Friday Five - The pharma week in review (17 October 2019)

More complementary M&A

Alexion is to acquire Achillion Pharmaceuticals in a deal potentially worth more than $1 billion, reflecting more strategic re-positioning among companies developing treatments for complement-mediated diseases. Just last week, UCB said it would acquire Ra Pharmaceuticals for $2.5 billion.

Was Alexion outbid for Ra Pharma or is its deal for Achillion a swift response? Regardless, both deals are likely to be scrutinised by the US Federal Trade Commission (FTC) for potential anti-competitive behaviour, warned some analysts. Alexion is now in control of seven of the 15 mid-to-late stage pipeline drugs being developed in this particular field of rare diseases.

Analysis - ViewPoints: Alexion dealmaking could prove a little too complementary

Alexion said acquiring Achillion provides it access to oral therapies that should uniquely position it to treat class C3 glomerulopathy (C3G), and extravascular haemolysis (EVH) in patients with paroxysmal nocturnal haemoglobinuria (PNH). Notably these represent a subset of PNH patients who do not respond to Alexion's marketed C5 inhibitor Soliris.

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Reyvow approved for acute migraine

The FDA this week approved Eli Lilly's Reyvow, a new treatment for acute migraine.

Importantly, the drug is not labelled as increasing cardiovascular risk, which could help to differentiate it from cheap, generic triptans. Furthermore, some 40% to 50% of acute migraine patients do not benefit with triptan therapy, suggesting Reyvow could have a sizeable market to play in.

Competition from other oral agents is not far behind, however, and experts have been concerned that Reyvow causes dizziness in a sizeable proportion of patients. Predicting adoption rates for Eli Lilly's newest approval therefore remains something of a headache.

See KOL Views: Can Eli Lilly turn Reyvow into more than a niche acute migraine drug?

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Abrocitinib impresses in AD

Pfizer unveiled impressive efficacy data for its oral, once-daily JAK inhibitor abrocitinib in patients with moderate-to-severe atopic dermatitis, raising expectations it could emerge as a viable competitor to Sanofi and Regeneron Pharmaceuticals' blockbuster therapy Dupixent.

Analysis - ViewPoints: Pfizer's abrocitinib raises bar for JAKs in atopic dermatitis

Cardiovascular safety issues were not in evidence, though scepticism towards the broader safety profile of JAK inhibitors is likely to persist for the meantime; particularly so in atopic dermatitis because Dupixent is widely perceived to be a very clean agent. Pfizer will present data from a second Phase II study early next year, providing it a further opportunity to build its case for abrocitinib.

See also Physician Views snap poll: Asking dermatologists to assess Pfizer's new Phase III atopic dermatitis data for abrocitinib and KOL Views: How much of a threat is Pfizer's abrocitinib in atopic dermatitis?

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A quick return for Reata

Just four days after announcing a deal to buy back exclusive rights to its portfolio of Nrf2 activators from AbbVie, Reata Pharmaceuticals confirmed that one of these agents - omaveloxolone - had met its primary endpoint in a mid-stage study for the rare condition Friedreich's ataxia. Reata said neither it nor AbbVie had been privy to the results before the buy-back deal was signed.

AbbVie can take solace in the fact that it is ideally looking for larger sales growth drivers to offset an anticipated decline in Humira sales, though Stifel analysts have bullishly suggested the market for effective Friedreich's ataxia therapies could be worth up to $3 billion.

Analysis - ViewPoints: Reata takes bardoxolone on solo tour

AbbVie received $330 million from Reata last week, but it remains to be seen if new momentum for omaveloxolone justifies this strategy. The company's shares did at least rise 39% on Monday.

AbbVie paid an eye watering $850 million upfront to in-license omaveloxolone and a separate drug, bardoxolone, back in 2012 before safety concerns upended the latter's promising role as a treatment for chronic kidney disease. 

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Johnson & Johnson, Teva look to pay off legal headwinds

Johnson & Johnson has reportedly offered to pay $4 billion to settle all US opioid lawsuits against the company as part of a wider deal involving drugmakers and distributors, Bloomberg reported this week. Meanwhile, sources indicated that Teva has proposed giving away more than $15 billion in generic drugs, including those that help fight opioid overdoses, in a bid to dismiss all the cases against it as part of an agreement that could span over 10 years.

Commenting on Teva's offer, Elizabeth Burch from the University of Georgia said the company may be signalling that it faces bankruptcy if it is turned down. "I guess free drugs are better than nothing, but it's not perfect," Burch said, adding "the real question is whether the local governments want to keep this company out of bankruptcy by accepting this offer."

Bernstein analyst Ronny Gal concurred that "any settlement that does not include bankruptcy and spreads the cost out over time would be a positive for Teva." He suggested that such a deal would also provide "multiple added benefits that reduce the economic impact of the settlements" for Teva.

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