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ImmuPharma’s flagship lupus drug to be made available to patients ahead of regulatory filing

Normally, patients have to wait until regulators have approved a drug before they get access to it, but up to 500 lupus sufferers will receive Lupuzor as part of a Managed Access Programme
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ImmuPharma is planning to divest its Ureka diabetes subsidiary

Some lupus patients will soon have access to a potentially “ground-breaking” new treatment after Immupharma PLC (LON:IMM) signed an agreement which will see it press ahead with a managed access programme (MAP).

The deal with a specialist provider will allow up to 500 sufferers ongoing access to Immupharma’s flagship drug, Lupuzor, for a minimum of two years.

In addition to helping patients, the AIM-quoted drug developer expects to collect more valuable data on Lupuzor, which will be useful if and when it decides to press ahead with regulatory filings.

WATCH: ImmuPharma firmly committed to Lupuzor ahead of managed access programme

Earlier this year, the drug missed its primary endpoint in a late-stage study, but the outcome was more nuanced than the top line results suggested and actually showed that Lupuzor worked well in certain patients, chiefly those who were antibody-positive.

After the end of the phase III trial, 62 patients took part in a ‘follow-up’ study – called an open-label extension study. Results from this are expected in the second quarter of 2019.

READ: ImmuPharma says pre-clinical study points to other indications for Lupuzor

“The board has been focused on delivering a business strategy which provides the optimum route forward for ImmuPharma and its shareholders, based on its current assets, resources and know-how,” said chairman Tim McCarthy.

“We are excited as a team to be progressing the MAP programme which allows Lupus patients early access to Lupuzor.

“In the medium term, we remain focused on achieving the full regulatory approval of Lupuzor which we believe has the potential to be a ground-breaking drug for Lupus patients and in turn has blockbuster potential in commercial terms.”

Nucant cancer programme making progress

Lupuzor isn’t ImmuPharma’s only drug going through the clinic. Its Nucant cancer treatment has yielded “promising results” in two phase I safety and dose-finding studies.

The company has signed heads of terms on a clinical development collaboration with oncology specialist Incanthera, in which ImmuPharma has taken a £2mln stake.

A licence agreement between the two is expected to be signed by the end of the year, a deal which is likely to see Incanthera pay an upfront licence fee of £1mln in shares and cover all of the development costs for the Nucant programme.

All future commercialisation revenues will be shared equally, ImmuPharma said.

Ureka to be divested

As for the firm’s Ureka subsidiary, which is looking to develop treatments for type II diabetes and NASH, the decision has been made to sell it.

Despite having “exciting and innovative technologies”, the board does not see as part of the long-term strategy.

As a result, the plan is to divest the Bordeaux-based subsidiary whilst still retaining an interest should any of its drugs achieve some commercial success further down the line.

“Our Nucant programme and Ureka subsidiary have been part of our portfolio for a number of years,” added McCarthy.

“We are equally excited by the potential of both. We believe the strategy we have announced today for both, will create enhanced value for shareholders going forward.”

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