Friday Five - The pharma week in review (10 April 2020)

The latest moves to combat COVID-19

As the number of clinical trials investigating potential COVID-19 treatments increases, therapies under development are falling into three broad categories; the near term re-tooling of existing marketed or late-stage agents (including antivirals), emergence of novel therapies with a sharp focus on neutralising antibody products and the long term goal of an effective vaccine.

More details here and also discussed in the first episode of our new COVID-19 podcast.

Gilead Sciences’ antiviral remdesivir remains the most closely watched agent and analysts were quick this week to highlight some changes to the design of studies being sponsored by Gilead (due to read out in May) which they suggest are likely being informed by data emerging from hospital-run studies in China (which are due to read out later this month).

Analysis here

Gilead has been ramping up its production of remdesivir and supplying it to some patients outside of clinical trials through expanded access programmes; compassionate use was also approved by EU regulators this week.

Elsewhere, GlaxoSmithKline and Vir Biotechnology said they will collaborate on various approaches to developing COVID-19 therapies (including a $250m equity investment by GSK in Vir) and Takeda and CSL will lead a coalition of companies which are aiming to accelerate the availability of plasma-derived therapy using plasma donated from patients who have recovered from COVID-19. 

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Pharma flexes its credentials to ride out the storm

FirstWord continues to track the potential implications of the COVID-19 pandemic on how the pharmaceutical industry operates (look out for more Physician Views poll data illustrating its disruptive effect on patient management and drug prescribing next week) with the most notable company disclosures to date concerning the delayed enrolment of new patients into clinical studies.

The start of Q1 earnings season next week should provide more visibility in what effect COVID-19 will have on operating performance but in the meantime investors will have been pleased to see Arrakis Therapeutics and Roche signing a new drug development partnership – unrelated to COVID-19 – earlier this week.

See ViewPoints: Dealmaking in the time of COVID-19

Analysts are confident that pharmaceutical companies – particularly the larger, established players – will be better insulated from COVID-19 fallout than other parts of the healthcare sector.

Elsewhere, venture capitalist Bruce Booth noted that biopharma venture capital funding into private companies reached an all-time high last month including two new funds worth a combined $1.5 billion brought in by ARCH Venture Partners to support early stage biotech investment.

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SAGE slims down

Away from the challenges caused by COVID-19, Sage Therapeutics is facing its own set of problems, caused by the failure of its experimental depression drug SAGE-217 to hit its primary endpoint in a Phase III clinical study in December. As a result, the company announced this week that it will cut its workforce by more than 50%.

Analysts were quick to applaud the cost cutting initiatives but noted that 2021 will be a critical year for the company as data will read out from two soon to be initiated new Phase III studies of SAGE-217 in patients with major depressive disorder. The company remains confident that these data read outs will not be impacted by the pandemic.

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Risdiplam approval pushed into H2

Roche said this week that the FDA has extended its priority review of the company’s filing for risdiplam in spinal muscular atrophy (SMA) from May 24 to August 24. According to Roche, the extension stems from the recent submission of additional data by the company, including results from the pivotal SUNFISH Part 2 study, which is says could help ensure access to risdiplam for "a broad range of people living with the condition, if approved."

The delay should provide some breathing space for Biogen, whose Spinraza franchise is expected to face the most pronounced competitive impact from risdiplam, though may prove to a blessing in disguise for Roche also if risdiplam is approved with a more comprehensive label and is launched later in the year when disruption to new drug launches caused by COVID-19 may have subsided.

Analysis – ViewPoints: A Roche delay and a Biogen reprieve

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Immunomedics’ stock rises

Immunomedics – frequently cited as the longest established biotech company without a drug approval to its name – saw its share price soar this week when it confirmed that an ongoing study of the experimental treatment sacituzumab govitecan in triple negative breast cancer patients has been stopped early.

Ironically the decision to stop this study is unlikely to have little bearing on the potential imminent US approval sacituzumab govitecan as a later line treatment for TNCB, CEO Behzad Aghazadeh told FirstWord.

It should, nevertheless, allow Immunomedics to maintain all important momentum with an approval decision by the FDA expected on or before June 2.

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