Friday Five - The pharma week in review (23 May 2019)

Merck & Co. acquires Peloton

Merck & Co. swooped in to acquire Peloton Therapeutics this week, heading off a planned IPO by the biotech company. The upfront cost is $1 billion.

The deal provides Merck access to PT2977, an oral therapy with a novel mechanism of action currently moving into late-stage development for renal cancer.

Merck recently secured approval for the combination of its PD-1 inhibitor Keytruda and Pfizer's tyrosine kinase inhibitor Inlyta for first-line renal cancer patients, but faces competition in this market.

It seems inevitable that PT2977 will now likely be studied as a combination agent with Keytruda with a view to offering clinical advantages over current therapies and potentially allowing Merck to market a combination therapy developed entirely ‘in house’.

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Amgen acquires Nuevolution

Amgen agreed to acquire the Danish drug discovery specialist Nuevolution for $167 million; the two companies have been collaborating since 2016.

Amgen has indicated that development of two oncology compounds discovered via this partnership is progressing rapidly and with associated royalty payments worth up to $800 million, the financial incentive to acquire Nuevolution is clear.

Amgen indicates that strategic rationale for the deal extends beyond this consideration, however, and will allow it to closer integrate Nuevolution's DNA-encoded library-based drug discovery platform with its internal R&D capabilities.

With Neuvolution also working with Johnson & Johnson and Almirall among others, Amgen may have also decided to move early to head of competition from any other motivated buyers.   

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Health-tech in focus

There were two notable announcements in the field of health-tech this week; a fundraising for the drug discovery computing platform Schrödinger and the collaboration between Verily and four major drug companies designed to enhance clinical study recruitment.

Schrödinger, which is backed among others by Bill Gates and Google Ventures, has previously out-licensed its capabilities to biotech companies, but hopes to start developing drugs itself. Focusing on cancer therapeutics, it hopes to have a drug candidate ready for clinical testing next year. It is one of numerous companies aiming to use a combination of computing power and access to large genetic data sets as a way to speed up the drug development process.

Elsewhere, Verily - the life sciences focused subsidiary of Alphabet - has partnered with Novartis, Otsuka, Pfizer and Sanofi to develop digitally-focused, patient-centred trial research programmes through its ongoing Project Baseline initiative. The collaborators will explore novel approaches to collating real-world data and hope to initiate clinical trials using the platform.

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An expert view on roxadustat

It is widely acknowledged that FibroGen recently made something of a pig's ear of releasing pooled safety data for roxadustat; an experimental treatment for anaemia in patients with chronic kidney disease.

The drug, which has been co-developed with AstraZeneca, is touted as a potential blockbuster and has been prominent on the radar of biotech investors. But when data was released earlier this month, FibroGen was punished for a lack of clarity in how the analysis could be understood by shareholders and whether it would meet the demands of the FDA.

Some complexities were to be expected; data was pooled from nine trials with differing endpoints required for the evaluation of safety from US and European regulators.

Encouragingly for all involved with roxadustat, a US-based nephrology key opinion leader FirstWord spoke to this week described safety results as encouraging and likely supportive of approval. Furthermore, non-inferiority versus placebo in non-dialysis patients will make it hard for the FDA to add a black box warning to roxadustat's label, the expert believes.

More here

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BioCryst's HAE hope looks to have come up short

The chances of BioCryst upsetting the applecart in the hereditary angioedema (HAE) market may have diminished despite its compound BCX7353 delivering positive Phase III data this week.

New HAE therapies from Takeda and CSL have significantly advanced the standard of care, but are antibody-based and must be given by injection. Investors have therefore been closely following BioCryst's progress as BCX7353 is an oral therapy.

Results published this week, however, suggest that BCX7353 may not sufficiently reduce the rate of HAE attacks to warrant sizeable switching away from more efficacious injectable therapies. Shares in BioCryst declined more than 50 percent as a result.

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