Go or no go? Novartis eyes a big new growth driver

The biggest approval decision in October will involve Novartis’s eye asset Beovu, while Biogen and Alkermes face a key verdict in MS.

After a tough couple of months Novartis will be hoping for some relief, with a US approval decision approaching for one of its big pipeline hopes, Beovu. The wet age-related macular degeneration project is forecast to be among the biggest launches of 2019, but it will be going up against the might of Regeneron and Bayer’s Eylea.

A nod for Biogen’s Tecfidera follow-on Vumerity could give that group some rare good news, while Alexion also hopes to cement its franchise-extension efforts with a new use for Soliris’s successor, Ultomiris.

Notable first-time US approval decisions due in October
Project Company PDUFA date Product NPV ($m)
Scenesse Clinuvel Pharmaceuticals Oct 6 41
Beovu (brolucizumab) Novartis Oct 15 (estimate) 5,590
Xipere Clearside Biomedical Oct 19 208
Cosyntropin Assertio Therapeutics Oct 19 72
FMX-101 Foamix Pharmaceuticals Oct 20 94
ET-202 Eton Pharmceuticals Oct 21 -
Zimhi Adamis Pharmaceuticals Oct 31 23
Vumerity Alkermes/Biogen Q4 437
Source: EvaluatePharma.

Approval of Beovu is expected. However, as the project has only shown non-inferiority to Eylea in the phase III Hawk and Harrier trials on best-corrected visual acuity, whether it can gain market share will be another matter.

Novartis, which used a priority review voucher to speed Beovu’s approval, hopes to differentiate its project on efficacy – the asset was linked with lower levels of disease activity versus Eylea – and convenience. Novartis’s project is injected into the eye every 12 weeks; while 12 and four-week dosing schedules for Eylea are approved, it is recommended every 8 weeks.

One way Novartis could make a splash is by undercutting Eylea’s price, but it is unlikely to do this from the start, Bernstein analysts believe. Instead, the company is taking the bold step of running various head-to-head studies of Beovu versus Eylea, with Merlin set to be the first to yield results next year.

Head-to-head studies of Beovu vs Eylea
Trial name Details ID Primary completion
Merlin Wet AMD pts with prior anti-VEGF treatment NCT03710564 Jun 2020
Kite DME NCT03481660 Jul 2020
Kestrel DME NCT03481634 Sep 2020
Kingfisher DME NCT03917472 Jul 2021
Raptor DME secondary to branch retinal vein occlusion NCT03802630 Sep 2021
Talon Wet AMD, VEGF-naïve pts NCT04005352 Aug 2022
Raven DME secondary to central retinal vein occlusion NCT03810313 Jan 2023
AMD: age-related macular degeneration; DME: diabetic macular oedema; VEGF: vascular endothelial growth factor. Source: EvaluatePharma, clinicaltrials.gov.

Another big decision due in the fourth quarter will involve Biogen’s Tecfidera follow-on Vumerity, licensed from Alkermes, although this looks likely to come in November based on its acceptance date. Again, Biogen has a decent chance of approval, but the company will need to move patients onto the new drug before Tecfidera generics hit, which could happen as early as next year depending on the outcome of an inter partes review requested by Mylan.

Biogen recently reported that Vumerity was superior to Tecfidera in the head-to-head Evolve-MS-2 trial, but pricing and marketing will also be important to Vumerity’s success, should it get the nod.

Meanwhile, Foamix is on shakier ground with its acne candidate FMX101. After mixed results in its first two phase III trials, the company carried out a third – and much larger – pivotal study. This did show a statistically significant improvement over placebo on both co-primary endpoints, but there were questions about the numerical benefit and the potential market for FMX101.

And Clearside Biomedical looks likely to receive a complete response letter for its uveitis project after the FDA requested more data on stability, following a new manufacturing process being put into place. Clearside plans to resubmit the NDA in early 2020.

Supplements

Among the supplementary approval decisions, Gilead’s Descovy looks like a shoe-in for approval in HIV pre-exposure prophylaxis following a positive panel vote in August, at least in men and transgender women who have sex with men; the committee cited a lack of evidence in cis-women.

Alexion’s Soliris follow-on, Ultomiris, could get the nod in its second indication, atypical haemolytic uremic syndrome, adding to its existing use of paroxysmal nocturnal haemoglobinuria. The company is trying to switch patients to the newer product as Soliris biosimilars approach; however, Soliris's intellectual property recently took a double whammy when the US Patent Office agreed to begin an inter partes review filed by Amgen, and the European Patent Office declined to issue two new patents.

Johnson & Johnson and Bayer’s blood thinner Xarelto, meanwhile, could have a tougher time in the prevention of venous thromboembolism in medically ill patients. J&J persevered here despite the failure of the Mariner trial last year – the company will have to hope that the totality of the data will convince the FDA (ESC 2018 – J&J not downhearted after Xarelto stumbles, August 28, 2018).

Glaxosmithkline’s Parp inhibitor Zejula is facing a decision in ovarian cancer patients with BRCA mutations who have received three or more chemo regimens. But all eyes will be on data from the Prima study, in first-line disease regardless of BRCA status, due for presentation at Esmo this weekend.

And some time in the fourth quarter Pfizer will hope to gain ground on its prostate cancer rival J&J: the former is due an approval decision on Xtandi in metastatic hormone-sensitive disease, a use for which J&J’s Erleada recently got the go-ahead.

Supplementary and other notable approval decisions due in October
Product Company Event type Date
Descovy Gilead Sciences sNDA for HIV pre-exposure prophylaxis Oct 5 (estimate)
PF708 Pfenex Biosimilar Forteo  Oct 7
Zilretta Flexion Therapeutics sNDA for repeat administration for osteoarthritis pain Oct 14
Xarelto Johnson & Johnson/Bayer sNDA for venous thromboembolism in medically ill patients Oct 14 (estimate)
Nplate Amgen sBLA for pts with ITP for 12 months or less Oct 19 (estimate)
Ultomiris Alexion Pharmaceuticals sBLA for atypical haemolytic uremic syndrome  Oct 18
Stelara Johnson & Johnson sBLA for moderate-to-severe ulcerative colitis Oct 20 (estimate)
Baxdela  Melinta Therapeutics sNDA/BLA for community acquired bacterial pneumonia Oct 24
Zejula Glaxosmithkline sNDA for fourth-line ovarian cancer with BRCA mutations or HRD Oct 24
Belviq/Belviq XR Eisai  sNDA for cardiovascular outcomes data Oct 25 (estimate)
PF-06410293 Pfizer Biosimilar Humira; FDA accepted filing in Jan 2019 October (estimate)
Fluzone Quadrivalent Sanofi sBLA for influenza vaccine – high dose Q4
Xtandi Pfizer/Astellas Pharma sNDA for metastatic hormone-sensitive prostate cancer Q4
HRD: homologous recombination deficiency; ITP: immune thrombocytopenic purpura. Source: EvaluatePharma.

This story has been updated to clarify Vumerity's likely approval date and Eylea's dosing schedules.

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