ImmuPharma shares soar as it teams up with Avion on Lupuzor

Specialist drug discovery and development company ImmuPharma announced a licence and development agreement with Avion Pharmaceuticals on Thursday, for the exclusive rights to ‘Lupuzor’ in the United States.

The AIM-traded firm described Lupuzor as its lead compound - a peptide therapeutic and a first-in class autophagy immunomodulator for systemic lupus erythematosus, which is a potentially life-threatening auto-immune disease.

In addition, it said Lupuzor also had the potential for treating other auto-immune diseases other than lupus.

A trademark licence agreement had also been signed, to allow Avion the use of various trademarks in connection with development, manufacture and commercialisation of products under the licence and development agreement.

Under the agreements, Avion and ImmuPharma would co-develop Lupuzor to allow registration for marketing in the US, Europe and elsewhere.

Avion would commercialise Lupuzor exclusively for the US, and ImmuPharma would retain all the rights to commercialise Lupuzor outside of the US, either through distribution partnerships or directly.

A new, optimised international phase 3 trial in lupus patients, which was expected to include patients in the US, Europe and elsewhere, was expected to start in 2020, following agreement of the trial design between Avion, ImmuPharma and the US Food & Drug Administration.

Avion would fund the full expected costs of the new phase 3 trial, up to $25m.

ImmuPharma said it would receive milestone payments of up to $70m, with a $5m milestone payment to be paid on regulatory approval of Lupuzor in lupus, and $65m to be based on achievement of overall sales targets.

It said it would also receive $5m for each additional approval, other than lupus, as Avion also had the rights in the US to explore further opportunities within Lupuzor's peptide platform, for other auto-immune indications.

ImmuPharma would receive tiered double-digit royalties from Avion of up to 17 percent, according to pre-specified annual US sales targets.

Avion had the right to use relevant trademarks for the development, manufacture and commercialisation of products, the company confirmed.

“We are delighted to be entering into this partnership with Avion, a company which has a strong track record within late stage clinical development and commercialisation of products within the US, the largest market for lupus patients,” said ImmuPharma’s chief executive officer Dimitri Dimitriou and president and chief scientific officer Robert Zimmer in a joint statement.

“Importantly, Avion's specialist sales team is well respected within the rheumatologist community, whose focus is on prescribing safe and efficacious treatments for auto-immune diseases such as lupus - this makes it a perfect fit for Lupuzor.

“We look forward to a long and successful relationship with the Avion team and look forward to sharing updates on progress with shareholders over the next period.”

Art Deas, chief executive officer of Avion Pharmaceuticals, added that Avion is “extremely pleased” to sign the partnership with ImmuPharma.

“After in-depth due-diligence around Lupuzor, its mechanism of action and learnings within the initial phase 3 results, we believe that Lupuzor has a unique position within lupus that sets it apart from competition, and we are delighted to be extending our footprint within this therapeutic area.

“With approximately 1.5 million patients in the US suffering from lupus, there is a significant unmet need for a safe and effective drug for this debilitating disease that we believe Lupuzor can meet.

“We look forward to forging a strong and successful relationship with ImmuPharma going forward.”

At 1624 GMT, shares in ImmuPharma were up 328.37% at 30.2p.