Friday Five - The pharma week in review (1 August 2019)

Pfizer/Mylan

Pfizer announced that it will combine its Upjohn off-patent branded and generic established medicines business with Mylan to form a new company. Under the all-stock transaction, Pfizer shareholders will own 57% and Mylan shareholders 43%.

For Pfizer, it represents the culmination of a strategy to separate out its innovative pharmaceuticals business, which was first touted by the company's previous CEO Ian Read nearly a decade ago (see ViewPoints: Better late than never? - Pfizer slims down).

Analysts have described the deal as a rescue package for Mylan, which has seen its shares fall by more than half in the past two years, largely due to a loss of pricing power in the generics market.

The new company will be positioned as the world's largest seller of off-patent and generic medicines with estimated revenues of between $19 billion and $20 billion next year.  

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King Keytruda

Merck & Co.'s oncology drug Keytruda has impressed yet again in the past few days.

Alongside Gilead Sciences' HIV therapy Biktarvy, it remains the industry's fastest growing product franchise by some margin, second-quarter results confirm (see Industry snapshot – Keytruda and Biktarvy put other growth drivers in the shade).

Earlier this week, Merck also confirmed that Keytruda delivered positive results in neoadjuvant triple negative breast cancer (TNBC) patients, irrespective of their PD-L1 status.

See ViewPoints: Keytruda steps back into the breast cancer ring and KOL Views: How will Keytruda’s initial success in KN-522 impact TNBC prescribing patterns?

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Q2 highlights

The broader narrative at Merck is that the company's pipeline needs to be fatter. Few are overly concerned at present, however, with Keytruda continuing to deliver impressive growth. In short, management has time on its side to solve this issue.

Elsewhere, AbbVie posted impressive early revenues for its new psoriasis treatment Skyrizi, while Pfizer's breast cancer therapy Ibrance continues to deliver strong growth. This is important, with Eli Lilly and Novartis both confirming survival benefits for their competing CDK4/6 inhibitors this week; Pfizer says it has successfully been targeting oncologists who had previously had little exposure to this drug class.

Sanofi and Regeneron Pharmaceuticals' Dupixent - for atopic dermatitis and asthma - provided the former with an important fillip when the French company announced its second-quarter results this week. Eyebrows were raised at a $2 billion impairment charge against the haemophilia A treatment Eloctate, brought into the fold via last year's acquisition of Bioverativ. Sanofi conceded it had underestimated the future impact of Roche's competing therapy Hemlibra (see ViewPoints: Sanofi's push into haemophilia A falters).

The most notable disclosure in Amgen's second-quarter results was not related to financials, but the pipeline; the company confirmed it has seen responses for its heavily touted KRAS inhibitor in colorectal cancer patients. Investors are hoping this product can be a multi-billion dollar blockbuster; Amgen needs one (see ViewPoints: Amgen’s big ticket item just got bigger). 

Eli Lilly's key blockbuster - the diabetes treatment Trulicity - continues to perform impressively, though it will be interesting to see what impact stems from the anticipated approval of Novo Nordisk's oral semaglutide later this year.   

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Entresto falls just short

Novartis' efforts to expand the population eligible patients to be treated with its heart failure drug Entresto have hit a snag; the company confirmed this week that a study evaluating use in heart failure patients with preserved ejection fraction (HFpEF) narrowly missed its primary endpoint.

After a slower than expected launch, Entresto has become a key growth driver for Novartis, with second-quarter sales rising 76% year-on-year to $421 million. A lack of competitor products on the horizon enhance its status within the company's portfolio.

Novartis is hopeful that a lack of established treatment options for HFpEF may allow it to leverage clinically important benefits demonstrated by Entresto in this disease setting (see ViewPoints: Can Entresto’s ‘clinical importance’ trump statistical significance in HFpEF?).

With HFpEF representing a milder condition than Entresto's approved indication of heart failure with reduced ejection fraction (HFrEF), the bar set for Novartis was always deemed to be relatively high. Whether it has shown enough evidence to warrant meaningful regulatory discussion remains to be seen.

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AbbVie's tau update

AbbVie was the bearer of disappointing news this week, confirming in its second-quarter results announcement that evaluation of an experimental antibody targeted against tau for progressive supranuclear palsy (PSP) has been discontinued, after a Phase II study failed to clear a futility analysis.

AbbVie will continue developing the candidate, known as ABBV-8E12, in a Phase II Alzheimer's disease study, though expectations for this drug - and possibly tau as a target - may need to be lowered (see ViewPoints: AbbVie fires warning shot for next great hope in Alzheimer’s disease).

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