Pharma R&D Productivity

  • It is taken for granted in the industry that pharmaceutical company productivity is in decline (here and here).
  • Indeed productivity has fallen by 8.4% per year since the 1950s.
  • However, these views are outdated (data tends to run to 2010), often fail to account for start-ups (i.e. by following a pre-existing cohort) and are an extrapolation of a trend.
  • The pictured chart is an updated graph of the number of new drugs or new molecular entities (NMEs) per $bn of R&D spend.
  • Interestingly it has actually been stable for much of the 2000s and can be explained in part by the industry having better information and how it is used. This article explains in depth.

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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