Ebb & Flow
Gilead (GILD) may be back on an upswing, after a bit of a slide in the early summer, aided last week by an FDA panel's unanimous recommendation for approval of first-in-class HIV treatment Isentress raltegravir from Merck (MRK). GILD is the only other company with a relatively late-stage integrase inhibitor in development. Its elvitegravir (GS 9137) has completed a Phase II trial.
GILD tacked on $1.29 to $37.66 on the week. The stock is off its peak of $42.11 on April 25, but still is up 19% from the beginning of the year.
At the NewsMakers in the Biotech Industry conference on Thursday, EVP of commercial operations Kevin Young said the company viewed the Isentress recommendation as good news.
"Number one, it validates the class," he said. Second, he said, it will soon provide an "approved comparator that we can put elvitegravir up against."
In its 2Q SEC filing, GILD disclosed that a Phase III trial design was dependent on a commercially available comparator, pushing back its earlier goal of a mid-2007 start of the Phase III. Last week, Young said GILD's preference is to put elvitegravir head-to-head with raltegravir, which has a mid-October PDUFA date.
In February, GILD presented positive Phase II data in HIV (see BioCentury, Feb. 26).
AMGN forges ahead
Amgen (AMGN) finally got a bit of good news last week, when the Senate voted unanimously to pass a non-binding resolution that calls on the Centers for Medicare & Medicaid Services to immediately reconsider its final National Coverage Decision (NCD) on erythropoiesis-stimulating agents for cancer and related neoplastic conditions.
AMGN got a bounce on the CMS news. It was up