Product Development

Puma’s neratinib AdCom unlikely to be thwarted by Roche’s APHINITY win; ER+ niche may find takers but an uphill task – experts

Puma Biotechnology's (NASDAQ:PBYI) neratinib FDA advisory committee (AdCom) review and approval chances in the extended adjuvant setting will unlikely be impacted by Roche's (VTX:ROG) Phase III Perjeta (pertuzumab) data in the adjuvant setting for Her2+ breast cancer, said experts.

However, during the 24 May AdCom review, Puma will face questions on data integrity of its Phase III pivotal ExteNET study (NCT02400476), since the trial design was changed through the course of the study and because of its Grade 3 diarrhea side-effect profile, said experts.

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Tau-targeting drugs hold rationale for AD, however concerns including optimal approach and patient selection remain – experts

Tau-targeting drugs have sparked debate for their potential to treat Alzheimer's disease (AD) with experts weighing up strong pathological rationale with concerns regarding scant clinical data, patient selection and whether antibody or vaccines are the best approach.

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Celgene’s marizomib sees Phase I/II recurrent GBM study on hold pending protocol amendment to expand enrollment – sources

Celgene's (NASDAQ:CELG) Phase I/II study of marizomib in combination with Roche's (VTX:ROG) Avastin (bevacizumab) in recurrent glioblastoma (GBM) is awaiting a protocol amendment to allow expansion of 40 additional patients, two sources said. The current study is on hold, added one source, despite the trial being listed as recruiting on ClinicalTrials.gov.

The current enrollment target is 66 patients, according to the trial's (NCT02330562) ClinicalTrials.gov page, which was last updated on 4 January and shows a July 2017 primary completion date.

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Gilead’s Phase II NASH drug expected to prove safe but limited data draws caution, MOA rationale for early efficacy signals – experts

Gilead Sciences' (NASDAQ:GILD) Phase II trial investigating GS-0976 for nonalcoholic steatohepatitis (NASH) has drawn cautious safety optimism from experts. Whilst available 10 subject data is too small to draw conclusions, GS-0976 mechanism does not elicit safety concerns, they added. But one expert noted the drug's downstream target could lead to side effects related to elimination of fat in the liver.

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GSK’s closed triple in COPD faces pulmonologist resistance on ICS use but GP generous prescribing to drive market

GlaxoSmithKline’s (LON:GSK) closed triple FF/UMEC/VI combination carries dampened enthusiasm for use in chronic obstructive pulmonary disease (COPD)with questionable risk/benefit profile of the inhaled corticosteroid (ICS), experts said.

The closed triple is a once-daily inhaler with an inhaled corticosteroid (ICS)/long acting muscarinic antagonist (LAMA)/ long acting beta agonist (LABA) combination of GSK’s Flovent (fluticasone), Incruse (umeclidinium) and vilanterol, respectively.

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BioMarin’s pegvaliase for PKU will likely remain second to Kuvan at initial launch, eventual uptake certain with unmet need, diet noncompliance – experts

BioMarin Pharmaceutical's (NASDAQ:BMRN) PEG-PAL (pegvaliase) if approved has most experts noting that it will initially remain second-line as an option for adult standard of care (SOC) for phenylketonuria (PKU) versus Kuvan (sapropterin). Kuvan’s preferable side-effect profile and physician experience, among other reasons, will have it maintain its first-line status, they said.

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AstraZeneca’s KESTREL head and neck cancer study has decent chance of positivity for durvalumab/tremelimumab – experts

AstraZeneca’s (LON:AZN) Phase III KESTREL study of durvalumab/tremelimumab has potential to show extended survival in patients with first-line recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), experts said.

Phase I durvalumab monotherapy data lends confidence in the combination’s ability to improve survival over the SOC regimen of Eli Lilly’s (NYSE:LLY) Erbitux (cetuximab)/5-FU/platinum chemotherapy (EXTREME), albeit with some reservations about potential toxicity, experts said.

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Legislation to force payer coverage of abuse-deterrent opioids faces resistance due to cost barriers; limited data to support benefit– experts

Proposed legislation across 23 US states to force payers to increase reimbursement of abuse-deterrent (AD) opioids will likely face significant resistance due to state cost implications, most experts said. The state payer- Medicaid- and private payers alike will likely argue that AD opioids do not currently have enough evidence to support the idea that they prevent abuse and addiction, experts added.

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Fibrogen could face IPF strategic conundrums to keep post-Phase IIb pamrevlumab pursuit viable - experts

Fibrogen (NASDAQ:FGEN) faces hurdles to advance pamrevlumab in idiopathic pulmonary fibrosis (IPF) beyond its Phase IIb results, experts said. Fibrogen may struggle to execute a robust randomized trial and may be hoping for acquisition interest after releasing Phase IIb data, a source said, while a pulmonologist who was familiar with company strategy pointed to its struggles after the 2014 approvals of...

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Roche’s emicizumab’s Phase III trial in haemophilia A has most experts questioning drug overall safety profile, clinical future unclear

Roche’s (VTX:ROG) report of a patient death in its Phase III ACE910 (emicizumab) HAVEN 1 study in haemophilia A had experts question a trial investigator’s claim the death occurred independently of the drug.

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