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Amryt in 'good position' to drive further expansion this year and beyond

Last updated: 11:03 15 Mar 2018 GMT, First published: 08:03 15 Mar 2018 GMT

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Shore Capital said a further de-risking of the pivotal trial design was worth a modest delay in timings

Amryt Pharma PLC (LON:AMYT) has licensed a non-viral gene therapy platform technology with potential applicability across a range of genetic diseases, including epidermolysis-bullosa (EB).

The technology has been licensed from University College Dublin and involves the delivery of gene therapy using high branched poly (β-amino ester) polymer technology. 

READ: Amryt Pharma signs fifth distribution deal in three months, appoints new head of Europe

The initial focus of development efforts to date has been in the area of EB and preliminary data suggest that the treatment could be potentially disease-modifying for patients with recessive dystrophic epidermolysis bullosa (RDEB).

Amryt intends to conduct various pre-clinical studies, funded from existing resources, in the coming months and will report the initial results in the final quarter of this year.

Joe Wiley, Amryt’s chief executive officer, said the licensing agreement represented a great opportunity for Amryt to get involved in the area of gene therapy.

“The HPAE [high branched poly (β-amino ester)] polymer technology gives us a potential platform technology, with an initial topical application in EB that does not rely on the use of viral vectors for the delivery of gene therapy. If successful, this platform has the potential to be broadly applicable in other dermatological conditions and possibly beyond,” Wiley said.

The licensing announcement coincided with the release of a trading update from the biopharmaceutical company, which revealed revenues for 2017 shot up to €12.8mln from €1.48mln in 2016

Amryt secures fifth distributor deal for Loujxta

Revenues from Lojuxta (lomitapide), which treats a rare life-threatening disorder that causes abnormally high levels of "bad" cholesterol, increased to €11.9mln in 2017; Amryt said the growth in revenues from Lojuxta was 65% higher than annualised revenues achieved before Amryt licensed the product in December 2016.

WATCH: Amryt Pharma signs 'major' licensing deal for gene therapy asset

Since November 2017, Amryt has agreed five new distributor relationships, which together cover seventeen new countries, for Lojuxta.

The company is actively negotiating national reimbursement decisions in the UK, France, Spain and Turkey, which it is hoping will materialise during the course of 2018. If successful, these market-access decisions will allow Amryt to provide access for a cohort of patients suffering from the life-threatening disease homozygous familial hypercholesterolaemia in each of these territories.

The cash balance at the end of 2017 was around €20.5mln.

Encouraging start to 2018

"2017 was a very strong year for Amryt and we are encouraged by the start to 2018, which places us in a good position to be able to drive further expansion through this year and beyond,” said Wiley.

“In EB, Amicus Therapeutics generously provided us with a valuable opportunity to review the data from their ESSENCE study in EB. Based on these data, Amryt now has the opportunity to refine its ongoing global Phase III EASE study of AP101 in EB, with the potential to increase the probability of success for the study. We are truly grateful to Amicus Therapeutics for the opportunity, which is a heartening example of collaboration in our industry in the best interests of patients,” Wiley said.

"We have ambitious plans for the remainder of 2018 and we look forward to announcing a series of agreements in the months to come. This is a pivotal year for Amryt and our focus continues to be on ensuring that we are delivering real change for people with rare diseases across the world. I am proud to say we are delivering on our promise," he added.

Wiley said the company would continue to seek to license further commercial stage assets to continue to grow its revenues.

Amryt a 'compelling investment opportunity', says ShoreCap

Amryt's nominated adviser, Shore Capital, said: "We note the updates to the pivotal trial, (including an increase in study size by c.28 patients, and more stringent patient selection criteria) were informed in the context of detailed access to data from Amicus’s P3 ESSENCE study in EB."

"We acknowledge the magnanimous gesture on the behalf of Amicus, with such privileged data sharing allowing Amryt the unique ability to update its trial design to better the chance of success in its pivotal study. Hence taken together we see this morning’s announcement as net positive, with the further de-risking of the pivotal trial design as justification for a modest delay in timings," the broker added.

"We continue to see Amryt as a compelling investment opportunity to gain exposure to a diversified Rare Disease platform with an attractive mix of clinical and commercialisation stage assets, and access to a potentially transformative gene therapy platform," it concluded.

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