GlaxoSmithKline's ViiV Healthcare Successful But Heat From Gilead May Be Its Downfall

Published: Jul 09, 2015

GlaxoSmithKline's ViiV Healthcare Successful But Heat From Gilead May Be Its Downfall
July 9, 2015
By Riley McDermid and Mark Terry, Breaking News Staff

Newer, better drugs being produced by global behemoth GlaxoSmithKline and smaller upstart companies like Gilead are treating HIV/AIDS so effectively that scientists in the field are now saying the disease may become so well managed it is no longer profitable.

“There are diminishing returns in HIV,” David Redfern, Glaxo’s chief strategy officer and the chairman of its AIDS treatment unit ViiV Healthcare Ltd., told Bloomberg News this week. “The industry has done a fantastic job of taking the fear of the late ’80s, and the death sentence, and taking that to one tablet a day.”

A spinoff of Glaxo, ViiV’s future has long been up in the air, after the company said this spring it would pull a planned public offering for the unit, which raked in $2.5 billion in 2014—around a quarter of Glaxo’s operating profit.

Those days may be numbered however, as competition from Gilead and other players continues to crowd the space, and most medicines that treat the disease see a 2026 deadline looming for their patent protection. Gilead alone brought in $10.3 billion from its AIDS portfolio last year, a lead that may be lost when Glaxo finds a wider acceptance for its combo of Tivicay and Triumeq, Redfern told Bloomberg.

“We are developing a new generation of products that will be even more competitive with Gilead’s portfolio,” Dominique Limet, ViiV’s chief executive officer, told the news service. “The future of the HIV market is mainly driven by two companies, ViiV and Gilead.”

Still, the efforts to study and contain HIV continue industrywide.

In May, GlaxoSmithKline and The University of North Carolina at Chapel Hill announced that they have created a partnership to develop HIV/AIDS cures. The partnership will launch an HIV Cure center as well as a company called Qura Therapeutics to handle the business, intellectual property and commercialization aspects of the deal.

The HIV Cure center will be built on the UNC-Chapel Hill campus. GSK will invest $4 million per year for five years for a total of $20 million to support the HIV Cure center research plan. A team of GSK researchers will join UNC researchers at the new space. UNC-Chapel Hill will provide lab space on its medical campus.

“The excitement of this public-private partnership lies in its vast potential,” said Carol Folt, UNC-Chapel Hill chancellor in a statement. “Carolina has been at the forefront of HIV/AIDS research for the last 30 years.”

GSK announced on May 6 that ViiV, a company jointly founded by GSK and Pfizer in November 2009, had initiated a Phase III clinical trial to evaluate the safety and efficacy of Tivicay (dolutegravir) and Edurant (rilpivirine) for maintenance therapy for adult HIV patients.

In addition, in June 2014 ViiV Healthcare and Janssen Sciences Ireland UC, a Johnson & Johnson company, announced a partnership. That group is investigating the combination of dolutegravir and rilpivirine in a single-tablet form for HIV treatment.

This promising development has motivated GSK to hold on to its 78 percent stake in ViiV, which has Pfizer and Shionogi & Co. of Japan as partners.

One of the approaches the new partnership intends to pursue is how to drive HIV out of hiding. A problem that has been observed in treatment for HIV, as compared to a cure, is that the virus can shift into a latent phase and hide in immune cells where current antiretroviral drugs can’t touch it. UNC researchers have been working on a therapy that flushes the virus from the latent reservoirs, which then can be targeted by other HIV drugs.

“After 30 years of developing treatments that successfully manage HIV/AIDS without finding a cure, we need both new research approaches to this difficult medical problem and durable alliances of many partners to sustain the effort that will be needed to reach this goal,” said David Margolis, professor of medicine and leader of the UNC Collaboratory of AIDS Researchers for Eradication (CARE), in a statement. “The ‘shock and kill’ approach has shown significant promise in early translational research on humans and has been the focus of research for the last several years.”

The investment in the HIV Cure center is a separate investment from GSK’s efforts in support of ViiV Healthcare. In addition, the company’s HIV Discovery Performance Unit will continue to work on new antiretroviral drugs at its research facilities at Research Triangle Park, N.C. ViiV will, however, play an advisory role to the HIV Cure center and to Qura Therapeutics.

As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.

The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.

The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.

But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.

That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?

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