Friday Five - The pharma week in review (21 February 2020)

Another crack in Keytruda’s armour

Merck & Co. has used an impressive run of clinical wins to turn Keytruda (pembrolizmab) into the king of the checkpoint inhibitor castle, with sales jumping by nearly $4 billion to more than $11 billion in 2019. Indeed, the anti-PD-1 mAb’s track record in indications like head and neck, renal and especially non-small cell lung cancer was such that its momentum felt almost unstoppable.

See – Spotlight On: Pharma's fastest growing drugs

However, this week brought news of another minor setback for Keytruda, as the FDA requested additional information rather than approving a new administration schedule that would extend dosing to six weeks from every three weeks. The EMA already approved the new regimen.

This comes on the heels of some readouts in small-cell lung cancer (SCLC) and triple negative breast cancer (TNBC) that some analysts have suggested were less stellar than investors had gotten used to. Merck appeared to brush off the significance of the news, and then again why wouldn’t it given the path that Keytruda is still headed on.

See – ViewPoints: Merck & Co. managing multiple Keytruda missteps

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Incyte back in stride

Incyte plans to begin diversifying away from Jakafi (ruxolitinib), a blockbuster JAK inhibitor that it markets with partner Novartis for myelofibrosis and other oncology-related indications, has run into some speed bump in the last couple of years.

The company looks to have hit on a winner this time, though, by way of a new topical formulation of ruxolitinib that CEO Herve Hoppenot says will lay the foundation for a fledgling dermatology division. This week, Incyte reported that the compound succeeded in a second Phase III trial to treat atopic dermatitis, which is expected to form the basis of an NDA submission later this year – assuming no surprises from long-term safety extensions. More here.

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Will Esperion’s new friends stick around?

All eyes this week remain fixes on the FDA this week as a decision on dyslipidaemia candidate bempedoic acid from Esperion Pharmaceuticals is expected on February 21. The agency declined to hold an AdCom, which along with bullish chatter and a positive review in Europe has convinced a number of investors to throw their lot in which the company over the last couple months.

The big question is how many plan on sticking around after what they hope is an uneventful thumbs up. Indeed, Esperion is facing no shortage of commercial headwinds in a market where the likes of Amgen and Regeneron/Sanofi have been struggling, and where Novartis’ inclisiran is also in front of regulators.

See: ViewPoints: Street warming to Esperion’s bempedoic acid – for now?

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bluebird not yet rocking or rolling

Investors were not pleased this week when bluebird bio disclosed a delay in its planned rolling BLA submission for Zynteglo (formerly known as LentiGlobin), which had been slated for year end 2019 but has been pushed back into 2H20 due to the need to provide some additional – but unspecified – chemistry, manufacturing and controls information.

Shares of bluebird were down more than 10% at one point, perhaps reflecting disappointment mixed with latent anxiety about why the company has yet to post any sales of Zynteglo in Europe, where it was approved last October.

See – https://www.firstwordpharma.com/node/1701917

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KOLs opine on tucatinib, val-rox

One expert discussed with FirstWord how they see tucatinib fitting into the treatment paradigm for metastatic HER2-positive breast cancer, notably in patients with brain metastases, after an NDA for the small molecule HER2 inhibitor was accepted for review by the FDA last week.

See – KOL Views Results: Expert predicts tucatinib will play a key role for HER2+ breast cancer patients with brain metastases

Another clinician opined on the commercial prospects of BioMarin Pharmaceutical’s valoctocogene roxaparvovec (val-rox), an adeno-associated virus (AAV) gene therapy that is in front of regulators in the US and EU as a treatment for haemophilia A. The FDA accepted an NDA for the programme and assigned it priority review this week.

See – KOL Views Results: BioMarin's val-rox likely a niche product in haemophilia A, says expert

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