GlaxoSmithKline (GSK)-UNC Chapel Hill partnership partner to find HIV and AIDS cure

GSK and UNC-Chapel Hill announce novel partnership to accelerate search for HIV cure

GSK UNC Partnership

Unique public-private collaboration will create HIV Cure center and a new company to bring together academic and pharmaceutical research scientists

Issued: GlaxoSmithKline PLC (GSK) -Research Triangle Park, NC

The University of North Carolina at Chapel Hill, a leading global public research university with significant expertise in HIV basic and clinical research, and GSK, a global, research-based pharmaceutical and healthcare company with a legacy of success in developing treatments for HIV, today announced the creation of a dedicated HIV Cure center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS. This unique public-private partnership will redefine the traditional way of conducting research and create a new model to seek the breakthroughs needed to tackle an extraordinarily challenging global health issue.

The HIV Cure center will be located on the UNC-Chapel Hill campus and will focus exclusively on finding a cure for HIV/AIDS. The new company, Qura Therapeutics, will handle the business side of the partnership, including intellectual property, commercialization, manufacturing and governance. Together, the HIV Cure center and Qura Therapeutics will serve as a catalyst for additional partners and public funding that will likely be needed to eradicate HIV worldwide. The collaboration is also expected to recruit and attract top talent from around the world.

“The excitement of this public-private partnership lies in its vast potential,” said UNC-Chapel Hill Chancellor Carol L. Folt. “Carolina has been at the forefront of HIV/AIDS research for the last 30 years. This first of its kind, joint-ownership model is a novel approach toward finding a cure, and we hope it serves as an invitation to the world’s best researchers and scientists. Today, Carolina’s best are taking another major step in the global fight against HIV/AIDS.”

“Like UNC, GSK has a long legacy of HIV research success. From the development of the world’s first breakthrough medicine for HIV patients in the 1980s, to our leadership in the market today through ViiV Healthcare, we’re continuously challenging ourselves to meet the needs of patients,” GSK CEO Sir Andrew Witty said. “This partnership is a testament to our past and present leadership, innovation and commitment to this field. We are inspired by the confidence that with the right resources and research teams, we will be able to make a meaningful impact towards a cure for HIV.”

UNC-Chapel Hill and GSK will focus on the latest scientific approaches to curing HIV, including a leading research approach toward an HIV cure, sometimes called “shock and kill.” This approach seeks to reveal the hidden virus that persists in people with HIV infection despite successful drug therapy, and augment the patient’s immune system to clear these last traces of the virus and infected cells. Part of this new paradigm was first tested at UNC-Chapel Hill and in 2012 a team led by UNC-Chapel Hill researchers demonstrated that latent HIV might be unmasked by new therapies. Recently, researchers at the university received Food and Drug Administration approval for a study in HIV-positive volunteers to combine this technique and an immune-boosting strategy.

“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 Dr. David Margolis, Carolina professor of medicine and leader of the Collaboratory of AIDS Researchers for Eradication (CARE). “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.”

“Although today’s treatments for HIV mean that millions of lives have been saved, people still have to take a lifetime of treatments, which takes an emotional toll and places an economic burden on society that is particularly challenging in countries with limited resources,” said Zhi Hong, senior vice president and head of the Infectious Diseases Therapy Area Unit at GSK. “This is why we must dedicate the next 30 years to finding a cure and scaling it up so that one day we will end the HIV/AIDS epidemic.”

Through the new company, GSK will invest $4 million per year for five years to fund the initial HIV Cure center research plan, and a small research team from GSK will move to Chapel Hill to be co-located with UNC researchers. The University will provide world-class laboratory space on its medical campus for the HIV Cure center and the new company. GSK will be contributing its expertise and know-how in medicines discovery, development and manufacturing, and UNC-Chapel Hill will bring to the table its research and translational medicine capabilities, talent, as well as access to patients and funding.

GSK’s investment in the HIV Cure center is separate from its investment in the discovery of novel antiretroviral (ARV) therapies in support of ViiV Healthcare, a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV and owned by GSK, Pfizer and Shionogi. GSK’s HIV Discovery Performance Unit will continue its work on new ARVs in the Research Triangle Park area of North Carolina. ViiV has significant clinical expertise and will play an advisory role to the HIV Cure center and Qura Therapeutics.

The announcement of the UNC-GSK collaboration will be made Monday, 11 May at 9:30am EDT and can be viewed online at the video link below:
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Video: UNC-Chapel Hill and GSK announce novel partnership
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Video: UNC-Chapel Hill, GSK Announce Partnership
Fast Forward to 37 minutes into the video to see announcement

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GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2014.
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GlaxoSmithKline (GSK)-UNC Chapel Hill partnership partner to find HIV and AIDS cure

By BETSY MCKAY
The Wall Street Journal

GlaxoSmithKline PLC (GSK) and the University of North Carolina at Chapel Hill (UNC) are jointly launching a research center that will focus on one of the areas of most intense interest in HIV/AIDS science: the search for a cure.

The public-private partnership brings together two long-standing players seeking to expand their reach in HIV research. Research scientists from both entities will work together in an HIV Cure center to be housed at UNC.

Glaxo and UNC said they would also jointly own a new company, Qura Therapeutics LLC, that will manage intellectual property and other business matters related to the partnership.

The $20 million investment by Glaxo over five years comes on the heels of the company’s decision to retain its 78% stake in Viiv Healthcare, a business it owns jointly with Pfizer Inc. and Shionogi & Co. of Japan that develops drugs for HIV, the virus that causes AIDS. Taken together, the moves signal Glaxo’s ambition to play a major role in a new generation of HIV therapies, Glaxo Chief Executive Andrew Witty said in an interview. “HIV is a very major part of this company,” he said.

Glaxo was a leader in developing antiretroviral drugs around two decades ago, but then its HIV-drug development slowed. Mr. Witty said that Viiv’s launch of two new drugs has exceeded expectations, persuading Glaxo to hold onto its stake, and that he is optimistic about prospects for new products. “We’re going to be very ambitious to try to make a big difference,” he said.

The partnership with UNC will help expand its opportunities to develop new products, he said. Scientists from Glaxo have been working toward an HIV cure over the past seven years, he said. The company has large research labs near UNC. “This is the obvious next step for us to go,” he said.

For years, a cure to HIV was considered out of reach. But it has emerged as a potentially realistic goal over the past three or four years and attracted research funding, as scientists have identified possible approaches to eradicating the virus.

Still, there have been several setbacks along the way. The challenge of finding a cure and the complex therapies that likely will be needed for it underscore the importance of collaboration between researchers from academia and industry, said David Margolis, director of the new HIV Cure center and a professor of medicine at UNC.

Collaboration is also important for developing therapies that require combinations of drugs or approaches—a problem that has plagued the development of drugs for HIV treatment and other diseases, he said. The components have to be developed and tested together, he said. “It’s not clear how one company would do that,” he said. Dr. Margolis also leads another HIV-cure research collaboration involving academic institutions.

AIDS researchers have known for two decades that HIV goes dormant, hiding in so-called latent reservoirs in immune-system cells where it can’t be affected by antiretroviral drugs. UNC has led one potential strategy for a cure in which a drug is used to flush the virus from its dormant state, making it a target for drug therapy.

Dr. Margolis said that strategy is “extremely promising,” but that the cure center will explore others. “We have to have a broad approach,” he said.

UNC Chancellor Carol Folt said the hope is that the partnership will expand, inviting in additional collaborators. “I see this as us really putting our muscle behind a pressing issue,” she said, calling an HIV cure “an extraordinary scientific challenge.”

In 2013, about 35 million people world-wide were infected with HIV, and 1.5 million people world-wide died of AIDS-related causes, according to the Joint United Nations Program on HIV/AIDS.

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University of North Carolina at Chapel Hill
UNC Chapel

UNC Chapel Hill

UNC Chapel Hill

UNC Campus

UNC Chapel Hill
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UNC Chapel Hill is located in the Raleigh-Durham metropolitan area
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Population: Raleigh-Durham-Chapel Hill, NC CSA 2,075,126
Raleigh-Durham Metro Map 2015

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GlaxoSmithKline (GSK)

In 1843 Thomas Beecham launched his Beecham’s Pills laxative in England, giving birth to the Beecham Group.

In 1830 John K. Smith opened its first pharmacy in Philadelphia. In 1865 Mahlon Kline joined the business, which 10 years later became Smith, Kline & Co. In 1891 it merged with French, Richard and Company, and in 1929 changed its name to Smith Kline & French Laboratories as it focused more on research.

SmithKline & French merged with Beckman Inc. in 1982 and changed its name to SmithKline Beckman. In 1988 it bought its biggest competitor, International Clinical Laboratories, and in 1989 merged with Beecham to form SmithKline Beecham plc. The headquarters moved from the US to England.

Burroughs Wellcome & Company was founded in 1880 in London by the American pharmacists Henry Wellcome and Silas Burroughs. Burroughs Wellcome & Company’s US headquarters moved from New York to North Carolina’s Research Triangle Park in 1972, when the new modern headquarters facility (Elion-Hitchings Building) opened. Gertrude B. Elion and George H. Hitchings were awarded the 1988 Nobel Prize “for their discoveries of important principles for drug treatment”- in Physiology or Medicine, for their synthesis of antimetabolite drugs – analogs of nucleic acid bases that selectively killed tumor cells but became treatments for gout (allopurinol), herpesviruses (acyclovir), and HIV/AIDS (AZT; zidovudine).

Glaxo was founded in the 1850s as a general trading company in Bunnythorpe, New Zealand, by a Londoner, Joseph Nathan. Glaxo Laboratories opened new units in London in 1935. The company bought two companies, Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively. After the company bought Meyer Laboratories in 1978, it began to play an important role in the US market.

In 1983 the American arm, Glaxo Inc., moved to Research Triangle Park (US headquarters/research) and Zebulon, NC (US manufacturing).

Glaxo and Burroughs Wellcome merged in 1995 to form Glaxo Wellcome.

Glaxo Wellcome and SmithKline Beecham merged in December 2000, forming GlaxoSmithKline (GSK).

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Burroughs Wellcome Company, was the developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS).

Today, the Burroughs Wellcome Fund (BWF) is a private, independent biomedical research foundation based in Research Triangle Park (RTP), North Carolina. Burroughs Wellcome Fund was founded in 1955 as the corporate foundation of the then RTP headquartered Burroughs Wellcome Company.

Remembering when the fight against HIV and AIDS began

AZT’s Inhuman Cost

Published: August 28, 1989

The New York Times

AZT is the only drug approved for use against AIDS. It’s now known that AZT also postpones the onset of AIDS in people infected with the virus. Yet there’s a massive obstacle to wider use of this life-saving drug – its extraordinary cost. At $8,000 a year for users, AZT is said to be the most expensive prescription drug in history.

Some 35 percent of AIDS patients have either no health insurance or policies that do not pay for drugs. Many might be unable to afford AZT without the help of a temporary Government program that ends in September 1989. All Americans bear the high cost of the drug, in taxes or insurance premiums.

There’s another reason to want AZT to cost less. If AZT reduces an individual’s infectiousness, as is possible though not yet proved, wide use of the drug might help sharply curb the epidemic. The present high price can only impede such efforts.

Drug companies deserve high profits on new drugs to encourage invention and risk-taking. What makes the cost of AZT hard to swallow is that all the invention and much of the risk was undertaken by the Federal Government.

The average cost of bringing a new drug to market is $125 million. The maker of AZT, the Burroughs Wellcome Company of North Carolina, refuses to state its costs, but it’s hard to believe they reached a fraction of this sum. AZT was first synthesized in 1964, as a possible anti-cancer agent, by Jerome Horwitz of the Michigan Cancer Foundation. In 1984, Samuel Broder of the National Cancer Institute encouraged companies to submit possible anti-AIDS drugs for screening by a special test developed in his laboratory. Burroughs Wellcome sent in AZT, a compound it happened to have on its shelves after studying it for another purpose.

Since few other pharmaceutical companies were much interested in AIDS drugs at that time, Burroughs deserves credit for pressing ahead. But to encourage it to take even this chance, the Government allowed it to apply for full patent rights, despite the heavy Federal contribution. The Government then conducted or supported many of the clinical tests of AZT, and for early production it provided all the thymidine, a critical ingredient.

Burroughs at first justified its astoundingly high price for AZT by noting rival drugs would soon be on the market. But the rival drugs still haven’t appeared. Burroughs did reduce the retail price from $10,000 to $8,000 in 1987. The company now says the present 40,000 AIDS patients are the only customers it can be sure of. Every epidemiologist expects the toll to rise far higher.

As other promising AIDS drugs reach the market, competition will force the price of AZT down. But that may be many months ahead, and meanwhile Burroughs’s apparent profit bears little evident relation to its risks.

Burroughs Wellcome is the subsidiary of a British company that is 75 percent owned by a charitable foundation, the Wellcome Trust. Wellcome’s trustees are academics, many of them retired, who distribute the revenues for medical research. This is no doubt a worthy cause. But it’s a strange kind of charity that cordons off people already suffering from a terrifying disease.

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