Amryt Pharma (AMYT)  said it has received reimbursement approval in France from the French Ministry of Social Affairs and Health for its Myalepta® (metreleptin) product.

Myalepta® (metreleptin), is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body (leptin deficiency).

It targets congenital or acquired general lipodystrophy (GL) in both adults and children of 2 and above and familial or acquired partial lipodystrophy (PL) in adults and children of 12 and above for whom standard treatments have failed to achieve adequate metabolic control.

Generalised and partial lipodystrophy are rare disorders which result in loss or lack of adipose tissue resulting in the deficiency of the hormone leptin. These disorders are associated with severe metabolic abnormalities including severe insulin resistance and hypertriglyceridemia.

Amryt outlined how Myalepta® had received marketing authorisation from the European Medicines Agency (“EMA”) back in 2018. Meanwhile, the French Haute Autorité de Santé (“HAS”) gave a favorable opinion for reimbursement in the same indications as today in 2019.

“We are very pleased to report the French Ministry of Social Affairs and Health’s approval of Myalepta® which will now give all French patients suffering from lipodystrophy the opportunity to access Myalepta®,” commented Dr Joe Wiley, CEO of Amryt Pharma.

He added that, “Today’s news represents further progress in our efforts to grow the geographic reach of our commercial products in both existing and new territories.”

Today represents another territorial win for AMYT as it expands the reach of its portfolio of products into both existing and new territories. Earlier this month, the group signed a distribution agreement with Medison Pharma Canada to distribute Myalepta® in Canada.

Shares in Amryt Pharma have increased by over 15% in value since the beginning of the year. The stock was trading 1.00% higher this morning at 220.18p following the news.

Reasons to Follow AMYT

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Leading Portfolio

AMYT’s portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  

Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.

The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.    

Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.  

In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.  

Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.  

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®.

Expanding Distribution Capacity

Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.  

The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.  

In recent weeks, Amryt received approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales, to treat partial and generalised lipodystrophy in adults and children 12+ years of age.

Positive Outlook

Last week, the Company released ‘record’ results for FY20 which it said were demonstrative of ‘the very positive performance and growth’ that its commercial products are delivering.  

Amryt is well positioned in the novel therapeutics market and strong momentum achieved in the year to date has prompted management to upgrade its guidance for FY20. “Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY21 of $200-$205m which demonstrates our confidence in our prospects,” Wiley told investors.
 
The Group said both metreleptin and lomitapide continue to deliver growth ‘across a host of metrics’ including revenue and EBITDA growth, cash generation and market expansion.   

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