throbber
12/17/2016
`
`Blockbuster Drug Launches 2016: The 7 to Watch
`
`Fortune.com
`
`H EALTH
`
`PHARMACEUTICALS
`
`7 New Blockbuster Drugs to
`Watch in 2016
`
`by Laura Lorenzetti
`
`@|aura|orenzetti
`
`MARCH 25, 2016, 8:06 AM EST
`
`Photograph by GP Kidd—Getty Images/Cultura RF
`
`Each of these new drugs could rake in $2 billion in sales.
`
`Blockbuster drugs, those medicines that bring in more than $1 billion in sales every year, are the holy
`
`grail of drug development. They can make a pharmaceutical company and send them to rock-star status
`
`among investors, as evidenced by the rise of Gilead Sciences after the launch of its hepatitis C
`
`treatments. This year’s slate of new drug launches features at least seven drugs expected to hit
`
`blockbuster status within the next five years, according to a study by Thomson Reuters.
`
`The line-up also reveals key trends within the pharmaceutical industry for this year and beyond,
`
`including an increasing focus on rare diseases, the development of more convenient single-dose
`
`regimens, and more affordable treatments.
`
`Here are the seven drugs set to launch this year and reach blockbuster status by 2020.
`
`Mylan v. Genentech
`1. Intercept Pharmaceuticals and Sumltomo Damlppon Pharma Mylan V. Genentech
`IPR2016-00710
`IPR2016-00710
`Genentech Exhibit 2128
`
`‘
`’“ " ‘
`“
`http://fortune.com/2016/03/25/new-blockbuster-drugs-to-watcw
`
`Genentech Exhibit 2128
`
`1/5
`
`

`
`12/17/2016
`
`Blockbuster Drug Launches 2016: The 7 to Watch
`
`= Fortune.com
`
`Indication: Chronic liver diseases, primarily primary biliary cirrhosis
`
`2020 Forecast Sales: $2.62 billion
`
`Intercept Pharmaceuticals’ ( ICPT
`
`) obeticholic acid has proved Very effective in treating non-alcoholic
`
`steatohepatitis, a type of liver inflammation caused by fat build-up in the organ. This condition has no
`
`approved treatment and a potentially large market, which is expected to push the drug to blockbuster
`
`status, if approved. About 2% to 3% of the global population has non-alcholoic steatohepatitis and the
`
`share will likely increase due to rising rates of pre-disposing factors like obesity and insulin resistance.
`
`2. Gilead Sciences and Japan Tobacco
`
`Drug: Emtricitabine and tenofovir alafenamide (F/TAF)
`
`Indication: HIV-1 infection
`
`2020 Forecast Sales: $2 billion
`
`Gilead’s ( GILD
`
`) two HIV-1 infection drugs in development are both expected to be big money-makers,
`
`and the company is hoping the new daily single-dosage options will be able to replace sales of its existing
`
`HIV treatments that are set to lose patent protections in 2017. The new TAF-based therapies show
`
`evidence that they are potentially a safer replacement for some current therapies, including Gilead’s own
`
`Truvada.
`
`3. Gilead Sciences and Janssen R&D
`
`Drug: Tenofovir alafenamide and emtricitabine and rilpivirine (R/F/TAF)
`
`Indication: HIV-1 infection
`
`2020 Forecast Sales: $1.57 billion
`
`Like the No. 2 drug on this list, Gilead’s secondary TAF-based combination therapy in partnership with
`
`http://fortune.com/2016/03/25/new-b|ockbuster-drugs-to-watch/
`
`2/5
`
`

`
`12/17/2016
`
`Blockbuster Drug Launches 2016: The 7 to Watch
`
`= Fortune.com
`
`of HIV patients and increasing numbers of those eligible for antiretroviral drugs means a large and
`
`lucrative market for the two new TAF-based drugs.
`
`4. Merck & Co.
`
`Drug: MK—5172A
`
`Indication: Hepatitis C virus
`
`2020 Forecast Sales: $1.54 billion
`
`Merck ( MRK
`
`) is getting ready to enter the heated market for hepatitis C treatments, going up against
`
`Gilead’s Harvoni and Abbvie’s Viekira Pak. Following a significant setback when theFood and Drug
`
`Administration withdrew its “breakthrough drug” status, Merck’s treatment could finally launch this
`
`year to give another safe and high-quality treatment for the disease. A recent warning by the FDA
`
`concerning Viekira Pak has dampened sales of Abbvie’s drug, which could give Merck a leg up when it
`
`eventually brings its hepatitis C drug to market. It could also pursue an aggressive pricing strategy to
`
`gain market share, given the currently high price tags on current treatments.
`
`http://fortune.com/2016/03/25/new-b|ockbuster-drugs-to-watch/
`
`3/5
`
`

`
`12/17/2016
`
`Blockbuster Drug Launches 2016: The 7 to Watch
`
`Fortune.com
`
`Drug: Venetoclax
`
`Indication: Chronic lymphocytic leukemia
`
`2020 Forecast Sales: $1.48 billion
`
`Abbvie’s ( ABBV
`
`) Venetoclax is a potential oral treatment for cancer, primarily focused on a type of
`
`chronic lymphocytic leukemia that is resistant to chemotherapy. The drug was a leading therapy at last
`
`year’s annual meeting of the American Society of Hematology after a clinical trial showed an overall
`
`response rate of 79.4% in patients with relapsed chronic lymphocytic leukemia. The drug is also being
`
`tested as a potential treatment for other hematological cancers like non-Hodgkin’s lymphoma, as well as
`
`in combination with tamoxifen in patients with metastatic breast cancer.
`
`6. ACADIA Pharmaceuticals
`
`Drug: Nuplazid
`
`Indication: Parkinson’s disease psychosis
`
`2020 Forecast Sales: $1.41 billion
`
`ACADIA’s ( ACAD
`
`) nuplazid could be the first and only drug on the market to help treat Parkinson’s
`
`disease psychosis, which affects up to 40% of Parkinson’s patients. Clinical trials have shown that the
`
`drug does not worsen motor symptoms, a vital factor for these patients, while improving night-time
`
`sleep, daytime wakefulness, and caregiver burden. Nuplazid may also work in other psychosis settings,
`
`such as schizophrenia and Alzheimer’s disease psychosis. The combination of those three diseases
`
`means ACADIA’s drug has a potentially massive and therefore lucrative market.
`
`7. Nippon Shinyaku and Actelion
`
`Drug: Uptravi
`
`http://fortune.com/2016/03/25/new-b|ockbuster-drugs-to-watch/
`
`4/5
`
`

`
`12/17/2016
`
`Blockbuster Drug Launches 2016: The 7 to Watch
`
`Fortune.com
`
`2020 Forecast Sales: $1.27 billion
`
`Nippon Shinyaky’s Uptravi is able to both delay the progression of pulmonary arterial hypertension, a
`
`type of high blood pressure that affects arteries in the lungs and heart, as well as reduce the risk of
`
`hospitalization. The drug is the only one on this list that’s already available. It entered the market in the
`
`first week of January 2016 and is expected to bring in $189 million in its first year, with sales increasing
`
`to $1.27 billion by 2020. Uptravi is being promoted as an additional therapy once baseline treatment has
`
`been started. A massive clinical trial showed that Uptravi reduced the risk of death from pulmonary
`
`arterial hypertension by 39% Versus placebo.
`
`Licensing
`
`http://fortune.com/2016/03/25/new-b|ockbuster-drugs-to-watch/
`
`5/5

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