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Old 08.05.2012, 16:02
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Major blow to Roche as potential blockbuster fails

This will definately have an impact on Roche (Basel) jobs
Its no secret that daletrapib was in one of the Therapeutic Areas not relocated to San Francisco, and thus a great hope for the Basel site.

Roche scraps cholesterol drug dalcetrapib after Phase III fail
World News

May 08, 2012
Kevin Grogan

Shares in Roche have taken a bashing after the Swiss major has pulled the plug on dalcetrapib, a drug which raises 'good' cholesterol, after suffering a late-stage study failure.

On the basis of results from the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial, the independent data and safety monitoring board has recommended stopping the study due to a lack of clinically meaningful efficacy. The more-than-15,000-patient trial evaluated the drug, a cholesterylester transfer protein (CETP) inhibitor, when added to existing standard of care in patients with stable coronary heart disease following an acute coronary syndrome.

No safety signals were reported but Roche has decided to terminate the study and the entire six-trial dal-HEART programme, two of which have been completed. Over 35,000 patients were involved in the studies.

Roche chief medical officer Hal Barron noted that "lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal". He added that "while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study".

Dr Barron went on to say that "we continue to be fully committed to the development of innovative medicines for people with cardiovascular disease". He noted that "our pipeline remains robust with 23 positive late-stage clinical trials reporting over the past 16 months and a significant increase in new molecular entities in late-stage development".

The CETP inhibitors has suffered setbacks in the past as at the end of 2006, Pfizer terminated torcetrapib in Phase III due to safety concerns. There are still some well-advanced drugs left in this class, however, namely Merck & Co's anacetrapib (Phase III) and Eli Lilly’s evacetrapib (just completed Phase II).

Nevertheless, the failure of dalcetrapib has led a number of observers to call into question the CETP class, which is seen by some as the next step forward from statins in terms of treating heart disease. Tim Anderson, an analyst at Sanford Bernstein issued a research note saying that "experts in the field of cholesterol management have remained uncertain about the general approach of raising HDL-cholesterol through CETP inhibition. Investors have also remained cautious".

Mr Anderson still believes "there is a 'bull case' to be made" with anacetrapib because "it seems to lack the safety problems of torcetrapib, and unlike dalcetrapib that only raised HDL (good) cholesterol, Merck's drug both raises HDL and lowers LDL (bad) cholesterol". He concluded by saying that "it is possible that the LDL lowering alone could carry anacetrapib across the finish line".

As for Roche, the loss of dalcetrapib, touted as a blockbuster, is a blow, though analysts already had fairly low expectations. Investors were disappointed, however, and the Basel-based firm's shares fell nearly 3.5% to close at 159.40 francs.

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Old 08.05.2012, 16:14
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Re: Major blow to Roche as potential blockbuster fails

More job losses? I hope not.
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Old 08.05.2012, 16:46
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Re: Major blow to Roche as potential blockbuster fails

Probably not so bad as they have other areas like diagnostics to back them up.
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Old 08.05.2012, 16:48
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Re: Major blow to Roche as potential blockbuster fails

That's a few 100 million down the drain then
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Old 08.05.2012, 17:40
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Re: Major blow to Roche as potential blockbuster fails

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Probably not so bad as they have other areas like diagnostics to back them up.
Not so sure about that, Roche has divested most of its bread and butter portfolio (e.g. vitamins, nutritional health, over the counter drugs) in favour of high value and blockbuster drugs. When so much of your revenue comes from so few drugs, you're in dire straits. Roche are far from alone here, most of the Pharma world is in the doldrums.
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Old 08.05.2012, 18:33
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Re: Major blow to Roche as potential blockbuster fails

other pharma majors do not have diagnostics like Roche does. Look at the website. That's why they will not in dire straits but can actually afford to send all the employees to the concert of Dire Straits.

Last edited by danny; 08.05.2012 at 18:48.
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Old 08.05.2012, 18:54
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Re: Major blow to Roche as potential blockbuster fails

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This will definately have an impact on Roche (Basel) jobs

As for Roche, the loss of dalcetrapib, touted as a blockbuster, is a blow, though analysts already had fairly low expectations. Investors were disappointed, however, and the Basel-based firm's shares fell nearly 3.5% to close at 159.40 francs.

Source
This is really normal in drug development. The expectation is for around 1 in 10 drugs to make it through the full phIII development and I think Roche had some adverts in Basel Airport to this effect. This was culled at the start of phIII since the results were not showing to be favorable. I would say it reflects good practice in stopping trials early rather than waiting until a submission gets kicked out. Just a thought.
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Old 08.05.2012, 19:21
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Re: Major blow to Roche as potential blockbuster fails

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other pharma majors do not have diagnostics like Roche does. Look at the website. That's why they will not in dire straits but can actually afford to send all the employees to the concert of Dire Straits.
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.
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Old 08.05.2012, 20:44
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Re: Major blow to Roche as potential blockbuster fails

Does that mean that all the folk used for the testing didn`t live up to their expectations?

Darn ... all that money down the drain! And now all those jobs lost?
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Old 08.05.2012, 21:51
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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.
Indeed a nice one. But the two companies are far away in terms of strengths.
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Old 08.05.2012, 22:00
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Re: Major blow to Roche as potential blockbuster fails

pretty tough time for the pharma companies right now.
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Old 08.05.2012, 22:01
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Re: Major blow to Roche as potential blockbuster fails

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Indeed a nice one. But the two companies are far away in terms of strengths.
so a good strategic fit, then
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Old 08.05.2012, 22:09
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Re: Major blow to Roche as potential blockbuster fails

Well..it just means that statistically, the drug really showed 'no benefit' in increasing the 'good' cholesterol levels in the subjects (as Roche wanted to see) when a midpoint analysis was done.
Although a huge loss for Roche (since the drug was already in Phase III trials), but as has been pointed above, it is quite normal in the process of drug development to find during a critical phase that the trial needs to be scrapped. This go/no-go checkpoint is usually good since it saves both time and money for the company, consumers as well as the regulatory authorities in the long run.
That is why pharma companies have huge R&D budgets. These also take into account the losses caused due to possible pre-mature discontinuations of ongoing trials.
I just hope in this case it doesn't mean job cuts
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Old 08.05.2012, 22:29
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Re: Major blow to Roche as potential blockbuster fails

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This is really normal in drug development. The expectation is for around 1 in 10 drugs to make it through the full phIII development and I think Roche had some adverts in Basel Airport to this effect. This was culled at the start of phIII since the results were not showing to be favorable. I would say it reflects good practice in stopping trials early rather than waiting until a submission gets kicked out. Just a thought.
Like I mentioned above, this drug was the great hope for the Basel site, metabolism is one of the few TAs that remains on this side of the pond, therefore it stands to reason that the impact will be most keenly felt here.
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Old 08.05.2012, 22:31
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Re: Major blow to Roche as potential blockbuster fails

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pretty tough time for the pharma companies right now.
and a hugely tough time for their employees too
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Old 08.05.2012, 22:35
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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
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
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Old 08.05.2012, 23:09
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Re: Major blow to Roche as potential blockbuster fails

They still own Genentech which hold the patent for dornase alpha. I can only imagine how much money they make off that drug.
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Old 08.05.2012, 23:13
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Re: Major blow to Roche as potential blockbuster fails

It's not good news...but it's not the end of the world. It's a forecast revenue loss not a 'real' loss. Q1 numbers were good. The pipeline is on the web site and it looks pretty strong. The products are only really split geographically in early stages.. in late stage and post launch the effort is spread across the company. Plus.. there's still plenty of cash in the bank.. they just decided not to spend any more than 10billion on one acquisition.
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Old 09.05.2012, 00:54
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Re: Major blow to Roche as potential blockbuster fails

it's a forecasted loss for sure, and Pharma typically carries a 10-20 yr strategic plan, thus would have analysed many 'possible' scenarios around this drug i.e. success vs failure vs non-approval etc. It was always a high risk investment, but the benefits far outweighed the risk, for patients and for the company.
Pipeline is very strong, so would not assume any cuts, apart from the normal re-shuffles and turnover of staff.
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Old 09.05.2012, 01:18
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Re: Major blow to Roche as potential blockbuster fails

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it's a forecasted loss for sure, and Pharma typically carries a 10-20 yr strategic plan, thus would have analysed many 'possible' scenarios around this drug i.e. success vs failure vs non-approval etc. It was always a high risk investment, but the benefits far outweighed the risk, for patients and for the company.
Pipeline is very strong, so would not assume any cuts, apart from the normal re-shuffles and turnover of staff.
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?
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