Product Development

Merck’s anacetrapib trial design could become standard for future CETP inhibitor trials in hypercholesterolemia; PCSK9 data potential success bar– experts

Merck’s (NYSE:MRK) Phase III anacetrapib REVEAL results have triggered expert discussion about potential optimal future CETP inhibitor hypercholesterolemia trial design options in order to be competitive with PCSK9 inhibitors. They noted CETP inhibitors needed to match the 14% benefit seen for PCSK9 inhibitors, whilst noting that similar patient numbers and trial length to REVEAL would likely be required and ideal LDL levels should fall between 61 and 100 in the inclusion criteria. 

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Versartis’ Phase III paediatric growth hormone trial primed for FDA approval, efficacy success but long-term safety risks possible – experts

• Same MOA as Genotropin provides efficacy reassurance
• GHD false positives will not impede efficacy read-outs
• Long half-life could bring IGF peaks, gives safety pause

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Vertex’s Phase II triple combos spurs optimism for F508del homozygous CF patients, heterozygous group draws pause - experts

Vertex Pharmaceutical’s (NASDAQ:VRTX) triple combinations of a CFTR potentiator and two correctors elicited expert optimism for Phase II due to encouraging preclinical rationale for F508del homozygous and F508del/minimal CFTR function heterozygous patients, albeit with caution in the latter.

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Revance’s Phase II RT002 has three cervical dystonia patients still responding at 36 weeks; potential reduction in clinic visits major breakthrough – source

Revance Therapeutics’ (NASDAQ:RVNC) RT002 (daxibotulinumtoxin a) is still demonstrating efficacy in three cervical dystonia patients after 36 weeks in an open-label Phase II trthat three ial, said a source familiar with the situation. The company recently presented positive 24-week efficacy/safety data and noted it would be measuring efficacy up to 36 weeks.

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HRD testing finds favor among experts for ovarian cancer PARP inhibitors despite broad labels, potential impact on market penetration - experts

Despite the broad label received in recent ovarian cancer approvals, experts said they are still considering using homologous recombination deficiency (HRD) tests to whittle down eligible patients before treatment.

Tesaro’s (NASDAQ:TSRO) Zejula (niraparib) was the first PARP inhibitor to be given a broad label for second-line ovarian cancer maintenance therapy, while Clovis Oncology’s (NASDAQ:CLVS) Rubraca (rucaparib) is also anticipated to have a similar label.

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TherapeuticsMD’s TX-004HR for postmenopausal dyspareunia CRL could be resolved with postmarketing study, label expansion possible – experts

Despite TherapeuticsMD’s (NYSEMKT:TXMD) FDA Complete Response Letter (CRL) for its TX-004HR (estradiol vaginal capsule) for postmenopausal dyspareunia, it still runs a good chance of approval for its lower doses without an extra, postmarketing 12-month study, experts said. If the study is done, it could be open-label, and is expected to show an excellent safety profile via endometrial biopsies, they said.

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DBV and Aimmune likely to claim individualized slices of peanut allergy pie, DBV’s patch may sway risk averse parents – experts

DBV’s (EPA:DBV) and Aimmune (NASDAQ:AIMT) respective peanut allergy products will see individual preferences affect uptake, experts said. However, DBV’s Viaskin Peanut could appeal more strongly to parents who may be willing to compromise on efficacy for better safety, they added.

While Viaskin Peanut is an epicutaneous immunotherapy that delivers increasing doses of the allergen through the skin with a patch, AR101 is an oral immunotherapy that uses standardized doses of peanut preparations.

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Ionis’ inotersen garners physician support despite investor malaise following patient death in Phase III FAP trial– experts

Ionis Pharmaceuticals’ (NASDAQ:IONS) inotersen garners continued physician enthusiasm for its overall safety profile even with a patient death in the Phase III familial amyloid polyneuropathy (FAP) trial, despite negative market reaction to the news. Experts also downplayed analyst and investor concerns the drug would play second fiddle to its potential future competitor, Alnylam’s (NASAQ:ALNY) Phase III candidate patisiran, due to safety concerns and a likely patient monitoring program.

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Roche’s APHINITY results in high-risk breast cancer subset still unlikely to preserve original enthusiasm

Roche’s (VTX:ROG) slim benefit with Perjeta (pertuzumab) in the APHINITY trial in Her2+ breast cancer has experts predicting a smaller than anticipated market use in the adjuvant setting including the more hopeful higher risk subset.

Roche had earlier announced the trial reaching its primary endpoint on 2 March, leading to an upward share price movement of 6.5% and expectations of Perjeta being added to the standard of care -- Roche’s (VTX:ROG) Herceptin (trastuzumab) and chemotherapy -- for adjuvant therapy in Her2+ patients.

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Eli Lilly’s Cyramza may see steady uptake due to clinician familiarity if approved for first-line gastric cancer; to be used in combo with FOLFOX

Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) will likely have limited uptake issues in most patients if it shows positive Phase III results in first-line gastric cancer due to clinicians' familiarity with second-line use of the drug, experts said.

Physicians' familiarity could boost their confidence in prescribing the drug and make predicting potential side effects easier, some experts noted.

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