HEALTH CARE
Wednesday 10th of May 2017 06:35:20 PM
Gilead Sciences Inc. — whose HIV-fighting drugs have helped to nearly triple the lives of people with the HIV virus and reduce the number of pills patients pop from 25 to one — expects this fall to ask government regulators to approve its final chronic HIV treatment.
But that's not the end of the Foster City-based company's journey with HIV patients, the company said. Instead, it will focus on drugs that act longer and, potentially, purge the AIDS virus.
Gilead (NASDAQ: GILD), which developed drugs like two-in-one, once-a-day Truvada and three-in-one Atripla, by the middle of the year expects data from a late-stage clinical trial of a drug called bictegravir. It could be added to a next-generation, Gilead-developed drug regimen called TAF, or tenofovir alafenamide.
The beauty of bictegravir, Gilead Chief Operating Officer Kevin Young said, is that bictegravir is designed to be kinder and gentler on HIV patients' bones and kidneys. That is important because HIV drugs by Gilead and others have increased the life expectancy of a 20 year old with HIV from 19 additional years to 53 more years, but researchers have found that HIV's wear and tear accelerates the aging of some organs.
"We believe this has the best of all worlds in terms of suppressing the virus and caring for the patient on a long-term basis," Young said Wednesday at Gilead's annual shareholder meeting.
If the bictegravir data are positive, Young said, the company will ask the Food and Drug Administration and European regulators in the third quarter to approve bictegravir.
Then that's it — no more chronic HIV drugs from Gilead.
Sort of.
Instead, 9,000-employee Gilead plans to turn its HIV focus toward longer-acting formulations. Much like it helped decrease the number of pills an HIV patient must take to one a day, Young said, Gilead could zero in on injections that would need to be taken monthly, quarterly or even longer between shots.
"It's more convenient than a daily pill," Young said.
Yet Gilead's HIV franchise isn't the biggest concern of Wall Street analysts and some the company's shareholders. Instead, they want the company to acquire drugs or companies with the more than $30 billion that Gilead has in the bank.
Gilead, led by Executive Chairman John Martin and President and CEO John Milligan, has that cash largely due to its HIV treatments and its hepatitis C drugs, which have effectively cured millions of people with the virus that causes liver cancer and leads to liver transplants.
Gilead's hepatitis C drugs — Sovaldi, Harvoni, Epclusa and Vemlidy — brought in nearly $34 billion over the past two years. A fourth drug, for people who have failed all other treatments, could be approved by the FDA by Aug. 8.
But by discharging the hepatitis C virus in as little as eight weeks, Gilead has created a world where its drugs aren't needed as much anymore.
"As you cure people, they move out of the health-care setting (for hepatitis C)," Young said.
Along the way, 30-year-old Gilead has charged wholesale prices as high as $1,000 a pill for Sovaldi and Harvoni, until discounts, rebates and competition changed what Gilead actually netted.
Gilead's overall net sales, which reached $32.15 billion in 2015 have been projected by Chief Financial Officer Robin Washington this year to be in the range of $22.5 billion to $24.5 billion.
While Gilead will acquire or partner with companies selectively, Young said, it will focus on tie-ups that have long-term opportunities and are "based on really good science."
As it is, Young said, the company is spending more on research and development in inflammatory diseases, such as rheumatoid arthritis, Crohn's disease and ulcerative colitis, representing 20 percent of the company's $3.1 billion to $3.4 billion R&D spend this year. Just two years ago, inflammation was 8 percent of $2.8 billion in R&D spending.
Its liver disease focus, meanwhile has shifted from hepatitis C to nonalcoholic steatohepatitis, or NASH. It specifically is focusing on a small group of patients — about 3 million of 12 million overall NASH patients — with an advanced form of the disease in which the liver is stiff from scarring and has difficulty functioning properly.
"It's a high-need population," Young said, and one that insurers will pay to cover.
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