Friday Five - The pharma week in review (29 August 2019)

Amgen all in on Otezla

Scuttlebutt suggested that Amgen was gearing up for a big deal but rather than buying an orphan in the rough – Alexion Pharmaceuticals was a rumoured target – the company splurged instead on Otezla (apremilast), a blockbuster psoriatic drug that Celgene is being forced to unload in order to get regulatory approval for its tie-up with Bristol-Myers Squibb.

The $13.4 billion that Amgen is paying, which ends up being closer to $11.2 billion net of future tax benefits, nevertheless comes in well above what analysts were expecting. The fee indicates that the process was very competitive while, more importantly, suggesting that Amgen is more confident in its own auto-inflammatory sales organisation than it is about the prospects for Bristol-Myers Squibb’s highly touted TYK2 inhibitor.

See – ViewPoints: Amgen agrees to book Bristol-Myers Squibb’s big bet on TYK2

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Amgen’s lawyers fallible after all

It seemed as though Amgen’s legal team could do no wrong after they pulled out a number of close decisions, notably an unexpected victory that may protect the aging Enbrel (etanercept) franchise for another decade, but this week brought an equally surprising reverse when a district court judge partially vacated a previous win by ruling that patents protecting Repatha (evolocumab) are invalid.

The decision offers a lifeline to Regeneron Pharmaceuticals and Sanofi, which are a step closer to ensuring that their competing anti-PCSK9 mAb Praluent (alirocumab) will remain on the market. More here.

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PCSK9 party planning

While Amgen and Regeneron/Sanofi continue to battle it out in court, the respective mAbs may soon both be facing another significant challenge in the form of The Medicine Company’s inclisiran, an anti-PCSK9 RNA therapy that this week scored what appears to be a solid success in the first of three crucial Phase III trials that are slated to readout this half.

The Medicines Company, which licensed the programme from Alnylam Pharmaceuticals, reported that twice-yearly inclisiran met all primary and secondary endpoints in the ORION-11 trial, with a safety profile that was “at least as favourable” as prior studies. This is important because rare but serious side effects have stung several other RNA therapies, so physicians are especially interested in learning more about the product’s tolerability profile. More here.

Detailed ORION-11 data will be presented on September 2 and FirstWord plans to speak with an expert in the immediate aftermath to solicit feedback on how the competition amongst the PCSK9 inhibitors is shaping up. See: KOL Views: How much did ORION-11 win boost inclisiran's competitive profile versus anti-PCSK9 mAbs?

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First opioid decision is a... loss?

A judge in Oklahoma rendered a $572-million verdict against Johnson & Johnson this week after deciding that the US drugmaker’s opioid marketing practices ran afoul of the state’s “public nuisance” statute, though the size of the penalty was far lower than what the Street was expecting. More – and far bigger – battles lay ahead, though unnamed sources suggest Purdue Pharma may be willing to pay up to $12 billion to settle thousands of lawsuits that have been against it.

See – ViewPoints: Johnson & Johnson’s loss in opioid case seen as win for industry

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KOLs opine on Farxiga, Rinvoq

One expert told FirstWord that positive top-line results for AstraZeneca’s Farxiga (dapagliflozin) in the Phase III DAPA-HF trial in heart failure patients are indeed a big deal, and in fact could be practice-changing if the benefits prove to be experienced by non-diabetics as well as diabetics when data are revealed later this year. More here.

See – KOL Views Results: Farxiga’s DAPA-HF may be practice-changing but only if HF benefit is without prejudice, says leading expert

Another clinician said that AbbVie’s newly approved Rinvoq (upadacitinib) is a welcome addition to the rheumatoid arthritis (RA) treatment landscape, though a black box warning consistent with other members of the JAK inhibitor class means that the onus is on the company’s relationships with formulary managers as much as rheumatologists will be key to dictating how the drug is used.

See – KOL Views Results: AbbVie’s dealings with formulary managers will play key role in dictating use of Rinvoq

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