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Saturday, July 29, 2017

Summer is a busy time, if you're one of those busy bees!

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It was a big week in pharma-related news, with lots of moving and shaking, which often seems to happen in unison as if the herd truly operates as one when it comes to reorganisation. First up was the news that GSK is definitely beginning to feel the impact of transitioning from Andrew Witty's underwhelming tenure in recent years, to incisive refocusing of the company's pipeline under new CEO, Emma Walmsley. 

Ms. Walmsley has pulled some 30 drug development programs from the table, clearly demonstrating her intent to build upon the brand's expertise in four main areas of business (respiratory, infectious diseases, oncology and inflammation) and probably exiting the rare disease segment completely. No doubt this new focus and vision will sharpen the company's bottom line in years to come, although how likely other pharma are to jump in and snap up assets that GSK has somewhat devalued via their deprioritisation remains to be seen. The R&D refocus is expected to save GSK over $1 billion by the end of the decade. 

The news coming from new Alexion CEO Ludwig Hantson rang a similar tone, with announcement that he too was cutting hard into their R&D programs, resulting in termination of deals with investor darlings Moderna, as well as with Blueprint and Arbitus. These three deals alone cost Alexion over $120 million in upfront cash, so that's quite a bold move, especially given the value seen in the Moderna deal. 

Similarly to GSK, Alexion intends to focus on four main therapeutic areas - haematology, neurology, nephrology and metabolic disorders - and bolster its rare disease business. Clearly, like Walmsley, Mr. Hantson was not necessarily thrilled by the pipeline he inherited upon accepting the top job, but in complementary fashion to Ms. Walmsley he has made decisive moves, and quickly. 

New Eli Lilly CEO Dave Ricks is in a similar frame of mind since arriving in January, and has stated his intent to pull some 10 oncology programs (Phase I and II) from the R&D pipeline, and either partner or out-license them. The company's goal is to sharpen the focus on their immunotherapy and combitherapy franchises, with increased attention to tumour resistance approaches. 

They will not just be looking inward, either, as business development efforts will be directed at new external early stage programs of interest. Mr. Ricks firm intent is to get some shine back on the Lilly logo, which has been somewhat tarnished with various later stage disappointments in recent times. 

In rougher news, AstraZeneca was rocked by a big-time failure and dent in its immunooncology (I/O) pipeline with the news their new I/O drug (durvalumab), alone or in combination with a CTLA-4 drug (tremelimumab), failed to meet its primary endpoint of progression-free survival (PFS). This was a devastating outcome for all involved in the MYSTIC trial of patients with advanced, non-small cell lung cancer, wherein the drugs failed to better chemotherapy in terms of PFS, even in patients selected for expression of PD-L1 on 25% (or more) of their tumour cells. 

This outcome had been rumoured for some time, and that rumour may even have fueled and propagated the rumours that AZ CEO Pascal Soriot was set to leave for the top job at Teva; to date Soriot has denied such rumours and stated that he remains committed to AZ. You can bet that there was frenzied interest in this looking-glass outcome from BMS, Roche and Merck, who are all embroiled in combitherapy I/O clinical trials, but not all in identical fashion. 

Merck (and maybe Roche) look set to make further gains in the space via their Keytruda-chemo combo, while the combos involving CTLA-4 are now in some doubt. BMS feel that there is still hope, and mention the fact that their drug targets PD-1, and not PD-L1 (like AZ's Imfinzi), so there may well be a different outcome. 

As I said, it was a busy week (!) and that includes further developments in the local ecosystem, with news of PreciThera's $36M Series A round garnering attention, not least as one of the founders is the ex-CSO of local biotech Enobia (formerly BioMep);  that company was acquired by Alexion for over $1 billion in the last days of 2011, and represents a rare but spectacular exit by a local Quebec-based biotech. 

The syndicate responsible for the Series A round includes Sanderling, Arix, CTI, Emerillon and FTQ, many of whom are relative veterans of such ventures. The company leverages the power of bioinformatics-based tools to compile data obtained from RNA sequencing as well as that in genomic and clinical databases, to delineate and validate the major pathway responsible for clinical symptoms in selected rare genetic disorders. As far as I am concerned, another new biotech here in the province can only be a very good thing, and here's wishing PreciThera all the very best in their quest to discover new drugs for orphan bone diseases.

That just about does it for this boy on this rather busy week, and now I have a sunny chaise longue and a cold drink crying out my name a few feet from my outdoor office table. Wishing one and all a glorious summer weekend!