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Today’s combined efforts of Emory, Gilead, Merck and Bristol-Myers have saved millions of lives worldwide.Īlthough these results are very gratifying, this is far from the end of the story. Gilead obtained approval for Truvada®, a fixed-dose combination of Emtriva and Viread in 2004. In 2005, Gilead Sciences and Royalty Pharma signed a deal with Emory to buy its royalty interest for FTC for $525 million. In 2002, Shire and GlaxoSmithKline jointly licensed Emory’s patents related to 3TC, now used in at least 5 products. In 2003, Gilead acquired Triangle for $482 million and in the same year, Emtriva was approved by the FDA. FTC was licensed by Emory in 1996 to Triangle Pharmaceuticals, a biotech company founded by Schinazi and others in 1995. While these highly coordinated efforts seem brilliant in their simplicity, the history of FTC, like other new discoveries, is a bit more convoluted.
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Nonetheless, Samuel and his team continue to push their way through the various regulatory challenges in Africa, Eastern Europe, China, Southeast Asia, Latin America and the Caribbean. This is no easy task as the regulatory process varies greatly by country and not all governments are motivated by humanitarian concerns.
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“We prefer to take the high road and pursue full regulatory approval in each country so that patients have sustainable access to the antivirals they need on an uninterrupted schedule.”
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“If you work with import waivers you might get products into a country one month, but not the next,” explains Clifford Samuel, senior director of International Access Operations at Gilead. Meanwhile, Gilead is hard at work clearing the political and regulatory paths in developing world countries. Other industry collaborations include local manufacturing and distribution by South Africa’s Aspen Pharmacare and a manufacturing collaboration in the Bahamas with PharmaChem Technologies and the Grand Bahama Port Authority. In addition, Gilead established partnerships with 10 Indian companies to produce and distribute quality, low-cost generic versions of Gilead’s HIV medications in 95 developing countries. “Gilead did a tremendous amount of work in stability studies to increase the shelf stability of the drugs in hot, humid climates and poor storage conditions typical in third world countries,” says Liotta.Ītripla is marketed jointly by Gilead and Bristol-Myers Squibb in United States, Canada and Europe, but in much of the developing world, marketing and distribution is handled by Merck & Co., Inc. Atripla reduces pill burden and simplifies dosing schedules, which not only makes things easier and more tolerable for patients, but also greatly eases storage, transport and distribution of the drug to places with less than ideal conditions. Atripla contains three drugs-efavirenz (Sustiva®), emtricitabine (Emtriva®), and tenofovir disoproxil fumarate (Viread®), combined in one tablet and hence can be used as a stand-alone therapy in patients. Gilead and Bristol-Myers Squibb gained FDA approval in 2006 for the first once-a-day, single tablet regimen for adults with HIV called Atripla®. Indeed, many people have persevered at getting the drugs to patients around the globe. “That’s the thing, thousands of people make contributions to the ultimate success of this drug,” says Liotta. “They are the unsung heroes that developed a compression technique to fit a full day’s dosage of all three drugs in a single tablet, and it’s not a ‘horse’ pill.” “Special credit goes to the scientists at Gilead,” says Liotta.
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Typically, HIV sufferers take a three-drug combination, with Emtriva being one of the three. To see available technologies from research institutions, click here to visit the AUTM Innovation Marketplace. SmartFresh ® helps drive growth in the produce industry by ensuring that fresh food crops get to market, which means consumers can expect fresher fruits and vegetables year-round. Ethylene-sensitive crops such as apples, avocados, bananas, broccoli, cucumbers, leafy vegetables, mangoes, melons, pears, plums and tomatoes are now candidates for longer life spans and fresher taste. Based on this successful union, AgroFresh developed a product called SmartFresh ® a synthetic produce enhancer. Rohm and Hass formed AgroFresh to develop its product platform.
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Rohm and Hass Company recognized the commercial potential of the university’s discovery and worked with the Office of Technology Transfer to license the ethylene-inhibiting technology. Researchers have discovered the secret to keeping fruits and vegetables juicy, crisp and harvest-quality-fresh through storage and the trip to the marketplace.