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The year of the blockbuster

Tracking the paths of the 12 drugs launching in 2018 that  are projected to reach blockbuster status

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Twelve new drugs targeting a broad spectrum of indications are predicted to achieve blockbuster status by 2022, according to the newly released 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics.

Emanating from the pipelines of global pharma giants like Novartis, Johnson & Johnson and Pfizer, as well companies such as Denmark’s Novo Nordisk and Indivior and GW Pharmaceuticals, both of the UK,  the projected blockbuster list includes four biologicals, one  RNAi-based drug, one vaccine  and six small molecules.

More blockbusters - drugs projected to achieve $1bn or more in sales within five years - have been predicted to launch in 2018 than  in any other year since the Drugs  to Watch report began in 2013.

The diseases targeted by the report’s projected market entrants include type 2 diabetes, endometriosis, childhood epilepsy, haemophilia, HIV, migraine, opioid addiction and shingles. Just one targets cancer. This diversity contrasts sharply with 2017 when more than half of the drugs on  our blockbuster list were  cancer treatments.

A year ago, our Drugs to Watch report highlighted eight drugs entering the market in 2017 that we projected could achieve blockbuster annual sales of $1bn or more by 2021. Of these, seven entered the market as anticipated. The one outlier was Ozempic, which as predicted was approved for treatment of type 2 diabetes that year but late approval in December 2017 delayed the expected year-end launch to February 2018. It is on our list  for 2018.

The Drugs to Watch projections were derived from Cortellis - a comprehensive biopharma database that brings together information gathered from diverse industry sources such as annual filings,
drug pipelines, patents, clinical trial read-outs, deal documents, company announcements and conference presentations.

Following an advanced analysis  of the database, a shortlist of drugs was manually researched and evaluated by life science experts at Clarivate. Each drug was reviewed
in its individual clinical and market context. Trial results, regulatory  data, market projections and regulatory designations were all taken into account.

The record number of predicted blockbusters reflects the continued innovation within the pharmaceutical industry - across all therapy areas - that has been spurred by tactics such as stratifying patients for clinical trials and harnessing the  use of biomarkers for targeting treatments. Progress has also been fuelled by partnerships between sharply focused biotech firms and deep-pocketed pharma companies.Streamlining of regulatory channels has helped to reduce the time it takes to get a drug to market, which has also been a factor in the record number of blockbuster forecasts for 2018. More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations  by the US FDA. Five of the 12 drugs  we identified are first-in-class  and four are indicated for  orphan diseases.

Drugs to watch in 2018

Aimovig (erenumab) from Amgen and Novartis: Migraine prevention is about to undergo a transformation with several novel calcitonin gene-related peptide (CGRP) receptor inhibitors likely gaining approval. A first-to-market advantage will be crucial for Aimovig, a once-monthly subcutaneously administered monoclonal antibody, which has a May PDUFA (Prescription Drug User Fee Act) date, since competition from two similar drugs targeting CGRP - from Eli Lilly and Teva -  is not far behind.

Biktarvy (tenofovir alafenamide + emtricitabine + bictegravir) from Gilead: Gilead’s HIV triplet comprising the nucleoside reverse transcriptase inhibitor tenofovir alafenamide, the nucleoside reverse transcriptase inhibitor emtricitabine and the novel integrase inhibitor bictegravir offers an effective and simple treatment option for patients with HIV. It is forecast to achieve sales in excess of $3bn and should help Gilead cement its leading position in the HIV market. EMA filing occurred in July 2017.

Elagolix from AbbVie: Oestrogen plays an essential role in the pathophysiology of endometriosis. AbbVie’s elagolix is a first-in-class oral gonadotropin-releasing hormone antagonist, which acts to reduce the levels of oestrogen. 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 expected mid-year. Endometriosis has no cure and requires symptomatic treatment
and a life-long management plan.

Epidiolex from GW Pharmaceuticals: With a PDUFA date in June, GW Pharmaceuticals’ Epidiolex (plant-derived cannabidiol) has the potential to become the first cannabinoid-based anti-epileptic medication. Epidiolex has been filed for two rare forms of childhood-onset epilepsy, Dravet syndrome and Lennox-Gestaut syndrome, and efficacy data has been compelling in both indications, supporting approval. The industry will watch carefully whether epidiolex encounters political hurdles associated with cannabis-derived medicines, particularly in the US where strict guidelines for the
use of medicinal cannabis exist.

Erleada (apalutamide) from Johnson & Johnson: Until mid-February 2018, no FDA-approved treatment options were available for men with non-metastatic castration-resistant prostate cancer (CRPC) until the spread of the cancer could be confirmed by radiographic assessment. J&J’s Erleada, a second-generation oral anti-androgen treatment, became the first to be approved in that setting. The therapy was filed in Japan in March and an EU filing (February)  is also pending.

Hemlibra (emicizumab) from Roche/Chugai: A novel approach to treating haemophilia A with inhibitors, once-weekly Hemlibra (emicizumab) is a bispecific antibody that simultaneously binds to both factor IXa and factor X, bringing them into spatially appropriate positions to mimic the function of factor VIII. Launched in the US at the end of 2017, promotion is expected to begin in full force in 2018 along with predicted launches elsewhere following approvals in Europe and Japan in February and March, respectively. Noteworthy are the deaths of five patients taking Hemlibra reported in March, which the drugmaker, however, determines as unrelated to the drug itself.  While currently approved for haemophilia A with inhibitors, the biggest impact from Hemlibra is likely to come from approval in the broader haemophilia A population without inhibitors; strong data has been shown in that setting based  on which the US FDA granted Hemlibra breakthrough therapy designation in April.

Lanadelumab from Shire: Data is supporting approval of Shire’s novel drug, lanadelumab, a fully human monoclonal antibody which prevents angioedema by inhibiting plasma kallikrein. Regulatory filings were submitted in the US and EU in Q1 with priority review and accelerated assessment granted in the US and EU, respectively. It could enter the market in late 2018. Our analysis gives an edge to lanadelumab versus current therapies due to its superior efficacy and more convenient dosing.

Ozempic (semaglutide) from Novo Nordisk: Novo’s weekly GLP1 analogue was approved for use in patients with type 2 diabetes late last year and launched in February 2018. Despite competing in the crowded type 2 diabetes market, Ozempic is forecast to perform well due to its superior efficacy and safety versus  competitor products.

Patisiran from Alnylam and Sanofi: Patisiran is an intravenously administered RNAi therapeutic targeting the transthyretin gene for the treatment of patients with debilitating hereditary transthyretin-mediated amyloidosis. It is expected to become the first FDA-approved RNAi therapeutic following Alnylam’s completion of its new drug application (NDA) submission in December 2017. Together with the Genzyme unit of Sanofi, Alnylam filed for EU approval that same month. The FDA granted patisiran priority review, fast track and breakthrough therapy designations. In the EU, the EMA granted accelerated assessment.

Shingrix (Zoster vaccine recombinant, adjuvanted) from GlaxoSmithKline: Shingrix was approved in the  US in October 2017 and was launched nationwide in March 2018, just as the Drugs to Watch report was released; EU and Japan approvals also occurred that month. It is the only vaccine to make the 2018 list and the first new shingles vaccine in more than a decade. Shingrix is projected to become the market-leading shingles vaccine within a couple of years.

Steglatro (ertugliflozin) from Pfizer and Merck: Sodium glucose co-transporter-2 (SGLT-2) inhibitors are the newest oral treatment options for diabetes, but SGLT-2 inhibitor Steglatro will be a late entrant to an increasingly crowded market and will compete directly with first-to-market Invokana, as well as Farxiga and Jardiance. Steglatro has strengths that will help it gain market share, including significant improvements in glycaemic control as mono- or combination-therapy as well as significant weight loss and blood-pressure-lowering effects, which led to FDA approval in December 2017. Steglatro has now been launched in the US and an EMA decision is expected before the middle of the year.

Sublocade (buprenorphine) from Indivior: Sublocade, having been launched in the US in March, could disrupt the market for medication-assisted treatment options to overcome opioid dependence. It is administered via subcutaneous injection once a month by a healthcare provider and does not require a detox period, thereby addressing limitations of other treatment options. Filings elsewhere are also being prepared.

A few additional therapies with blockbuster potential are also worth watching in 2018, especially if they receive accelerated approval. These include Juno Therapeutics’ CAR T-cell therapy, lisocabtagene maraleucel, for diffuse large B-cell lymphoma, and Alexion’s next-generation Soliris treatment, ravulizumab, for paroxysmal nocturnal haemoglobinuria.

Overall the roster of Drugs to Watch for 2018 is impressive, boosting the outlook for more than a dozen companies and partners, while bringing hope to patients dealing with several of the most intractable diseases.

Article by
Richard Harrison

is chief scientific officer at Clarivate Analytics

24th June 2018

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