Welcome to your weekly digest of approaching regulatory and clinical readouts. Coming up for Galapagos are phase II data this quarter with GLPG2737, a channel corrector for cystic fibrosis that also forms part of the company’s triple combination therapy, a phase I trial of which will report in the third quarter.
Meanwhile, Amgen’s Kanjinti is up before the FDA by May 28. This could be the second Herceptin biosimilar approved in the US and is a valuable pipeline product for the company, but launch is not expected until next year when a number of other biosimilar versions could also be on the market.
Looking to the triple
Galapagos expects data from its phase II Pelican trial, in 22 cystic fibrosis patients homozygous for the F508del mutation, in the second quarter. The German trial tests the company’s CFTR corrector GLPG2737, given twice daily, plus Orkambi versus placebo and Orkambi.
The primary measure is change in sweat chloride at day 28. Change in FEV
Perhaps most importantly, Pelican will provide a first look at the efficacy of one of the components of the group's triplet – the ultimate treatment goal is a combination of one potentiator and two correctors to treat 90% of cystic fibrosis patients.
The company’s first triplet study, the Falcon, last month started testing GLPG2737 in combination with a second corrector, GLPG2222, and a potentiator, GLPG2451.
Data are due in the third quarter from part 1 of Falcon, involving treating eight F508del homozygous patients with a fixed-dose combination of ‘2222 and ‘2451 for two weeks, followed by two weeks of the triplet.
The second part will report either this year or early in 2019, testing two separate eight-patient cohorts of F508del homozygous and F508del/min patients. A higher-dose dual combination of ‘2222 and ‘2451 will be given for two weeks, followed by two weeks of triplet.
The open-label trial is being conducted initially in the UK with expansion to other European countries. The primary endpoints are safety, tolerability and PK while secondary outcomes include efficacy measures such as sweat chloride and FEV
Safety will be a hot topic in Falcon as ‘2451 has a half-life of around one month, leading to concerns about toxicity. Galapagos and its partner Abbvie are lagging at least two years behind the market leader, Vertex, whose two triplet combinations started phase III last month..
|Biggest selling cystic fibrosis products in 2024|
|Global indication sales ($m)|
|Product||Company||Mechanism of action||2018e||2024e||Status|
|VX-659 + tezacaftor + ivacaftor||Vertex||Two CFTR correctors and one potentiator||-||3,485||Phase III|
|Symdeko||Vertex||One CFTR corrector (tezacaftor) and one potentiator (ivacaftor)||308||1,772||Marketed|
|Pulmozyme||Roche||DNase 1 stimulant||784||801||Marketed|
|Orkambi||Vertex||One CFTR potentiator (ivacaftor) and one corrector (lumacaftor)||1,482||644||Marketed|
Amgen’s ABP 980, now known as Kanjinti, will get a US approval decision by Monday. In March the product, a biosimilar of Roche’s Herceptin, gained a positive EU CHMP opinion in March to treat Her2-positive metastatic breast cancer, Her2-positive early breast cancer and Her2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
In Europe Herceptin’s patents have already expired, but in the US the drug's so-called Cabilly patents hold until December, with manufacturers litigating over several others that stretch into 2019.
Mylan and Biocon’s Ogivri became the first Herceptin biosimilar to gain the US green light at the end of last year. Analysts do not expect launch until the first half of 2019. Mylan settled patent litigation with Roche last year, though details of cost or when or where Ogivri might be launched remain undisclosed.
Kanjinti is Amgen’s third-most valuable pipeline asset, with an NPV of $1.9bn (Biosimilar knockbacks expose increasing big pharma focus, May 3, 2018). Allergan has worldwide royalties.
Pfizer, Merck & Co, and Celltrion and Teva, are also vying for a share of the US Herceptin biosimilar market, which in 2019 could get very crowded indeed.
|Herceptin and its main challengers|
|Global sales ($m)|
|Product||Company||US status||EU status||2018e||2024e|
|Herzuma||Celltrion (WW)/Teva (US & Canada)||CRL Apr 2018||Approved Feb 2018||66||497|
|PF-05280014||Pfizer||CRL Apr 2018||Filed Jul 2017||-||426|
|Kanjinti||Amgen/Allergan (royalties)||PDUFA date May 28||Positive CHMP opinion Mar 2018||36||334|
|Ontruzant||Merck & Co/Samsung Bioepis (royalties)||Filed Dec 2017||Approved and launched Mar 2018||18||299|
|Ogivri/Canmab||Mylan/Biocon||Approved Dec 2017, launch H1 2019?||Filed Nov 2017||34||284|
|CRL: complete response letter. Source: EvaluatePharma.|
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