Snippet roundup: Novartis meets CAR-T filing deadline, Numab snares Ono
Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, March 27 to March 31, 2017, we had thoughts on the following: Biogen gets good news on Tecfidera patent fight; Early trial boost for Replicel; Private equity groups cash in on Convatec; Novartis meets the first of its two first-quarter CAR-T promises; Ono takes bispecific approach a stage further with Numab.
These snippets were previously published daily via twitter.
Biogen gets good news on Tecfidera patent fight
March 31, 2017
Forward Pharma’s best-case scenario has not emerged. Although it has already pocketed $1.25bn from patent rival Biogen as part of a long-running intellectual property dispute, the US Patent Trial and Appeal Board (PTAB) ruled in favour of Biogen in an interference claim over patents on Tecfidera. The ruling reduces the chances that Denmark-based Forward will receive royalties on future US sales of Tecfidera – Evercore ISI analyst Umer Raffat said the royalties could have amounted to $300m a year – not to mention potentially allowing for entry of Tecfidera generics in 2025 instead of 2028. It is not clear whether Forward will appeal the ruling. European Union patents are still subject to legal proceedings. Biogen shares rose 1%, while Forward’s shares fell 20% before trading was halted.
Early trial boost for Replicel
March 30, 2017
Regrowing tendon tissue using fibroblasts derived from hair follicles sounds impressive, but the data on Replicel Life Sciences’ RCT-01 are early and limited. Still, the phase I/II React trial, which enrolled just eight patients with Achilles tendinosis, was positive, with Replicel saying that all five of the treated patients showed “clinically relevant” improvements in tendon composition, blood supply, physical function and pain sensation. This included an overall 15.3% improvement from baseline in total score on the VISA-A scale of Achilles tendon injury severity. Two patients showed “select measures of near-complete recovery in function” and four showed clinically relevant signals of improvement in pain on running and jumping based on their score on the VAS scale of pain severity. Average improvement in VAS score for these four participants was 62.9% over baseline. The company believes the collagen-producing non-bulbar dermal sheath cell preparation also has potential in repairing injures to tendons in the knee and elbow as well as the rotator cuff.
Private equity groups cash in on Convatec
March 30, 2017
After taking Convatec public last year, its biggest shareholders have cashed out to the tune of over $2bn. The private equity groups Nordic Capital and Avista Capital Partners have agreed to sell a 20% stake to Novo A/S, Novo Nordisk’s parent company, for £1bn ($1.25bn), and have also offloaded a 19% stake in an upsized share placement worth £975m. Nordic Capital now owns around 16% of Convatec, while Avista holds around 7%. The sell-off goes some way towards justifying the $4bn that the private equity groups paid for Convatec in 2008, and follows a $1.8bn IPO last year, the biggest ever in medtech. It is harder to see why Novo has shelled out for a share in Convatec, which produces devices including colostomy bags and catheters, hardly the most dynamic medtech segment. Convatec reported 2016 revenues of $1.69bn in 2016, up 2% year-on-year, but EBITDA fell 18% to $336m.
Novartis meets the first of its two first-quarter CAR-T promises
March 30, 2017
Novartis stayed true to its word in getting its lead CAR-T asset, CTL019, filed in the US in the first quarter, submitting a BLA with two days to spare yesterday. For investors following the adoptive cell therapy space, however, a more important event – also promised in Q1 – is readout from CTL019’s Juliet study in lymphoma. This is because lymphoma is a larger indication than the childhood leukaemia for which CTL019 has just been filed, and Juliet will enable comparison against Kite’s rival KTE-C19. Kite intends to complete its own BLA – also in Q1 – based on six-month data from the Zuma-1 study, which will be scrutinised further at this weekend’s AACR meeting. Novartis, meanwhile, previously said it would report interim three-month data from the first 50 patients in Juliet, with a primary analysis of 80 patients by the half-year; a lymphoma filing is still expected this year, the Swiss firm said yesterday. CTL019 and KTE-C19 each have breakthrough therapy designation, and with the FDA granting priority review to Novartis’s BLA a regulatory decision on CTL019 could come by the end of September.
Ono takes bispecific approach a stage further with Numab
March 28, 2017
Work on improved antibody constructs continues apace, thanks largely to the advent of immuno-oncology. The latest beneficiary is the private Swiss company Numab, which has just snared Ono, the originator of Bristol-Myers Squibb’s blockbuster anti-PD-1 MAb Opdivo, as a partner. While two years ago Amgen’s Blincyto became the first bispecific MAb to get US approval, Numab attempts to go a stage further, designing bi, tri, tetra and hexaspecific molecules that have specific pharmacokinetic profiles. It will work with Ono on a lead immuno-oncology target in a deal the companies say could be worth up to Sfr258m ($262m) in fees and research funding, though clearly this will be heavily backend loaded. Still, for a young company this is not bad going: Numab was founded in 2011, and already counts Intarcia as a partner under a collaboration looking to combine exenatide with an antibody fragment that will work with a known diabetes target outside the GLP-1 pathway.