Adienne plans Swiss IPO to fund pivotal GvHD trial and advance orphan drug pipeline

Adienne Pharma & Biotech is planning to list its shares in Switzerland. The orphan drug specialist is seeking the cash injection to push its graft-versus-host disease (GvHD) drug over the regulatory finish line, and advance programs against Gaucher’s disease, mantle cell lymphoma and typical hemolytic uremic syndrome.

Lugano, Switzerland-based Adienne is yet to say how much money it hopes to raise, but has officially indicated its desire to go public in a statement. The IPO plan marks a notable evolution in Adienne, which, despite being more than a decade old, is still mostly owned by a company controlled by the husband-and-wife team who serve as CEO and chief human resources officer of the Swiss orphan drug player.

The CEO, Antonio Franceso Di Naro, plans to “retain a clear majority stake” in Adienne following the IPO, but needs to bring on outside financing to support the business’ growth plans. Having won European approval for hematopoietic progenitor cell transplant conditioning treatment Tepadina in 2010--and gained clearance to temporarily import into the U.S. to fix a shortage in 2013--Adienne describes itself as “historically profitable,” but now faces rising R&D costs.

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Adienne’s main focus is a Phase II/III trial of CD26-targeting monoclonal antibody Begelomab in patients with steroid-resistant GvHD. The trial is comparing the overall response rate and transplant-related mortality among subjects who receive either begelomab or a conventional second-line treatment. Adienne expects to have results from the 184-person trial in 2018, at which time it will assess whether the data are good enough to support approvals on both sides of the Atlantic.

Preparations for those hoped-for approvals will swallow up some of the anticipated IPO haul.

“The proceeds from the planned IPO would further support ... the scale up the group's manufacturing, our commercialization capabilities ahead of the launch of begelomab and the other trials of our clinical and preclinical development programs,” Di Naro said in a statement.

Those preclinical programs include drugs against Gaucher’s disease, mantle cell lymphoma and typical hemolytic uremic syndrome. Adienne is advancing an antibody against the uremic syndrome, a personalized vaccine for the rare lymphoma and a biosimilar enzyme replacement therapy (ERT) in Gaucher’s. Sanofi’s ($SNY) Genzyme, Shire ($SHPG) and Pfizer ($PFE) sell ERTs in the U.S..

If Adienne can round up the money to further its programs, it will continue the relative resurgence of biotech IPOs in Switzerland. After five years without a biotech IPO, the stock exchange listed Molecular Partners (SWX:MOLN) in 2014, and went on to add Cassiopea to its ranks of traded stocks last year. Given that the exchange has only featured three IPOs this year--and rarely hits double figures--the lack of new biotech listings is far from a sector-specific issue.

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