Friday Five – The week in review

Cardiovascular corner

Data presentations at the annual meeting of the American College of Cardiology (ACC) have dominated industry news flow this past week; none more so than eagerly anticipated outcomes data for Amgen's PCSK9 inhibitor Repatha.

In a nut-shell, Repatha did demonstrate a significant reduction in cardiovascular events, but not to the extent that many were expecting, nor did it demonstrate a reduction in cardiovascular mortality. This suggests that utilisation of the PCSK-9 class will likely increase, but payers will not be swayed into granting unrestricted access, given the cost of these therapies – The Q&A: Contextualising Repatha’s FOURIER performance – the four key questions.

Other notable presentations at the ACC meeting included real-world data from a registry analysis (the CDV-REAL study), which appears to suggest that other SGLT-2 inhibitors (not only Eli Lilly and Boehringer Ingelheim's Jardiance) confer a cardiovascular benefit by significantly cutting hospitalisations for heart failure and death – ViewPoints: Can Farxiga and Invokana ride on Jardiance's cardiovascular coat-tails?

Data from a large observational study – using real-world information collected from the US Medicare database collected in 2013 and 2014 – was presented at ACC showing that Bristol-Myers Squibb's Eliquis demonstrated the strongest efficacy among novel anticoagulants in preventing stroke versus warfarin, and a best-in-class safety profile based on bleeding rates. A separate analysis indicated that Eliquis is also the most cost-effective of the novel therapies – ViewPoints: Observational study could provide boost for Bristol-Myers Squibb, Pfizer’s Eliquis in AF setting.

With the ACC meeting serving as a backdrop, Esperion Therapeutics announced this week the FDA has indicated a willingness to approve its investigational cholesterol-lowering drug bempedoic acid on the strength of positive Phase III data alone, and ahead of results from any required outcomes study. Esperion shares rose more than 70 percent on the news, although key opinion leaders anticipate that positive outcomes data will be necessary if the drug is to be a commercial success – ViewPoints: A lower regulatory bar, but can Esperion's dyslipidaemia hopeful realistically compete without outcomes data?


The expert view

FirstWord's IAV desk continues to seek out views from key opinion leaders, physicians in the field and other industry experts regarding agenda-setting news events…

On the back of positive cardiovascular outcomes data for Amgen's Repatha at the ACC meeting, we consulted with a leading KOL to ascertain the impact of these results – KOL Views: FOURIER not a big win for Amgen’s Repatha but far from a disaster, according to leading cardiologist. See also Spotlight On: Mixed messages – how might Repatha’s FOURIER data impact expectations for Praluent’s ODYSSEY trial?

Furthermore, our snap-poll of US and EU5-based cardiologists provided further insight on what these data may mean in terms of clinical practice – Physician Views Poll Results: Cardiologists predict slight-to-moderate increase in PCSK9 use on back of positive outcomes data.

We also polled dermatologists this week to gauge reaction to new data presented by Novartis, which suggests that its psoriasis treatment Cosentyx could be disease modifying – Physician Views Poll Results: Cosentyx emerges as a preferred psoriasis brand with momentum on its side


Setbacks at Novartis and AstraZeneca

There were a number of high-profile setbacks this week. Novartis announced that its investigational treatment for acute heart failure, serelaxin, had failed to hit its co-primary endpoints in a second Phase III study, while AstraZeneca confirmed that it has received a second complete response letter (CRL) from the FDA for its hyperkalaemia therapy ZS-9.  

Both events will prompt some soul searching; at Novartis because management was confidently talking about the potential multi-billion dollar opportunity for serelaxin just two months ago and at AstraZeneca because it acquired ZS-9 for $2.7 billion (when it bought ZS Pharma) two years ago – ViewPoints: Some stress for Novartis as serelaxin fails late-stage trial and ViewPoints: AstraZeneca's second stumble with ZS-9 will be a housewarming gift for Galenica’s new incarnation.

Indeed, with AstraZeneca also confirming last week that it has sold the COPD therapies Tudorza and Duaklir onto Circassia for $50 million in stock – these were two of the drugs AstraZeneca acquired for $600 million up-front from Allergan in 2015 – the company's recent M&A strategy is likely to come under scrutiny.

AstraZeneca's flurry of deal-making was one means by the current management team to turnaround a weak performance over the previous decade in delivering new drugs to market. On a more positive note, both AstraZeneca and Novartis emerge in a better light when assessing how quickly Big Pharma is to discard drugs that are seemingly poised for failure.


But Eli Lilly moves forward

Positive clinical data from Eli Lilly this week, which confirmed that its investigational breast cancer treatment abemaciclib met its primary endpoint in the MONARCH-2 trial. This should allow Eli Lilly to file abemaciclib as a monotherapy agent in later lines of treatment for HR-positive, HER2-negative breast cancer; an indication which may deliver limited commercial opportunity, but which could underscore the potency of abemaciclib versus marketed CDK4/6 inhibitors; Pfizer's established Ibrance and Novartis' recently approved Kisqali – Physician Views Poll Results: Ibrance to remain in pole position, but Novartis' Kisqali looks primed for oncologist adoption.


Pharma's legal eagles

Pharma appears to be keeping the lawyers busier than normal at the moment. In addition to the ongoing dispute between Amgen and Regeneron Pharmaceuticals regarding intellectual property around the PCSK9 inhibitors, a secondary legal battle has opened between the two players, this time focused on patents covering monoclonal antibodies against the IL-4 receptor.

Regeneron and partner Sanofi filed a pre-emptive lawsuit on March 21 seeking declaratory judgment that Dupixent (dupilumab), a mAb against IL-4R and 13, does not infringe a patent covering the binding of mAb to IL-4R owned by Amgen. In the complaint, Regeneron says that it has learned that Amgen recently hired legal counsel to explore prosecuting infringers of the very same ('487) patent.

Dupixent is a prospective blockbuster that is currently under review at the FDA for atopic dermatitis with a PDUFA date of March 29. The programme is also in development for a host of other allergy-related indications, and is estimated by some analysts to have peak sales potential of more than $5 billion. So it is perhaps no surprise that Regeneron and Sanofi came out guns blazing upon learning about Amgen's putative machinations.

It was also confirmed this week that the US patent office has upheld the validity of a patent protecting Biogen's multiple sclerosis treatment Tecfidera‎ following a challenge by hedge fund manager Kyle Bass. Following an agreement reached between Biogen and Forward Pharma in January, both companies are now awaiting an interference ruling (against Forward) which will determine if the company receives a future 10 percent royalty on Biogen's US sales of Tecfidera – ViewPoints: Biogen gets the wins, but Forward Pharma may share the trophy.

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