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Tag Archives: colorectal cancer

Québec’s $122 million New Biopharmaceutical Strategy Includes $30 million for Genomics, May Include SR&ED Tax Credit Financing

mdeieThe Province of Québec rolled out a new “biopharmaceutical strategy” Thursday that they say aims to provide “development support for biotech and biopharmaceutical firms.”

The Roll-Out:

The announcement was beautifully coordinated with the relevant constituencies, as illustrated by the near-immediate chorus of support:

The Big News:

BIOQuébec can’t help bragging a little that “the Minister has retained some of the recommendations made by BIOQuébec.” The pride is justified, though.  Biotech advocates have been asking — since before the last federal budget — for a way to monetize the refundable tax credits they’ve been banking.  As part of the new strategy, BIOQuébec says the government will allow

“biotechnology companies within the human health industry [to] benefit from a short term support measure thanks to the quarterly financing of their tax credits.”

Interestingly, BIOQuébec appears to have some information about that initiative that is missing from the government publications (nope, not even in the French version), which only say it aims to “implement new methods of funding R&D tax credits adapted to the specific needs of health-related biotechnology firms.”

Money Talks:

On the financial front, the initiative also highlights a 10-year tax holiday (sparse on details, but expect it to look a lot like the OTEC in Ontario) and Teralys Capital.

Finally, the strategy notes “three specialized start-up funds aimed at the technology sectors” with $41 million each that will be supported by “private-sector partners.”  Is the Pfizer-FRSQ Innovation Fund one of these?  Wednesday, that fund announced grants totalling $2.3 million for genomics studies of inflammatory bowel disease and metastatic colorectal cancer.

My Bottom Line:

This looks like a broad set of initiatives that aims to improve everything from student recruitment through R&D and commercialization to purchasing and reimbursement decisions.  I particularly can’t wait to see what the SR&ED monetization program looks like.  Hopefully we’ll learn in time to work with other governments *cough*Ontario*cough* as they start 2010 budget processes.

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Trends Update — “Personalized Effectiveness”: Amgen Gets Prospective Data to Back KRAS-Vectibix Plan

B&W_DNA_sequenceA few weeks ago, when the FDA changed the labeling on anti-EGFR drugs, Amgen was pretty enthusiastic about “avoiding unnecessary treatments in patients [with a specific genetic marker] who are unlikely to benefit” from Vectibix.  Avoiding these patients leaves more reimbursement available for patients who would benefit from Amgen’s product.

Now Amgen has even better data to support its personalized approach to colorectal cancer treatment: their study of Vectibix as a first-line treatment tracked the KRAS genetic status of participants and showed “significantly prolonged progression-free survival” for the wt-KRAS group.

In patients with mutated KRAS, Vectibix wasn’t just “unnecessary,” it actually showed worse outcomes than the control group, meaning genetic testing of all colorectal cancer patients will be a top priority.

A second important note for companies thinking about companion diagnostics and personalized effectiveness is that the Amgen study was a prospective study that will support much more robust conclusions.  H/T @ldtimmerman.

In contrast, recall that the CMS decision not to reimburse genetic testing for Warfarin dosing specifically cited the lack of prospective data on which to base a decision.

This new data from Amgen will:

  1. Drive tumor genotyping as a standard of care; and
  2. Help make the economic case for companion diagnostics.

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Pfizer and Ontario BIP Program Funding New $6.9 million “POP-CURE” Project for Colorectal Cancer Genomics

B&W_DNA_sequence Pfizer Global Research and Development is contributing $6 million and the Ontario government is contributing $900,000, through the Biopharmaceutical Investment Program (BIP), for a new project “to discover and validate new targets for the diagnosis, prognosis and treatment of colorectal cancer.”  Brad Wouters, a Senior Scientist with the Ontario Cancer Institute (OCI) and a Senior Investigator at the Ontario Institute for Cancer Research (OICR), will lead the project.

Here’s the scoop from the OICR press release:

“Dr. Wouters and a team of scientists at OCI and OICR will use genomic and molecular pathology approaches and develop a large clinical biobank to identify molecular signatures in colorectal cancer. These molecular signatures will be used to accelerate the development of biomarkers for early detection, monitoring and treatment of cancer.”

The Canadian Press article includes some additional background info on the project, which Paul Lévesque, president of Pfizer Canada, says began with a trip by Ontario researchers to meet Pfizer scientists in San Diego almost two years ago.

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Trends Update — Personalized Medicine: Clinical Data on Personalized Cancer Treatment

A study presented at the American Association for Cancer Research meeting this week showed benefits to patients from using molecular profiling to customize chemotherapy regimens.

The pilot study, with Daniel Von Hoff, M.D. as the senior investigator, used immunohistochemistry and microarray profiling to select treatment regimens for 66 patients who had ovarian, colorectal, breast and other cancers.   The data compared progression-free survival and tumor size after the patients moved to a new treatment regimen with the same patients’ progression before molecular profiling.  Forty percent of patients in the trial survived at least 15 months compared to 20 percent of the control population.

A story in Forbes notes personalized cancer treatment data in a colon cancer study and two glioblastoma studies that were also presented at the AACR meeting.
 

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