Product Development

Johnson & Johnson’s (NYSE:JNJ) Tremfya (guselkumab) for moderate-to-severe psoriasis is likely to be in formulary tier 3 or 4, due to a crowded market and its potentially high price, experts said. However, Tremfya could have preferential choice in tier 3 due to its improved dosing over other tier 3 options and future real-world data, some added. It could also move to tier 2 due to clinical similarities with Johnson & Johnson’s (J&J’s) Stelara (ustekinumab) but will face major roadblocks from established competition, others said.

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Merck’s (NYSE:MRK) enrollment pause triggered by deaths in its Phase III studies for Keytruda (pembrolizumab) in multiple myeloma (MM), has left experts perplexed as to the cause of the deaths, though autoimmune toxicity remains a possibility.

Still, some experts said it is unlikely to damage the development of other PD-1 and PD-L1 checkpoint inhibitors in MM, citing the fact that both another study of Keytruda in MM, as well as studies of other checkpoint inhibitors using combinations -- similar to the ones in the paused trials -- all remain ongoing.

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Zynerba Pharmaceuticals' (NASDAQ:ZYNE) ZYN002 cannabinoid (CBD) in fragile X syndrome (FXS) has prompted expert uncertainty over whether preclinical efficacy will translate to clinical efficacy in the ongoing Phase I/II trial despite mechanistic rationale. Whereas mouse model success suggests a MOA worth investigating, experts noted rival FXS treatments have failed to translate murine efficacy into the clinic.

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The Medicines Company’s (NASDAQ:MDCO) Vabomere (meropenem-vaborabactam) will chiefly be used as a second-line option for complicated urinary tract infection (cUTI) following expected FDA approval, said experts. They were divided over Vabomere’s ranking among other second-line competitors and antibiotics in late-stage development, especially its biggest potential opposition, Achaogen’s (NASDAQ:AKAO) plazomicin.

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Eli Lilly (NYSE:LLY) has increased the doses of solanezumab in both the A4 and DIAN studies of Alzheimer’s disease (AD), according to two sources familiar with the studies. The A4 study duration has also been extended by one and a half years, they added.

The sources did not comment on the new dose being used in the A4 study. The doses on both ClinicalTrials.gov pages are still listed as 400mg and have not been updated since the alleged protocol amendments. 

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Kite Pharma’s (NASDAQ:KITE) Phase I/II ZUMA-4 study of axicabtagene ciloleucel (axi-cel) in pediatric acute lymphoblastic leukemia (ALL) has a protocol amendment that allows patients who have previously received Amgen’s (NASDAQ:AMGN) Blincyto (blinatumomab) to enter the study, a source said.

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Novartis (VTX:NOVN) temporarily encountered manufacturing problems at its European chimeric antigen receptor T-cell (CAR-T) manufacturing facility, forcing at least one site in the Phase II JULIET trial of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) to go through the US facility, a source with knowledge of the situation said. The logistical issue occurred after the European sites’ activation and resulted in lengthening the time between apheresis and reinfusion, the source added. 

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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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