albuferon

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chuck - 27 Jul 2009 17:47 GMT

Is albuferon on the threshold of approval?
What is the expected rate of SVR for persons using albuferon instead of
pegylated interferon in treatment with Ribavirin?
Would albuferon with ribivirin and a protease inhibitor show promise for
type 1 patients?

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Waterspider - 27 Jul 2009 18:14 GMT

> Is albuferon on the threshold of approval?
> What is the expected rate of SVR for persons using albuferon instead of
> pegylated interferon in treatment with Ribavirin?
> Would albuferon with ribivirin and a protease inhibitor show promise for
> type 1 patients?

Sorry, Chuck.

This article
http://drugdiscovery.pharmaceutical-business-review.com/comment/human_genome_sci
ences_albuferon_unlikely_to_threaten_hcv_standard_of_care_200309
says albuferon therapy is no improvement on standard treatment, and may not
be as effective. The only benefit they point out is the economic advantage
of having more competition in the pharmaceutical market. Good article, from
a business perspective.

The manufacturer's website says it will be applying for various marketing
permissions this fall. That process can take months, if not years.

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chuck - 27 Jul 2009 22:00 GMT

> Sorry, Chuck.
>
[quoted text clipped - 7 lines]
> The manufacturer's website says it will be applying for various marketing
> permissions this fall. That process can take months, if not years.

The web site said that the drug has demonstrated non-inferiority, which in
my book says at least equivalent efficacy and then goes on to say it has not
demonstrated substantial superiority to pegylated interferon. If I can
achieve the same chance of SVR while doing half as many shots, that alone
demonstrates a markedly superior product. I guess the suits at the FDA don't
need to do the shots and neither do the traders on wall street.

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Waterspider - 28 Jul 2009 00:45 GMT

> "Waterspider" <nospam@all.com> wrote in message
>> Sorry, Chuck.
[quoted text clipped - 6 lines]
>> The manufacturer's website says it will be applying for various marketing
>> permissions this fall. That process can take months, if not years.

> The web site said that the drug has demonstrated non-inferiority, which in
> my book says at least equivalent efficacy and then goes on to say it has
> not demonstrated substantial superiority to pegylated interferon. If I can
> achieve the same chance of SVR while doing half as many shots, that alone
> demonstrates a markedly superior product. I guess the suits at the FDA
> don't need to do the shots and neither do the traders on wall street.

I know you want to be optimistic, but it's important to be objective too.
You're right that investors don't have to do the shots, but realize that
they care about their money as much as you care about your liver. This
paragraph from the article, to me, says that albuferon is not as effective
and likely has worse side-effects, making it more likely that you won't
complete treatment:

"Albuferon met its primary efficacy endpoint of non-inferiority to
peginterferon alfa-2a (Roche's market leading Pegasys), with 48.2% of
patients achieving SVR in the 900-mcg Albuferon arm, versus 51% in the
Pegasys treatment group in an intention-to-treat analysis. Importantly, the
rate of Albuferon treatment discontinuations due to adverse events was more
than double that of Pegasys, at 10.4% versus 4.1%. Adverse events observed
were those typically associated with interferon therapy."

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