Gilead, GlobeImmune's Hep B Drug Flunks Phase II Study

Gilead, GlobeImmune's Hep B Drug Flunks Phase II Study
May 27, 2015
By Mark Terry, Breaking News Staff

GlobeImmune, Inc. , headquartered in Louisville, Colo., announced disappointing results today for its Phase II clinical trial of hepatitis B drug GS-4774.

Though found to be safe and tolerated well, GS-4774, did not meet the primary endpoint of the study—it failed to indicate a reduction in hepatitis B surface antigen (HbsAg) at week 24. However, there was some reduction seen at 48 weeks.

“We believe that this first Phase II trial of GS-4774 in virally-suppressed patients suggests initial biologic activity at the highest dose tested,” said Timothy Rodell, president and chief executive officer of GlobeImmune in a statement. “We look forward to collaborating with our partner Gilead Sciences, Inc. to identify potential next steps for GS-4774 in this patient population as well as to seeing the results from the second ongoing Phase II trial of GS-4774 in HBV treatment-naïve patients.”

Other companies involved in developing hepatitis B drugs include Arrowhead Research Corporation , Tekmira and Isis Pharmaceuticals, Inc. .

Arrowhead Research’s ARC-520, utilizes siRNA to attack the HBV virus. On April 13, 2015, the company announced that the U.S. Food and Drug Administration (FDA) had given it the go-ahead for a Phase IIb trial, titled Heparc-2004.

Tekmira, headquartered in Vancouver, British Columbia, announced in January of this year that it had inked a merger agreement with OnCore Biopharma, of Doylestown, Pa., to create a global company focused on developing therapeutics for HBV. Tekmira has a Phase I-ready HBV RNAi drug and OnCore has multiple HBV programs. The combined company’s lead product was expected to be TKM-HBV, an RNAi drug designed to eliminate HBV surface antigen expression.

In July 2014 Isis Pharmaceuticals received $1 million from U.K.-based GlaxoSmithKline as part of a deal to develop drugs for hepatitis B. This was on top of $11 million previous funding from GSK for HBV therapeutics. Isis and GSK have three novel antisense drugs for HPB in their pipeline.

In 2011 Gilead Sciences and GlobeImmune announced an exclusive worldwide license and collaboration agreement to develop and commercialize vaccine products for hepatitis B for use in conjunction with Viread (tenofovir disoproxil fumarate) and other oral therapies. The collaboration’s goal was to create vaccine products with specific HBV DNA antigens clonedGlobe into a type of yeast, S. cerevisiae. The theory is that the combination of a vaccine with the oral suppressive effects of the antiviral therapy would result in greater loss of surface antigen, a marker for improvement of chronic HBV infection.

GlobeImmune’s GS-4774 was tested in 178 patients that compared three different doses of the drug, administered with an oral antiviral therapy compared to antiviral treatment by itself.

GlobeImmune did not respond to requests for an interview in time for deadline.

Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”

Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.

“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”

We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?

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