Friday Five - The pharma week in review (18 September 2020)

Gilead acquires Immunomedics

Gilead Sciences announced this week it will acquire Immunomedics for $21 billion – the biggest M&A deal in bio-pharma this year to date. Gilead gains access to Trodelvy, a new treatment for metastatic triple-negative breast cancer (TNBC) recently granted accelerated approval by the FDA.

The deal also checks boxes regarding broader industry trends, by accelerating Gilead’s strategy to enhance and grow its presence in the oncology market and further validating a renaissance for antibody-drug conjugates (ADCs).

Analysis – ViewPoints: Gilead learns its ADCs

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Leaving Merck to collaborate with Seattle?

On cue, Seattle Genetics – which sought to in-license Trodelvy from Immunomedics but saw its attempt rebuffed by activist shareholders – announced on Monday that Merck & Co. will pay it $600m upfront as part of a deal to develop and commercialise the experimental ADC ladiratuzumab vedotin.

Ladiratuzumab vedotin, which targets LIV-1, is currently being investigated in Phase II trials for breast cancer and other solid tumours. The companies plan to evaluate the drug, formerly known as SGN-LIV1A, as monotherapy and in combination with Merck's anti-PD-1 therapy Keytruda in triple-negative breast cancer (TNBC), hormone receptor-positive breast cancer and other LIV-1-expressing solid tumours.

Analysis – ViewPoints: With Immunomedics off the market, Merck & Co. turns to Seattle Genetics

With analysts highlighting that Gilead has paid a lofty premium for Immunomedics, it begs the question whether interest in the latter from Merck & Co. prompted an auction. If so – Seattle appears to have been a further beneficiary of Big Pharma’s renewed interest in ADCs.

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Early data reported for Eli Lilly’s COVID mAb

Eli Lilly reported encouraging but early Phase II data for its investigational SARS-CoV-2 neutralising antibody LY-CoV555 in patients with mild-to-moderate recently diagnosed COVID-19.

The data show that versus treatment with placebo LY-CoV555 reduced the rate of hospitalisation, though in a relatively small number of patients.COVID-19-related hospitalisation or emergency room visits occurred in 1.7% of the 302 patients who received LY-CoV555 at any dose, compared to 6% of the 150 participants given placebo. Lilly noted that this corresponds to a 72% risk reduction, although it did not say whether the difference was statistically significant.

Furthermore, three doses of LY-CoV555 were evaluated – 700mg, 2800mg and 7000mg – and only the middle dose of 2800mg met the primary endpoint of significantly reducing levels of SARS-CoV-2 after 11 days; lack of a dose response (high efficacy with a higher dose) increases the risk that benefit with LY-CoV555 occurred by chance.

Analysis - ViewPoints: Initial data for Lilly’s LY-CoV555 offer only crumbs on COVID-19 mAbs

Elsewhere on the COVID-19 treatment and vaccine front…

US plans to ship first coronavirus vaccines within 24 hours of FDA approval

Lilly, Incyte's Olumiant cuts recovery time when added to Veklury in hospitalised COVID-19 patients

FDA probes whether to allow AstraZeneca to resume COVID-19 vaccine trial in US

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Previewing ESMO

Oncologists will meet – virtually of course – for the 2020 annual meeting of the European Society of Medical Oncology (ESMO) meeting this coming weekend.

Important clinical readouts will include data showing the potential role of CDK4/6 inhibitors – specifically Eli Lilly’s Verzenio – for the treatment of adjuvant HR-positive, HER2-negative breast cancer and how immunotherapy could be used to treat neo-adjuvant triple-negative breast cancer (TNBC).

FirstWord Pharma PLUS subscribers can read our full ESMO preview here. Look out for our coverage of the event over the next week.

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Roche and Pfizer’s pipelines in focus

Roche and Pfizer both held R&D events this week.

The former continues to present an impressive pipeline and promising long-term outlook for its pharmaceuticals business. Notable highlights discussed this week include the rapid progression of fenebrutinib – a BTK inhibitor – into Phase III studies for multiple sclerosis (jumping directly from pre-clinical investigation!) and an update on the early adoption of Roche and PTC Therapeutics’ recently approved spinal muscular atrophy (SMA) treatment Evrysdi.

We dissect more of the highlights here

Pfizer’s event focused heavily of initiatives to improve its R&D productivity and advancements in immunology & inflammation, oncology and rare diseases, with the spotlight unsurprisingly also focused on its efforts to tackle COVID-19.

The status of its most advanced offering, an mRNA-based vaccine being co-developed with the German biotech company BioNTech, has arguably been enhanced by recent challenges faced by another vaccine front-runner being co-developed by AstraZeneca and the University of Oxford.

Analysis – ViewPoints: Pfizer paints an optimistic picture for its COVID-19 vaccine

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