On the US approvals front a quiet June is about to give way to an even quieter July. But the fact that 2019 has, so far, been a relatively slow year for the FDA will not bother Karyopharm if it can get the nod for its lead candidate, selinexor.
The project is due a decision in multiple myeloma by July 6, a three-month delay to its original PDUFA date, and approval is far from assured. Assets from Merck & Co and Shield Therapeutics are also in line for consideration, while Celgene’s Otezla could get a thumbs-up in a new indication, Behçet’s disease, as Bristol-Myers Squibb looks for a buyer for the product.
The FTC said this week that Bristol would have to sell the psoriasis drug for its purchase of Celgene to go through; investors reacted by knocking nearly $6bn off Bristol’s market cap.
Approval in Behçet's is unlikely to make much difference to Bristol’s negotiations: the inflammatory condition is rare in the US and Europe. Celgene previously said it would also seek a supplemental approval for Otezla in moderate to severe scalp psoriasis in the second quarter.
Take two for selinexor
Meanwhile, Karyopharm’s investors face a nervous wait over selinexor, which is awaiting a decision in relapsed/refractory multiple myeloma patients who have received at least three prior therapies. The company’s share price plunged in February after an FDA advisory panel recommended delaying approval until readout of the Boston trial in earlier-line patients.
The subsequent delay gave investors hope that accelerated approval could still be within reach, with analysts speculating that the company had submitted some of the Boston data to the agency early (Karyopharm’s selinexor delay could speed approval, March 15, 2019).
There are concerns about toxicity with selinexor, but the very sick population that Karyopharm is initially targeting could work in the company’s favour. Still, even if it is approved it might remain a last-ditch option, and moving into earlier lines of therapy could be another story. In February, EvaluatePharma sellside consensus put 2024 selinexor sales at $1.2bn; expectations have now dropped to $370m.
|Notable first-time US approval decisions due in July|
|Project||Company||PDUFA date||Product NPV ($m)|
|MK-7655A||Merck & Co||Jul 16||
|Feraccru||Shield Therapeutics||Jul 27||96|
Merck & Co is set to hear by mid-July on its latest antibacterial, a combination of relebactam, imipenem and cilastatin known as MK-7655A. The project is due a verdict in complicated urinary tract and intra-abdominal infections caused by certain Gram-negative bacteria in adults with limited or no alternative therapies.
Merck recently bagged approval for Zerbaxa, another antibacterial combination product, in the new use of pneumonia. Although there is a big need for new antibiotics, the market for such products is far from lucrative.
Meanwhile, a positive decision on the oral iron supplement Ferracru would give its originator, Shield Therapeutics, a big boost. The product is already available in Europe for the treatment of iron deficiency in patients with or without anaemia.
Finncap analysts expect Ferracru to get the US nod for iron deficiency anaemia, but noted that a general iron deficiency label would double the addressable market.
Shield’s future had looked dim after the failure of the Aegis-CKD trial in early 2018, but the UK company later carried out a new analysis, with better results. Earlier this year, the Aegis-H2H trial found that Ferracru was non-inferior to injectable iron. Shield will have to hope that this data package will be enough to convince the FDA.
Another project that could be due a nod is Samsung Bioepsis’s Humira biosimilar Imraldi, which was accepted for review by the FDA in September. Three other Humira biosimilars have US approval – Amgen’s Amjevita, Novartis’s Hyrimoz and Boehringer’s Cyltezo – although Humira’s maker, Abbvie, has agreements with most of their manufacturers to keep them off the market until 2023.
|Supplementary and other notable approval decisions due in July|
|Otezla||Celgene||sNDA for Behçet's disease||Jul 21|
|Imraldi||Samsung Bioepis||Humira biosimilar; FDA accepted filing in Sep 2018||Possibly July|