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`Blockbuster Drug Launches 2016: The 7 to Watch
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`Fortune.com
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`H EALTH
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`PHARMACEUTICALS
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`7 New Blockbuster Drugs to
`Watch in 2016
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`by Laura Lorenzetti
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`@|aura|orenzetti
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`MARCH 25, 2016, 8:06 AM EST
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`Photograph by GP Kidd—Getty Images/Cultura RF
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`Each of these new drugs could rake in $2 billion in sales.
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`Blockbuster drugs, those medicines that bring in more than $1 billion in sales every year, are the holy
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`grail of drug development. They can make a pharmaceutical company and send them to rock-star status
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`among investors, as evidenced by the rise of Gilead Sciences after the launch of its hepatitis C
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`treatments. This year’s slate of new drug launches features at least seven drugs expected to hit
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`blockbuster status within the next five years, according to a study by Thomson Reuters.
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`The line-up also reveals key trends within the pharmaceutical industry for this year and beyond,
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`including an increasing focus on rare diseases, the development of more convenient single-dose
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`regimens, and more affordable treatments.
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`Here are the seven drugs set to launch this year and reach blockbuster status by 2020.
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`Mylan v. Genentech
`1. Intercept Pharmaceuticals and Sumltomo Damlppon Pharma Mylan V. Genentech
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`12/17/2016
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`Blockbuster Drug Launches 2016: The 7 to Watch
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`= Fortune.com
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`Indication: Chronic liver diseases, primarily primary biliary cirrhosis
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`2020 Forecast Sales: $2.62 billion
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`Intercept Pharmaceuticals’ ( ICPT
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`) obeticholic acid has proved Very effective in treating non-alcoholic
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`steatohepatitis, a type of liver inflammation caused by fat build-up in the organ. This condition has no
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`approved treatment and a potentially large market, which is expected to push the drug to blockbuster
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`status, if approved. About 2% to 3% of the global population has non-alcholoic steatohepatitis and the
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`share will likely increase due to rising rates of pre-disposing factors like obesity and insulin resistance.
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`2. Gilead Sciences and Japan Tobacco
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`Drug: Emtricitabine and tenofovir alafenamide (F/TAF)
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`Indication: HIV-1 infection
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`2020 Forecast Sales: $2 billion
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`Gilead’s ( GILD
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`) two HIV-1 infection drugs in development are both expected to be big money-makers,
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`and the company is hoping the new daily single-dosage options will be able to replace sales of its existing
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`HIV treatments that are set to lose patent protections in 2017. The new TAF-based therapies show
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`evidence that they are potentially a safer replacement for some current therapies, including Gilead’s own
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`Truvada.
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`3. Gilead Sciences and Janssen R&D
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`Drug: Tenofovir alafenamide and emtricitabine and rilpivirine (R/F/TAF)
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`Indication: HIV-1 infection
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`2020 Forecast Sales: $1.57 billion
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`Like the No. 2 drug on this list, Gilead’s secondary TAF-based combination therapy in partnership with
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`12/17/2016
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`Blockbuster Drug Launches 2016: The 7 to Watch
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`= Fortune.com
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`of HIV patients and increasing numbers of those eligible for antiretroviral drugs means a large and
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`lucrative market for the two new TAF-based drugs.
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`4. Merck & Co.
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`Drug: MK—5172A
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`Indication: Hepatitis C virus
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`2020 Forecast Sales: $1.54 billion
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`Merck ( MRK
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`) is getting ready to enter the heated market for hepatitis C treatments, going up against
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`Gilead’s Harvoni and Abbvie’s Viekira Pak. Following a significant setback when theFood and Drug
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`Administration withdrew its “breakthrough drug” status, Merck’s treatment could finally launch this
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`year to give another safe and high-quality treatment for the disease. A recent warning by the FDA
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`concerning Viekira Pak has dampened sales of Abbvie’s drug, which could give Merck a leg up when it
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`eventually brings its hepatitis C drug to market. It could also pursue an aggressive pricing strategy to
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`gain market share, given the currently high price tags on current treatments.
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`12/17/2016
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`Blockbuster Drug Launches 2016: The 7 to Watch
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`Fortune.com
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`Drug: Venetoclax
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`Indication: Chronic lymphocytic leukemia
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`2020 Forecast Sales: $1.48 billion
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`Abbvie’s ( ABBV
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`) Venetoclax is a potential oral treatment for cancer, primarily focused on a type of
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`chronic lymphocytic leukemia that is resistant to chemotherapy. The drug was a leading therapy at last
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`year’s annual meeting of the American Society of Hematology after a clinical trial showed an overall
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`response rate of 79.4% in patients with relapsed chronic lymphocytic leukemia. The drug is also being
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`tested as a potential treatment for other hematological cancers like non-Hodgkin’s lymphoma, as well as
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`in combination with tamoxifen in patients with metastatic breast cancer.
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`6. ACADIA Pharmaceuticals
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`Drug: Nuplazid
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`Indication: Parkinson’s disease psychosis
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`2020 Forecast Sales: $1.41 billion
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`ACADIA’s ( ACAD
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`) nuplazid could be the first and only drug on the market to help treat Parkinson’s
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`disease psychosis, which affects up to 40% of Parkinson’s patients. Clinical trials have shown that the
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`drug does not worsen motor symptoms, a vital factor for these patients, while improving night-time
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`sleep, daytime wakefulness, and caregiver burden. Nuplazid may also work in other psychosis settings,
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`such as schizophrenia and Alzheimer’s disease psychosis. The combination of those three diseases
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`means ACADIA’s drug has a potentially massive and therefore lucrative market.
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`7. Nippon Shinyaku and Actelion
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`Drug: Uptravi
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`http://fortune.com/2016/03/25/new-b|ockbuster-drugs-to-watch/
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`12/17/2016
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`Blockbuster Drug Launches 2016: The 7 to Watch
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`Fortune.com
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`2020 Forecast Sales: $1.27 billion
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`Nippon Shinyaky’s Uptravi is able to both delay the progression of pulmonary arterial hypertension, a
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`type of high blood pressure that affects arteries in the lungs and heart, as well as reduce the risk of
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`hospitalization. The drug is the only one on this list that’s already available. It entered the market in the
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`first week of January 2016 and is expected to bring in $189 million in its first year, with sales increasing
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`to $1.27 billion by 2020. Uptravi is being promoted as an additional therapy once baseline treatment has
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`been started. A massive clinical trial showed that Uptravi reduced the risk of death from pulmonary
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`arterial hypertension by 39% Versus placebo.
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`Licensing
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