12:00 AM
Sep 10, 2007
 |  BioCentury  |  Finance

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 as much as $2.05 to $53.39 on Wednesday, but settled for a $0.79 gain to $50.90 at week's end. On Friday, FDA released briefing documents for its joint meeting of the Cardiovascular and Renal Drugs and Drug Safety and Risk Management advisory committees on Tuesday this week to discuss updated information on the risks and benefits of ESAs to treat anemia due to chronic renal failure.

On the positive side for AMGN, the documents demonstrated an interest in targeting a more specific hemoglobin range of 11-12 g/dL, rather than the current ESA labels that recommend maintaining the lowest hemoglobin level sufficient to avoid the need for red blood cell transfusion and not to exceed 12 g/dL.

But it was another focus, on ESA hypo-responders, that might have made investors nervous. The documents said the FDA wants the committees to discuss the definition of an ESA hypo-responder, "as well as the types of clinical data needed to support labeling alterations to optimize safer use of ESAs in these patients."

The agency also noted that hypo-responders "may signal an increased risk for serious cardiovascular events" (see Online Links, A7).

In March, FDA modified the labels of the ESAs to include a warning on the increased risk of death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/L.

Stuart Weisbrod of Merlin BioMed said he's looking for a rebound from AMGN if it gets positive news from the ESAs panel. "No one is willing to bid up the stock ahead, but there could be a relief rally...

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