The Friday Five – 5 questions raised this week in pharma

June 19, 2014
Ref: The Friday Five Desk

Will industry embrace social media more aggressively now?

Further long-awaited guidance from the FDA on pharma's use of social media – specifically regarding social media platforms with character space limitations (i.e. Twitter) and the correction of independent third-party misinformation – were published this week.

Lack of clarity from the FDA on the issue of social media as a whole has suitably lowered expectations among industry players, while there have been numerous suggestions this past week that new guidance is unlikely to act as a catalyst for a radical change in how pharma shifts its approach to either topic.

Rather, the latest guidance reinforces the notion that while social media and the internet have played a key role in expanding patient access to healthcare knowledge, pharmaceutical manufacturers have been conspicuously absent, Lori Leskin, a partner at Kaye Scholer told FirstWord.

Regarding the use of Twitter, we may see more usage concerning those products that have a more straight forward safety profile, says Leskin, as one of the FDA's requirements is that promoted benefits of a drug need to be offset by the promotion of associated risks; "at least industry knows what the playing field looks like," she adds.

One view, argued by Jeffery Wasserstein, a partner at Hyman, Phelps and McNamara, is that "social media, unlike what FDA is used to, is fast and interactive, not static and slow to change." A more holistic approach to regulating social media would have been appropriate, says Wasserstein, although Leskin refutes this view as unrealistic, suggesting that the FDA has always been a conservative body with regards to public health safety. To expect anything else was perhaps wishful thinking, she adds.

Can Novartis deliver a more focused approach to margin expansion?

Novartis provided the first public overview of its slimmed down and more focused operations this week, with CEO Joseph Jimenez promising both revenue and (prioritising) margin expansion, while maintaining the company's strong track record in drug development via retained investment in R&D expenditure.

Investors, of course, would expect nothing less – and as noted by Bank of America Merrill Lynch analyst Graham Parry, Novartis' share price is probably pricing in most of this positive sentiment already.

However, at the crux of Novartis' growth aspirations – its ability to deliver new, innovative products to market – the company can continue to highlight an array of impressive pipeline compounds. Front and centre at Wednesday's presentation was the experimental chronic heart failure therapy LCZ696, for which the company expects efficacy data to be "medical practice changing" noted JP Morgan's Richard Vosser in a note to investors. See ViewPoints: Novartis' blockbuster aspirations in heart failure market remain intact.

Confidence in the compound is becoming increasingly reinforced, with LCZ696's strong efficacy profile appearing unburdened by any notable safety concerns. While data from the PARADIGM-HF study will be presented at the European Society of Cardiology (ESC) meeting at the end of August, another notable catalyst will be the initiation of Phase III studies for Novartis' CAR-T therapy CTL019 in acute lymphoblastic leukaemia, which will shortly begin when full technology transfer to Novartis is complete.

Will Pfizer's CAR-T licensing deal prove sufficiently differentiated versus competitors?

Retaining a focus on the emerging development space for CAR-T therapies, this week also witnessed Pfizer move into the space via a licensing deal with the French biotechnology company Cellectis.

The collaboration looks important on a number of fronts; it is the first notable strategic move by Pfizer since its efforts to acquire AstraZeneca fizzled out last month and clearly demonstrates a commitment to pursuing immuno-oncology development on Pfizer's part. More intriguingly, industry commentators have been quick to point out that Cellectis' technology platform may provide Pfizer distinct advantages over the likes of Novartis and Juno Therapeutics who are the leading the race in CAR-T development.

See also - Spotlight On: Immuno-oncology high on Pfizer's agenda as it plots post-AstraZeneca strategy with Cellectis deal.

Cellectis – which saw its share price up 67 percent on Wednesday as a result of the lucrative agreement – was not the only biotech to benefit from Pfizer's investment. Capitalising on the opportune timing of the deal, Kite Pharma announced on Thursday that it was upsizing its imminent IPO (June 23) from 6 million to 7.5 million shares, and the price range from $12 to $14 per share to $15 to $16 per share. Not only was the IPO oversubscribed prior to announcement of the Pfizer/Cellectis deal, but Pfizer is likely to be seen as having set a new benchmark for upfront financial commitment in the CAR-T space.

Will recent R&D momentum see biotech investors through a summer sell-off?

Pfizer's deal with Cellectis provided further validation of the CAR-T approach, but it was not the only positive news regarding cutting edge drug discovery this week. bluebird bio also delivered positive data for its gene therapy product LentiGlobin in patients with beta-thalassaemia major; a success that could have broader implications across the broader gene therapy space, one expert told FirstWord – see ViewPoints: bluebird data possible boon for gene therapy.

Early-stage biotech Agios Pharma also contributed to notable R&D momentum this week, first announcing that Celgene had in-licensed its acute myeloid leukaemia therapy AG-221 and then presenting more impressive Phase I data for the compound at the annual meeting of the European Hematology Association (EHA).

Leerink Swann analyst Howard Liang noted "while the duration of response data are still early, given that a response of (between) 2.5 to 4 months is likely already meaningful for [acute myeloid leukaemia], we believe the initial evidence on durability adds an important data-point to the drug's profile and suggests that this so-far well tolerated oral drug could provide a meaningful benefit in a substantial portion of patients."

Analysts appeared to be equally enthusiastic about Celgene's patronage of AG-221, which simultaneously validates Agios' compound and the US biotech's reputation for savvy business development.

Analysts at Deutsche Bank used the Agios announcement as an opportunity to stress that in contrast to the current overhang on Celgene, which stems from intellectual property concerns regarding its flagship drug Revlimid (the 'Markman' case), not only does the company "have the most transformative pipeline" across the large cap peer set, but that its "unique R&D strategy (essentially two pipelines; one internal and one external) remains unappreciated in the long term."

Did anyone 'win' at ADA?

There were few surprises at the annual meeting of the American Diabetes Association (ADA), but a handful of key themes were nonetheless crystallised coming out of the conference. Among these was further confirmation – if analyst assessment is correct – that Novo Nordisk's Tresiba is the superior basal insulin product; a point of frustration, one must assume, at the Danish company given that it remains some years from the US market. In contrast, Sanofi's data for Toujeo – its competitor in waiting and a supportive brand for Lantus – failed to excite analysts.

With regard to oral therapies, ADA provided further evidence that Eli Lilly's dulaglutide will provide the strongest competition yet for Novo Nordisk's Victoza in the GLP-1 agonist market, while fixed-dose combination DPP-4 and SGLT-2 inhibitor products may also pose a threat to GLP-1 agonist growth. One opportunity to bolster sales of Victoza stems from its combined use with Tresiba, while Phase II data to be presented in the first quarter of next year will provide greater clarity on whether Novo Nordisk can sufficiently advance the race to develop an oral GLP-1 agonist.

See ViewPoints: Late to one party, but Novo Nordisk still the trend setter in diabetes

ViewPoints: Sanofi's Lantus successor Toujeo fails to excite analysts at ADA meeting

Physician Views Poll Results: Endocrinologists favour Victoza over dulaglutide – but only just...plus other key findings ahead of the ADA meeting