Snippet roundup: CSL makes HAE and Shire extends ADHD franchise

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

This week, June 19 to 23, 2017, we had thoughts on the following: CSL threatens Shire’s top-dog status in HAE; Philips picks up Electrical Geodesics for cheap; Shire’s last play in ADHD; panel nod paves way for Victoza cardiovascular benefit label; Cell Medica seizes the chance to consolidate.

These snippets were previously published daily via twitter.

CSL threatens Shire’s top-dog status in HAE

23 June, 2017

CSL has beaten Shire to the punch in hereditary angioedema (HAE) – yesterday’s FDA approval of Haegarda should give it around a year’s head start over its rival’s prophylactic project lanadelumab. Both are given subcutaneously, making them more convenient than Shire’s intravenous product Cinryze, the only other agent approved for prophylactic HAE treatment. But CSL will have to make its first-mover advantage count – recent data suggest that lanadelumab has similar efficacy to Haegarda, and Shire’s candidate also has the benefit of less frequent dosing. Shire is also attempting to stop its rival via the courts, suing CSL for infringing the ‘111 patent, which was issued in April. The HAE market is set to become crowded, with Shire also developing a subcutaneous version of Cinryze, known as SHP616, and Biocryst trialling a potentially even more convenient oral candidate that recently reported interim phase II results. It will be interesting to see how CSL prices Haegarda – going in low could disrupt the market, but would make it harder to hit its sales target of $750m to $1bn. Credit Suisse analysts estimate that the current overall HAE market is worth $1.4bn, which could rise to $4bn. CSL has its work cut out to grab a chunk of this from Shire.

Philips picks up Electrical Geodesics for cheap 

23 June, 2017

The brain activity monitoring company Electrical Geodesics has been bought by Philips for £29m ($36.7m) cash – but at 105p per share, the deal represents a drop from Electrical Geodesics’ IPO price. It listed on AIM in April 2013 at 120p a share. The Dutch giant says the technology it will obtain through the deal will allow it to address disorders including stroke, epilepsy, traumatic brain injury and Parkinson’s disease. Electrical Geodesics’ products include a dense array electroencephalogram device with up to 256 electrodes, which the company says can produce higher quality images than other systems. Electrical Geodesics’ technology, which last year had sales of $14.3m, will likely be slotted into Philips’s patient monitoring segment.  

Shire’s last play in ADHD

22 June, 2017

Shire is now in a position to stretch its ADHD franchise out for another six years. US FDA approval of Mydayis (SHP465) extends the UK group’s presence here to 2029 – it had been due to end in 2023 with Vyvanse’s patent expiry. Mydayis is not a full replacement, however: forecasts put sales at $416m in 2022, according to EvaluatePharma’s consensus of sellside analysts, so it is not on track to become a blockbuster like Vyvanse or Adderall before it. However, it will help finalise Shire’s transition into an orphan disease and blood products player. The share of Shire’s sales owing to CNS diseases has shrunk from 42% in 2012 to an estimated 20% this year, and will stabilise at this level through to 2022. Meanwhile, blood-disease agents acquired from Baxalta and other speciality pharma groups have begun to pull their weight.

Panel nod paves way for Victoza cardiovascular benefit label

21 June, 2017

A positive adcom vote for Novo Nordisk’s GLP1 agonist Victoza means that this should soon get a cardiovascular benefits claim on its label, putting it on a par with Lilly and Boehringer’s Jardiance. Proving a cardiovascular benefit is looking increasingly important for diabetes drugs and, with most of its rivals not due to report outcomes data for at least a year, Novo has a chance to make its advantage count. Victoza now looks like it will become the first GLP1 agonist and the second type 2 diabetes therapy to boast a cardiovascular label claim after the panel voted 17-2 that it reduces cardiovascular risk. Johnson & Johnson’s SGLT2 inhibitor Invokana cannot be too far behind, having recently shown a cardiovascular benefit in its Canvas programme. And Novo’s once-weekly injectable GLP1, semaglutide, has also succeded here – the company filed for US approval in December and is expecting a decision by the end of the year. Lilly’s Trulicity is currently forecast to be the top diabetes drug in 2022, according to EvaluatePharma – but surely its future now hinges on a positive result in the Rewind trial next year.

Cell Medica seizes the chance to consolidate

20 June, 2017

Cell Medica has wasted no time in putting to use the proceeds of its recent £60m ($74m) raise – one of the largest by a UK company – today closing the takeover of Catapult Therapy TCR. The acquired business was effectively a vehicle for the work of Professor Emma Morris at UCL on an autologous engineered T-cell receptor (TCR) therapy against WT-1. It was majority-owned by Cell Therapy Catapult, a UK government body set up to funnel £70m of taxpayers’ money into these types of treatments, with stakes also held by UCL Business and Imperial Innovations; however, terms of the takeout are not being disclosed. One curious aspect is that WT-1 is a cancer antigen that Adaptimmune – the most advanced TCR player – insists is insufficiently presented in vivo. Still, Cell Medica has ongoing work in engineered TCRs expressed on NK T cells, and last year struck a deal with UCL looking to enhance TCR therapies. Moreover, WT-1 is an antigen that Juno is targeting with its phase I/II engineered TCR project JTCR016, and for Cell Medica this is surely sufficient endorsement.

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