Pace of Pharmaceutical Innovation Accelerates as Record Number of New Blockbuster Drugs Forecast to Hit the Market in 2018

PHILADELPHIA, March 22, 2018 /PRNewswire/ -- Clarivate Analytics, the global leader in providing trusted insights and analytics to accelerate the pace of innovation, announced today the launch of its annual "Drugs to Watch" report. The analysis identified 12 new drugs forecast to achieve annual sales of $1 billion or more (ie, blockbuster status) by 2022 using the Cortellis database, which includes information gathered from diverse sources including drug pipelines, patents, clinical trials, chemistry, deals and company announcements. More blockbuster drugs have been predicted to launch in 2018 than in any other year since the Drugs to Watch report began in 2013.

The drugs forecasted to launch in 2018 cover a wide range of therapeutic areas--ie, type 2 diabetes, endometriosis, childhood epilepsy, hemophilia, HIV, migraine, opioid addiction and shingles. Noteworthy examples on this list include:

    Drug & company               Disease & Impact
    --------------               ----------------

    Aimovig                       Migraine: Migraine is the third
                                  most common disease in the world,
                                  with an estimated global
                                  prevalence of 14.7% (ie, 1 in 7
                                  people).(1) Fewer than 50% of
                                  patients with migraine are
                                  satisfied with their current
                                  treatment. After little movement
                                  for many years, the migraine-
                                  prevention market is about to
                                  undergo a transformation with
                                  several new drugs, known as
                                  calcitonin gene-related peptide
                                  (CGRP) receptor inhibitor.

    (erenumab)

    Amgen (USA)                   Aimovig (erenumab) has the
                                  potential to contribute to the
                                  transformation of the migraine
                                  market in 2018.

    Novartis (Switzerland)


    ---

    Biktarvy                      HIV infection: 37 million people
                                  globally are living with HIV; 21
                                  million of whom receive
                                  antiretroviral therapy.(2) While
                                  antiretroviral therapy does not
                                  cure HIV infection, it suppresses
                                  viral replication and allows an
                                  individual's immune system to
                                  strengthen and regain the capacity
                                  to fight off infections.

    (tenofovir alafenamide +

    emtricitabine + bictegravir)  Expanding access to antiretroviral
                                  treatment is at the heart of a new
                                  set of targets for 2020, issued by
                                  the WHO, which aim to end the AIDS
                                  epidemic by 2030.(2) Biktarvy
                                  offers an effective and simple
                                  treatment option for patients with
                                  HIV.

    Gilead (USA)
    -----------

    Ozempic                       Type 2 diabetes: More than 425
                                  million people globally live with
                                  diabetes, 90% with type 2
                                  diabetes. By 2045, this number is
                                  projected to rise to 629
                                  million.(3)

    (semaglutide)

    Novo Nordisk (Denmark)        Despite competing in a crowded
                                  market, Ozempic represents a new
                                  treatment that helps patients
                                  effectively control their blood
                                  sugar and significantly reduces
                                  the health risks commonly
                                  associated with diabetes-such as
                                  strokes and heart attacks. It is
                                  forecast to perform well due to
                                  its superior efficacy and safety
                                  versus competitor products.
    ----------------------       ---------------------------------

                                 Shingles: It's estimated around one
                                  in every four people will have at
                                  least one episode of shingles
                                  during their life.4 The only
                                  vaccine to make the list is GSK's
                                  Shingrix (Zoster vaccine
                                  recombinant, adjuvanted), which is
                                  set to become the market leading
    Shingrix                      shingles vaccine.

    (Zoster vaccine

    recombinant, adjuvanted)




    GlaxoSmithKline (UK)
    -------------------

    Sublocade                     Opioid dependence: More than 15
                                  million people are living with
                                  opioid dependence worldwide.5 This
                                  disorder is ongoing and is rapidly
                                  evolving into a public health
                                  crisis, with the US government
                                  declaring a public health
                                  emergency in late 2017.

    (once-monthly buprenorphine)

                                  Sublocade looks set to disrupt the
                                  market for medication-assisted
                                  treatment to overcome opioid use
                                  disorder. It is administered via
                                  subcutaneous injection once a
                                  month by a healthcare provider and
                                  does not require a detox period,
                                  thereby addressing the limitations
                                  of other treatment options.

    Indivior (UK)
    ------------

2018 is also expected to see the launch of the first FDA-approved cannabidiol-based drug (Epidiolex)--potentially opening up a new market for cannabidiol-based medicines--and the first approved treatment option for men with castration-resistant prostate cancer (Erleada) whose cancer has not yet spread.

"Despite political and regulatory uncertainties in the USA and EU markets, the annual Drugs to Watch report 2018 shows that the pace of pharmaceutical innovation continues to accelerate," explained Mukhtar Ahmed, President, Life Sciences at Clarivate Analytics. "2018 is on track to see many new potential game-changing drugs come to market, which will benefit the lives of millions of patients around the world."

Data for this report were compiled from the Cortellis database, the premier source of life sciences competitive, clinical and regulatory intelligence and analytics which includes data gathered from diverse sources, including annual filings, drug pipelines, clinical trials, patents, chemistry, company announcements, deals and conferences.

ABOUT CORTELLIS

Cortellis delivers the unique insights needed to reduce risk and increase success across the drug development lifecycle from early discovery to commercialization and beyond. The Cortellis suite of solutions serves the needs of life science professionals with unmatched content, intelligent search, best-in class analytics and insightful visualization tools. For more information, visit clarivate.com/cortellis.

ABOUT THE DRUGS TO WATCH REPORT

The annual Drugs to Watch report was first published in 2013. Using data from Cortellis, the report aims to forecast which drug launches in a given year will achieve blockbuster status within five years of launch. Following an advanced analysis of this database, a shortlist of drugs is manually researched and evaluated by life-science experts at Clarivate Analytics, who review each drug in its individual context and assess clinical trial results, regulatory data, market data and regulatory designations for each drug.

The full report is available at: http://info.clarivate.com/drugstowatch2018

Follow us on Twitter: @Cortellis | #blockbusterdrugs2018

ABOUT CLARIVATE ANALYTICS

Clarivate Analytics is the global leader in providing trusted insights and analytics to accelerate the pace of innovation. Building on a heritage going back more than a century and a half, we have built some of the most trusted brands across the innovation lifecycle, including Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet. Today, Clarivate Analytics is a new and independent company on a bold entrepreneurial mission to help our clients radically reduce the time from new ideas to life-changing innovations. For more information, please visit clarivate.com.

REFERENCES

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606966/

2. http://www.who.int/hiv/en/

3. https://www.idf.org/about-diabetes/what-is-diabetes.html

4. https://www.nhs.uk/conditions/shingles/

5. https://www.ncbi.nlm.nih.gov/pubmed/24661272

        Drug                                                Disease                                     2018  2019  2020  2021  2022 Company (HQ)
        ----                                                -------                                     ----  ----  ----  ----  ---- -----------

    1   Hemlibra (emicizumab)*,†,|,¶,‡‡                     Hemophilia A with factor VIII inhibitors     496 1,457 2,356 3,362 4,002 Roche (Switzerland)/Chugai (Japan)
    --- ------------------------------                      ----------------------------------------     --- ----- ----- ----- ----- ----------------------------------

    2    Biktarvy (tenofovir alafenamide + emtricitabine +
         bictegravir)**,¶, ††                               HIV infection                                896 2,282 3,387 4,296 3,716 Gilead (U.S.)
    ---  -------------------------------------------------  -------------                                --- ----- ----- ----- ----- ------------

    3   Ozempic (semaglutide)*                              Type 2 diabetes                              260   862 1,576 2,583 3,469 Novo Nordisk (Denmark)


    ---

    4   Erleada (apalutamide)¶,**                           Non-metastatic CRPC                           25   500 1,200 1,600 2,000 Johnson & Johnson (U.S.)
    --- ------------------------                            -------------------                          ---   --- ----- ----- ----- -----------------------

    5   Shingrix (Zoster vaccine recombinant, adjuvanted)§§ Shingles                                     242   537   879 1,202 1,368 GlaxoSmithKline (UK)
    --- --------------------------------------------------- --------                                     ---   ---   --- ----- ----- -------------------

    6   Patisiran§,|,¶,‡‡                                   Hereditary TTR amyloidosis                    83   373   726 1,104 1,212 Alnylam (U.S.)/Genzyme (U.S.)
    --- ----------------                                    --------------------------                   ---   ---   --- ----- ----- -----------------------------

    7   Epidiolex (plant-derived cannabidiol)‡|,¶,**        Dravet syndrome and Lennox-Gastaut syndrome   19   266   645   936 1,191 GW Pharmaceuticals (UK)


    ---

    8   Aimovig (erenumab)*,‡‡                              Migraine                                     115   361   685   941 1,170 Amgen (U.S.)/Novartis (Switzerland)
    --- ---------------------                               --------                                     ---   ---   ---   --- ----- -----------------------------------

    9   Lanadelumab*,†,|,¶,‡‡                               Hereditary angioedema                         74   350   629   902 1,153 Shire (Ireland)
    --- --------------------                                ---------------------                        ---   ---   ---   --- ----- --------------

    10  Elagolix¶,**,‡‡                                     Endometriosis                                 57   268   549   896 1,152 AbbVie (U.S.)
    --- --------------                                      -------------                                ---   ---   ---   --- ----- ------------

    11  Steglatro (ertugliflozin)**                         Type 2 diabetes                              220   482   769 1,024 1,087 Pfizer (U.S.)/Merck (U.S.)


    ---

    12  Sublocade (once-monthly buprenorphine)‡,¶,**        Opioid dependence                            121   308   439   634 1,072 Indivior (UK)
    --- -------------------------------------------         -----------------                            ---   ---   ---   --- ----- ------------

Table: Analysis of 12 new drugs forecast to enter the market in 2018 and achieve blockbuster sales of over $1 billion by 2022
Data were obtained from the Cortellis Competitive Intelligence database, accessed March 05, 2018 (Source: Thomson Reuters I/B/E/S). Forecasts are in U.S.$ million. CRPC=castration-resistant prostate cancer. TTR=transthyretin*=biological drug. †=Breakthrough Therapy designation. ‡=Fast Track designation. §=RNA interference. |=Orphan Drug designation. ¶=Priority Review. **=small molecule. ††=novel integrase inhibitor. ‡‡=first-in-class. §§= vaccine.

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