Friday Five - The Pharma Week in Review

Strategic manoeuvres

  • Roche CEO Severin Schwan is adamant that a push for greater efficiencies at the Swiss company will not prompt it to merge its Pharma Research and Early Development (pRED) and Genentech Research and Early Development (gRED) units. Schwan also said Roche is modelling worst-case scenarios for biosimilar erosion to its key oncology brands in both the EU and US markets, but remains confident new drug launches will offset this headwind.
  • According to reports, Novo Nordisk could announce between 2000 and 3000 job cuts and scrap long-term financial guidance when it reports its second-quarter results in August. Cost reductions have been blamed on "uncertain and unpredictable" markets and pricing pressure on its insulin brands.
  • Shares in Madrigal Pharmaceuticals jumped nearly 10 percent on news the company is considering a sale after receiving takeover interest from companies seeking to develop treatments for NASH. Last month, the company announced updated results for its mid-stage candidate MGL-3196.
  • Sanofi extended its investment into mRNA by entering a deal (via its Sanofi Pasteur vaccine unit) with Translate Bio to develop mRNA vaccines for up to five undisclosed infectious disease pathogens. Analysis - ViewPoints: Translate Bio completes its facelift with Sanofi deal
  • Sage Therapeutics out-licensed Japanese, Taiwanese and South Korean marketing rights for its experimental depression therapy SAGE-217 to Shionogi. An upfront fee of $90 million is significant for these territories, reflecting the promise of '217, which is poised for faster passage through the US regulatory arena than previously thought (see Regulatory recon below). With US and European rights still held by Sage, the company's status as a probable takeout candidate will remain sharply in focus. See -ViewPoints: Discussing Sage Therapeutics' progress with CSO Al Robichaud

From the clinic

  • Allergan provided compelling evidence from a Phase IIb/III trial to suggest its oral CGRP inhibitor atogepant could offer comparable efficacy in preventing migraines versus injectable agents (ViewPoints: Allergan’s faith in CGRP may pay off in a big way). Amgen and Novartis' Aimovig recently become the first injectable CGRP inhibitor to reach the market with subsequent approval of similar agents over the next 12-18 months; analysts have forecast this drug class to generate billions of dollars in peak revenues. Amgen will need to run at least one Phase III study to confirm its findings, but could emerge as a long-term competitor of note thanks to oral dosing (see Physician intelligence below).
  • GlaxoSmithKline confirmed the GEMINI 1 and 2 trials met their primary endpoints by showing non-inferiority for Tivicay and lamivudine versus a three-drug regimen in treatment naïve HIV patients. Importantly, no patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance. GlaxoSmithKline believes two-drug regimens, which should reduce exposure to toxicities and side effects, will allow it to retain market share in the face of increased competition from Gilead Sciences.
  • Galmed Pharmaceuticals saw its share price soar on the back of Phase IIb data for its experimental NASH therapy Aramchol, though closer inspection reveals question marks about potential pivotal-stage study design and the chances of Aramchol delivering positive data in Phase III trials (ViewPoints: Galmed soars on mid-stage NASH data, but questions remain).
  • AstraZeneca and Eli Lilly announced they are to end late-stage testing of the experimental Alzheimer's disease treatment lanabecestat. It is not the first drug in this class to be abandoned as the number of failed approaches to developing an effective AD treatment accumulates. However, more recently Biogen and Eisai reported that in a mid-stage study, the BACE inhibitor elenbecestat demonstrated a significant difference compared to placebo in amyloid beta levels in the brain in patients with mild cognitive impairment due to AD, or mild-to-moderate dementia due to AD (ViewPoints: Eisai, Biogen offer sign of life for BACE inhibition)

 Physician intelligence

More here

  • In response to new Phase IIb/III data, feedback from 77 neurologists we surveyed this week indicates Allergan's atogepant (see From the clinic above) represents a viable long-term threat to injectable CGRP inhibitors for the prevention of migraine; oral dosing could even compensate for lower efficacy, prescriber feedback suggests.
  • We are also speaking to a KOL this week to ascertain further how significant new data for atogepant could be.

Digging a little deeper

Regulatory recon

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