Upcoming events – Life beyond sola and Ampyra for Lilly and Acorda

Welcome to your weekly digest of approaching regulatory and clinical readouts. Ending last year with the news that solanezumab was finally dead in the water, Lilly hopes to start 2017 off with the approval of baricitinib in rheumatoid arthritis (RA), its top pipeline asset, in the first quarter. It will need to make headway in a crowded field (see tables below).

And Acorda, continuing to shift attention away from Ampyra, its multiple sclerosis drug that has been dogged by efficacy and patent challenges, is expecting top-line phase III data from CVT-301 in Parkinson’s disease. Results are also expected in the first quarter, and the group will be keen for a better outcome with the latest project.

Fashionably late

Solanezumab consensus 2022 forecasts once hit $1.8bn, but with that asset finally done and dusted it is time for baricitinib to step up. The Jak inhibitor is Lilly’s top pipeline asset, with 2022 sales of $1.8bn, according to EvaluatePharma's consensus of sellside analysts, and an NPV of $3.8bn.

In December it gained a positive opinion from the European Medicines Agency's advisory committee, with final approval due in the next couple of months, triggering a $65m milestone payment to Incyte. The decision was based on five phase III clinical trials in adults with moderate to severe RA, and the label sought is in adults who have inadequately responded to, or who are intolerant of disease modifying anti-rheumatic drugs like Humira.

Baricitinib, which will be known as Olumiant if approved, has its US decision shortly, and on approval a $100m payment will go Incyte’s way.

It will have to fight to carve out a niche in the increasingly competitive RA space. On its side is oral dosing and the fact it has beaten Humira in a head-to-head trial. According to consensus from EvaluatePharma it will be the fourth-biggest RA drug by 2022.

Leerink analysts note that baricitinib’s breakout could depend heavily on formulary positioning in 2018/19 and a willingness to discount versus the heavily entrenched anti-TNF and anti-IL-6 agents. Lilly also recently said it would start phase III trials in psoriatic arthritis this year, which could, according to the analysts, represent an additional 40-50% of the market size of RA.

Ampyra’s problems

Acorda gained CVT-301, a reformulation of the decades-old mainstay therapy levodopa, through its acquisition of Civitas in 2014.

The project is self-administered as an inhaled powder aimed to treat "off" episodes that become frequent in Parkinson’s patients as the benefit of oral levodopa increasingly wears off after long-term treatment. The company says pulmonary delivery bypasses the digestive system, which for oral medications can be associated with a slow and variable onset of action.

Data are expected in the first quarter from the phase III efficacy trial and a long-term safety study. The Span-PD trial is in 345 patients given 35mg, 50mg or placebo, in combination with standard of care. The primary measure is the change in Unified Parkinson’s Disease Rating Scale Part 3 motor score at 30 minutes after treatment in patients experiencing an "off" episode.

The safety trial evaluates the treatment of up to five "off" episodes per day, and includes an observational cohort control of patients managed using their standard treatment. The primary measure is pulmonary safety over 12 months.

US filing, via the 505(b)(2) pathway, is expected in the second quarter. On the competitor front Sumitomo Dainippon Pharma's APL-130277 is a sublingual formulation of apomorphine also in development for "off" episodes, and phase III data are expected this year, with a filing also in the first half.

Acorda’s biggest money maker, the MS treatment Ampyra, has had its clinical significance challenged, and its launch failed to live up to expectations. It also faces patent challenge, with an inter partes review decision expected in March (Acorda stumbles with Ampyra patent threat, February 11, 2015).

The company has guided to $535-545m Ampyra sales this year, with 2022 sales forecast at $607m, according to consensus from EvaluatePharma. CVT-301 forecasts sit at $445m for 2022, and as the company’s biggest growth driver, and another reformulation, it will want to avoid another patent battle.

To contact the writer of this story email Joanne Fagg in London at [email protected] or follow @JoEPVantage on Twitter