semafore’s SF1670.