Amryt Pharma (AMYT ) has confirmed reimbursement approval has been granted for its lipid lowering product Lojuxta® (lomitapide) in the Kingdom of Saudi Arabia by the Ministry of Health in the Kingdom of Saudi Arabia.

The biopharmaceutical group said Lojuxta® is now an adjunct to a low-fat diet and other lipid-lowering treatments with or without low density lipoprotein apheresis, a treatment similar to dialysis.

The intention of this product is to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolaemia (HoFH), a rare life-threatening condition characterised by markedly elevated circulating levels of low-density lipoprotein cholesterol and accelerated, premature atherosclerotic cardiovascular disease (ACVD).

“We are very pleased that the Ministry of Health in the Kingdom of Saudi Arabia has approved the reimbursement of Lojuxta® which will give Saudi patients suffering from HoFH the opportunity to access Lojuxta®,” said Dr Joe Wiley, Chief Executive of Amryt Pharma.

He added, “Today’s news represents further progress in our efforts to grow the geographic reach of our commercial products in both existing and new territories and to make Lojuxta® available to HoFH patients in need globally.”

Shares in Amryt Pharma have performed strongly over the past year increasing from 118p to 52 wk highs of 218p in October. The shares opened at 188p this morning at 189.50p following the announcement.

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®.

New Distribution Partner

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.  

Outlook

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 by around 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m. 

For more news and updates on Amryt Pharma: