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ImmuPharma's US licensing deal provides a path to commercialisation for flagship lupus drug


  • Developer of a promising treatment called Lupuzor, for the autoimmune disease lupus

  • Signed a licensing deal with a US firm worth US$95mln in milestone payments and carried costs

  • Successful completion of a phase III trial should pave the way for commercialisation

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Quick facts: ImmuPharma PLC

Price: 15 GBX

Market: AIM
Market Cap: £25.1 m

This makes it a perfect fit for Lupuzor

Boss Dimitri Dimitriou said of the company's deal with Avion Pharmaceuticals

What it does

ImmuPharma PLC (LON:IMM) is the developer of Lupuzor, a treatment for the autoimmune disease lupus.

Lupus is what’s called a systemic autoimmune disease that occurs when the body's immune system attacks its own tissues and organs.

Inflammation caused by lupus can affect many different systems, including joints, skin, kidneys, blood cells, brain, heart and lungs.

While, thankfully, it is rare, Lupus’ symptoms are painful and sometimes fatal.

The condition is poorly treated with only one bespoke drug for the condition – Benlysta, developed by GlaxoSmithKline. AstraZeneca is expected to add a second medication when it brings anifrolumab to the market next year.


Major inflexion point

Shares in the group exploded into life on November 28, surging 300% at one point, after ImmuPharma said it had inked a deal with US group Avion Pharmaceuticals.

The latter will fund the US$25mln costs of a reformatted phase III clinical trial next year following agreement of the trial design with the US Food & Drug Administration.

The UK group will receive up to US$70mln of milestone payments, with US$5mln due on regulatory approval of the product and a further US$65mln dependent on sales targets.

ImmuPharma will also get royalties of up to 17% on sales, while there are financial incentives to expand Lupuzor’s use into other autoimmune diseases.


What the boss says: chief executive Dimitri Dimitriou

"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.

"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."


How it is doing

The Avion deal has effectively vindicated management’s faith in the drug, which missed its primary endpoint in a phase III study last year.

Experts and those who had followed ImmuPharma for some time said the outcome of the phase III was far more nuanced than the top-line results suggested and showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the trial, 62 patients took part in a follow-up study – called an open-label extension study.

Results released in July confirmed Lupuzor’s “outstanding and robust safety profile”, with no serious adverse events reported.

On top of that, ImmuPharma was also able to show a third of the patients taking the drug were in remission at the end of the assessment.

Losses in the six months to June were £3.9mln (£4.1mln), with cash at the period-end of £2.3mln.




What the analysts say

In a note released in December, research house Life Sciences Division said:

"We now see Lupuzor as having the ability to generate blockbuster sales in the US (US$1bn+) alone (previously US and EU combined) – which when coupled with a royalty stream of up to 17% on revenues, could see an annual royalty to ImmuPharma’s bottom line of US$170m per year."

"What is particularly impressive about this deal is not only ImmuPharma’s ability to identify and execute a new licensing partner for Lupuzor but also the opportunity available for ImmuPharma to find new distribution and marketing partners outside the US for Lupuzor, for e.g. in Europe, where a new trial would not even be required given Avion’s funding commitment."


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ImmuPharma: Analyst discusses 'impressive and potentially blockbuster' ...

The Life Sciences Division's Navid Malik gives his view on the recent recent deal ImmuPharma PLC (LON:IMM) struck with US speciality drugs group Avion Pharmaceuticals. Malik reckons its lupus candidate Lupuzor could become a 'US blockbuster' by generating over US$1bn revenues per year.

on 16/12/19

3 min read