Remdesivir Update

  • Remdesivir, an antiviral, is one of the leading drugs in development for COVID-19.
  • Recent published cohort analysis was supportive.
  • In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%).
  • Crucial to understand the limitations of this data – the need for a randomised placebo controlled trial.
  • Gilead’s (GILD) CEO Daniel O’Day in an open letter expresses this.
  • These trials are ongoing with results coming in end of April/May.
  • While it may feel like a long wait for data given the urgency of the situation, it has been only two months since the first clinical trials began. Given that it can take a year or more to have the first clinical data for an investigational treatment, it is remarkable that we expect to have the first remdesivir trial data so soon.” 
  • The latest buzz from Chicago is also just a snapshot and drawing conclusions is “scientifically unsound“.
  • We will have to wait – but not long.

Insulin Biosimilar Competition

  • Under the radar the FDA has introduced a new regulatory pathway for insulin biosimilars (generic copies of biologic drugs).
  • Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products.”
  • This will increase competition.
  • Likely a big issue for the insulin oligopoly Sanofi, Novo Nordisk and Eli Lilly.

Covid Drug Development

  • Clinicaltrials.gov counts 104 active studies in the US.
  • There is also SOLIDARITY, a WHO megatrial announced on Friday.
  • Drugs in Clinical Trials:
  • Chloroquine (Plaquenil) – 70 year old treatment for malaria repurposed. Only small open label trials done so far (here, here and here) show encouraging early results.
  • Siltuximab, Sarilumab and Tocilizumab – all IL-6 inhibitors (for anti-inflammatory conditions) repurposed and being clinically tested.
  • Remdesivir – previously tested for other viruses including Ebola. Two phase III studies initiated.
  • Ritonavir/lopinavir – HIV medication repurposed. Although initial trial failed.
  • Drugs in Pre-Clinical Development:
  • Regeneron – are using their novel antibody discovery technology to find a cocktail of antibodies.
  • TAK-888 – a hyperimmune globulin that has previously shown benefit in severe acute viral respiratory infections.
  • RNAi – Alnylam are using siRNA technology pre-clinic to find a candidate.
  • WP1122 – Moleculin Biotech are testing a glucose decoy prodrug.
  • Vaccines:
  • 39 in development, 12-18 months away, full list here.

Viruses & Bats

  • Fascinating article about why viruses, like the current Corona virus outbreak, tend to come from bats.
  • Why Bats? They are mammals, so sufficiently close to us, not domesticated, and live in huge flocks
  • Bracken Cave, in Texas, is home to roughly 20 million breeding Mexican free-tailed bats, similar to the (human) population of the Mexico City urban area. In places there are 500 bat pups per square foot on the wall. To a virus that represents a tasty buffet.

Schrodinger

  • Citron Research, famed for short selling reports, are recommending long this stock – Schrodinger (SDRG).
  • They describe it as – “the most disruptive software platform to ever hit the pharmaceutical industry, which also happens to be backed by the world’s most sophisticated investors, has just gone public.
  • Looks interesting and is worth investigating. The shares are sadly ca. +100% since IPO already.
  • As always with investing – this is not a recommendation, do your own work, use common sense.

Biotech

  • Biotech investors take note – Eli Lilly are out for deals.
  • Eli Lilly and Co aims to announce roughly one $1 billion to $5 billion deal every quarter in 2020, its chief financial officer told Reuters, as the U.S. drugmaker looks to build up its pipeline of future products.
  • It will focus largely on earlier stage opportunities across key therapeutic areas including oncology, pain, immunology, and neurology

Drug Pricing

  • Pharma companies are starting to really come into their own with introducing innovative ways of pricing.
  • Alnylam only charges the $575k price for givosiran if the effect seen is on par with clinical trials.
  • Novartis now collects the $2.1m price tag for Zolgensma over 5 years.
  • Sanofi are offering $99/month subscriptions for insulin.
  • Pricing is a big issue for US Pharmaceuticals. There are start-ups looking at this issue as well – Generics 2.0.

Cancer Mortality Rates

  • New stats from the US Cancer Society show that between 1991 and 2017 the mortality rate of cancer has dropped 29%.
  • According to the report, this was due to lower smoking rates, improved early detection methods and advances in treatment.
  • This trend means more than 2.9m lives were saved since 1991.
  • Really amazing.
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