Friday Five – the pharma week in review

Where next for NASH?

Late-stage failure of Gilead Sciences' NASH hopeful selonsertib raises many more questions than answers.

Does this disease, which has attracted multi-billion dollar revenue estimations, remain poorly understood by drug developers, or was Gilead simply too quick to press on with pivotal-stage studies for an asset that delivered less than compelling mid-stage data?

What are the implications for other developers in the field evaluating different mechanisms of action? Intercept Pharmaceuticals will be the next company to unveil Phase III data. And what are the implications for Gilead and its incoming CEO Daniel O'Day? This setback in NASH has prompted renewed debate that the company lacks a special touch outside of antiviral drug development; O'Day's experience at Roche is designed to change that.

Analysis - ViewPoints: NASH - All eyes on Intercept to finish what it started and ViewPoints: Strike one for Gilead's Phase III hopes in NASH, as all eyes turn to Intercept


Spravato could provide new hope for depression patients

Johnson & Johnson's nasal spray Spravato (esketamine) - a chemical cousin of ketamine - appears poised to secure approval in the US for treatment-resistant depression, following a positive AdCom vote this week.

This is also good news for other companies developing similar agents, which could expand the range of options available for patients with depression who have failed oral therapies, though with approval of Spravato, the focus  will increasingly shift on how quickly the drug could be adopted in light of what are expected to be somewhat onerous safety and monitoring measures.

Analysis - FDA advisory panel backs approval of Johnson & Johnson's depression drug Spravato

We will be snap-polling psychiatrists over the next week to gauge how they expect to use Spravato.


King Keytruda

Data to be presented this week at the ASCO-GU conference in San Francisco are set to position the combination of Merck & Co.'s PD-1 inhibitor Keytruda and Pfizer's tyrosine kinase inhibitor Inlyta as a new standard-of-care therapy for first-line renal cell carcinoma (RCC).

Abstract data released earlier this week from the Keynote-426 trial showed the combination reduced the risk of death by 47 percent versus Sutent monotherapy, irrespective of patients' prognosis status and PD-L1 status.

The result looks certain to exert more pressure on Bristol-Myers Squibb's Opdivo and Yervoy franchises, which were first approved in combination for frontline RCC last year. Uptake of the pairing has been swift on the back of a 37 percent reduction in risk of death and despite data from the CheckMate-214 study suggesting this benefit was largely driven by PD-L1 positive patients.

Merck's success will also diminish any opportunity for Pfizer and Merck KGaA's PD-L1 inhibitor Bavencio; which used in combination with Inlyta has demonstrated a progression-free survival benefit in first-line RCC, but is yet to meet its overall survival endpoint.

Keytruda, once again, has come out on top of the pile.

See also - ViewPoints: Exelixis playing Cabometyx to win


The end of an era for Advair

Revitalisation of GlaxoSmithKline's oncology pipeline - a key feature of company disclosures in recent weeks (see Key takeaways from GlaxoSmithKline's Q4 earnings and investor call - has come at the right time; Mylan confirmed this week the launch of the first generic Advair product in the US. It will be made available at a 70 percent price discount to GlaxoSmithKline's respiratory brand, exerting pressure on Advair and newer products in the company's respiratory franchise.

Away from generic-induced pricing pressure, Sanofi and Regeneron Pharmaceuticals also confirmed this week they will drop the list price of their PCSK9 inhibitor Praluent to $5850 in the US market; matching the price of Amgen's Repatha and providing further evidence of the market realities this drug class faces.

By April, the FDA will decide whether data from Sanofi and Regeneron's ODYSSEY outcomes study can be added to Praluent's label. This, combined with the price drop, could ratchet up competitive pressure on Amgen as Praluent's outcomes trial enrolled what is widely considered to be a sicker population than Repatha's. Cardiologists in the US will now have the option to prescribe either agent with the factor of cost significantly reduced or eliminated altogether.


Revlimid's IP future looks a little more certain

As the dust settles on Bristol-Myers Squibb's planned acquisition of Celgene - a deal expected to be finalised in the third quarter  an important hurdle was passed this week when generics manufacturer Dr Reddy's Laboratories failed in its attempt to initiate a process to overturn three dosing patents for Celgene's flagship oncology drug Revlimid.

Other patents are being challenged, though analysts were quick to note that this week's decision by the Patent Trial and Appeal Board (PTAB) was an important one if Revlimid is to retain US market exclusivity through to 2022.

Launch of generic Revlimid prior to this would raise significant questions about Bristol-Myers Squibb's rationale for acquiring Celgene, not to mention put management under greater pressure to deliver late-stage products from the pipeline to market.

See also - Alvogen launches first generic version of Celgene's Revlimid in certain European markets

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