Product Development

Biogen’s (NASDAQ:BIIB) recently announced Phase II trial design for opicinumab in relapsing remitting multiple sclerosis (RRMS) has experts optimistic that patient inclusion criteria could allow a positive trial outcome. That said, the company’s decision to allow any disease-modifying therapy (DMT) in the trial had some experts noting overall data analysis would be challenging.

Some experts also noted lingering doubts on positive results considering previous mixed trial results and the drug’s uncertain mechanism of action.

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Advanced Accelerator Applications’ (NASDAQ:AAAP) Lutathera (177Lu-DOTATATE) for gastroenteropancreatic neuroendocrine tumours (GEP-NET) could face further FDA approval delays if concerns about its safety profile persist due to its radiolabeled molecule, experts said. However, they were overall optimistic Lutathera would be eventually approved due to its encouraging efficacy data.

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Kala Pharmaceuticals’ (NASDAQ:KALA) KPI-121 (loteprednol etabonate) for acute symptoms of dry eye will have difficulty achieving its Phase III co-primary endpoint of significant ocular discomfort reduction as the drug demonstrated a failure in Phase II, said experts.

The trial design between Phase II and Phase III are very similar, with the only discernable difference being duration, and could see a replication in the failure. However, they added, the other co-primary endpoint of bulbar conjunctival hyperemia reduction has a good chance of repeating Phase II success.

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Merck KGaA (ETR:MRK) has offered to pay for any additional disease-modifying therapies that multiple sclerosis (MS) patients may require during Mavenclad (cladribine) therapy, as part of ongoing reimbursement discussions with the UK’s National Institute for Health and Care Excellence (NICE), according to two sources familiar with the situation.

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Gilead Sciences’ (NASDAQ:GILD) early ASH 2017 abstract data from the Phase I/II ZUMA-6 study of Yescarta (axicabtagene ciloleucel)/Roche’s (VTX:ROG) Tecentriq (atezolizumab) in diffuse large B-cell lymphoma (DLBCL) drew concerns from experts about high toxicity rates, albeit with the caveat of the data’s earliness and small patient numbers.

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AstraZeneca’s (LON:AZN) benralizumab will likely have a dosing advantage over competitors in severe eosinophilic asthma, but may struggle to reach optimal market expectations, experts said. Convincing some physicians that it offers a superior efficacy profile for the majority of patients will be the major challenge, experts said.

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Multiple reported patient deaths through the FDA reporting system for patients taking Roche’s (VTX:ROG) Ocrevus (ocrelizumab) for multiple sclerosis has led to the company launching an investigation into the cases, said a source familiar with the situation. Two additional sources familiar with the drug said they also heard about the deaths, adding a number of questions regarding the nature of the cases remain unanswered.

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GlaxoSmithKline’s (LON:GSK)/ViiV Healthcare’s Phase III Tivicay (dolutegravir)/ Epivir (lamivudine) combination for HIV treatment-naïve patients versus triple therapy has experts unsure about its success, due to the comparator’s high bar and uncertainty associated with doublets when a triple has been approved.

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Asterias Biotherapeutics’ (NYSEAMERICAN:AST) AST-OPC1 initial cohort data from its Phase I/IIa study has experts cautiously excited for its potential to treat spinal cord injury in this and additional cohorts. Given the uncontrolled trial design, efficacy possibility can be hedged, they said; however, the data was strong enough to convince them of a real effect size.

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BeiGene’s (NASDAQ:BGNE) Phase III study comparing BGB-3111 against AbbVie (NYSE:ABBV)/Johnson & Johnson's (NYSE:JNJ) Imbruvica (ibrutinib) in Waldenström’s macroglobulinemia (WM) has enrolled 53 patients out of 167 as of 3 October with CRO Parexel (NASDAQ:PRXL), said a source briefed on the trial.

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