Replies to post #67588 on Biotech Values

[tinkershaw]

<<<If the growth rate seen from 2Q08 to 3Q08 is maintained, it will take ten quarters — i.e. until the first quarter of 2011 — for Tysabri sales to reach the 100,000-patient goal set forth by BIIB and ELN.>>>

The 100,000 goal is by the end of 2010, so that would only be off by one quarter. And this taken from a growth rate during the quarter where the 2 new PML cases hit, and a quarter where in Europe there is a lot of holiday vacation being seasonally taken (this would not have an impact on U.S. numbers, but does materially impact EU numbers).

Prior to PML, if you look at the ramp rate, tysabri had started to form a hockey stick curve. The 2 new PML cases put a bit bump in that path.

All depends on the safety profile going forward. It is clear that the incidence of PML is much less than 1 in 1000. It is also clear that if caught early and properly treated, PML can be managed, at least in some patience, making the safety profile relatively better than anticipated.

Further, the publicity is now coming to light that biological drugs of many makes, have their own side effects, many of them PML, and that the deleterious effects of doing nothing or staying on CRABS may be much worse than taking the risk (of a different kind than exists with CRABS) of going on tysabri.

All in all, I think the biggest thing holding tysabri back is Avonex and Biogen's marketing campaign to maximize its sales in both products and minimizing any cannibalization.

Be that as it may, as who knows, 10 PML cases could pop up tomorrow, if things remains as they are, given the numbers you cited, which would only put tysabri one quarter behind in its schedule, the 100,000 patient goal (which will equal ~ $2.5-$3 billion in revenues) is very obtainable from those numbers.

The tysabri numbers actually outperformed the estimates by every analyst that I read, and there were at least 3 or 4 with projections. In fact, the current numbers on tysabri now equals or exceeds the peak estimate of one current analyst by 2013.

Nevertheless, it seems like it is a show me period for ELN. So we shall have to wait to be shown whether this projections will come true or not.

Tinker

[masterlongevity]

did you see the crohn's sales?

only 200 crohn's pts to date have been treated with tysabri.


also, question...

would be interested to see what the new market share numbers are for MS market. Avonex seems to be growing nicely and tysabri is growing a little. is the overrall market growing dramatically or is the market share for one of the other therapies decreasing?

[DewDiligence]

Tysabri Growth Rate Dropped by Half in 4Q08 vs 3Q08

http://www.reuters.com/article/marketsNews/idINBNG24187920090113

›Tue Jan 13, 2009 12:11pm EST
By Toni Clarke

BOSTON, Jan 13 (Reuters) - Biogen Idec Inc said on Tuesday that the number of new patients taking its multiple sclerosis drug Tysabri slowed in the fourth quarter compared to the third quarter amid concerns over its safety.

The company said the number of patients taking Tysabri rose about 6 percent in the fourth quarter to 37,600, up from 35,500 at the end of the third quarter.

Biogen made its forecast to investors at the JP Morgan Healthcare conference in San Francisco.

The figures represent a slowdown compared to the growth rate in the third quarter, when the number of new patients rose 11.6 percent over the 31,800 reported in the second quarter.

Tysabri is considered critical to Biogen's growth, as well as to the growth of its partner Elan Corp Plc, which said on Tuesday it is exploring its strategic options, including a potential merger or sale.

Growth rates have been slowing amid concern over the risk for patients of developing a potentially deadly brain infection known as progressive multifocal leukoencephalopathy, or PML.

Tysabri was temporarily withdrawn from the market in 2005 after it was linked with PML but reintroduced in 2006 with stricter safety warnings.

Biogen has said it expects 100,000 patients to be taking Tysabri by 2010, a number some analysts believe will be difficult to meet. [“Impossible to meet” would be more accurate, IMO.]

Third-quarter sales of Tysabri rose 16 percent to $171 million. That was a slowdown from a growth rate of 29 percent in the second quarter, when sales rose to $147 million from $115 million in the first quarter.

Four cases of PML have been diagnosed since the drug was reintroduced. In December, Biogen said one patient had died. The patient had received 14 monthly infusions of Tysabri as a stand-alone treatment. Previously she had received other therapies.

After developing the brain infection, the patient was treated with a procedure known as plasmapheresis, in which blood is removed, cleared of the drug, and replaced.

Meanwhile, two patients who developed PML in Europe appear to be recovering following treatment, even though one had not been expected to survive. Last month Biogen said a fourth patient in Europe had developed PML. That patient was also still alive in December.‹