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Gilead’s potential new drug strategy

May 31, 2017

Gilead Sciences has been in the doldrums. Its first-quarter results, released on May 2, showed total revenues down. It reported $6.5 billion for the first quarter 2017 compared to $7.79 billion the first quarter of 2016. The big hits have been in its Hepatitis C (HCV) franchise.

Much talk has been made about who and when Gilead should buy something to bolster its falling revenue. However, Geoffrey Porges and Bradley Canino, analysts with Leerink, recently met with Gilead’s chief scientific officer Norbert Bischofberger, to discuss the company’s pipeline. They noted that the meeting highlighted Gilead’s “focus moving to oncology and inflammation, little room for improvement in HIV treatments.”

That’s of concern, because for the most part, Gilead is a dominant player in HIV, and the company’s recent release of Genvoya, according to the company’s executive vice president of commercial operations Jim Meyers, was “the most successful launch in U.S. HIV history.” And the company’s victegravir/F/TAF combination therapy is also being well received.

However, the company appears to be focused on retaining its share of the HIV market and building its NASH and cancer programs.

NASH, or nonalcoholic steatohepatitis, is an area of huge unmet need. Sometimes called the “silent liver disease,” it resembles alcoholic liver disease, but appears in people who drink little or no alcohol. However, it can be quite severe and lead to cirrhosis. Gilead has three products in its NASH pipeline. They are selonsertib, GS-9674, and GS-0976. Selonsertib is in a late-stage trial, while the other two are in Phase II trials. Each has a different mode of action, which gives the company the possibility of the drugs being prescribed alone or as combination therapies.

And Keith Speights, writing earlier this month for The Motley Fool, said, “Don’t be surprised if Gilead acquires another NASH program. John Milligan made an offhanded remark, after mentioning the NASH drugs the company has acquired, that ‘we may do more there.’ In addition, Milligan hinted that an earlier-than-expected regulatory submission for selonsertib could be a possibility.”

Porges and Canino wrote, “In NASH, Gilead has differentiated themselves by focusing their trials on patients with severe F3-F4 fibrosis scores and on showing that their treatment can produce the important clinical benefit of reversing fibrosis. Ultimately they expect NASH, like cancer, Hep C and other serious diseases, to require combination treatment strategies.”

That being said, NASH is a complex disease and while many companies are working to develop drugs for approval, they may be years away. Analysts at Bernstein wrote in a research note recently, “We see commercialization [of NASH drugs] as highly challenging. Diagnosis is currently tied to liver biopsy; there are no ‘easy’ measures of treatment effectiveness (like HbA1c, total cholesterol or blood pressure). Broad acceptance of less invasive disease markets is still years away.”

In terms of immunology, the company appears excited about its filgotinib, currently in a late-stage clinical trial for rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. A possibility of a combo treatment with filgotinib and entospletinib is in a Phase II trial for graft-versus-host disease.

Porges and Canino wrote, “In inflammation, Dr. Bischofberger commented that there are still opportunities to improve efficacy in treatments for autoimmune diseases in spite of the array of biologic anti-inflammatories. The company believes that they have the potential to lead the new wave of medicines for these diseases with filgotinib.”

And the company has a clear focus on oncology. Gilead recently brought on Allessandro Riva, formerly head of global oncology for Novartis (NVS). He joined Gilead as senior vice president, Hematology and Oncology Therapeutic Area Head. Many investors view this as an indication Gilead had plans to accelerate its M&A activity in the oncology arena.

Bischofberger told Leerink the company is “nearing the back-end of a long evaluation of what direction to this in this category.” The three main areas of focus are targeted therapies, immuno-oncology, and cellular therapies. The company plans to stay away from cytotoxic/chemotherapies, which everybody appears to be moving away from anyway.

FierceBiotech notes, “But the company remains committed to targeted therapies that block kinase signaling, with their Phase II Syk inhibitor entospletinib and a Phase II BTK inhibitor tirabrutinib the big hopes.”

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