Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, February 5-9, 2018, we had thoughts on the following: $53m for Rani’s preclinical pill injector; Glaxo protects its dividend; Sanofi pleads patience on Praluent readout; Array saves the best for last; Titan set to be a late third entry to the robotic surgery market; Imvamune answers another Bavarian 999 call; Trial failure dashes Shield’s global ambitions.
These snippets were previously published daily via twitter.
$53m for Rani’s preclinical pill injector
February 9, 2018
Administering protein therapeutics orally, in defiance of rapacious digestive enzymes, has always been difficult if not impossible. Rani Therapeutics thinks it has cracked the problem with a technology that can inject antibodies and similar molecules into a patient from the inside, and has just raised $53m to develop it. The RaniPill is an oral capsule containing robotic technology; once in place in the small intestine it opens up to reveal needle-like structures that can painlessly inject protein drugs into the intestinal wall. The device has not yet been tested in humans – clinical trials ought to start this year – so much remains to be done, and the relative expense of such a device compared with a simple syringe might provide a commercial problem. Even so, the technology has met with great interest from pharma companies: investors in this latest round include Shire and Genescience Pharmaceuticals, and previous rounds have seen Novartis and Astrazeneca pony up cash.
Glaxo protects its dividend
February 7, 2018
Glaxosmithkline’s chief executive, Emma Walmsley, might make the right noises about improving the group’s pharma pipeline, but a 4% share price rise this afternoon highlighted what investors are really interested in: the dividend. The UK company expects to maintain its 80p dividend in 2018, and Ms Walmsley stressed repeatedly during Glaxo’s earnings call today that returning cash to shareholders came above large-scale M&A in the company’s list of priorities. This appeared to assuage any worries that Glaxo might sacrifice its dividend to acquire Pfizer’s consumer unit – although Ms Walmsley was tight-lipped on the potential deal following media reports last week that Glaxo and Reckitt Benckiser were the only companies left in the bidding. Still, all was not rosy for Glaxo, which now seems resigned to a mid-2018 launch of a substitutable generic version of its best seller, Advair – if this happens the company expects 2018 US Advair sales to more than halve to £750m ($1bn). It is more important than ever for Glaxo to strengthen its pipeline, and the group’s new chief scientific officer, Hal Barron, will provide an update on R&D plans when the company reports its second-quarter financials.
Sanofi pleads patience on Praluent readout
February 7, 2018
The hotly awaited top-line readout from the Odyssey Outcomes study of Sanofi’s struggling heart drug, Praluent, is unlikely to emerge before a grand unveiling at this year’s American College of Cardiology meeting. The French firm has reserved a spot among the late-breaking abstracts on March 10 to present the data, which have yet to arrive in house, executives confirmed today on a conference call. The anti-PCSK9 antibody desperately needs to boost its disappointing launch – sales came in at only €53m ($65m) last quarter. Elias Zerhouni, Sanofi’s head of R&D, highlighted the importance of showing a convincing reduction in cardiovascular mortality, in particular death due to coronary heart disease, measured as a component of the trial’s primary endpoint. Fourier, the large outcome trial of Amgen’s rival anti-PCSK9 medicine, Repatha, observed no effect on the rate of cardiovascular death when considered as an individual outcome, and differentiation here will be important. Fourier was technically a success, reducing the risk of the primary composite endpoint by 15%. However Sanofi and partner Regeneron need to achieve something closer to a 20% reduction in risk on the primary endpoint for Odyssey Outcomes to come to the product’s rescue.
Array saves the best for last
February 7, 2018
Array Biopharma might end up with the best Mek and Braf inhibitor combination, based on new overall survival data from the Columbus trial of encorafenib/binimetinib in melanoma. But the project, due a US approval decision by the end of June, is behind Roche and Novartis’s similar combos – both Zelboraf/Cotellic and Mekinist/Tafinlar already have the go-ahead in the indication Array is seeking, Braf-positive unresectable or metastatic melanoma, with the latter also awaiting approval in the adjuvant setting. The approved combos generate annual sales of over $1bn in melanoma, but the entry of immuno-oncology agents has limited the size of this market. The bigger opportunity for Array is colorectal cancer, where its rivals do not appear to have any late-stage trials ongoing. The Beacon-CRC phase III study, set to complete in 2019, is testing encorafenib/binimetinib plus Erbitux in metastatic disease; Array hinted at plans for a trial in first-line colorectal cancer on its earnings call yesterday. The group is also testing binimetinib with PD-(L)1 inhibitors in colorectal, non-small cell lung and pancreatic cancers. Array’s shares rose 16% yesterday, but the company will still have to work hard to find a foothold in melanoma.
Titan set to be a late third entry to the robotic surgery market
February 7, 2018
Back in October Transenterix became the second company to obtain US approval for a true robotic surgery system, becoming the David to Intuitive Surgical’s Goliath. Another group aiming to contest this market, Titan Medical, has not done so well. On a conference call yesterday Titan’s chief executive, David McNally, said that it would not be able to submit its US approval application for its Sport system this year after all, since the design of the product is not yet finalised. Unlike the systems from Intuitive and Transenterix, Sport is intended to allow surgeries to be performed through a single incision; it is still being tested in animals and cadavers rather than patients. A 510(k) submission in 2019 could mean clearance the same year or in 2020, unless the application is rejected – Transenterix had a system knocked back by the FDA in 2016. Titan raised more than $45m last year, but this is only sufficient to take it into the third quarter of 2018, so it is looking at cross-listing on a US exchange – it is currently trading at 44 Canadian cents per share on the Toronto exchange. The group is also pursuing CE marking in Europe but has no clarity on timing, so without any definite catalysts until 2019 it is hard to see who would buy into its US offering.
Imvamune answers another Bavarian 999 call
February 7, 2018
Even before Bavarian Nordic’s Prostvac crashed the company was quietly emphasising other pipeline assets, such as its RSV vaccine MVA-BN RSV. Last night its post-Prostvac survival strategy was given another boost when its smallpox vaccine Imvamune yielded a positive hit in a pivotal, 440-volunteer study. Not only did Imvamune show non-inferiority to ACAM2000, the smallpox vaccine that is currently approved for the US stockpile, it also gave a statistically better immune response, Bavarian said. Bavarian stock was up 4% this morning, perhaps most importantly driven by the prospects of a US priority review voucher; a filing is to be made in the second half, and the last such voucher to be sold on fetched $130m. Imvamune is licensed for stockpiling by EU authorities, and Bavarian will hope that in the US it can displace ACAM2000, which is contraindicated in certain people. But securing stockpile contracts is a source of lumpy revenue, perhaps explaining why Sanofi sold the ACAM2000 business to Emergent Biosolutions for $98m last year, and Bavarian will need a more predictable revenue stream if it is to win favour with biotech investors.
Trial failure dashes Shield’s global ambitions
February 5, 2018
The failure of Shield Therapeutics’ phase III Aegis-CKD study, announced this morning, is a devastating blow to the UK company. The trial, which tested Shield’s oral iron supplement, Feraccru, in pre-dialysis kidney disease patients, was to form the basis of a US filing and a substantially expanded European label, both of which now look unattainable on the back of these results. The twice-daily oral drug failed to sustain a significant increase in haemoglobin levels in anaemic patients over the 16 weeks of the study compared with placebo, a surprising outcome given earlier readouts of the trial, and previous studies. Feraccru is approved in Europe to treat anaemia caused by inflammatory bowel disease, a much smaller patient pool than the kidney disease market. Adding to the gloom is the fact that a positive result would have allowed Shield to raise crucial funds – on current burn rates it only has enough to last until the summer. The company struggled to get its IPO away in early 2016, floating on London’s Aim and raising £32.5m ($47m), less than a third of what it was initially targeting. With investors heading for the exit this morning that extra cash will be sorely missed in the coming months. Shield shares crashed 51% to 55p this morning, giving the company a market value of £63m and leaving management with hard choices to make.