Which drugs entering the market in 2018 are poised as blockbusters? DCAT Value Chain Insights examines the contenders launching this year.

A recent analysis by Clarivate Analytics points to 12 drugs entering the market this year that are expected to reach sales of at least $1 billion by 2022. So which drugs are making the mark?

Potential blockbusters to watch

In its Drugs to Watch 2018 report, Clarivate Analytics identifies 12 new drugs forecast to achieve annual sales of $1 billion or more (ie, blockbuster status) by 2022. The analysis is based on data from the Cortellis database, which includes information gathered from diverse sources including drug pipelines, patents, clinical trials, chemistry, deals and company announcements. More blockbuster drugs are predicted to launch in 2018 than in any other year since the Drugs to Watch report began in 2013. More than half of these drugs have been granted priority review, breakthrough therapy or fast-track designations. Five drugs on the list are first-in-class (meaning that these drugs have a new mechanism of action), and four are for orphan diseases.

Table I (see end of article) identifies the drugs that are projected to enter the market in 2018 and reach blockbuster status by 2022. By 2022, three drugs are forecast to exceed annual revenue of more than $3 billion while nine additional drugs are forecast to generate annual sales of between $1 billion and $2 billion. Table I (see end of article) ranks these potential blockbuster drugs by highest sales forecasts for 2022.

1. Roche’s and Chugai’s Hemlibra (emicizumab). Ranked by Clarivate Analytics as the drug with the highest 2022 sales forecast, Roche’s and Chugai’s Hemlibra (emicizumab) is a bispecific antibody to treat hemophilia A wiith factor VIII inhibitors.The drug simultaneously binds to both factor IXa and factor X, bringing them into spatially appropriate position to mimic the function of factor VIII, according to information from Clarivate. The US Food and Drug Administration (FDA) approved Hemlibra in December 2017 and in 2018, promotion is expected to begin in full force with launches projected elsewhere. In February 2018, the European Medicines Agency (EMA) approved Hemlibra and launches in both Europe and Japan are expected in 2018. Clarivate projects sales of $496 million for 2018, and blockbuster status in 2019 with sales of $1.457 billion. Sales are expected to increase to $4.002 billion in 2022.

Roche’s and Chugai’s Hemlibra (emicizumab) is one of three orphan drugs (defined as drugs that treat rare diseases, defined in the US as diseases affecting fewer than 200,000 people) entering the market in 2018 with projected blockbluster status. The others are Shire’s lanadelumab for treating hereditary angioedema and Alnylam’s and Sanofi’s Genzyme’s patisiran for treating hereditary transthyretin amyloidosis.

2. Gilead Sciences’ Biktarvy (tenofovir alafenamide + emtricitabine + bictegravir). Gilead Sciences’ Biktarvy (tenofovir alafenamide + emtricitabine + bictegravir) is a new single-tablet HIV treatment, which was approved by the FDA in February 2018. This once-daily tablet contains the new integrase inhibitor, bictegravir, plus the nucleoside reverse transcriptase inhibitor, tenofovir alafenamide and the nucleoside reverse transcriptase inhibitor, emtricitabine. A marketing-authorization application in the European Union was filed in July 2017.

Sales of $896 million are expected for Biktarvy in 2018, rising to blockbuster sales of $2.282 billion in 2019 and forecast to be $3.716 billion in 2022, according to the Clarivate report. The launch is expected to help Gilead gain market share from GlaxoSmithKline’s (GSK) HIV regimens based on the once-daily integrase inhibitor, Tivicay (dolutegravir), which includes GSK’s Triumeq (dolutegravir /lamivudine/ abacavir), which was launched in 2014.

3. Novo Nordisk’s Ozempic (semaglutide). Novo Nordisk’s Ozempic (semaglutide) is one of two potential blockbusters entering the market in 2018 to treat Type II diabetes; the other is Pfizer’s/Merck & Co.’s Steglatro (ertugliflozin). Novo Nordisk’s Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1). GLP-1 treatments help stimulate the body’s own insulin release. The drug was approved by the FDA in December 2017 and launched in February 2018. Novo Nordisk’s GLP-1 analog Victoza (liraglutide), a top-selling drug for the company, has lost market share to longer acting, weekly GLP-1 analogs, particularly Eli Lilly’s Trulicity (dulaglutide), according to the Clarviate report. Novo Nordisk’s Ozempic is projected to reach sales of $3.469 billion by 2022, putting it on par with projected 2022 sales of Novo Nordisk’s Victoza at $3.912 billion and Eli Lilly’s Trulicity at $4.090 billion, according to the Clarivate report.

4. Johnson & Johnson’s Erleada (apalutamide). Johnson & Johnson’s Erleada (apalutamide), which was approved by the FDA in February 2018, is the first FDA-approved treatment for nonmetastatic castration-resistant prostate cancer (CRPC). The CRPC market is dominated by oral next-generation anti-androgens, Johnson & Johnson’s Zytiga (iabraterone) and Pfizer’s and Astellas’ Xtandi (enzalutamide), which are both approved for CRPC that has metastasized. Clarivate projects blockbuster sales of Erleada in 2020 with sales of $1.200 billion. Sales are forecast to reach a $2.000 billion by 2022.

5. GlaxoSmithKline’s Shingrix (Zoster vaccine recombinant, adjuvanted). GlaxoSmithKline’s Shingrix (Zoster vaccine recombinant, adjuvanted), a vaccine to treat shingles, is the only vaccine launching in 2018 with potential blockbuster status, according to the Clarivate report. The FDA approved the vaccine in October 2017, and it was set to enter the market in early 2018. It will be the first new shingles vaccine in more than a decade and will compete with Merck & Co.’s Zostavax (shingles vaccine [live]), previously the only FDA-approved shingles vaccine.Clarivate projects sales of $1.368 billion in 2022.

6. Alnylam Pharmaceuticals’ and Sanofi Genzyme’s patisiran. Alnylam Pharmaceuticals’ and Sanofi Genzyme’s patisiran, an intravenously administered RNA interference (RNAi) therapeutic targeting the transthyretin gene, is designed to treat hereditary transthyretin amyloidosis, a rare disease characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body’s organs and tissues. The companies filed for marketing authorization in the US and the EU in December 2017 with a FDA Prescription Drug User Fee Act (PFUDA) review date in August 2018 and a later review date in the EU. Sales in 2022 are projected at $1.212 billion, according to information from Clarivate.

7. GW Pharmaceuticals’ Epidiolex (plant-derived cannabidiol). Epidiolex (plant-derived cannabidiol) by GW Pharmaceuticals, a Cambridge, UK-based pharmaceutical company, is slated for blockbuster status for treating two forms of epilepsy: Lennox-Gastaut syndrome, a form of severe epilepsy that is characterized by multiple types of seizures and intellectual disability, and Dravet syndrome, another severe form of epilepsy. Following a new drug application submission to the FDA in June 2017, GW Pharmaceuticals’ Epidiolex (plant-derived cannabidiol) has the potential to become the first cannabinoid-based anti-epileptic medication. The FDA has granted the drug priority review with a PDUFA review date in June 2018. A marketing- authorization application for the drug in the EU was also submitted in December 2017. Clarivate projects 2022 sales at $1.191 billion.

8. Amgen’s and Novartis’ Aimovig (erenumab). Amgen’s and Novartis’ Aimovig (erenumab), a drug to treat migraines, is expected to reach blockbuster status in 2022 with sales of $1.170 billion, according to Clarivate’s Drugs to Watch for 2018 report. It is one of several calcitonin gene-related peptide (CGRP) receptor inhibitors expected to enter the market over the next several years and has the potential to be the first-to-market CGRP inhibitor to market. CGRP, a neuropeptide, has been shown to be released during migraine attacks and may play a causative role in induction of migraine attacks, according to the report.

Both Eli Lilly’s galcanezumab (once-monthly dosing) and Teva’s fremanezumab (once-monthly or quarterly dosing) filed for US approval in October 2017. Alder’s intravenously administered monoclonal antibody, eptinezumab (quarterly dosing), is in Phase III development, and a regulatory filing is expected to be filed in 2018. Aimovig is anticipated to become the market leader in the CGRP class, with forecasts of $1.170 billion in 2022, followed by Teva’s fremanezumab at $999 million (which has preferable quarterly dosing), according to the Clarivate report. Sales for galcanezumab in 2022 are forecast at $546 million and eptinezumab at $368 million with the eptinezumab forecast expected to increase to $946 million in 2023. Other oral CGRP inhibitors of note include Allergan’s atogepant and Biohaven’s rimegepant, according to the report.

9. Shire’s lanadelumab. Shire’s lanadelumab for treating hereditary angioedema, is a fully human monoclonal antibody that inhibits plasma kallikrein, which could enter the market in late 2018. Regulatory filings were submitted in the US and EU in February 2018 with priority review and accelerated assessment granted in the US and EU, respectively. Sales of lanadelumab is forecast to start out modestly with sales of only $74 million in 2018, increasing to $1.153 billion in 2022, according to the Clarivate report. Shire’s Cinryze (C1 esterase inhibitor [human]) is the dominant product now for prevention of angioedema attacks, but one of its main drawbacks is its intravenous administration. The first subcutaneous product to prevent attacks of angioedema was CSL Behring’s Haegarda, launched in mid-2017 and also a C1 esterase inhibitor.

10. AbbVie’s and Neurocrine Biosciences’ elagolix. AbbVie’s and Neurocrine Biosciences’ elagolix for the management of endometriosis with associated pain is another drug expected to enter the market in 2018 with potential blockbuster status. Endometriosis is often a painful disorder in which tissue that normally lines the inside of the uterus, the endometrium, grows outside the uterus. Elaglox is a first-in-class oral gonadotropin-releasing hormone (GnRH) antagonist, which acts to reduce levels of estrogen as well as other hormones such as progesterone.

Elagolix was filed for approval in the US in September 2017 for the management of endometriosis with associated pain.The FDA accepted the filing for elagolix with a priority review, and a decision is now expected in the third quarter of 2018, based on an April 10, 2018 press release from the companies, which specified the revised FDA review date from the second quarter of 2018 to the third quarter of 2018. Clarivate projects sales of $1.152 billion by 2022.

11. Pfizer’s and Merck and Co.’s Steglatro (ertugliflozin). Pfizer’s and Merck & Co’s Steglatro (ertugliflozin), which was approved by the FDA in December 2017, is a sodium glucose co-transporter-2 (SGLT-2) inhibitor that will compete with earlier SGLT-2 inhibitors already on the market: Johnson & Johnson’s Invokana (canagliflozin), launched in 2013; AstraZeneca’s Farxiga (dapagliflozin), launched in early 2014; and Boehringer Ingelheim’s and Eli Lilly’s Jardiance (empagliflozin), launched in late 2014. Clarivate projects 2022 sales of $1.087 billion.

12. Indivior’s Sublocade (once-monthly buprenorphine). Indivior’s Sublocade (once-monthly buprenorphine) was approved by the FDA in November 2017. The Clarivate report points out that it is the first once-monthly formulation of buprenorphine. Following its launch in March 2018, the Clarivate report notes that this treatment could disrupt the market for medication-assisted treatment options to overcome opioid use.

The Clarivate report notes that the current standard of care for medication-assisted treatment is oral buprenorphine taken daily. Indivior’s Suboxone (buprenorphine and naloxone sublingual tablet) leads in this market, with other options including: Orexo’s Zubsolv (buprenorphine and naloxone sublingual tablet); BioDelivery Sciences’s Bunavail (buprenorphine and naloxone buccal film); oral methadone taken daily; Braeburn Pharmaceuticals/Titan’s Probuphine (a six-month subcutaneous sustained-release implant of buprenorphine); and Alkermes’ Vivitrol (a once-monthly naltrexone formulation). Sublocade is administered via subcutaneous injection once a month by a healthcare provider. The treatment does not require a detox period and so addresses the limitations of other treatment options. In view of the opioid crisis in the US, Clarivate projects that sales of Sublocade are forecast to reach blockbuster status in 2022 at $1.072 billion.

To access the full report by Clarivate Analytics, Drugs to Watch 2018, please click here.

Source: Data were obtained from the Cortellis Competitive Intelligence database, accessed March 05, 2018: Thomson Reuters I/B/E/S.

Note: Above estimates are based on data as of March 8, 2018.

On April 10, 2018, AbbVie and Neurocrine Biosciences announced that the Prescription Drug User Fee Act (PDUFA) review date for elagolix was moved three months later from the second quarter of 2018 to the third quarter of 2018.