Icelandic billionare’s biosimilar company raises $450M, preps for Nasdaq launch with SPAC merger

As Ice­landic bil­lion­aire Róbert Wess­man tries to take down Ab­b­Vie’s megablock­buster Hu­mi­ra in court, he’s al­so tak­ing his biosim­i­lar up­start to the big time with a $2.25 bil­lion SPAC merg­er, Nas­daq launch and $450 mil­lion raise an­nounced ear­ly Tues­day.

While Wess­man’s Alvotech has not won FDA ap­proval for any of its biosim­i­lar can­di­dates yet, the com­pa­ny was the first to file with the FDA for ap­proval of its high-con­cen­tra­tion Hu­mi­ra biosim­i­lar and to have suc­cess­ful­ly con­duct­ed a switch­ing study in sup­port of a high­ly-cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion. But oth­er com­pa­nies like Am­gen, Boehringer In­gel­heim and Pfiz­er have since caught up ahead of the launch­es of their own Hu­mi­ra biosim­i­lar com­peti­tors in 2023.

‘So when those biosim­i­lar com­pa­nies en­ter in 2023, we ex­pect that on­ly 10% of Hu­mi­ra sales in the US – around 15 to 16 bil­lion, on­ly 10% will be [the low­er con­cen­tra­tion] 50 mg. We, on the oth­er hand, were the first to get fil­ing ac­cep­tance [with the FDA] of the high­er con­cen­tra­tion, so we can fo­cus on 90% of the mar­ket when we come out,’ Wess­man pre­vi­ous­ly told End­points News.

But the high­er con­cen­tra­tion ver­sion of a Hu­mi­ra biosim­i­lar may be a moot point, as BI said in a re­cent cit­i­zen pe­ti­tion to FDA that the agency has yet to weigh in on:

In Boehringer In­gel­heim’s view, these biosim­i­lar prod­ucts, in­clud­ing Cyl­te­zo, should be con­sid­ered to have the same ‘strength’ as the cor­re­spond­ing OC [orig­i­nal con­cen­tra­tion] and HC [high­er con­cen­tra­tion] ver­sions of Hu­mi­ra be­cause they con­tain the same to­tal drug con­tent per con­tain­er (e.g., 40 mg), re­gard­less of the vol­ume of ex­cip­i­ents.

What’s more, if Alvotech proves to be suc­cess­ful in de­feat­ing Ab­b­Vie in court, Ab­b­Vie CEO Rick Gon­za­lez said re­cent­ly in an earn­ings call that al­though he thinks such an out­come is doubt­ful, all of the oth­er FDA-ap­proved Hu­mi­ra biosim­i­lars would come to mar­ket too along­side Alvotech’s biosim­i­lar, po­ten­tial­ly in late 2022.

Mean­while, Alvotech’s pipeline al­so in­cludes biosim­i­lar can­di­dates to Ste­lara (ustek­inum­ab), Eylea (afliber­cept), Pro­lia/Xge­va (deno­sum­ab) and Sim­poni/Sim­poni ARIA (goli­mum­ab).

And Alvotech’s part­ners, in­clud­ing Te­va in the US and Sta­da in the EU, have li­censed prod­ucts in ex­change for mile­stone pay­ments and roy­al­ties. As of June 30,  Alvotech said it had re­ceived li­cense fee com­mit­ments of up to $1.15 bil­lion un­der these part­ner­ships, ap­prox­i­mate­ly 80% of which are still to be col­lect­ed.

‘Alvotech has built a high­ly at­trac­tive plat­form with a long-term view to lead the biosim­i­lars mar­ket,’ said Zaid Parde­si, man­ag­ing di­rec­tor at Oak­tree and CFO of Oak­tree Ac­qui­si­tion Corp II, which is work­ing with Alvotech on the SPAC merg­er. ‘The Com­pa­ny’s di­verse pipeline and unique ca­pa­bil­i­ties, in com­bi­na­tion with its world-class dis­tri­b­u­tion part­ners, set the stage for mean­ing­ful val­ue cre­ation and ac­cel­er­at­ed growth go­ing for­ward.’

As part of the SPAC, Alvotech is ex­pect­ed to get $450 mil­lion in cash — $250 mil­lion from the SPAC’s trust, $150 mil­lion from a PIPE fi­nanc­ing and a $50 mil­lion eq­ui­ty com­mit­ment. The merg­er is ex­pect­ed to close in the first half of 2022.
https://endpts.com/icelandic-billionares-biosimilar-company-raises-450m-preps-for-nasdaq-launch-with-spac-merger/