FirstWord Lists: The drugs that will shape 2016

The recent launches

Opdivo – Bristol-Myers Squibb

A recent analysis of Big Pharma growth rates over the next decade by analysts at Bernstein highlights the importance of Opdivo to Bristol-Myers Squibb's long-term performance. The PD-1 inhibitor is already approved for melanoma and second-line non-small-cell lung cancer. Pivotal data in the much larger first-line NSCLC market is due to be unveiled later this year. Merck & Co. hopes to present similar data for its competing therapy Keytruda by the end of 2016.

Entresto – Novartis

A 2015 approval, Novartis' heart failure treatment Entresto will be one of the most scrutinised in terms of uptake over the course of the next 12 months. Management has sought to lower expectation, particularly in the US market, but a stronger trajectory will be expected in the second half of 2016 as reimbursement hurdles are overcome. With a lack of competition on the horizon, peak annual sales could exceed $10 billion, suggest analysts.

Darzalex – Johnson & Johnson

When Johnson & Johnson releases its 2015 full-year results next week, a familiar narrative will likely emerge; which pipeline therapies will replicate the considerable success enjoyed in terms of new product launches over the past 6 years? The answer is possibly already on the market: Darzalex, approved in late 2015 for the treatment of late-stage multiple myeloma, has key opinion leaders very excited (ViewPoints: Johnson & Johnson's Darzalex tops ASH winners list). Genmab – which discovered the antibody – has likened Johnson & Johnson's study programme to a military campaign in its breath of coverage. Commercial uptake and progress on line extensions will be watched closely by investors.

Repatha/Praluent – Amgen/Regeneron & Sanofi

Approved by the FDA last year for the treatment of primary hyperlipidaemia and homozygous familial hypercholesterolaemia, uptake of the PCSK9 inhibitors Repatha (Amgen) and Praluent (Regeneron Pharmaceuticals/Sanofi) will be watched with much interest over the coming months. More significant will be cardiovascular outcomes data, which Amgen expects to publish later this year. If the results are positive, the sales trajectory of both products is likely to improve considerably (Physician Views Poll Results: Taking an early look at the competing anti-PCSK9 mAb launches). Will Pfizer file its competing PCSK-9 inhibitor bococizumab this year? Their outcomes data is due to be announced in 2018.

The new approvals

Ocrelizumab – Roche

Due to be filed with regulators imminently, analysts are confident that Roche's ocrelizumab will be approved – by the FDA at least – by the end of 2016. Critically, the drug looks odds on to secure approval for both relapsing remitting and primary progressive forms of multiple sclerosis; in the case of the latter indication, it will be the first therapy to do so. (Physician Views Poll Results – Roche's ocrelizumab will compete with oral multiple sclerosis therapies, say neurologists). Biogen will present Phase II data this year for anti-Lingo; expectations have fallen, but the remyelination therapy could be transformative; both for Biogen and in how MS is treated.

Venetoclax – AbbVie/Roche
Earlier this month, AbbVie and Roche confirmed the FDA has granted priority review status to venetoclax as a secondary therapy for lymphocytic leukaemia, which suggests US approval will occur this year. For AbbVie in particular, venetoclax appears key to the company's commercial aspirations in the leukaemia market, primarily through combination usage with Imbruvica. Key opinion leaders think the drug can be a game changer.

grazoprevir/elbasvir – Merck & Co.

Despite dominance of the hepatitis C market by Gilead Sciences' Sovaldi and Harvoni mega-brands, key opinion leaders and analysts are enthused about the opportunity for Merck & Co.'s combination of grazoprevir and elbasvir, in terms of impressive efficacy in niche populations such as patients with chronic kidney disease, those co-infected with HIV and intravenous drug users. Physicians also view launch of this combination – which is expected to gain FDA approval by the end of January – as potentially improving access and reducing the cost of therapy, if Merck chooses to price at a sufficient enough discount versus AbbVie's Viekira Pak franchise (JP Morgan 2016: Gilead exudes confidence on the eve of Merck & Co.'s HCV landfall).

Baricitinib – Eli Lilly & Incyte

Can Eli Lilly's revival continue and what role will the JAK inhibitor baricitinib play? The oral therapy was submitted to the FDA last week for the treatment of moderately to severely active rheumatoid arthritis, which should see approval secured by late 2016. Baricitinib enters the regulatory arena backed with a comprehensive Phase III data set; most significantly it has bettered current standard of care Humira (AbbVie) in head to-head studies (Physician Views: Now filed with the FDA, how do rheumatologists assess the opportunity for baricitinib?)

The pipeline candidates

atezolizumab - Roche

Can Roche successfully deliver the third PD-(L)1 inhibitor to market (after Merck's Keytruda and Bristol-Myers Squibb's Opdivo). Regulatory filings in second-line bladder cancer and second-line non-small cell lung cancer in early 2016. Analysts remain confident that Phase II data will be sufficient to secure approval in the lung cancer setting, but it remains to be seen if atezolizumab can gain share at the expense of the two earlier launches. Roche's combination studies with chemotherapy in first-line patients continue to intrigue.

Dupilumab – Regeneron & Sanofi

Phase III data for Sanofi and Regeneron's dupilumab in atopic dermatitis is expected in the very near future. Speaking at the JP Morgan Healthcare conference earlier this month, Regeneron CEO Leonard Schleifer has high hopes for dupilumab across a range of allergic conditions, where he believes the antibody could be "transformative." (JP Morgan 2016: Regeneron putting its money where its mouth is on dupilumab).

Solanezumab – Eli Lilly

Can Eli Lilly's experimental Alzheimer's disease treatment solanezumab deliver a definitively positive outcome in Phase III studies at the second time of asking? Many are doubtful, but investors are hopeful; approvable-data would be transformational for the company. In the Alzheimer's disease development space, also watch for progress with the BACE inhibitors; Merck & Co. is leading the race with AstraZeneca/Eli Lilly not far behind.

CAR-T therapies – Novartis, Juno Therapeutics, Kite Pharmaceuticals
Focus around CAR-T therapies will shift in part this year from the clinical to regulatory arena. Novartis is awaiting pivotal data in paediatric relapsing, remitting acute lymphoblastic leukaemia with a US filing anticipated in late 2016. Juno Therapeutics is on track to submit its CAR-T treatment JCAR15 for adult ALL by year end, with Kite hopeful of filing KTE-C19 in diffuse large B-cell lymphoma in 2016 also.

ITCA-650 – Intarcia

Speaking to FirstWord earlier this month, Intarcia CEO Kurt Graves confirmed the company's diabetes treatment ITCA-650 will be filed in mid-2016. ITCA-650 is a small implantable device which delivers regular dosing of the GLP-1 agonist exenatide over a six or 12 month period. Graves outlined Intarcia's commercial strategy to FirstWord last year; understandably it will be built around the theme of improved compliance

The biosimilars battleground

Benepali – Samsung Bioepis

Approved in the EU last week, Biogen expects to launch Benepali – a biosimilar version of Amgen and Pfizer's Enbrel – over the coming weeks. Benepali represents the second complex biosimilar to be approved in Europe and a first for both Biogen and partner Samsung in this segment. The Korean technology player has delivered on bullish promises; Benepali has moved from non-clinical development to approval in four years (Physician Views: How will rheumatologists use Biogen and Samsung's biosimilar Enbrel product?).

Remsima – Celltrion & Pfizer

Will Celltrion's Remsima – a version of Johnson & Johnson/Merck & Co.'s Remicade – become the first biosimilar monoclonal antibody to gain US approval later this year? A re-scheduled AdCom meeting on February 9 (a March 2015 meeting was postponed for undisclosed reason) will provide a clearer indication. Pfizer will market Remsima in the US, having acquired Celltrion's existing partner Hospira last year.

Humira – AbbVie

The TNF inhibitor is the world's best-selling drug, with 2015 sales forecast to reach around $14 billion. AbbVie believes that patent exclusivity will hold until 2022, but is yet to fully convince Wall Street. Focus in 2016 will remain sharpened on this narrative as the biosimilar market continues to evolve and AbbVie's patent estate comes under further scrutiny. Recent events are in the company's favour.