Friday Five – the pharma week in review

Evenity looks approvable…but is it useable?

Amgen and UCB's Evenity looks well positioned to secure US approval for the treatment of osteoporosis, following a positive AdCom recommendation on Wednesday. 

The FDA issued a complete response letter in 2017 owing to pivotal-stage data linking Evenity to an increased rate of cardiovascular adverse events. Sixteen of 19 AdCom panellists agreed that a narrower label for women at a high risk of fracture, together with a black box warning, are adequate measures to support approval.

However, AdCom discussion was suggestive of some consensus that there is insufficient data to properly characterise the cardiovascular risk and analysts at Bernstein suggested adoption of the drug by physicians will likely be heavily limited until this issue is resolved.

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Biotech continues to snag Big Pharma leadership  

The exodus of senior management from Big Pharma to biotech continues apace with it confirmed this week that David Berman - formerly head of AstraZeneca's immuno-oncology R&D unit - moved to head up R&D at Immunocore in September, while Roche's head of neuroscience R&D Omar Khwaja is to become chief medical officer at Voyager Therapeutics.

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AstraZeneca's management shake-up

Confirmation of Berman's departure also adds to the recent turnover in senior positions at AstraZeneca, which has seen former MedImmune head Bahija Jallal assume the role of CEO at Immunocore and Mark Mallon - previously AstraZeneca's executive vice president of global product and portfolio strategy - snag the top job at gastrointestinal specialists Ironwood Pharmaceuticals.

AstraZeneca also confirmed this week the pending departure of Sean Bohen, its head of product development, who is expected to leave the company later this year.

Earlier this month, AstraZeneca announced that José Baselga, who most recently served as physician in chief at Memorial Sloane Kettering Cancer Center, will join the company to head a newly-created R&D unit for oncology. AstraZeneca said it is looking to more closely align its research and commercial operations.

In a note to investors, Wolfe Research analyst Tim Anderson wrote "do these departures foretell an R&D crisis at the company, or some sort of imminent bad news? Not likely, in our view. However, the optics of having respected leaders leave a company is never good."   

Another analyst, speaking anonymously to FirstWord, described the concurrent departure of Bohen, Jallal and Mallon as "a bit of bad timing and the pull of biotech."

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Cosentyx headwinds from ECLIPSE

Feedback from one of our latest Physician View snap-polls suggests that Novartis' Cosentyx franchise - used to treat moderate-to-severe psoriasis - faces an increased competitive threat from Johnson & Johnson's Tremfya, following the presentation of positive head-to-head data in favour of Tremfya from the ECLIPSE study.

Cosentyx is one of Novartis' key sales growth drivers, though encouragingly for both companies, dermatologists expect their overall use of biologic psoriasis therapies to increase notably over the next few years.

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Notable items in brief…

Two pharma firsts relating to China this week: BeiGene became the first company from mainland China to secure FDA breakthrough therapy status - for its BTK inhibitor zanubrutinib as a second-line therapy in mantle cell lymphoma (more here) - and AstraZeneca became the first multinational company to in-license Chinese marketing rights for a domestically discovered innovative pharmaceutical product (Luye Pharma's lipid-regulating Xuezhikang capsules).

In the first 9 months of 2018 AstraZeneca generated 19 percent of its global sales in China, a significantly higher proportion than any of its Big Pharma competitors. This week also saw Chinese approval for Ironwood’s Linzess for irritable bowel syndrome (IBS), which AstraZeneca will co-promote.

The FDA is to increase the number of staff to oversee the review of cell and gene-based therapies in anticipation of a notable increase in investigational new drug (IND) applications, the agency announced this week. By 2025, the FDA expects to approve between 10 and 20 new cell and gene-based products a year, said commissioner Scott Gottlieb.

A notable approval this year is likely to be Novartis' Zolgensma, an experimental gene therapy for the treatment of spinal muscular atrophy (SMA), which is scheduled for US marketing clearance by May.

Be sure to check out our analysis of the key drugs that will shape 2019, which features Zolgensma, here.

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