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Baricitinib delay casts a pall over Lilly's results update

FDA requests further data that could keep the drug off the market for a couple of years

Eli Lilly

Eli Lilly is facing a lengthy delay in the US approval of its would-be arthritis blockbuster baricitinib, news which cast a shadow over the company's second quarter results announcement.

The company confirmed in April that the FDA had issued a complete response letter (CRL) rejecting baricitinib - which is already on sale in some markets including the EU as Olumiant - but at the time the depth of the US regulator's reservations about the drug were not apparent.

Now it is clear that the FDA is very concerned about the safety of the Incyte-developed JAK inhibitor, particularly with regard to thromboembolic events seen in phase II and phase III trials, and is asking for additional data that could keep the drug off the market for at least a couple of years and potentially even more.

That dashes any hope that Lilly will catch up with Pfizer and its Xeljanz (tofacitinib) JAK inhibitor - already on the brink of blockbuster status - and makes it quite possible that baricitinib will be beaten to market by other rivals such as Gilead Sciences' filgotinib and AbbVie's upadacitinib (ABT-494). Analysts at Jefferies suggested the thromboembolic risks could "impair the future commercial value of the product".

It's the latest in a series of pipeline knock-backs for the drugmaker - including sailed trials for breast cancer drug abemaciclib and Alzheimer's candidate solanezumab - that have extended its reliance on older products such as Trulicity (dulaglutide) for diabetes and cancer drug Cyramza (ramucirumab).

Despite healthy growth - respectively 139% to $480m and 27% to $186m - in the second quarter, Trulicity and Cyramza are facing increasing competition in the market, with the latter benefiting from a price rise. Also entering a competitive sector was Lilly's new psoriasis drug Taltz (ixekizumab), which nevertheless rocketed to almost $140m in the quarter, while diabetes drug Jardiance (empagliflozin) showed signs of benefiting from new outcomes data with a 157% rise to $103m.

All told, Lilly's group revenues rose 8% to $5.82bn, but the company has trimmed back its full-year forecasts to $21.8bn-$22.3bn from $22.0bn to $22.5bn.

R&D revamp

The other big news from the US pharma group includes a big restructuring of its cancer R&D, which will now be rearranged around seven key pipeline drugs - including abemaciclib, a PD-L1-targeting antibody, a PI3K/mTOR dual inhibitor and a small-molecule CHK1 inhibitor prexasertib.

Meanwhile seven others have been put up for sale or partnering, including galunisertib, a small molecule inhibitor of TGF beta R1 kinase, and p38 MAP kinase inhibitor ralimetinib. The full list is available here.

Article by
Phil Taylor

26th July 2017

From: Sales

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