4/8/2019
`
`Blockbuster Drug Launches 2016: The 7 to Watch | Fortune
`
`7 New Blockbuster Drugs to Watch in 2016
`
`Photograph by GP Kidd—Getty Images/Cultura RF
`
`By LAURA LORENZETTI March 25, 2016
`
`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.
`
`fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`
`1/4
`
`Biogen Exhibit 2185
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 4
`
`
`
`Blockbuster Drug Launches 2016: The 7 to Watch | Fortune
`
`7 New Blockbuster Drugs to Watch in 2016
`
`Photograph by GP Kidd—Getty Images/Cultura RF
`
`By LAURA LORENZETTI March 25, 2016
`
`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.
`
`fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`
`1/4
`
`Biogen Exhibit 2185
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 4
`
`
`
`4/8/2019
`
`Blockbuster Drug Launches 2016: The 7 to Watch | Fortune
`1. Intercept Pharmaceuticals and Sumitomo Dainippon Pharma
`
`Drug: Obeticholic acid
`
`Indication: Chronic liver diseases, primarily primary biliary cirrhosis
`
`2020 Forecast Sales: $2.62 billion
`
`Intercept Pharmaceuticals’ (ICPT, +2.79%) 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, -0.28%) 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 Johnson & Johnson’s (JNJ, -0.01%) Janssen unit is
`expected to improve renal and bone mineral density measurements compared
`with some existing drugs. Those results combined with the improved longevity
`
`fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`
`2/4
`
`Page 2 of 4
`
`
`
`4/8/2019
`
`Blockbuster Drug Launches 2016: The 7 to Watch | Fortune
`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, -0.26%) 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.
`
`5. Abbvie
`
`Drug: Venetoclax
`
`Indication: Chronic lymphocytic leukemia
`
`2020 Forecast Sales: $1.48 billion
`
`Abbvie’s (ABBV, +0.60%) 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.
`
`fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`
`3/4
`
`Page 3 of 4
`
`
`
`4/8/2019
`
`Blockbuster Drug Launches 2016: The 7 to Watch | Fortune
`6. ACADIA Pharmaceuticals
`
`Drug: Nuplazid
`
`Indication: Parkinson’s disease psychosis
`
`2020 Forecast Sales: $1.41 billion
`
`ACADIA’s (ACAD, -3.74%) 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
`
`Indication: Pulmonary arterial hypertension
`
`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.
`
`fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`
`4/4
`
`Page 4 of 4
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
