Isotechnika buoyed by deal with Vifor for voclosporin in lupus
04 January 2012
By Eleanor Malone
Isotechnika's share price rose by 12.5% to Can$ 0.135 after the Canadian firm announced that it had
licensed out its lead drug for a secondary indication. Vifor Pharma, the speciality pharma business of
Swiss firm Galenica, has acquired rights to voclosporin for lupus and all proteinuric nephrology indications;
Isotechnika is developing it primarily for the prevention of kidney transplant rejection.
The details of the deal are confidential, but Isotechnika said that upfront and milestone payments would be
significant, and that it would receive royalties on sales. It will also sell voclosporin capsules to Vifor, which
currently focuses on iron replacement products for iron deficiency but also has been examining the
potential use in lupus nephritis of Roche's immunosuppressant CellCept (mycophenolate mofetil), for
which it holds the autoimmune disease rights through its 2007 acquisition of Aspreva.
Vifor obtains rights worldwide including the US and EU but excluding Canada, South Africa, Israel, China,
Taiwan and Hong Kong. In order to facilitate this, ILJIN Life Science Co, which had held rights to
autoimmune indications in the US, has licensed back to Isotechnika the relevant territorial rights for the
indications in the Vifor deal. ILJIN, a subsidiary of the South Korean industrial group ILJIN Holdings,
obtained US and other rights to voclosporin in January last year under a staggered licensing deal involving
a commitment from Isotechnika to advance Phase III trials in kidney transplant rejection and from ILJIN to
provide an upfront licensing payment and subsequently purchase stock in fixed tranches, starting this
month.
Vifor told Scrip that voclosporin's safety profile had been well established and that: "The prudent strategy
will be to execute a Phase II dose-finding study in lupus nephritis patients."
Voclosporin is a calcineurin inhibitor, in common with the currently marketed organ transplant rejection
therapies ciclosporin (Novartis's Sandimmune/Neoral and generic versions) and tacrolimus (Astellas's
Prograf/Advagraf and generic versions). It is derived from ciclosporin but designed to minimise the safety
and side-effect issues including headache, nausea, diarrhoea, high blood pressure, tremors and kidney
toxicity associated with both ciclosporin and the more potent tacrolimus.
The company notes that in Phase II trials in prevention of kidney transplant rejection, voclosporin has
been shown to have a wider therapeutic window and lower incidence of new onset diabetes after
transplantation (NODAT) than tacrolimus. Isotechnika is now preparing for Phase III trials in 600 new
kidney transplant patients in North American and Europe with data expected in the first half of 2015.
The deal with Vifor provides a welcome boost to Isotechnika, which saw its partner Lux Biosciences
withdraw a European marketing approval application for Luveniq, a version of voclosporin to treat chronic
non-infectious uveitis, following a negative opinion from the EMA last year. Lux was already conducting
additional clinical trials in the indication to meet questions raised in an FDA complete response letter in
2010.
In 2009 the drug met its primary endpoint versus placebo in a Phase III trial in psoriasis, but failed to show
non-inferiority to ciclosporin, a secondary endpoint. Roche decided not to exercise an option at that point,
leaving Isotechnika with the autoimmune rights but insufficient funding for further development in the
indication.
Although Roche/Aspreva's Phase III study of CellCept in lupus nephritis failed in 2007 to meet its primary
endpoint in a Phase III induction therapy trial, last November results of a Vifor-funded Phase III trial in
maintenance therapy were published in the
New England Journal of Medicine, showing that it met its primary endpoint of superiority over azathioprine
in delaying treatment failure in patients with lupus nephritis. Vifor said the new deal with Isotechnika would
have no impact on its agreement with Roche, although "current clinical planning assumptions for
voclosporin are likely to further establish CellCept as the standard of care treatment for patients suffering
from lupus nephritis".