Friday Five – The Pharma Week in Review (16 July 2021)

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Biogen looks to close the gap in BTK race

Over the past year, expectations have grown for BTK inhibitors to become an important new class of treatment for both relapsing and progressive forms of multiple sclerosis.

Biogen, which already has one in-house BTK inhibitor in Phase I development, said this week it has agreed to in-license another – called orelabrutinib – from the Chinese biotech company InnoCare Pharma.

The deal will cost Biogen $125 million upfront and accelerate its potential route to market, with orelabrutinib already in Phase II testing.

Biogen also highlighted the ability of orelabrutinib to cross the blood brain barrier, which further suggests that InnoCare's drug could be viewed internally as superior to Biogen's in-house asset.

By comparison, Sanofi, Merck KGaA and Roche have all recently advanced their own BTK inhibitors into Phase III studies for MS.

Analysis – ViewPoints: Biogen looks to close gap on MS competitors in BTK inhibitor field

Lilly's KRAS hits the clinic

Eli Lilly will imminently begin patient enrolment in a Phase I clinical study of its KRAS inhibitor LY3537982, an update on clinicaltrials.gov reveals.

Amgen's first-in-class KRAS inhibitor Lumakras was approved by the FDA in May for the second-line treatment of KRAS G12C mutated non-small-cell lung cancer (NSCLC).

It is one of the most noteworthy drug approvals on 2021, as KRAS was long considered to be an undruggable cancer target.

Eli Lilly has argued, however, that the effectiveness of first-generation KRAS inhibitors falls somewhat short of other small-molecule targeted cancer therapies and it believes LY3537982 can improve on the early benchmark set by the likes of Amgen and Mirati Therapeutics.

Initial data from this Phase I study, due to read out next year, will provide a big clue if Eli Lilly is right.

Novo Nordisk in-licenses ATTR amyloidosis candidate

Looking to build out from its core therapeutic focus in diabetes and obesity, Novo Nordisk reiterated to FirstWord this week that one of its key strategic aspirations by 2025 is to establish a presence in other serious chronic diseases, with a focus on cardiovascular disease, non-alcoholic steatohepatitis (NASH) and chronic kidney disease.

To this end, the Danish company announced that it will pay $100 million upfront to acquire Prothena's investigational ATTR amyloidosis treatment PRX004, currently in Phase I studies, as part of a deal that could rise in value by another $1.2 billion based on potential development and commercial milestone payments.

Despite the ATTR amyloidosis market and pipeline becoming increasingly crowded, Novo Nordisk thinks PRX004 could have an important role to play if it can meet clinical expectations based on promising early-stage data. More here.

The expert view on Jardiance's new data

Following on from the positive top-line data announced for Boehringer Ingelheim and Eli Lilly's Jardiance in heart failure with preserved ejection fraction (HFpEF) last week, FirstWord caught up with a leading expert in the field to gauge expectations ahead of a full readout at next month's European Society of Cardiology (ESC) meeting.

If Jardiance can demonstrate a cardiovascular event or death risk reduction of more than 20%, this would represent a significant advance for the field, the KOL noted.

FirstWord Pharma PLUS subscribers can read the full interview here.

Two-thirds of endocrinologists think tirzepatide is practice-changing for type 2 diabetes

And more positive news for Eli Lilly with our latest Physician Views poll providing further evidence that tirzepatide will reset treatment expectations for type 2 diabetes, following the recent presentation of detailed results from the SURPASS Phase III programme at the annual meeting of the American Diabetes Association (ADA).

Two thirds of the endocrinologists we snap-polled say that tirzepatide has already demonstrated enough promise to be considered practice-changing. More analysis of the results can be found here.

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