Snippet roundup: Mylan lines up Botox biosimilar but Vernalis sinks

Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.

This week, February 26-March 2, 2018, we had thoughts on the following: Ionis up but no hard data; Mylan Botox rival brings frowns to Allergan investors; Vernalis looks to Plan C; DBV’s positive milk data quickly turn sour; Akorn falls as Fresenius investigates.

These snippets were previously published daily via twitter.

Ionis up but no hard data

March 2, 2018

Shares in Ionis Pharmaceuticals are up 3% pre-market on data from the phase I/II study of its antisense Huntington’s disease project Ionis-HTTrx, despite no outcomes data having been posted. The two highest doses, 90mg and 120mg, reduced mutant huntingtin protein in the cerebrospinal fluid by an average of 40%, which the company says translates to reductions of 55% in the cortex and 20% in the caudate regions of the brain. Ionis’s partner, Roche, is to begin an approval trial, according to Stifel analysts – the current study, with just 46 patients and 13 weeks’ treatment duration, will not be sufficient on its own. More importantly, though, all the data so far concern surrogate biomarkers, so the actual functional benefit of Ionis-HTTrx, aka RG6042, is yet to be proven. And while the project’s safety profile is clean so far, longer-term trials will be needed to show that knocking down healthy huntingtin – Ionis-HTTrx hits both forms of the molecule – will not cause neurotoxicity. One threat here could be Wave’s two antisense candidates, which strike only the mutant protein, though they are further behind than Ionis-HTTrx, with phase I/II trials not due to report until autumn 2019. Still, this is a long, slow race: Roche will have to enrol a few hundred patients in the phase III trial, and it could take three years to complete.

Mylan Botox rival brings frowns to Allergan investors

March 1, 2018

All good things must come to an end, something Allergan might discover soon. Its top money-spinner, Botox, could see biosimilar competition as soon as 2022 after Mylan’s decision to license in a botulinum toxin project from Revance Therapeutics for $25m up front. Launched in 1989, Botox has withstood competition from me-too projects like Dysport in the aesthetic and therapeutic spaces and evaded real biosimilar challenges because of the complexity and heavy regulation of toxin manufacturing. Revance has gained expertise in this space through development of RT002 (daxibotulinumtoxin A), which has advanced through phase II trials in facial wrinkles and cervical dystonia, and is being tested in plantar fasciitis. Bernstein analyst Ronny Gal wrote today that the Mylan-Revance partnership would likely target the therapeutic treatments rather than the aesthetic market, as patients seeking to soften facial wrinkles pay the full cost of treatment and the Botox brand name matters. Still, therapeutic uses like migraine and overactive bladder are significant revenue contributors, with aesthetics forecast to account for 53% of the $4.1bn in sales in 2022. Allergan shares sank 3% in early trading today following Mylan’s post-market announcement of the deal – they now stand close to a five-year low.

Vernalis looks to Plan C

February 28, 2018

It would be tempting to think that time was up for Vernalis, if the UK biotech had not managed to climb out of equally dark holes on previous occasions. Today investors were left with no illusions that its latest shift looks to have come to naught – a move into the US cough and cold market almost 10 years ago has yielded nothing but sunk costs. Two pipeline projects remain stalled at the FDA while its one marketed drug, Tuzistra XR, has now failed to sell as expected. Stifel analysts estimate that Vernalis is spending around £31m ($43m) annually on sales and marketing, and forecast sales of only £4.3m for Tuzistra XR in fiscal 2018. Little wonder that Vernalis has been “considering alternative strategies” for the US business. However, a wider strategic rethink at the company is also ongoing, it emerged today. Investors had hoped for great things from Ian Garland, who arrived as chief executive at a hollowed-out Vernalis in 2008, fresh from selling Acambis to Sanofi. They now see little hope of returns – Vernalis’s shares sank 27% today, giving the company a £21m enterprise value, less than half its cash balance.

DBV’s positive milk data quickly turn sour

February 27, 2018

With doubts hanging over the regulatory and commercial success of its main peanut allergy patch product DBV Technologies needed a big win in milk allergy. Positive results from the phase IIa Miles trial of Viaskin milk showing that the 300mg patch helped with desensitisation to milk in small children with milk allergies, however, were not enough. DBV shares initially went up 7%, but were down 2% in early afternoon, compounding how far the stock has fallen from the €86.64 high reached before the disappointing phase III Peptides peanut data in October. The latest readout in milk allergy is also not without its issues. Echoing the results in the peanut allergy trials, efficacy for Viaskin milk was strongest in younger children, and although milk allergy is more prevalent than peanut in children, a lot of children outgrow milk allergies. As such, parents might want to take a wait and see attitude, rather than starting therapy. Observers have also questioned the inconsistency of dose dependency in the trial, with efficacy improving between the 150μg and 300μg arms, but not the 500μg arm. While these questions remain, so will doubts about the drug’s performance in any future phase III trials, and so far DBV appears not to have convinced investors that Viaskin Milk’s potential will not go off.

Akorn falls as Fresenius investigates

February 27, 2018

Fresenius’s acquisition of Akorn has been thrown into doubt after the buyer said it had commissioned an external investigation into alleged breaches of FDA data integrity rules at the generics group. At €4.4bn ($5.4bn) the deal was the fourth largest signed last year; if it is kyboshed 2017’s already dismal biopharma deal total will fall to just $73bn, the lowest annual figure since 2012. “We received information from an anonymous source alleging deficiencies and misconduct regarding the product development process for new drugs at Akorn,” Stephan Sturm, Fresenius’s chairman, said on a call today, adding that if the allegations are proven to be serious Fresenius would consider withdrawing its offer. In pre-market trading Akorn’s share price fell to pre-bid levels, indicating that shareholders already consider the deal to be toast. Bernstein analysts suggest that Akorn’s poor performance across 2017, and the indictment in October of its chairman John Kapoor on racketeering and fraud charges relating to a different company, might mean Fresenius investors would not be too heartbroken if the acquisition was called off. The lack of movement in Fresenius’s own shares would seem to support this contention.

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