Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, May 21 to 26, 2017, we had thoughts on the following: Biocryst heading toward lower dosing in HAE trial; Panel rates Retacrit; Ingrezza no better in paediatric Tourette’s than in adult; Kevzara fights for a spot in rheumatoid arthritis; Non-inferiority not enough for Bydureon; Celgene’s MS Radiance dims.
These snippets were previously published daily via twitter.
Biocryst heading toward lower dosing in HAE trial
26 May, 2017
Biocryst shares received a 31% lift on Thursday after publishing an interim phase II analysis of the hereditary angioedema pill BCX7353, suggesting a reduction in attack rates for two of three doses. Part one of this study found signs of efficacy versus placebo in 14 patients taking a 350mg once daily dose. On Thursday, Biocryst reported data from part two, which tested a 125mg, 250mg and 350mg dose. On an intention-to-treat basis, the 350mg and 125mg reduced the attack rate on weeks two through four by 73% and 45% respectively compared to patients taking placebo, but the 250mg dose missed significance with a 44% reduction. Patients in the 350mg dose group were the only ones to report adverse events, with three of 18 patients discontinuing BCX7353 because of them – one involved a liver enzyme elevation. Part three of the study will involve the two lower doses from part two plus a 62.5mg daily pill. BCX7353’s reduction in attack rates comes in slightly below those of CSL’s Haegarda and Shire’s lanadelumab (SHP643) in phase III trials, which had bigger enrolment and longer dosing periods.
Panel rates Retacrit
26 May, 2017
Retacrit is on course to become Pfizer’s second FDA-approved biosimilar following a panel vote in its favour yesterday. A copy of Amgen’s anaemia therapy Epogen, aka Procrit, Retacrit was backed by 14 of the 15 members of the oncologic drugs advisory committee for all four of its indications: anaemia in patients with kidney disease, HIV and non-myeloid malignancies, and to reduce the need for transfusions in patients at high risk of blood loss when undergoing surgery. The panel stated that Retacrit was “highly similar” to Epogen, though the FDA will make the final decision on whether to approve it as interchangeable with Amgen’s product. Retacrit is forecast to be the ninth biggest selling anaemia drug in 2022 with revenues of $440m, according toEvaluatePharma’s sellside consensus.
Ingrezza no better in paediatric Tourette’s than in adult
24 May, 2017
Neurocrine Biosciences’ hopes of extending Ingrezza’s reach beyond tardive dyskinesia to Tourette’s syndrome have been snuffed out. The project failed to significantly improve paediatric patients’ scores on the Yale global tic severity scale at week six in a phase II trial, similar to its setback in adult patients earlier this year. Nonetheless, Neurocrine plans to push on with another phase IIb trial using a higher dose, slated to start by the end of the year. The sellside consensus had forecast sales of only $50m in Tourette’s by 2022, but a post-market selloff following the news saw the group’s valuation sink by nearly $400m. April’s tardive dyskinesia approval gives Neurocrine a chance to unlock a revenue stream forecast to be worth $656m by 2022, although Ingrezza is expected to be going head to head against Teva Pharmaceutical Industries’ Austendo. Tourette’s patients, meanwhile, may be waiting awhile for relief – the pipeline, which includes Austendo, remains almost exclusively in phase II or earlier testing.
Kevzara fights for a spot in rheumatoid arthritis
23 May, 2017
Regeneron and Sanofi finally have FDA approval for their rheumatoid arthritis drug Kevzara. But Johnson & Johnson’s rival IL-6 MAb sirukumab, which was once almost a year behind, is now hot on its heels with a decision due by September 22. EvaluatePharma consensus expects the latter to become the biggest of the new IL-6 inhibitors, although both lag behind the incumbent, Roche’s Actemra, which has been on the market since 2008 so has the advantage of a long head start. Regeneron and Sanofi will hope that Kevzara’s relatively reasonable list price – $39,000 per patient per year, around 30% below the cost of the TNF inhibitors Humira and Enbrel – could help it gain a foothold in the crowded RA market. But it will still have its work cut out as it will be going up against biosimilars as well as other drug classes. Sellside consensus does not expect Kevzara to make the top 10 RA drugs in 2022.
Non-inferiority not enough for Bydureon
23 May, 2017
Bydureon might be doomed to trail in the wake of Novo Nordisk’s rival GLP-1 agonist Victoza, but at least Astrazeneca can now claim cardiovascular safety, the bare minimum these days for diabetes drugs. The Exscel study found that Bydureon was non-inferior to placebo on the composite primary endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke – but it did not show superiority. So far, only two out of four cardiovascular outcomes trials of the GLP-1s have shown a benefit, and both wins went to Novo Nordisk, although the Leader study of Victoza could have been more emphatic. Lilly’s Trulicity has the opportunity to steal a march on the market leader with data from its cardiovascular outcomes study, Rewind, due next year. But competition from the SGLT2 inhibitor class is likely to be even stiffer – Lilly and Boehringer’s Jardiance is so far the only diabetes drug to boast a benefit on cardiovascular outcomes on its label. Novo submitted data from the Leader study to the FDA and EMA in October, so could be due a label change soon.
Celgene’s MS Radiance dims
22 May, 2017
A hit in the phase III Radiance trial ought to mean an NDA submission this year for Celgene’s potential blockbuster MS drug ozanimod. Both 0.5mg and 1mg oral doses of the sphingosine-1-phosphate modulator reduced the annualised relapse rate compared with weekly intramuscular injections of Biogen’s interferon Avonex. But the trial missed on an important measure that could see its potential limited: in a prespecified pooled analysis ozanimod could not show an improvement over Avonex in time to confirmed disability progression. However, with a hit on the same relapse rate endpoint in the Sunbeam trial in February, the data could well be good enough for approval. Carving out decent sales might be harder. Roche’s Ocrevus is forecast to make sales of more than $4bn in 2022 despite launching just last month but it is the only drug approved in both the relapsing-remitting and primary progressive forms of the disease. And Tecfidera, while failing to live up to the heady expectations that presaged its arrival on to the market, is still comfortably at the top of the table. Ozanimod’s 2022 MS sales are pegged at just $724m, according to EvaluatePharma’s consensus data.