Tag Archives: Pharma CI

Icarus Consultants closed on Labor Day

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Bidston Hill Windmill © Pieter Droppert 225x300 Icarus Consultants closed on Labor DayAfter all the “excitement” of hurricane Irene last week in the New Jersey/New York metro area, this weekend offers the Labor Day holiday. It is to many the last hurrah of summer.

According to the United States Department of Labor, the public holiday on the first Monday in September pays tribute to the American worker, “creator of so much of the nation’s strength, freedom, and leadership.”

Economic prosperity and access to healthcare are very much linked with employment in the United States, so it is sad to see the recent poor job creation results.

Icarus Consultants will be closed on Monday, September 5 and will reopen for business on Tuesday. We wish all our current and prospective pharma and biotech consulting clients an enjoyable weekend.

Pfizer Xalkori crizotinib price in line with Zelboraf in melanoma

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Xalkori crizotinib logo Pfizer Xalkori crizotinib price in line with Zelboraf in melanomaLate 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.

Pharma Drug Development – time for a new strategy and model of innovation?

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Chicago Millenium Park 300x225 Pharma Drug Development – time for a new strategy and model of innovation?Innovation is key to the success of any business. Whether it is coming up with the idea of new products or services to offer customers, or better or more efficient ways to do something, innovation is something that all businesses do.

Innovation can be breakthrough, think of Pfizer’s crizotinib for the treatment of ALK-positive advanced non-small cell lung cancer. It can also be incremental e.g. improvements in formulation and drug delivery that may mean fewer doctor visits and better patient adherence.

It is undisputed that the pharmaceutical industry has not received a good return on investment (ROI) from it’s R&D spending over the past ten years.  One only has to look at the number of new products that have come to market during this period.

Several commentators believe the problem has been the strategy for innovation within the industry.   Pieter Droppert on Biotech Strategy Blog has recently written a series about different views on how innovation in drug discovery could be improved:

There is an active debate around innovation and drug development strategy.  Whether the paradigm will shift to a new model remains to be seen.

In the meantime, we at Icarus Consultants are constantly thinking about new ways to offer more value to our clients. That’s something we should all strive to do, whatever business we are in.

Boston – Cambridge, Massachusetts is the leading East Coast Biotech Region

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Pieter Droppert recently spent a few days in Boston and Cambridge, MA. On Biotech Strategy Blog, he outlines three factors that make these two cities stand out as a biotechnology region.

Icarus Consultants is frequently in Boston/Cambridge visiting clients and undertaking business development, so do contact us if you are interested in meeting up.

Pieter has produced a short 2 minute video based on his “Letter from Boston” blog post, that you can watch below:

Metastatic Melanoma Competitor and Market Analysis

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One of the services that Icarus Consultants offers is to monitor competitor activity in a market, therapeutic area or pathway, and advise clients on new developments.

For those interested in metastatic melanoma, this week saw Roche/Genentech make marketing applications to the FDA in the United States and European EMEA for PLX4032 (vemurafenib) in BRAF V600E mutation-positive metastatic melanoma.

Sally Church on Pharma Strategy Blog has more about the Roche/Genentech filing, and has written extensively about BRAF inhibitors and mechanisms of resistance.

If you are interested in learning more about how Icarus Consultants can help you keep track of competitor activity in a pharma market, business or therapeutic area, please contact us.

 

Zytiga (abiraterone acetate) price will impact the Prostate Cancer market following FDA approval

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logo zytiga Zytiga (abiraterone acetate) price will impact the Prostate Cancer market following FDA approvalSally 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.

 

Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining case

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LA Times Pieter Droppert quoted in LA Times Story on US Supreme Court Pharma Marketing & Data Mining caseIt 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.

Icarus Consultants to attend EAU in Vienna

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Black Forest Cake 300x267 Icarus Consultants to attend EAU in Vienna

Photo Werner Kunz via flickr

Icarus Consultants will be at the forthcoming European Urology Association annual meeting in Vienna, Austria from March 18-22, 2011.

If you are going to be in Vienna and would be interested in meeting up for Kaffee Und Kuchen, please contact us.

Incidentally, our favorite is a slice of Schwarzwälder Kirschtorte (Black Forest gateau).

 

AACR PI3-Kinase Conference Coverage #PI3K

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Sally Church on Pharma Strategy Blog will be providing live coverage of the AACR PI3-Kinase conference that starts today in San Francisco.

Sally AKA @MaverickNY will be live tweeting from the event that starts at 7pm (california time) today, Thursday, February 24 and runs through Sunday morning, February 27. The Cover it Live widget on her blog will be aggregating all the tweets that use the conference hashtag #PI3K, so if you are unable to be in San Francisco, you can follow what’s happening by clicking here.

This AACR special conference has an impressive line-up of leading key opinion leaders and experts in the field.  The keynote session this evening is on “Targeting PI3K/mTOR in breast cancer” by Jose Baselga, from Mass General.  The session chair is Lewis Cantley.

Some of the new products in development that will be discussed at the meeting include: GSK2126458, INK1117, AZD8055, MK-2206 and SAR245408 (XL147).  If you are interested in purchasing an Icarus Consultants in-depth meeting report, do contact us.

Pharma Corporate Strategy – Gilead acquires Calistoga

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Today’s announcement that Gilead Sciences is acquiring Calistoga pharmaceuticals for $375M shows that acquisition remains a key strategy for companies looking to add promising new drugs to their pipeline.

Calistoga’s CAL-101 is a PI3-kinase inhibitor that targets cancer and inflammatory diseases. You can read more about the acquisition of Calistoga by Gilead on Biotech Strategy Blog.