Friday Five – Your weekly pharma review

Novartis announces CEO succession plan

Novartis confirmed that R&D chief Vasant Narasimhan will replace Joe Jimenez as CEO next February. Narasimhan's appointment has been made to coincide with the company's entry into a new growth phase, said chairman Joerg Reinhardt. After serving seven years as CEO, Jimenez said he will return to the US and hinted at a future role in the health-technology sector.

Narasimhan inherits a company that retains a reputation for innovative R&D and the more streamlined operating structures implemented by Jimenez. That said, a number of challenges await, with a notable focus on converting scientific breakthroughs into commercial success in the form of products such as Entresto and Kymriah. Narasimhan will also oversee whatever plan Novartis decides to implement regarding Alcon, its ophthalmology unit, which remains under strategic review. He must also decide whether to sell Novartis' sizeable stake in Roche and choose whether to divest its share of the consumer healthcare joint venture set up with GlaxoSmithKline in 2014.

Jimenez, who inherited Alcon from predecessor Daniella Vasella (who oversaw its acquisition in 2008 shortly before stepping down), will provide an update on the business at year-end – ViewPoints: In Novartis' Jimenez, pharma loses a progressive CEO.

Gilead's free run at CAR-T

Gilead Science is set to play the role of chief competitor to Novartis in the emerging field of CAR-T therapy, although it remains to be seen if other large-cap players are as keen about this therapeutic approach at present. An SEC filing this week shows that Gilead was the only active bidder for Kite Pharma, which it agreed to acquire for around $12 billion last month – ViewPoints: Gilead flew solo in Kite chase.

The filing reveals some other interesting details, showcasing Kite's internal revenue projections for the CAR-T therapy axi-cel, which in 2020 are approximately double that of current consensus forecasts. Challenges are also in evidence, however, with Kite management internally modelling notably higher costs for axi-cel versus analyst expectations, while Novartis may have recently opened a can of worms where CAR-T pricing is concerned.   

Furthermore, concerns about CAR-T toxicity will not dissipate anytime soon. Cellectis – which is looking to lead the field in 'off the shelf' CAR-T products suffered an unfortunate setback this week – ViewPoints: Cellectis off to a rough start with its first test of solo CAR-T asset.

ESMO a go-go

New clinical data scheduled to be presented at this weekend's European Society of Medical Oncology (ESMO) congress could have significant implications for a raft of Big Pharma players and smaller biotechs – ESMO 2017 Preview – What to watch - FirstWord will be in attendance.

Two important presentations for AstraZeneca – comprising data from the PACIFIC and FLAURA trials – hold additional relevance given the company's high level of exposure to pivotal R&D readouts and its recent setback with the MYSTIC study – see ViewPoints: ESMO 2017 – expectations high for AstraZeneca's PACIFIC data and ViewPoints: ESMO 2017 – where is the bar set for AstraZeneca's FLAURA trial?

Among other readouts, Merck & Co. will present updated results from the Keynote-021 trial assessing Keytruda plus chemotherapy in first-line non-small-cell lung cancer (ViewPoints: ESMO 2017 – will updated Keynote-021 data nudge Merck & Co.'s chemo-combo further into the treatment paradigm for NSCLC?), while subtleties in competing datasets may provide further indication as to how competitive dynamics will play out in the PARP inhibitor market 

Presentation of data from Bristol-Myers Squibb's CheckMate-214 trial has taken on additional significance following the company's announcement on Thursday that the study has been halted because its combination of Opdivo and Yervoy has shown an overall survival benefit versus Sutent in previously untreated renal cell carcinoma. Only recently, Bristol-Myers Squibb had confirmed the '214 trial had failed to meet one of its three co-primary endpoints – progression-free survival (PFS) – so the update represents an important reprieve – KOL Views Results: Leading oncologist cautions against jumping to conclusions on PD-(L)1/CTLA-4 combinations in RCC.

AstraZeneca may also see the OS win as a positive sign for MYSTIC, which is also assessing a PD-(L)1/CTLA-4 combination and also missed its PFS endpoint at an interim analysis – albeit in a different indication (lung cancer).  

Restructuring, divestment and acquisition

In a relatively busy week for business development, Eli Lilly announced on Thursday that it will reduce its headcount by some 3500 positions, or 9 percent of its workforce. The company recently announced positive news regarding the refiling of its JAK inhibitor Olumiant for rheumatoid arthritis, but faces the threat of new competition in the diabetes market and risk of generic erosion to Alimta sales in the US market from 2018 (if a patent ruling is unfavourable). Eli Lilly is also scheduled to present keenly anticipated data for its CDK4/6 inhibitor abemaciclib at ESMO this weekend, which should give the clearest view to date on how competitive this drug could be versus Pfizer's Ibrance and Novartis' Kisqali.

Merck KGaA announced this week it is exploring strategic possibilities for its consumer healthcare division, including a potential sale. "Scarcity of quality assets" in this market could facilitate a favourable deal, noted analysts at Morgan Stanley, and makes strategic sense given recent divesture of its biosimilars business and renewed pipeline momentum within the innovative pharmaceuticals business. A partial sale or strategic partnerships to enhance growth opportunities in the consumer healthcare market were also highlighted as options by the company.

Namesake Merck & Co. announced the acquisition of Rigontec to further its aspirations in immuno-oncology. The biotech specialises in harnessing innate immunity to turn "cold" tumours into "hot" ones that are responsive to checkpoint inhibitors – ViewPoints: Merck & Co. taps Rigontec in a growing bid to turn up the heat in immunotherapy.

A flurry of data readouts

Insmed's shares jump as late-stage study of lung disease therapy ALIS hits main goal (see also ViewPoints: Phase III success for ALIS means it is time for Insmed to look East)

Verastem's duvelisib hits main goal of late-stage study; filing in US targeted for 2018

Sarepta's shares rise on positive Phase I/II results for experimental DMD drug golodirsen (see also ViewPoints: Sarepta open to an abbreviated path for golodirsen – but will FDA play ball?)

Amgen, AstraZeneca's experimental drug tezepelumab hits main goal of mid-stage study for uncontrolled asthma

AstraZeneca targets US filing for COPD therapy Duaklir after late-stage study success

Alnylam suspends dosing in studies of RNAi therapeutic fitusiran for haemophilia after patient death

Voyager Therapeutics Announces Positive Results from Ongoing Phase 1b Trial of VY-AADC01 for Advanced Parkinson’s Disease (see also ViewPoints: Voyager makes its case to Sanofi)

AbbVie’s Upadacitinib (ABT-494) Meets Primary Endpoint in Phase 2b Study in Atopic Dermatitis

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