pharma


18
Oct 08

Increasing importance of competitive intelligence in bear markets

In tough economic times, many companies are forced to downsize, trim budgets and preserve profit margins, while expecting a leaner, meaner organisation to survive the tempest. The reality is that the changes leave fewer people to accomplish the same amount of work on less marketing dollars; productivity becomes the new name of the game.

This is where good companies get smarter and focus on cost effective ways of making their budgets go further. One of the biggest challenges with pure market research, for example, is that results are often regional, forcing clients to consider a broad selection of target markets in which to base future directions on. Cutting the scope (i.e. reducing the number of sites) risks missing key data and generalising on more limited patterns.

Enter competitive intelligence, a much broader, more strategic way of gathering general trend data that can help make sense of the market. It is also a good way of keeping tabs on your competitors, because the stronger ones will survive the downturns better.

There are a host of clever tools and secondary data sources out there that can be mined effectively and a big picture of the target market described without the need for repetitive and expensive traditional market research interviewing people or holding focus groups. This is a much more ‘think outside of the box’ approach that rewards creative, enterprising marketers who want to get ahead of their competition.

The lean and mean approach starting with competitive intelligence first means that you can now find the needles in the haystack to point you in the right direction first, then test the specifics rather than relentless and expensive iterations of field testing. After all, those market research honorariums soon start to add up when the budget is tight. As an analogy, if you think about an archer – how can you hit the target if you can’t even see it?

What can companies gain from competitive intelligence prior to market research?

Essentially, because of it’s highly strategic nature, competitive intelligence bridges the gap between management and customers. On the one hand clear, simple elucidation of the risks involved enable management to grasp the big picture quickly and easily, while also offering identifiable actions to the customer that can be executed. Suddenly, this simplification of the data to the salient points enables all levels of the organisation to unite and focus rather than get bogged down in masses of conflicting data.

Using this approach, well designed competitive intelligence and market research questions become complementary and provide a more robust solution of strategic oversight and deep dives into more targeted areas.

Sometimes less really is more.

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1
Oct 08

Procrit linked to deaths in stroke patients

Johnson and Johnson’s Ortho Biotech has informed the FDA of preliminary safety findings from a clinical trial conducted in Germany investigating the use of Procrit (epoetin alfa) to treat acute ischemic stroke. The clinical trial utilised doses of Procrit that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product.

The trial was designed to determine whether the drug could help patients who have had an acute ischaemic stroke, an unapproved indication in both the EU and US.

However, it seems that the results showed that over ninety days after the start of the trial, there were more deaths in the group of patients who received Procrit compared to patients who received the placebo (16% versus 9%). Approx. half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received Procrit compared to 1% of patients in the placebo group.

Submission of additional data to the FDA is expected within the next few weeks. Once a review of these data is completed, it is likely that the FDA will communicate their conclusions and recommendations to the public. The finding of increased mortality in patients receiving Procrit in the German trial would suggest the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

More information can be found on the FDA’s Center for Drug Evaluation and Research (CDER) site.

Erythropoeitin stimulating agents (ESA’s) have had a chequered history over the last year with a number of safety concerns arising to the authorities attention, including whether or not they stimulate tumour growth and increase the risk of death.

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2
Sep 08

Abiraterone and prostate cancer

One drug that has been tearing up the newsfeed this year is abiraterone, a novel drug in phase II trials for prostate cancer.

In February, data was presented at ASCO’s Genito-urinary satellite meeting that looked promising. Dr D.C. Danila and researchers from Memorial Sloan Kettering reported a small phase II trial in castration resistant metastatic prostate cancer after failure of docetaxel therapy.

They looked at abiraterone acetate (AA), an oral and irreversible inhibitor of CYP17 that decreases testosterone and DHT levels to undetectable. The study sought to determine the proportion of patients achieving a PSA decline of >50% and to assess toxicity. It was a multicenter trial using abiraterone 1000mg orally daily and prednisone 5mg daily. Successful abiraterone activity was defined as a PSA decline >50% in >30% of patients. It was defined as not successful if the PSA decline occurred in <10%>50% PSA decline. Radiological assessment was possible in 26 men who had at least 3 cycles of treatment. No decreases in bone metastasis by bone scans were noted, but some had unchanged bone scans. The addition of prednisone reduced the frequency of adverse events. Circulating tumor cells (CTCs) was used as an additional means to asses response to treatment and did correlate with PSA changes.

A total of >5 CTCs prior to treatment that decreased to <3 (link) – including more details on the company developing the agent.

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28
Jul 08

Improving survival in Liver Cancer – at what cost?

No effective therapy is available for advanced hepatocellular carcinoma (liver cancer), it’s a terminal condition. Over 18,000 people typically die from it in the USA each year. It is much more common in Africa and East Asia where the risk of infection from Hepatitis B and C is much higher, which are associated with increased risk factors for the disease.

Hepatocellular carcinomaImage via Wikipedia

In this month’s New England Journal of Medicine, a randomised trial involving 602 patients with advanced hepatocellular carcinoma was reported. Sorafenib, a multikinase inhibitor of Raf, vascular endothelial growth factor receptor, and platelet-derived growth factor receptor, improved median survival by 3 months compared to placebo (10.7 vs. 7.9 months, P<0.001). Adverse events, including diarrhea and weight loss, were more frequent in patients receiving sorafenib.

Three months doesn’t sound a lot, but improvements in cancer survival nearly always occur in small increments. The other side of the coin is at what cost?

An editorial by Dr Lewis Roberts in the same journal noted the following:

“The pharmacy price of sorafenib is approximately $5,400 per month in the United States, {euro}3,562 per month in France, $1,400 per month in Korea, and $7,300 per month in China. Even in industrial nations, the high cost of new drugs produces significant stresses on health system budgets. There are substantial ethical implications in having effective therapies available for life threatening diseases that are priced beyond the reach of the populations most in need of therapy.”

Would you pay $15,000 for an extra three months of life?

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