BioPharma

A look ahead to the top 10 drug launches of 2017

A dermatitis drug on track for annual sales of $4.6 billion in 2022? Evaluate Pharma has released its projections for the top 10 drug approvals of 2017, with a mixture of already-famous names and some surprise entries.

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Despite capturing the media’s eye, oncology drugs – including CAR-Ts – will comprise just three out of the top 10 drug launches in 2017, according to life science commercial intelligence firm Evaluate Pharma.

It’s proof that headlines don’t always equate to sales. Evaluate is expecting the biggest launch of the year in the field of dermatitis, with a drug for primary progressive multiple sclerosis coming in a close second.

The dermatitis drug, dubbed Dupixent (dupilumab), is a monoclonal antibody being developed by Sanofi and Regeneron. It works by restricting activation of the IL-4/IL-13 pathway, preventing inflammation without suppressing the wider immune system.

Following solid Phase 3 data delivered in June 2016, the two companies have filed for both FDA and EMA approval in adults with inadequately controlled moderate-to-severe atopic dermatitis. Dupixent has breakthrough therapy designation in the U.S., which should expedite the review process and generate a response around March 29.

By 2022, Evaluate predicts annual sales for Dupixent will reach $4.6 billion. That will likely come from several patient populations. Market Realist notes that Dupixent is also being shaped as a possible treatment for pediatric dermatitis and asthma.

In second place in Evaluate’s projections for blockbuster 2017 launches is Roche’s multiple sclerosis drug Ocrevus (ocrelizumab). As the first drug to treat the primary progressive form of the disease, sales could hit close to $4 billion by 2022.

Ocrevus is an anti-CD20 monoclonal antibody that has already been filed with the FDA. Roche was expecting a response in late December, but the FDA has pushed its review deadline back to late March.

Importantly, the drug has also shown efficacy in relapsing-remitting MS, which affects around 85 percent of patients. In these patients, Ocrevus delivered a 47 percent reduction in annualized relapse rates compared to Rebif, a first-generation MS therapy. By comparison, Biogen’s Tecfidera, which clocked up $2.9 billion in sales in its first year, reduced relapse rates by 67 percent when compared to a placebo.

As with Dupixent, Ocrevus is being heralded as a more selective immunosuppressant, knocking out the antagonistic CD20-positive B-cells without obliterating the immune system. Earlier drugs in this field have been less targeted and, therefore, came with some potentially fatal complications. The downside is that it will need to be delivered via intravenous infusion; Tecfidera comes as an oral pill.

Evaluate Pharma’s third pick for valuable launches this year is AstraZeneca’s first foray into the checkpoint inhibitor space.

Durvalumab is an anti-PD-L1 monoclonal antibody that is pending FDA approval for bladder cancer. The biologic now has breakthrough designation in bladder cancer and fast track designation for patients with PD-L1 positive metastatic head and neck squamous cell carcinoma. By 2022, Evaluate is projecting durvalumab will generate $2.3 billion in revenue.

Biogen’s spinal muscular atrophy therapy, Spinraza, came in fourth on the list — the only entry that has already been approved.

In fifth and ninth place respectively, are two CAR-T therapies. Kite Pharma’s KTE-c19, which Evaluate estimates will bring in around $1.4 billion by 2022. The first approval is expected in non-Hodgkin’s lymphoma.

Novartis also made the list with its anti-CD-19 CAR-T, now in Phase 3 trials for the treatment of pediatric ALL.

Johnson and Johnson claimed spots six and seven on the list, with two monoclonal antibodies for psoriasis (guselkumab) and rheumatoid arthritis (sirukumab). GlaxoSmithKline’s shingles vaccine, Shingrix, was number eight.

AstraZeneca’s benralizumab, an anti-IL-5 monoclonal antibody for asthma, rounded out the top ten with an estimated $806 million in sales by 2022.

Photo: pialhovik, Getty Images

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