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Old 09.05.2012, 07:48
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Re: Major blow to Roche as potential blockbuster fails

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I find this fascinating.

"success vs failure vs non-approval" and "benefits outweighing the risk".

What does that mean? What does the "risk" part mean?

And "phase III"? Is that when the "risk" is measured?
Phase 3 is the final stage of testing a drug. http://en.wikipedia.org/wiki/Clinical_trial

Risk is typically assessed before a project begins, and - ideally - throughout the project. Simplistically, when the potential return multiplied by the likelihood of that return no longer exceeds costs, the project should be cancelled, regardless of any monies already spent.

As for the benefits outweighing the risk, that was probably true at the beginning, but spouting off phrases like that now that the risk of failure is 100% just sounds silly.
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  #22  
Old 09.05.2012, 08:51
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Re: Major blow to Roche as potential blockbuster fails

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Maybe one day Roche will Ride Across the River and become Brothers in Arms with Novartis. They're not So Far Away. Together The Man's Too Strong, Why Worry?

There's only One World of sick people going through the Walk of Life, so Your Latest Trick to succeed in pharma is trying to get Money For Nothing.
I got that communiqué.

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Yes...even if it is a Swiss company there is nothing to expect because Roche management is mostly foreign and see high costs of Switzerland as a burden. Add to this the easiness to sack and you see the catastrophe coming...like at Merck Serono
But Roche is mostly owned by a Swiss family, who don't always react like normal shareholders.
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Old 09.05.2012, 09:40
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Re: Major blow to Roche as potential blockbuster fails

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But Roche is mostly owned by a Swiss family, who don't always react like normal shareholders.
That is what has always distinguished Roche from its competitors, a company not beholden to its shareholders but able to take a longer term view.
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Old 09.05.2012, 11:00
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Re: Major blow to Roche as potential blockbuster fails

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"success vs failure vs non-approval" and "benefits outweighing the risk".

What does that mean? What does the "risk" part mean?
Whenever we start developing a new drug, there's a risk (indeed, a 9/10 chance, from the start) that it won't be effective or safe enough to be used, so the research spend up to that point is lost. That's the degree of risk, put simply.

The potential patient group for this drug, had it been successful, was HUGE - "our estimate is that dalcetrapib could have prevented 100 thousand deaths, strokes or other serious CV events every year." " Overall, more than 200 million patients worldwide could have benefited from this medicine." - so the risks were weighed up against the potential benefits and found to be worthwhile taking.

"success vs failure vs non-approval" refers to the (large) added costs and potential reputation damage if we'd decided to continue developing the drug despite the negative interim results. It is possible that the trials may have gone on to show efficacy, but the chances are much lower, and if we'd tried to push it through for registration and been rejected (i.e. not approved) then it would be very damaging for the company, as well as expensive.

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And "phase III"? Is that when the "risk" is measured?
No. Risk is continually measured. Phase three is when we start large-scale trials on real patients, with a view to using the results to show that the medicine is safe and effective. It (approximately) marks the transition from Research to Development, and involves significant cost and resources.

The whole 'risk' thing is being highlighted as it's a sign of the application of a policy of 'smart risk-taking' over the last few years. We must be prepared to take risks, but recognising them and being prepared to reassess based on changing information allows us to mitigate those risks as much as possible.
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Old 09.05.2012, 11:03
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Re: Major blow to Roche as potential blockbuster fails

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and a hugely tough time for their employees too
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Yes...even if it is a Swiss company there is nothing to expect because Roche management is mostly foreign and see high costs of Switzerland as a burden. Add to this the easiness to sack and you see the catastrophe coming...like at Merck Serono
It's absolutely nothing like MS. The number of people involved so far in this drug is a very small proportion of staff, and the numbers directly affected by canning it are even smaller.

It's a blow to our pipeline strategy, for sure, but nothing like as significant as you seem to think.
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Old 09.05.2012, 11:04
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Re: Major blow to Roche as potential blockbuster fails

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They still own Genentech
Not any more. We merged into a single company three years back.
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Old 09.05.2012, 11:44
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Re: Major blow to Roche as potential blockbuster fails

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Not any more. We merged into a single company three years back.
There is a difference between acquisition and merger....just saying.
Roche paid a premium for Genentech and now there are doubts whether it is worth it (in long term after the I.P on Avastin and Herceptin expires).
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Old 09.05.2012, 11:48
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Re: Major blow to Roche as potential blockbuster fails

Another thing, many organizations within Roche work independently i.e. Roche Diagnostics is independent of Roche Pharma. Within Roche Pharma, there are further divisions. If one division is failing (in this case, late stage development and metabolism) then they take the hit....i.e. contractors and temp. employee working on that particular project may not have their contracts renewed.
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Old 09.05.2012, 11:51
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Re: Major blow to Roche as potential blockbuster fails

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But Roche is mostly owned by a Swiss family, who don't always react like normal shareholders.
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That is what has always distinguished Roche from its competitors, a company not beholden to its shareholders but able to take a longer term view.
Merck Serono is owned by a family too, admittedly a German one.
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