To eternity and beyond for Enbrel, maybe
Amgen won an unexpectedly clean victory in its legal skirmish over patents covering Enbrel (etanercept), potentially barring biosimilars such as Sandoz’s Erelzi (etanercept-szzs) from the market in the US until potentially 2029. The autoimmune blockbuster was given the green light by the FDA in 1998.
The Sandoz product was first approved by the FDA in 2016 but has yet to record any sales in the US while intellectual property battles have worn on. The situation has played out differently in Europe, where Erelzi and a second competitor are being commercialised, but the prospect of holding the door in the US for another decade has Amgen shareholders salivating.
Amgen shares jumped 11% in the days after the news was announced late on August 9, representing a boost in market cap of $13 billion.
Anti-IL-17 strikes again
Eli Lilly reported results from a head-to-head Phase IV trial this week demonstrating that its IL-17A inhibitor Taltz (ixekizumab) proved superior to Johnson & Johnson’s Tremfya (guselkumab) in achieving 100% clearance in moderate-to-severe plaque psoriasis patients after 12 weeks. The findings come on the heels of a recent survey of 200 dermatologists indicating that clinical data from comparative trials may hold the key to swaying prescribing patterns in highly competitive markets like psoriasis.
Much for I/O to fight for in bladder cancer
Roche recently revealed top-line Phase III IMvigor130 results showing that Tecentriq (atezolizumab) prolonged progression-free survival when added to chemotherapy in front-line urothelial carcinoma, simultaneously dispelling concerns about its utility in the setting raised by a confirmatory second-line study and possibly signalling the arrival of anti-PD-(L)1 mAbs as part of upfront treatment.
Several big question remain, however, including whether Tecentriq’s impact will be meaningful enough to convince physicians not to save immuno-oncology for patients who progress on chemotherapy. In addition, with results coming soon from a similar Phase III trial of Merck & Co.’s Keytruda (pembrolizumab) – the market leading PD-(L)1 agent in bladder cancer – the onus will be on Roche to make a case for its drug.
AstraZeneca’s PARP hot on heels of GSK
AstraZeneca and partner Merck & Co. reported encouraging Phase III results for Lynparza (olaparib) as front-line maintenance therapy in ovarian cancer this week, in a sense evening the score with Zejula (niraparib) from GlaxoSmithKline, which confirmed positive pivotal findings in a similar study last month.
The big question when detailed data are divulged, presumably later this year, will be whether and in whom the use of Roche’s Avastin (bevacizumab) will be appropriate. AstraZeneca/Merck’s PAOLA-1 trial compared Avastin with and without Lynparza, which the PRIMA trial evaluated GlaxoSmithKline’s Zejula versus placebo. More here.
Not the change of pace Nektar wanted
Nektar has been bedevilled lately by doubts about whether its bempegaldesleukin (formerly known as NKTR-214) is as effective an I/O complement as it initially appeared, so the company should have been relieved that a focus turned elsewhere this week.
Unfortunately attention instead turned to manufacturing inconsistencies that Nektar disclosed in its 2Q19 earnings announcement, which CEO Howard Robin acknowledged could have contributed to bempegaldesleukin’s poor performance in some patients. Specifically, the company found that complete responses were observed in 56% of melanoma patients receiving products from ‘optimal’ lots versus 18% in those treated with ‘suboptimal’ lots. A similar divergence was seen in renal cell carcinoma (RCC) and urothelial carcinoma studies.
The general consensus from the announcement was that Nektar might have had an easier job contending with poor response rates than it will with the new uncertainty over the quality of its manufacturing protocols. Accordingly, its share price plummeted about 30% post-earnings. More here.
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