Biotech Values

[DewDiligence]

GILD’s GT3 issue, which the whole world seems willing to overlook, surfaces in this Bloomberg piece on the phase-2 study of Sofosbuvir + Daclatasvir in treatment-experienced patients:

http://www.bloomberg.com/news/2013-04-27/gilead-bristol-hepatitis-c-drug-combo-cures-100-in-study.html

In a study among 41 patients of Gilead’s sofosbuvir combined with Bristol’s daclatasvir, with or without the generic antiviral ribavirin, 40 had undetectable virus in their blood 12 weeks after finishing six months of treatment, according to results presented today at a meeting in Amsterdam [EASL]. The other patient didn’t turn up to the last appointment and was later found to be virus-clear. [I.e., the SVR rate was 100%.] Patients in both groups had failed prior treatment with either…Incivek or Victrelis.

The two companies have planned no further trials of the combo because…Gilead is focusing on a cocktail that contains only its own drugs. The lack of a late-stage study, and the expense of the pills, will probably put the combination out of reach for doctors and patients, said Geoffrey Dusheiko, a professor of medicine at the Royal Free Hospital in London.

“It’s a conundrum for us,” Dusheiko said in an interview after the results were presented at the European Association For the Study of the Liver’s conference. “It looks a very promising regimen, it really does. But I’m really not sure it’ll see the light of day.”

…while ledipasvir [a/k/a GS-5885] may be effective against patients with hepatitis C genotype 1, the most common form worldwide, it may not work for those with genotype 3, which accounts for about 25 percent of cases in Europe and 45 percent in the U.K., said Graham Cooke, a clinician at Imperial College London. Daclatasvir and sofosbuvir are both active in that group…

The word may preceding the phrase “not work for those with genotype 3” in the above excerpt is unnecessary; by GILD’s own admission, GS-5885 is not active in GT3.